2003 - Pontifical Academy for Life

ETHICS OF BIOMEDICAL RESEARCH IN A CHRISTIAN VISION
PROCEEDINGS OF THE NINTH ASSEMBLY OF THE PONTIFICAL ACADEMY FOR
LIFE
Vatican City, 24-26 February 2003
Edited by :
JUAN DE DIOS VIAL CORREA
ELIO SGRECCIA
LIBRERIA EDITRICE VATICANA
2004
Presentation (Prof. JUAN DE DIOS VIAL CORREA and H.E. Msgr ELIO SGRECCIA)
Discourse of the Holy Father JOHN PAUL II
INTRODUCTORY REPORTS
H.E. Msgr. JAVIER LOZANO BARRAGÁN, New paradigm: roots and proposals
Prof. VINCENZO CAPPELLETTI, Biomedicine in the twentieth century
STATEMENTS IN THE ROUND TABLE
""The Contemporary Frontiers of Biomedical Research at the Service of Man""
Prof. MÓNICA LÓPEZ BARAHONA, Some recent advances in molecular biology with a direct
impact on human life
Prof. ANGELO VESCOVI, Neural stem cells: functional stability, plasticity and therapeutic
potential
Prof. IGNAZIO MARINO, Ethics of biomedical research: for a christian approach
Prof. ANTONIO BATTRO, New frontiers in neuroeducation
1 SUBJECTS REPORTS
Prof. ADRIANO BOMPIANI, Experimental research in the field of biomedicine. Spheres, methods,
validity criteria for research projects
Prof. GONZALO HERRANZ, Some Christians contributions to the ethics of biomedical research: a
historical perspective
Prof. ADRIANO PESSINA, The relation between biomedical research, anthropology and ethical
philosophy. Notes for a methodological reflection
Prof. ROBERT SPAEMANN, Ars longa, vita brevis
Prof. WILLIAM MAY, Human dignity and biomedical research: the respective positions of the
subject of research and the researcher
Prof. DANIEL SERRÃO, Ethics of experimental research in humans: principles and guidelines
Prof. EUGENE DIAMOND, Conflicts of interest in medical ethics
Rev. Prof. ROBERTO COLOMBO, The vulnerable subjects of biomedical research: the case of the
human embryo
Prof. ANTONIO SPAGNOLO, Ethics research committees (ERCs): operational procedures and
quality of the ethical review
Prof. JUAN DE DIOS VIAL CORREA, Ethics of animal experimentation
Prof. ADRIANA LORETI-BEGHE’, International regulations and biomedical research:
contemporary advances and future prospects
Prof. PIERMARCO AROLDI, The involvement of the general public in biomedical research: the
role of the mass-media
H.E. Msgr. ELIO SGRECCIA, Policy in biomedical research: values and priorities
APPENDIX: FINAL DOCUMENTS
Final Communiqué
Proposal of an Ethical Commitment for Researchers in the Biomedical Field
2 JUAN DE DIOS VIAL CORREA,
ELIO SGRECCIA
PRESENTATION
The theme of the most recent annual Assembly of the Pontifical Academy for life: “Ethics of
Biomedical Research. A Christian View” (Vatican City, 24-26 February 2003) was characterized by
the sheer scale of the questions examined and the actuality of many of the problems posed.
The ethics of research concern, in particular, the whole process that the planned investigation entails:
the project’s objectives; the way it is funded; the ethics of experimentation, which involves many
problems in turn (risks, consent, method of enrolling patients, validity of the investigative programme,
objectivity of the controls, dissemination of the results); the technological or clinical implications of the
phase of application; the allocation of financial resources; the justification for any patents; and the
manufacture and sale of related drugs or therapeutic aids. Even experimentation on laboratory animals
is not devoid of ethical problems, which are now being taken into consideration with greater awareness.
Some particularly delicate questions concern not only the process of research as such, but the object or
subject of the experimentation: the embryo, the foetus, the woman at the age of fertility, the problems
deriving from assisted procreation, cloning, the use of stem cells, or those relating to experimentation
on primitive populations. These are problems that have already invested the judicial sphere and remain
controversial and hotly debated also in the international assemblies.
Another new phenomenon of recent times is the ever greater incidence that economic and financial
problems have on the development of research as a whole, including biomedical research. Innovative
scientific research, and the capacity to export its results and products, are proportioned to a country’s
level of economic development. Biomedical research is not exempt from this reality: the economically
more developed countries are those that have more advanced programmes of scientific research and a
higher level of medical assistance.
The work of the important conference, whose results are being presented here, preceded as usual by
preparation within a task force of experts, touched on a large part of these issues, without ignoring the
cultural context in which they are placed, current trends in research and the most advanced frontiers in
which research in the biological, neurological, medical and surgical research is now being conducted.
Specific issues such as those of research on the human embryo, experimentation on animals, and on
stem cells, were accompanied by, and examined in the light of, specifically bioethical, philosophic,
socio-political and legislative themes.
But there is a further feature that adds to the significance of the assembly and the value of the volume
that contains its Proceedings: at the end of the meeting, apart from the Conclusions that sum up the
various issues examined and ethical guidelines enunciated, an “Appeal to Researchers” was also issued.
It calls on researchers to add their signature to a demanding ethical pledge against which future
research could be evaluated and dialogue pursued. There has already been a significant response to this
appeal, also on the part of whole institutes.
This appeal echoes that of the Holy Father, included in his address to the participants: “I therefore
renew a heartfelt appeal that scientific and biomedical research, by avoiding any temptation to
manipulate the human person, may dedicate itself with commitment to exploring ways and resources
for the support of human life, the cure of diseases and the solution of the ever new problems in the
biomedical field” (L’Osservatore Romano, Monday-Tuesday, 24/25 February 2003).
3 This volume, therefore, marks a point of specific connotation of the Christian values in the field of
biomedical research. But it also reflects the course followed by the Pontifical Academy for Life, which,
as the Holy Father said in the same address, “should represent in the field of biomedical research a
point of reference and illumination not only for Catholic researchers, but also for all those who wish to
operate in this sector of biomedicine for the true good of every human being” (ibid.). That is an
invitation the Pontifical Academy for Life cannot ignore. It has the responsibility to accept it with
humility and spirit of service.
4 John Paul II
Address to the Members of the Pontifical Academy For Life
February, 24th 2003
Dear Members of the Pontifical Academy for Life,
1. The celebration of your Assembly gives me the joyful opportunity to greet you and to offer my
appreciation for the intense dedication which the Academy for Life shows for the study of new
problems, particularly in the field of bioethics.
I would like to say a special "thank you" to your President, Prof. Juan de Dios Vial Correa, for his kind
words of greeting and to your Vice-President, Bishop Elio Sgreccia, who is zealous and energetic in his
dedication to the task entrusted to him. I warmly greet the members of the Board of Governors and the
speakers for this significant meeting.
2. In the work of your Assembly, with a detailed programme offering complementary reflections, you
have wished to address the topic of biomedical research from the perspective of reason illumined by
faith. This perspective does not restrict the field of observation, but rather extends it, since the light of
Revelation comes to the aid of reason to offer a fuller understanding of what is intrinsic to human
dignity. Is it not the human being, as scientist, who promotes research? Often the human being is the
subject on whom the experiments are carried out. In every case, the results of biomedical research are
at the service of the human being.
It is a recognized fact that improvements in the medical treatment of disease primarily depend on
progress in research. In this way above all, medicine has been able to make a decisive contribution in
wiping out lethal epidemics and in treating serious illness successfully, notably improving in many
parts of the developed world, the duration and quality of life.
We must all, believers and non-believers, acknowledge and express sincere support for these efforts in
biomedical science that are not only designed to familiarize us with the marvels of the human body, but
also to encourage worthy standards of health and life for the peoples of our planet.
3. Furthermore, the Catholic Church wishes to express gratitude to so many scientists who are
dedicated to biomedical research. In fact, the Magisterium has frequently asked their help for solutions
to sensitive moral and social problems and from them has received convincing and effective
collaboration. Here I especially wish to mention Pope Paul VI's invitation to researchers and scientists
in his Encyclical Humanae vitae, to make a contribution "to the welfare of marriage and the family" by
seeking "to explain more thoroughly the various conditions favouring a proper regulation of births" (n.
24). I make my own his invitation, stressing its permanent application, which is made even more timely
by the pressing need to find "natural" solutions for the problems of conjugal infertility.
In the Encyclical Evangelium vitae, I myself appealed to Catholic intellectuals to be active in the
leading centres where culture is formed so as to introduce into society, in a concrete way, a new culture
of life (cf. n. 98). With this in mind, I founded your Academy for Life, "to study and to provide
information and training about the principal problems of law and biomedicine pertaining to the
promotion and protection of life, especially in the direct relationship they have with Christian morality
and the directives of the Church's Magisterium" (Apostolic Letter given Motu proprio, Vitae
mysterium, 11 February 1994, n. 4; ORE, 9 March 1994, p. 3). In the area of biomedical research, the
Academy for Life can therefore be a point of reference and enlightenment, not only for Catholic
researchers, but also for all who desire to work in this sector of biomedicine for the true good of every
human being.
5 4. I therefore renew my heartfelt appeal so that scientific and biomedical research, resist every
temptation to human manipulation, dedicate itself firmly to exploring ways and means to sustain
human life, to treat disease and to solve the new problems that arise in the biomedical domain. The
Church respects and supports scientific research when it has a genuinely humanist orientation, avoiding
any form of instrumentalization or destruction of the human being and keeping itself free from the
slavery of political and economic interests. In presenting the moral orientations dictated by natural
reason, the Church is convinced that she offers a precious service to scientific research, doing her
utmost for the true good of the human person. In this perspective, she recalls that, not only the aims,
but also the methods and means of research must always respect the dignity of every human being, at
every stage of his development and in every phase of experimentation.
Today perhaps more than in other ages, given the enormous developments of the experimental
biotechnologies that deal with the human being, scientists must be aware of the insuperable limits that
the protection of the life, the integrity and dignity of every human being impose upon their research. I
have often returned to this subject because I am convinced, with regard to certain results and claims of
experimentation on human beings, that no one can remain silent, and especially not the Church, whose
present silence would in the future be condemned by history and even by the devotees of science
themselves.
5. I would like to address a special word of encouragement to Catholic scientists so that they may make
a competent and professional contribution in the sectors where help is more urgently needed for the
solution to problems that affect human life and health.
I especially direct my appeal to the institutes and universities endowed with the title of "Catholic", that
they endeavour to measure up to the high standard of the spiritual values that presided over their
beginnings. We need a true and just movement of thought, and a new culture of a high ethical character
and of unexceptional scientific value to promote a genuinely human and effectively free progress in
research.
6. One last observation is necessary: there is an increasingly urgent need to fill the very serious and
unacceptable gap that separates the developing world from the developed in terms of the capacity to
develop biomedical research for the benefit of health-care assistance and to assist peoples afflicted by
chronic poverty and dire epidemics. I think especially of the tragedy of AIDS, which is very serious in
many African countries. It is essential to realize that to leave these peoples without the resources of
science and culture means to condemn them to poverty, financial exploitation and the lack of health
care structures, and also to commit an injustice and fuel a long term threat for the globalized world. To
value endogenous human resources means to guarantee the balance of health care and, in short, to
contribute to the peace of the whole world. Thus the relevant moral dimension of biomedical scientific
research necessarily opens to the dimension of justice and international solidarity.
7. I hope that the Pontifical Academy for Life, that begins its 10th year, will take this message to heart
and will ensure that it reaches all researchers, believers and non-believers, and contribute in this way to
the mission of the Church in the new millennium.
To support this special service, that is dear to my heart and necessary for humanity today and
tomorrow, I invoke upon you and upon your work the constant help of God and the protection of Mary,
Seat of Wisdom. As a pledge of heavenly light, I gladly impart to you, to your family members and
colleagues, my Apostolic Blessing.
(original version, in Italian, published in "L’Osservatore Romano", Lunedì-Martedì 24/25 Febbraio
2003, p. 5)
6 JAVIER LOZANO BARRAGÁN
NEW PARADIGM: ROOTS AND PROPOSALS
Attending to United Nations meetings, and seeing the different positions of the Governments in the
World about the principles and values according to which one must build the Bioethics, I tried to find
an ethical system from which one can logically understand those official issues. Between several
settlements I find finally the right material to construct the synthesis. This system is called the New
Paradigm, that now I will expose synthetically in the first part of my talk. Once individualizing the
system, I thought it was necessary to go to his roots. Some of them I will present in the second part, and
in the third part I will make some evaluation and positive proposals.
THE NEW PARADIGM [1]
It is strange that in the matter of Ethics the norms will have a compilation into a Paradigm that in its
own concept for many is only a hypothesis and properly not required to be truth. And it is still more
strange that one can configure norms not according to the truth; but the fact is that we have now this
Paradigm and it is taken as supreme law for many Departments of Health in the World, and guides the
behaviour of many Bioethics Committees. I synthesize it in 12 points:
The authors
Within the United Nations, the World Health Organisation and UNESCO, were requested to accept this
Paradigm in particular by three NGOs: "The Women's Environment and Development Organisation",
"The Earth Council Green peace" and "The International Planned Parenthood Federation". They have
adopted a series of principles within the context of what is called 'new ethics' or 'global ethics'. Some of
their significant points are as follows:
The global development
Today's world, as it is, cannot go on; after the Cold War we are faced with unsustainable ecological
situations, we are going towards a total degradation of the planet because of pollution caused by toxic
refuse of every kind, as well as radioactive waste. All of this brings us a constant malaise that continue
cannot go on. We need to work for the everyone's well-being and prosperity. We need to achieve global
prosperity and well-being.
The sustainable development
Such global prosperity and well-being is possible only with global development and not with that kind
of development which has been achieved so far. This is because such development can no longer be
sustained. We should achieve SUSTAINABLE development, that is to say development that will no
longer damage the planet, where, indeed, through harmonious development, there will be prosperity
and well-being for everyone, a prosperity and well-being that centres around the person.
The quality of life
Global prosperity and well-being with sustainable development is the aim of the new global ethics. It is
that convergence towards which the new paradigm is directed. This global prosperity and well-being is
7 what constitutes that goal known as QUALITY OF LIFE, which is defined 'as the perception of the
individual of his position in life, in the context of the culture and the system of values in which he finds
himself, in relation to his goals, expectations, standards and interest'. This is a concept of life of vast
range that embraces in a complex way the physical health of the person, his psychological state, his
personal beliefs, his social relations and his ability to relate to the relevant data of his environment
(WHOQOL).
The fields of quality of life
Quality of life covers six fields: 1. physical health; 2. psychological health; 3. industrialisation and
environmental degradation, the ineptitude of institutions, environmental pollution, the fabrication of
food, 4. social injustice, 5. forms of religious extremism and other kinds of extremism, intolerance and
social exclusion have to be fought, 6. the new spirituality that transcends all other spiritualities and
religions; it fights them and replaces them because they are seen as bastions of resistance against some
of the values and goals of the new paradigm.
The values
The values of free enterprise, national sovereignty, religions, dogmas, natural law and traditional values
must be rejected because they are irrelevant and because they have created an ethical void. Now, new
values have to be created, the only ones that will allow people to live in peace.
The values of the new paradigm are those that inspire a culture of peace: love, sharing, care,
comradeship, a process that leads decisions to be taken after consultation participatory democracy,
decentralisation, negotiation, processes of arbitration and positive adjudication, no war, respect for life,
freedom, justice and fairness, mutual respect, and integrity.
The pillars
These ethics are based upon five pillars: human rights and responsibility, democracy and the
components of civil society, the protection of minorities, commitment to the peaceful solution of
conflicts and open negotiations, inter-generational equity.
The spirituality
Given that the various religions of the world are not able to generate these global ethics, it is necessary
to supplement them with a new spirituality whose goal is global prosperity and well-being with
sustainable development. Nature, the earth (called 'Gaia'), is divine and inviolable. Man is one of
various elements, and is to be understood only in harmony with the earth. This is said not to be a new
religion but a new spirituality. The religions that have existed hitherto have been concerned with the
other life - this spirituality is concerned with this earthly life. It is a spirituality without God, to be
located at a temporal level, whose final goal is the liveability of the actual world and in it the prosperity
and well-being of man.
However, in this new spirituality valid elements present in different creeds are not rejected. They are
brought together to form global ethics. In this way, and in particular from the religions of the American
native communities, are taken their respect for nature and necessary interaction between man and
nature. From Judaism is taken the concept of holiness; from Buddhism, serenity and impassivity; from
Hinduism, respect for animals; from Islam, the virtue of justice; and from Christianity, charity and
mercy.
8 Despite all this, it is asserted that no religion is competent to resolve the ecological problem; no
religion has valid answers for this epoch of globalisation. We need to fight against hegemonies that are
sought after and dogmatic hierarchies that want to impose their points of view. The objective is to
shape a shared framework of behaviour that points out the fundamental ethical principles for emerging
global society. Overpopulation, industrialisation, environmental degradation, the ineptitude of
institutions, environmental pollution, the fabrication of food, social injustice, forms of religious
extremism and other kinds of extremism, intolerance and social exclusion have to be fought. The new
spirituality transcends all other spiritualities and religions; it fights them and replaces them because
they are seen as bastions of resistance against some of the values and goals of the new paradigm.
The problems
The problems to be solved are classified into four groups: the first concerns re-establishing the correct
relationship between man and nature; the second, the meaning of happiness, life and fullness; the third
examines the relationship between the individual and the community, and the fourth is concerned with
the balance between fairness and freedom.
The norms
Such new ethics are independent of dogma and natural law. They redefine the connection between
knowledge and ethical practice. This connection is not causal as is the case with the sciences - it is
situational. That is to say, there is no need for evident norms that govern behaviour. It is, rather, the
behaviour of today that will be translated into norms of behaviour for the future. The problem is to
generate agreement so that the peoples of the world accept these new global ethics, and for this reason
it is necessary to motivate everyone in the most effective way.
The foundations
The three foundations upon which these new ethics and this new spirituality are founded are human
rights, health for everyone, and education.
The human rights
Human rights are based upon total fairness amongst men. For this reason, the only acceptable remedy
required is, on the one hand, a stabilisation of population levels, and on the other, a massive transfer of
wealth from the rich to the poor. For some supporters of these ethics, capitalism is the root of all evils,
and for this reason a requirement of the new order is opposition to economic globalisation. They argue
that we need to create a new, shared standard of life for everyone. The diversity of cultures is respected
and at the same time the aim is the imposition of a universal culture.
Health for all
Health for everyone requires the presence of eight elements: education in health, suitable food, clean
water, elementary forms of care, mother-child health, vaccination against the principal infectious
diseases, the prevention and control of local endemic diseases, the suitable treatment of illnesses and
management of common disasters, access to essential drugs and medicines, and reproductive health.
This right is inherent in social security, involves the eradication of poverty, global social fairness, and
is achieved through global governance. It requires concern for education and democratic tendencies.
9 Education for all
Education must be education for all. The contents of the basic curriculum of the education of the
population is divided into four categories: social and economic development with emphasis on social
demography; the environment and the ecosystem, and management of the inter-relationship between
the population and the environment in particular; sexuality and the achievement of personal
complementariness; and the family and prosperity and well-being. Emphasis is placed upon human
rights, sustainable development, fairness within humanity; health security, participation, governability,
techniques for shaping support, global citizenship, peace, the protection of the environment and
reproductive health. This education must be holistic. It is the key to obtaining agreement on acceptance
of the new paradigm. And because it must be interdisciplinary it has to generate a complex process. It
must be both formal and informal.
The principles of bioethics
All this helps to outline the principles of bioethics closed to the Transcendent. Within such bioethics,
which some people have called 'subjective' or 'autonomous', some general normative principles have
been formulated in order to be able to map out the study of human behaviour within the life and health
sciences. These principles are three in number and they are as follows:
1. The principle of autonomy.
2. The principle of doing good (and on the negative side of not doingharm).
3. The principle of justice.
The principle of autonomy means the freedom of the moral agent, and this means that an action is good
if it respects the freedom of the moral agent and other people. The principle of doing good means that
good should always be done and doing wrong should always be avoided. The principle of justice means
that each person should be given what is due to him.
The origins of the these principles
Given that as a matter of fact this form of bioethics does not contain objective norms, the justification
of such principles is complicated. Some people have attacked these principles, arguing that they have
already gone beyond American principleism (a reference to the place where they were drawn up).
Others, on the other hand, provide a justification for these principles and argue that their formulation
was carried out along experimental lines on the basis of the good and bad results of actions carried out
in the field of bioethics accompanied by a synthesis of their consequences.
Various explanations are given or none are given at all. The different positions are as follows:
The evolutionistic theory
The evolution of the species continued when man appeared and man continues to evolve not only as
regards his nature but also in terms of his culture, and thus for each stage of his history there is a
different culture and a different set of ethics. In the contemporary stage of his history, those principles
of bioethics are the valid one.
10 The subjectivist theory
It is not possible to know values: each person must proceed as he thinks fit and as a general result of
this procedure the principles that are adopted arise.
The contract theory
Given the subjectivist theory leads us to full relativism, it is applied, however, with the support of
consent, that is to say agreeing with everyone and proceeding in line with the opinion of the majority, a
sort of social contract between the members of society. Everyone agrees on these principles.
The clinical theory
However, given that it is not always possible to reach agreement, each case is examined in turn and the
action taken is that considered the best for that particular case.
The utilitarian theory
If one asks what the best is for that particular case, the answer provided involves the utilitarian theory
of cost/benefit, according to which what costs least and gives the best results should be carried out.
The theory of new principles
Some authors (for example Peter Singer) argue that one should not dwell upon the old principles but
rather invent new ones. Thus, for example, one should not adhere simply to the principle 'thou shalt not
kill' but adhere, instead, to a new one, which affirms: 'kill only if you decide freely to do so and take
responsibility for all the consequences'. The principles that are adopted can be adopted as ethical
principles, as long as each person decides freely and takes responsibility for all the consequences.
SOME ROOTS OF THIS PARADIGM
Without entering into complex Eastern thought but remaining within the Western cultural sphere, we
find two opposing ways of thinking, in varying conditions of contradiction with each other, about the
ethical point that logically arises from their mental worlds. These two approaches have registered major
successes but also great failures. Those two positions we find in the line of to be and to become, and in
the line of to be and to think. In this second part, we will also proceed in a very schematic way.
To be and to become
In classical Greek antiquity we find two philosophers Parmenedas and Heraclitus with divergent
approaches: that of Parmenedas of 'ειναικάιπαντα' (one and all), immobility, and that of Heraclitus of
'πανταρει' (everything evolves), mobility. Classical Greek philosphers would, through Aristotle, join
the two alternatives in hylomorphism. Many centuries later, in the face of nominalism, St. Thomas
Aquinas declared 'ens est id quod est' (being is what is), objective reality, whereas Duns Scoto stated
'ens est id quod potest esse' (being is what can be), mere possibility. This last way of thinking, opens
the door to the Empirisme of Bacon, Hobbes, Hume and Locke, with all its advantages and
disadvantages. The science will be separated from its transcendental goal, in the sense of St. Agustin,
and closed in the material experience as such.
11 By another point of view, Nominalism of William of Ockham is very important in the Middle Age
problem of the reality of Universals, according to whom the Universal is nothing else but a mere vocal
emission.Consequently there are no universal truths, and as a result, no norms of universal mandatory
application.
Thinking and being
The great change came with Descartes, or to put it more accurately, with his followers, because
Descartes probably remains in the platonic way of thinking belonging to the Oratory of LaBerule. The
alternative was: do I think it because it is being, or is it being because I think it? If one accepts the first
part of the alternative then an objective truth exists; if one accepts the second, the truth is what I accept
it as.
In the context of the second part of the alternative a large part of contemporary thought was forged, and
this had decisive consequences as regards ethics because it meant the absolute autonomy of man: it is
he who decides in the final analysis what is true and what is false, what is good and what is bad. This
full autonomy would also be deduced from other key points in the thought of Descartes, that of 'clear
and distinct' ideas which belong only to substances: God, the conscience, and extension. The basic
condition for a thing to be seen as a substance is its full independence. Descartes said that a substance
'est id quod ita existit ut nulla alia re indigeat ad existendum' (it is what exists so and does not need
anything else to exist). This Cartesian concept would lead later to the full independence and autonomy
of man. Man in himself, was held to be, absurdly, his own project.
His own present reality was his future project and in the best of cases, along the lines of Engels, the
'pious atheist', his project was the myth arising from the multiplication of his own wishes to the point of
mathematical infinity. We are here in the line of the positivistic way of thinking in the Encyclopaedism,
specially of August Comte.
In this line of not objectivity, denying the possibility of acceding to the noumenon, Kant advanced in
ethics to collective and formal subjectivity with his 'categorical imperative'; so he formulates the norm
according to the consensus of the majority.
For his part, Hegel gave political consistency to this subjectivity by locating the highest realisation of
the 'spirit' in the State, in the prusian State, and so making the political power the norm of morality.
Subsequently, following the path of Engels, Marx said that 'Hegel would be made to walk with his feet
on the ground' in dialectical materialism, where the classless society was seen as the only source of
morality in the autonomy of consequent historical materialism.
Contemporary currents
In the logical development of this subjectivism, six currents of thought have today become established.
They are easily applied to this Paradigm, and they are:
Eclecticism, which accepts any type of behaviour, outside its system, context or evaluation;
Historicism, according to which truth changes according to adaptation to a specific epoch
Scientism, in which it is affirmed that the only acceptable truth is experimental truth in the scientific
field;
Pragmatism, where ethical decisions are made taking into account only the criteria of utility according
to the cost/benefit tandem guided by the opinion of the majority;
Nihilism, in which there is the simple abandonment of the idea of reaching objective truths;
Post-modernity, in which nihilistic positions are adopted.
It is obvious that in this whole way of thinking in the field of Ethics, the outcome was merely
subjective ethics opposed to the objectivity of nature, which was no longer seen as real, because
objectivity is conceived statically (here include also the Natural Law). As a result, it was declared that
12 'objective' ethics, based upon nature, is the outcome of ignorance or out of fashion, belonging to the
Ages of darkness of the mankind. The experimental sciences are based in the mobility of things that is
the only reality. Especially in the field of medicine: it was asserted that whereas until a short time ago
this belonged to the field of the observable, now, instead, all its action develops within the field of 'that
which can be manipulated'.
Passing from the scientific plane to the religious plane, the Christian Protestant approach has strongly
contested the very concept of 'nature', at least of human nature, because it sees nature as essentially
vitiated. If nature is indeed like that, it is logical that human nature cannot be moral norm.
SOME EVALUATION AND PROJECT
The values of the new paradigm
It is right to react against environmental degradation, and it is also right to be aware of the fact that
development has its limits and that development that does not take into account the degradation that it
causes to nature should not be supported. At the same time, it is right to search for prosperity and wellbeing and that the greatest prosperity and well-being for the greatest number of the inhabitants of the
planet should be ensured.
It is equally right that quality of life should be procured, especially if by this is understood selfawareness of the position that a person occupies in his overall - both ecological and cultural in a broad
sense - situation, which includes the economic, social, religious, political and cultural aspects, in the
strict sense of the terms, of the field of education.
It is right to defend human rights, respect for social minorities, for democracy, for fairness amongst all
men, that is to say their fundamental equality, both as regards men and women, to re-establish a correct
relationship between man and the environment and between the individual and the community. It is
right to defend social justice, and the economic injustice present in today's world is very evident.
To require health for everyone, at least as regards its basic elements, is an inescapable requirement, and
obtaining education for all is also a primary need.
The anti-values of the new paradigm
The most important anti-value lies in the fact that the new paradigm presents itself, as they say, as a
new spirituality, which takes the place of all religions because these are inadequate to the task of
preserving the ecosystem. In practical terms, this is a new secularist religion, a religion without God, or
to put it another way, with a new God - the earth itself, which they call Gaia. The subordinate element
of this divinity is man.
The series of values that the new paradigm upholds are values that are subordinated to this divinity,
which is translated into the supreme ecological value, known as sustainable development. Within this
sustainable development the supreme ethical goal is prosperity and well-being.
It is certain that this paradigm totally denies Christianity and its founding historical fact, namely the
Word made flesh, the redemptive death of Christ and his glorious resurrection. If one accepts this
historical fact, the pre-supposition of the new paradigm collapses completely.
This does not mean that the values espoused by the new paradigm also collapse. Indeed, these are not
extraneous to Christian thought but are to be placed within it. Ever since Genesis, reference has been
made to homo sapiens and homo faber. The two have to be reconciled: man is not the despotic master
of nature but a wise worker who dominates nature and respects its laws.
What makes the new paradigm unacceptable is its denial of God and the life beyond, and, in concrete
terms, the denial of Christ as the only saviour.
13 The use of terms in the New Paradigm often carries some confusion: they never speak of persons but
individuals, not equality, but equity, not government but new governance, not family but peer, not
procreation, but reproductive health, etc.
The equality of the sexes is to be accepted- not, however, in the sense of homosexuality and the
destruction of the family. Birth control is to be accepted - but not in a destructive sense such as that
planned through the culture of death, which is applied in a special way in the third world.
Prosperity and well-being is not the same as happiness. Christ does not promise us in an illusory way
total prosperity and well-being in this world, but he does promise us happiness. The point of
discernment for any religion, or as the new paradigm says, any spirituality, is the solution to the
problem of death. This is something that the new paradigm does not in the least possess because it
simply avoids it, and what death involves, and in a special way suffering, pain and illness. Christ is the
only person to give a satisfying answer to it: with his glorious cross in the resurrection.
One of the great problems of the new paradigm is when it becomes aware of the fact that everything
has to be based upon examples of agreement that do not arise from objective truths but from subjective
opinions. It thus tries to create artificial forms of agreement. Such forms of agreement are absolutely
variable and for this reason ethics or bioethics based upon the new paradigm do not have consistency.
An ethical law without authentic foundation cannot be a true law. Saying that the actual behaviour must
convert itself in norm for the future generations is totally insane.
Regarding to the principles of Bioethics
As we can see, in each of the given explanations to justify those principles one arrives at a form of
relativism, not only in observing the alleged origins of these principles but also in examining the
principles themselves. It is indeed the fact the principle of autonomy corresponds to acting with
freedom, but this means that for this moral action those who do not possess freedom are not taken into
consideration: people such as invalids, children, foetuses, and embryos.
Regarding to the principle to do good, but what is good? What really does good to a person? If we do
not know anything about what can be good for a person, we cannot do good to that person. The same
applies to the principle of justice: what is due to every person?
The very principles advanced, seen in themselves, do not have an explanation. It is usually said that
these principles must be understood as actual principles, that is to say as merely principles to be
actually applied, and not as prima facie principles, that is to say as theoretical principles. But the
difficulty remains in the case of principles to be actually applied as well: why should I act in this way if
it is not reasonable?
In addition, when these principles come into conflict with each other which of them should prevail? For
example, if the principle of autonomy comes into conflict with the principle of doing good and this, in
its turn, comes into conflict with the principle of justice, which principle should we follow? We need a
further and prior principle, which gives them unity and which resolves a possible conflict. The
principle of autonomy, and thus the principle of freedom as well, has its own limits when it has before
it the good of a third party, and the good of a third party is also limited when it has before it what is due
to another person. In the final analysis, however, the principles do not lay down what is due to that
person. Thus some people make recourse to what they call ethical narrative, in which they narrate, one
after the other, only the cases that occur, and action is taken following the example of what came
before. Or refuge is taken in what they call female perception, that is to say what the refined goodness
adjudges advisable. In this way one draws near to another criterion that they call the criterion 'of virtue',
by which the person who decides what is good and what is bad is the person who has sufficient virtue,
where by virtue is understood acting according to recta ratio. In referring to upright reason, one draws
near to the classic conception of objective bioethics.
14 The principles must be accepted only by their objective foundation, withdrawing them from the
relativism of the mere subjectivity.
Being and thinking
The answer to the question we raised at the beginning according to the Cartesian mentality must be: the
being is not because I think in it, but I can think in it because it exists. This is the objectivity in which
the Ethics must be founded.
As regards the current of thought that gives objectivity to ethics, we encounter the AristotelianThomistic position, which, in fundamental terms, was adopted by the Magisterium of the Catholic
Church, without neglecting the valid elements that are found in the subjectivist discourse already
discussed and in all the inputs from Catholicism that have enriched it.
In this current of thought therefore truth lies in the conformity of thought with the object. It is not the
thought of man that creates reality, but the existence that gives reality the possibility of being thought.
The criterion of morality by which we know if an action is good or bad is certainly man, the subject,
but this subject is objective, is the human nature, considered in his complexity which implies his
opening to the Transcendent.
Morality consists of the pathway by which to realise the 'human project' but this pathway not only does
not exclude the transcendent model from man himself but necessarily includes it. A person cannot at
the same time be his own present and his own future. In this form man does not create morality morality transcends him, it is there and he meets it, is object 'ob-jacet'. It is not the case that the subject
is not implied, indeed it is the subject who follows the pathway and in a certain way marks it out, even
though not according to his absolute free will because there are norms that transcend him. Man has his
own autonomy in enjoying his freedom. However, this autonomy, this norm of being himself, is not
absolute. Man in his limited and constantly constructed reality must necessarily be open to a model that
transcends him.
THE PROJECT: SUBJECTIVITY, OBJECTIVITY AND MOBILITY OF THE HUMAN NATURE
Bioethics as a project
In speaking about the life sciences and in asking ourselves about correct human behaviour to be
followed in the experimental sciences that manipulate life, the question includes the following factors:
human life, lack of human life, increase in human life, improvement of human life, norms to be
followed to obtain this improvement, and deviations to be avoided. In other words, we find ourselves
face to face with the tandem 'need-satisfaction'. This means that there is a living subject who aspires to
improve himself, he has to tread his path; if he has to follow a path he must mark it out, and if he marks
it out, he must first know where it leads if he wants to mark it out. In the field of life one has to know
what life is, what the best life that one wishes for is, which pathways should be followed to achieve it
and which should be avoided, because these latter, rather than giving life, could lead to its loss.
Bioethics thus appears as a project for the construction of man through the life and health sciences.
Technology and bioethics
To make the point more clearly, we could imagine neutral technology (since in fact there are no neutral
sciences because every science is analysis and synthesis, and synthesis can never be neutral). If then we
could speak about neutral technology, closed within itself, we would have to say that according to the
laws of the laboratory - hypothesis, experimentation, thesis, new hypothesis, new thesis and new
15 experimentation - the framework of technology in itself is mere possibility, whereas the framework of
ethics is the goal. For this reason, technology in itself can build or destroy man, technology in itself is
blind, however advanced and marvellous it may appear to be. Biotechnology in itself is blind and
ambivalent.
An intelligent project
For this reason, so that a real bioethics can exist that provides us with norms for behaviour in the field
of health and life, the first thing that we must ask ourselves concerns the project for man that people
have in mind in the manipulation of these fields of health and life. Curiously, having a project denotes
intelligence but at the same time also indicates weakness because a project represents an intention to
improve reality which appears deficient, because, if such were not the case, the projects to improve it
would not exist. Authentic bioethics must appear as a project to improve human life itself which
contains all the life and health sciences as its intelligence, as that intus legere (read within) that in every
analysis always has present the synthesis of arrival which can be nothing else but the construction of
human life.
The best self
For a project regarding life to function (like any other project), it has to understand as completely as
possible the life reality that it wishes to improve, and the 'best self' to which it aspires. This best self,
which is a goal and a purpose at the same time, is the model whose reproduction is sought. According
to these two realities, a tendency, a pathway, an ethos from the self to the best self, is marked out. This
pathway is ethics and, in our case, bioethics. In it we find norms that cannot be merely formulations or
imperatives outside the self but real constructions of the same 'self' that gradually draw it near to this
best self, increasing its vital density. Therefore a science must always finally be conceived in the sense
of St. Agustin, as a teleological knowledge; if not it will be dehumanising and destroying man himself.
Freedom
It is ethical theory and practice as a whole that opens up to the true concept of freedom, which does not
consist simply in doing what one wishes but in that attribute of will that directs it towards one's own
construction. In this sense, the criterion of morality is man himself in his total complexity and not in
closing himself up in his own ability to construct himself and in his enormous capacity to destroy
himself. This complexity leads him to be aware of his own reality which means being in a relationship,
being open and beginning, therefore, to walk, or rather to open himself freely to the Other, which in
this case is the fullness of Strength, Truth and Love, namely God. Man, through freedom, in his project
of construction, always opens himself to forces of the authentic progress of biotechnology in order to
increasingly achieve his life fullness in constant harmony with God, with the whole of mankind and
with the total environmental context.
Revelation
Many times one does not dare to speak in the scientific fields of Revelation, especially in Bioethics, but
I think that this is the proper dimension of an authentic objective Bioethics that will be open to the
whole project of man.
In Catholic thought such open, 'objective', real, without frontiers, ethics open up to full communication
with Almighty God the Father who realises in us the Truth of the Son through his Incarnation, Passion,
16 Death and Resurrection. He fills up all our aspirations leading us along the pathway that is Christ in the
fullness of the love of His Spirit. Catholic ethics and bioethics are Christ's walking within us to the
Father through his death and resurrection through the love of the Holy Spirit. Bioethics is in this way
the walking of the Spirit in us through the pathways of the life and health sciences. 'Those who are led
by the Spirit are the children of God'. The spirit infuses in man the ability to walk towards the
construction of total Christ, which is virtuous life, and maps out the understanding of Christ himself as
a pathway through the commandments and the Sermon on the Mount. Catholic bioethics, therefore, is:
The systematic and deep study of the behaviour that constructs man through the life and health sciences
in walking with Christ towards the Father, fullness of life, through the strength of the Holy Spirit.
This theological vision expresses a deep and structural dialogue with all the relevant sciences and
forms of technology, with all the unifying forms of thought of analyses carried out by the different
philosophical and theological currents, entering into dialogue as well with other religions taking into
account the fact that it is a study of behaviour and thus, as a result, it cannot remain within the
trajectory of reflection but must take concrete form in light that guides in the difficult solution of the
problems raised by genetic engineering.
[1] This espousal of what is contained in the ‘New Paradigm’ is taken from Kim Yersu, 1999, A
Common Framework for Ethics of the Twenty-first Century, UNESCO, Division of Philosophy and
Ethics, cited November 15, 1999 atwww.unesco.org drg philosophyandethics
Other websites in Italian:
* Etica globale: il nuovo paradigma
... SALUTE. INTERVENTO DELL'ARCIVESCOVO JAVIER LOZANO BARRAGAN. Sabato,
14 dicembre 2002. Etica globale: il nuovo paradigma. JAVIER LOZANO
...http://www.vatican.va/roman_curia/pontifical_councils/hlthwork/documents/rc_pc_hlthwork_
doc_20021214_barragan-med-med_it.html
* Sito Web Italiano per la Filosofia-L'Unita'-5 LUGLIO 2001
BRUNO GRAVAGNUOLO. Etica globale cercasi ... Non che Maffettone pretenda di stilare
un'Enciclopedia etica o un'antropologia globale del futuro.
... http://lgxserver.uniba.it/lei/rassegna/010705a.htm
* Sito Web Italiano per la Filosofia-Il Sole 24 Ore-27 APRILE 2002
... affrontare il problema dell'indigenza nel mondo. L'etica globale che auspico è basata sulla
solidarietà, non sulla paura della paura. ... http://lgxserver.uniba.it/lei/rassegna/020427g.htm
* Mosaico: audiovisivi
... radici antiche. La differenza tra morale ed etica: può esistere un'etica globale. I contenuti di una
nuova proposta morale. L'etica
... http://www.mosaico.rai.it/audiovisivi/index.asp?vid=1772&menu=
* Green Cross Italia
... Tema due: l'importanza dell'etica globale per il nuovo millennio: ... Tema due: questioni inerenti
all'importanza dell'etica globale per il nuovo millennio.
... http://www.greencrossitalia.it/ita/news/speciale_lione/news_006.htm
17 VINCENZO CAPPELLETTI
BIOMEDICINE IN THE TWENTIETH CENTURY
PHYSIOPATHOLOGY: A PARADIGM
Towards the end of the Nineteenth Century, rather during its last twentyfive years, a renewed type of
medicine emerges, a “scientific” medicine in which physiology and pathology are applied and
combined into an integrated unit. This theoretical paradigm owes its existance to two outstanding
parsonalities of the utmost intellectual significance: Rudolf Virchow (1821-1902) and Claude Bernard
(1813-1878). At the time, Virchow was working in Berlin, both at the University of which he becomes
dean in ’93, as well as at the Academy of Sciences. His is the above expression, though his has a
slightly different formulation, of “pathologische Physiologie”, indicating the strongpoint of medical
knowledge at the end of the last Century. In the first issue of Archiv für pathologische Anatomie und
Physiologie und für klinische Medizin, published in 1847 under his direction, Virchow had made clear
that “diseases are not independent entities enclosed within themselves; they are not substances
intruding in our body, nor parasites which live off the body: diseases are simply the development of
vital phenomena in abnormal conditions”. According to this definition, physiopathology --to go back to
the current term- lastly has so vast a connotation as to identify not only with medicine as such, but with
biology: “the doctrine of life in general and of man’s life in particular”, as Virchow himself defined it
in an article published in the Archiv in ’53.
Hazardous inferences and daring transferences were ultimately also furthered by the trend philosophic
knowledge had followed during the years mentioned. Preceded by numbers of considerations and
recommendations, such as the most famous document developed by the Prussian King’s Ambassador to
the Holy See, Wilhelm von Humboldt, the University of Berlin was founded in 1809. The
PrussianState had decided its foundation as a symbol of national rebirth after the 1896 Jena defeat by
Napoleon. The new Institute was also meant to reunify scientific and humanistic knowledge. However,
in the first two decades, the influence of philosophy prevails given the presence of Fichte, Hegel and
Schelling, notwithstanding the prestige and work of the physiologist Johannes Müller (1801-1858).
Müller was called “the man who bore on himself the mark of the extraordinary” as one of his students,
the neurophysiologist Emil du Bois-Reymond, defined him in his celebrative speech at the Academy of
Sciences[1]. But it was Alexander Humboldt (1769-1859), the geographer and brother of Wilhelm, who
caused humanistic predominance to alternate with the scientific one, consequently to a series of
conferences on wide ranging naturalistic explorations. The conferences were collected later (1845-’58)
in the five volumes of Kosmos[2].
But in Müller’s milieu, though sciences continued to be subordinate to philosophy, in the Berlin
University environment the cellular theory had reached a definite formulation as a result of Theodor
Schwann’sMicroscopical Researches on the Correspondence of Structure and Growth in Animals and
Plants[3], of 1839. Owing to Schwann, a longlasting, millenary doubt concerning two fundamental
questions could be cleared: where has life its primary seat and which are its constitutive properties.
Now an answer was possible, inverting the questions: the distinctive properties of life are growth,
reproduction and excitability, while the simplest structure which shows these properties is the cell, with
which, therefore, the fundamental living unit can be identified.
The importance of the cell theory can hardly be overestimated. Both theory and experimentation came
to be closely, in some cases fundamentlly, linked to the Schwannian outlook,considered a primary
axiom of biological disciplines. Virchow, had confirmed the concept that pathology is the physiology
of diseased situations, thus basically correlating pathology to Schwann’s new views by entitling his
work of 1858 --later definitely associated with his name: Cellular Pathology in its Foundation in
Physiological and Pathological Histology[4]. In his work in general pathology Virchow, as we
18 mentioned, identified and assimilated it to physiopathology, and introduced in the cell theory a twofold
innovation. The first and fundamental one was the “omnis cellula e cellula” law, according to which the
new cell units were formed by the division of preexisting cells and not by interstitial substances
through “generatio aequivoca”. The second innovation, a corollary to the preceding one, distinguished
in growth: assimilation and reproduction. But despite its exceptionally vast innovative range, the
formulation of cell physiopathology shows limits which, today, might be called reductionistic. In fact,
cell physiopathology neglects relationships which do not describe but interpret and explain, in favour
of autonomous and unsuppressible realities of the organ and the organism.
Organ physiology was soon to follow, owing to Hermann Helmholtz (1821-1894) in Müller’s same
school.Scientifically, this school had equalled the theoretical fertility of Hegel’s school. The Optical
Physiology Manual[5] written and published between 1856 and 1867, and The Theory of Sound
Sensations as the Physiologic Foundation of Musical Theory[6], issued in ’63 and frequently reprinted,
did not contradict the cellularity postulate but added the need of a structural complexity on which to
base, and from which to evince, the specific function, namely the object of physiological research.
Already in Schwann’s Researches, the basic, defining analysis of life had gone beyond morphology by
associating property and form. Schwann had succeeded where others had failed. Before being anything
else, life is the morpho-functional unit which Galen had detected in macroscopic dimensions and the
Nineteenth Century microscopists rediscovered on a hundred times smaller scale.
But function and functionality did not suffice to ensure the passage from morfpho-physiology to
physiopathology, such as was theorized by Virchow and, explicitly or implicitly, had been accepted by
all of the end of Nineteenth Century medicine, including clinical medicine, ever vigilant of its privilege
of being in direct touch with disease and patient. The functional thesis opened two substantial
innovations: the concept of structure and the category of quality. There can be no function unless
anchored to a cell-aggregate or to a chemical-factors aggregate, as it was later called. And also the cell
which Schwann considered the elementary living unit, shows to be a hypercomplex chemical and
morphological aggregate. Nor can there be function without qualitative specificity: glycogenesis is not
ematic transport of oxygen, nor is heat and sound perception, just to mention one of many examples.
To mention Virchow again, in abandoning the implicit presupposition of nature being uniform and
lacking basic differences, physiology or physiopathology ended by leading Galileian geometrization
and Cartesian mechanism towards an irreversible decline. This was perceived by the neurophysiologist
Emil du Bois-Reymond (1818-1896), also a Müller student, in his lecture on The Seven Riddles of the
World[7], held on July 8th 1880 during the Leibnizian meeting at the Berlin Academy of Sciences.
Nature conceived as a system of material atoms in movement, generates seven inexplainable and thus
incomprehensible entities. Starting from the presupposition we mentioned, these entities are: absence of
matter and force, origin of movement, origin of life, nature’s seeming design, origin of the elementary
sensation, rational thought and language, and free will. Actually, the “enigmas” were not seven but
numberless: wherever a peculiarity emerged from a quantitative substratum, if one omitted to search
the root of the quality, beside noting the evidence of the quantity, it would have made it impossible to
understand the experience or, to quote Plato, to “save the phenomena”.
Du Bois was aware of the abyss mechanistic science was facing and ended his academic lecture with an
honest invitation to prudence: «Dubitemus». More drastic had a former lecture of him sounded, about
The limits of natural knowledge[8] There, du Bois concluded by a desperate «Ignorabimus». And when
issuing, in 1884, both lectures together[9], it was the «Ignorabimus» to seal them. During the same
years, the materialist and mechanistic Virchow moved to more moderate stances, namely to
“mechanical vitalism”, according to which there supposedly is a specific force which orients
movements in the processes of the single cells and in those of the organism. But physiology rested in
French, not only in German hands. Seen and valued from today’s point of view, Claude Bernard’s
intellectual stature overrides all the others, specially as to research, as to microscopy associated to
genuinely physiological methods, and lastly,as to an incredible quantity of epistemological and
19 metaphysical intuitions. The main medical fields in which Bernard, the experimentalist, developed new
and lasting knowledge as Maestro at the Collège de France, constitute an exeptional record: they range
from nutritional and digestive processes to pancreatic juice functions, from hepatic glycogenesis to the
activity of vasomotor-nerves and from the mechanism of curare paralysis to the relation between the
vegetative nervous system and thermoregulation. In such research Bernard adopted original methods
such as the one he himself called “chemical autopsy”. Virchow’s basic text in biology and medicine,
namely Cellular Pathology, is matched as to importance by Bernard’s Lectures on Living Tissues
Properties, which he held at the Sorbonne in 1864 and published in ’66[10]. Together with this work a
series of other similar volumes appeared, all of them ensued from teaching and they circulated during
those twentyfive years. They include: Lectures on Experimental PhysiologyApplied to Medicine[11],
issued in ’56, and the posthumous Lectures on Surgical Physiology[12], published in ’79.
Bernard’s attitude towards the Germans is halfhearted: he prefers the notion of protoplasm to that of
cell, and he reminds Virchow that in the vast synthesis of cellular pathology one should not lose the
“feeling of what is special” so as to get to what is individual and to the ”idiosyncrasy”, whichis the
basis of all of medicine.
More important still, is Bernard who authors works that can and must be considered philosophic such
as: Introduction to the Study of Experimental medicine[13] of 1865, and the posthumous Principles of
experimentalmedicine[14] issued only in 1947 by L. Delhoume as a voluminous compendium, and
lastly the Cahier rouge, equally unpublished but subsequently issued in complete edition by M.D.
Grmek in 1962[15]. The maze of intuitions, doubts, arguments contained in these works seems, at
times, to take divergent if not outright opposite directions. This network of concepts shows that
simplifications such as German machanicistic and French organicistic marialism are inacceptable. In
short: here outright perplexity is preferred to deceptive certainties and all the reflections of the
philosopher Bernard are imbued with these characteristics. Science and philosophy must procede
together, but the corner stones of the scientific building are facts. Life is creation, but it is also death.
Vital processes obey determinism, but individuality prevails in any case. Anatomy studies organisation,
but function is indeducible from form. The only form of reasoning is the deductive one in syllogisms,
but the scientist has to allow for “expèriences pour voir”. The physiologist and phylosopher Bernard’s
acknowledgement of life as such, and of thew human mind investigates into life, is open and solemn.
The birth of scientific medicine issued from the pre-scientific one, based on observation, had been
impersonated by Thomas Sydenham (1624-1689) in the Century of Galilei, Boyle and Newton. Now it
was the Maestro of the Collège de France who perceived the birth of scientific medicine and conributed
to its development. Bernard cherished the Institution founded by Francis I in 1513, because its purpose
was to scrutinize the future of science and to discuss its methods. ”Scientific medicine, which I am
asked to teach, does not exist”, stated Bernard in one of his lectures. Almost everything had still to be
done, but one fact had been made certain: the core of future scientific medicine could not be but
physiopathology.
PSYCHOPATHOLOGICAL ANOMALY
The two fathers of physiopathology were Bernard, who had died about fifteen yars previously, and
Virchow, who was still active and had become dean of the Berlin University that same year. At that
time, a young and promising student of the Vienna School of Medicine, by the name of Sigmund Freud
(1856-1939), publishes in 1893, on “Archives de neurologie” an article entitled: Some remarks about a
comparative study of organic and hystericalparalysis[16]. A work which is clearly anomalous as
compared to the physiopathological paradigm of scientific medicine. And this anomaly was meant to
increase, to grow gigantically as the passage took place from psychoanalysis to psychosomatics and on
from there to the point of this anomaly being accepted and included anew within the general realm of
20 medicine, even though in the way of a compromise. This point calls for a parenthesis: so far we have
been using a sociological terminology (R. Merton, Th. Kuhn), namely terms such as paradigm and
anomaly, whith the advantage of endowing specific terms with precise meanings. If referred to the term
paradigm, which is a sum of basic assertions relating to a theory or a discipline, anomaly means that
phenomenon which, to the contrary of a pure and simple enlargement, contradicts one or more basic
principles of the original theoretic framework while accepting other principles of this framework’s
normative assertions. If referred to physiopathology, seen as a paradigm, the psychoanalytical and
psychosomatic outlook is anomalous, while contemporary microbiology was not. But let us go back
where we left off. In the paper we mentioned, Freud wrote about a new type of paralyses which were
neither simulated nor connected to cerebral lesions, and were distributed over various parts of the body
“as if the anatomy of the nervous system did not exist”. This was the onset of the long Freudian
itinerary of neuropsychoses as defence mechanism against phobias, obsessions, narcissism, anxiety
psychoneuroses. In all of these pathological conditions the psychological experience expresses itelf
somatically through an individual symptomatic pattern, though the somatic changes do not follow the
origin and the development of these pathologic conditions. All of this, physiopathology could not
accept and indeed it refused it decisively through the head of the Vienna school of neurology Theodor
Meynert. But this school had already abandoned, with Virchow, the precondition of strict materialism
in favour of a different, wider and better defendable ideology, namely organicism. According to the
latter, the soma had causal priority and was followed by its effects, among which psychic disorders.
According to Freud, a patient suffering from hysterical paralysis was experiencing the effect of
memories which had escaped consciousnes. It was the preceding traumatic event, not an anatomic
lesion, which caused the motor defect and determined its aspect. But how could one reach forgotten,
submerged psychic contents? In Studies on Hysteria, published in ’95, together with Joseph Breuer
(1842-1925)[17], the main clinical case history was that of Anna O., which offered a therapeutic
process the patient herself had invented. While she gave free vent to her thoughts, Anna O. felt her
motor disturbances and the state of excitement in which she lived, vanish. The therapist had to abstain
from any external interference, particularly hypnosis, and to adopt “a procedure of cleansing, layer
after layer, which we chose to compare to the technique of unearthing a buried city”.In the case of
Emmy von N., which was included in the Studies, Freud formulated one of the fundamental principles
of analysis, namely that of “conversion” [Konversion]. In it, the psychic energy which is detached from
a repressed event, is transposed into a somtic symptom showing a content and a meaning that have to
be regained. But in those same years, Freud faced the symptom analysis from another point of view,
namely as an equivalent of an axiety attack, lacking the “event content” which can be summoned up
from the conversion analysis.
It is at this branching-off point, that psychosomatic medicine starts its course through its most eminent
Authors and texts setting its theoretical foundation, nemely: Franz Alexander, Psychosomatic
Medicine:its Principles and Applications[18]; Michael Balint, The Basic Fault. Therapeutic Aspects of
Regression[19]; Viktor von Weizsäcker, Nature and Spirit[20]; Günther Ammon, Psychoanalysis and
Psychosomatics[21].
Psychosomatic medicine recedes from the personal case history, from the ego, and approaches more
closely the genesis of the ego-structures penetrating in the heart of the actual relationship which has
produced the illness, the so-called “psychosomatogenous family”. According to Ammon, the crucial
point of the morbid event in a patient suffering from psychosomatic reactions is the disorder of the
basic somatic ego functions: aggressiveness and narcissism. The apex of subjectivity, between
consciousness and «the power of destiny», as Freud puts it Inhibition, Symptom and Anxiety[22],
shades into a remote horizon for those who follow the psychosomatic path rather than the
psychosomatic itinerary along Freud’s steps or those of his brilliant but unfaithful pupil Carl Gustav
Jung (1875-1961): the analyst of symbolic expression between depth psychology and human
sciences[23]. In the meantime a new psychiatry had arisen through Karl Jaspers (1883-1969) and his
21 GeneralPsychopathology[24], aiming at new interpretations and therapeutic efforts in the subverted
universe of psychosis.
The abovementioned arguments would seem to make it easier for psychopathological anomaly to be
considered part of physiopathology seen as paradigm. But this is not what happens, because the
corporeal phenomenon, such as physiopathology is inclined to consider it, does not present an
ontologically adequate basis on which the mind, or better still, the mental phenomenon can be grafted.
Bernard’s convinced opinions such as expressed in the Cahier rouge, namely that the characteristic of
everything is to be seen in its “sum total”, which, in turn, does not have a “specific material
substratum” but is “so to say the soul of the thing.” have remained isolated.Here we are on the
borderline of the immaterial which science far too often has considered and considers the border line of
what is thinkable, at least scientifically speaking. But it will be information theory and cybernetics to
cross the border, the fallacious border of what is conceivable. In the Fourthies and Fifties the cybernetic
expert Norbert Wiener states that such materialism which is not open to the immateriality of
information has no right to belong to modern scientific thought.
The physiopathological paradigm deserves credit for having faced and completed a substantial
evolution in the Twentieth Century aiming at detecting and describing the neurological and
neuroendocrinological oneness of the organism. The autonomous nervous system has thus become the
guarantor of internal homeostasis. The nervous system and the endocrine glands correlate into a new
research program namely that of the abovementioned neuro-endocrinology, cancelling the clear cut
difference Bernard had postulated between correlation-function and nutritional-function. But the unity
of the individual stemming from this, though representing an encouraging achievement, must be
subordinated to the psychosomatic unity of the person. Such unity, supported by an ontology at least a
virtual one, represents the new aim. Credit for having outlied it goes to the physiopathological
paradigm and to all of medicine. Now, paradigm and medicine will have to reach this aim, articulate
and define it in the coming decades.
THE REALM OF CHEMISTRY
At the end of the Eighteenth Century, the chemical analysis of life goes along with the traditional
morphological disciplines and with the most recent development of physiology represented by Antoine
L.Lavoisier (1743-1794) and his “chemical revolution”. Lavoisier was as courageous a forerunner in
discovering the elementary constituents of nature, as Galilei and Newton had been in dealing with the
laws of motion. Both the two revolutions then taking place, the social and the chemical one, reached
their climax in the same place and year. In Paris, in the year 1789, the States General assembled, and a
treatise was published, namely the General Treatise on Chemistry[25].
Air is no longer a simple body but shows to be an admixture of an oxydizing element plus an additional
one, which is insufficient to preserve life and is therefore called “azote”. The process of breathing
become clear: the lungs hold the oxygen contained in the inspired air and expell the residual part. In
those same years, the outlook from which living organisms had been observed and described, for
instance by the naturalist Georges L.Buffon (1707-1788) and by the physiologist Gottfried R.
Treviranus (1776-1837), tended to unify in “biology”, defined by Virchow: “a theory of life in general
and of man in particular” which he considered fully implemented in his own physiopathology. Between
the prospective of such biology and the new chemistry, Lavoisier had established an intrinsic relation,
and it was not by chance that one of his innovative reports had appeared in 1885, in the Annales de la
Société de médecine[26]. Lavoisier was guillotined, believed to be the “King’s farmer”, a tax collector
at the Crown’s service. Therefore he died young, but the road he had opened lead to remote,future
goals.
22 Physiological chemistry
Among other “elements”, also carbon was listed in great detail in the Treatise. Carbon combines with
the oxidative principle of air, forming an acid compound at the gaseous state. The privileged position of
carbon in the electrochemical table of elements was to be adequately explained later and gave birth to
“organic chemistry, which, at first, was linked to the organism considereed a presumable sythesisfactor for carbon compounds. Later, “organic” chemistry was detached from the “vital force”
hypothesis. Felix Hoppe-Seyler (1825-1895), derived from orgaic chemistry a “physiological
chemistry”. He also discovered hemoglobin, contained in red blood cells, as oxygen-conveyor to the
tissues. But it was Anders Angström (1814-1875), who discvered hemoglobin’s chemical structure and
dosage. Those were the years in which physiopathology and scientific medicine come to life with
Virchow and Bernard. the latter blieved, as some of the volumes of the imposing Leçons series show,
in an ample and close tie between chemistry and life. In 1878, Wilhelm Kühne, a German student of
Bernard, coined the term “enzyme” and contributed in detecting enzymatic gastric, interstinal abd
pancreatic factors acting in digestive processes. Enzymatic transformations, as the metabolic ones, can
be obtained outside the organism. In 1828, Friedrich Wöhler (1800-1882), produced urea, which is
usually produced experimentally, in protein metabolism, while in 1897, Edouard Büchner (1860-1917),
transformed glucose in ethanol and carbon dioxide, using a yeast-cell extract. Between the end of the
Nineteenth and the onset of the Twentieth Century, physiological chemistry and physiopathology had
worked out intense correlations which showed that chemical processes were practically ubiquitous in
vital processes, to the extent of thereseeming to be a cause and effect relation. “Biochemistry” comes in
when the theory of evolution explains the transition from inorganic nature to living nature as being part
of its discoveries, so that this transition becomes a less problematic question to the advantage of the
observation of reality with the use of concepts that act as evidence simulators. For instance, the
concepts of evolution itself, of selection, of adaptation and self-organization, presuppose their own
implementation. But the basic problems of transition from physics and chemistry to life proper, show
up again in the subsequent passage from biochemistry to “molecular biology”.
Biochemistry
The Twentieth Century inherited a kind of chemistry one could call external to the organism. Part of
this chemistry, as paradoxycal as it may seem, is a class of substances, namely “vitamins”, which the
organism itself is unable to synthesize despite the essential importance vitamins have for certain
functions. The Polish biochemist Casimir Funk (1884-1967), gave vitamins their name and, in 1914,
wrote a detailed work on these substances: Vitamins and their Importance in Physiology and
Pathology[27]. But the exogenous chemical substances, though strengthened by “organic catalyzers”,
as Funk defines them, in no way equal, as to variety of production and importance, the endogenous
substances stemming from chemical processes which take place in the tissues of the human and animal
body. Beside enzymes, equally important are “hormones”, so named by William M. Bayliss (18601914) and Ernest H. Starling (1866-1927), and the “chemical mediators” between nerves and muscles,
discovered by Otto Loewi (1873-1961) and Henry H. Dale (1875-1968). These substances penetrate in
functional connections and recesses and seem to recall the human-machine metaphor evoked by
materialist Julien de la Mettrie (1709-1751) in the Eighteenth Century and still effectively representing
the problem of the concurrence and the synergies of the parts when inserted in the whole. Endogenous
chemistry is of primary importance in two fundamental processes: metabolism and immunity.
Living organisms matabolismis is considered one of the main discoveries of the Twentieth Century.
Biochemists tend to call it “intermediary metabolism”, indicating all the protein-, sugar- and fattransformation stages which reach the branching point where substances are used ether for energy
production or to activate syntheses.
23 Hans A.Krebs (1900-1981), Albert Szent-Györgyi (1893-1986), and Fritz A. Lipmann (1899-1986): all
these names recall the exodus, in the Thirties, of a large number of scientific research pioneers from
continental Europe. Important concept definitions are due to the work of these authors, such as
metabolic process, reaction cycle, molecular conveyor, high energy potential chemical ties. Thus a
strict, binding order is introduced in the relation between inorganic nature and living nature. Inside the
so-called central area of metabolism, the “Krebs cycle” unifies the metabolic processes of proteins,
glycogens and lipids through catabolic and anabolic reactions which, in turn, are followed by liberation
and absorbtion, respectively, of energy. Lipmann’s research has stressed the role of a particular
substance: adenosinetriphosphate (ATP), with its molecule containing two phosphoric high energy
potential valences and therefore acting as energy accumulator and supplier. In recent years, Edwin G.
Krebs and E. Fisher, showed the presence of ATP in the glicogenous conversion chain in glucose,
through phosphorilation of the glycogenophosphorylase enzyme involving a process in turn catalized in
two ways by the double enzymatic factor kinase- phosphatase. The years of “molecular biology” are
approaching. The Schwann- and Virchow- cell has turned into a highly complex laboratory of which
microscopy has revealed the macromolecular components, placing the cell again at the centre of
biomedicine.
Discoveries on immunity proceed along the same lines as those on matabolism. They had started with
the observations and experiments of Charles Richet (1850-1935), whereby poisenous substances from
sea anemones were inoculated according to a set scheme in laboratory animals which did not become
immune but died, due to doses that would have caused limited effects in normal conditions. In 1902,
Richet coined the term of “anaphylaxis”, meaning extreme defence, and described it in an exhaustive
work in 1911[28]. Anaphylaxis develops into one of the chapters of immuno-pathology, while
immunity is more adequately described in physiological terms. Immunity tends to represent for
vertebrates, that which phagocytosis represents for invertebrates: namely a process in defence of
biochemical specificity. The process is activated when heterogenous substances cross the skin or
mucose barrier of a vertebrate and penetrate in its tissues. As the antigen penetrates --i.e. protein or
carbohydrate substances, but also lipids, acids and nucleic acids-, lymphatic organs produce antibodies,
consisting of immunoglobulines which combine chemically with the antigen activating it. Phagocytotic
cells operate synergically with the lymphocytes, which elaborate the antibodies. There are two theories,
the instructive one and the selective one, which try to explain the production of antibody substances.
According to the first one, prevailing in the Thirties, the antibody is produced by the direct action of the
antigen, inside the producing cells. According to the most recent selective theory, antibodies are
formed starting from the matrix of an information which preexists in the organism involved: the
antigen selects the cells capable of receiving it and, indirectly, provokes their proliferation.
The Australian immuno-pathologist Frank M. Burnet (1899-1985), added to the above mentioned
theory, the hypothesis of clonal selection, transfering the immunological inquiry to the molecular level
of immunoglobulines. While adhering to the globuline surface, the antigen selects the respective
antibody clone in the lymphatic organs which, in turn, cause the antigen’s selective multiplication. The
same mechanism is supposed to explain “autoimmunity”: some parts of the body which have become
heterogenous to the organism, become a target of defensive reaction to which immunity leads. The
standard work for this most recent problem is Burnet’s Autoimmunity and Autoimmune Diseases[29].
But in the Fifties, in physiopathology and specifically in immunopathology, a new chapter had opened,
the one of organ transplantation. The first organ transplanted successfully was the kidney, in 1955 in
two mono-chorionic twins. Then came the heart by the South African surgeon Christian N. Barnard.
Later other organs followed: liver, lungs, pancreas and intestin. Immunopathology faces a number of
problems such as: the answer of the recipient organism to the transplant, the rejection of the
transplanted tissues by the recipient organism, -but also the reverse case of bone marrow transplant in
which the transplanted cells reject the tissues of the recipient organism-. As a solution to these
problems, immunopathology uses pharmacological treatments to suppress rejection causing the so
24 called “immunosuppression”. Immunopathology tries solutions also with specialistic means and at any
rate represents the central point whereto all attemps converge. Pharmacology offers a new active
substance: cyclosporine, an 11 amminoacid cyclic polypeptide which interferes with interleucine, a
substance activating lymphocites, the producers of antibodies. Progress in immunity-research equals as
we said, progress in metabolism-research, and both belong to the scientific conquests of the Twentieth
Century.
Molecular Biology
Cell theory had added to the macroscopic magnitude of life, the microscopic visibility of life and thus
allowed a definition, not merely intuitive, of the living being. Physiological chemistry and biochemistry
had obtained a result of no lesser importance, namely the tie between living nature and inorganic
nature, whereby the former, as was at least implicitly suggested, depended on the latter. Precisely this
relationship reversed with the progression from biochemistry to molecular biology, the sterile paradigm
being put aside of «biocolloidology» (M. Florkin), and structuristic -- anchored at Linus Pauling’s
(1901-1994) The Nature of the Chemical Bond[30]- having replacede physicochemistry. The molecules
of life show a highly complex structure, a qualitative difference and are connected by explicit or virtual
synergies or scopes. But complexity is the term which predominates over all the others and implies an
organized and coded complexity. The first one to oppose the transmissible order of a “code-script” to
the statistical average and to consider this average insufficient to explain the hereditary transmission of
characteristics in living organisms wass Erwin Schrödinger (1887-1962), the discoverer of wave
mechanics. In What is life?[31], which contains his Trinity College lectures of 1949 in Dublin,
published the following year, mechanical philosophy of nature is substantially rectified. Referring to
Bergson’s judgment on Bernard, one could say that Schrödinger’s essay is a discourse on the method
for Twentieth Century science. A discourse, but also a prophecy: between 1944 and 1953, nucleic acids
endow the above mentioned code with a specific identity. James D. Watson’s and Francis H. Crick’s
short essy entitled Molecular Structure of Nucleic Acids[32] appears on the monthly “Nature” in April
1953, after a decade of study. The contribution of immunopathology to the new order of ideas had been
of great importance. However, as biochemist Erwin Chargaff, observes, the question required that
chemists and biologists accept the existance of gigantic molecules in nature. Farsighted Schrödinger
had described genes as macromolecules consuming negative entropy.
New horizons open up, new knowledge can be acquired. Partially, such learning integrates what is
already known about metabolism biochemistry, and partially it concerns the functional regulation of the
entire organism, including hereditary characteristics transmission. The structural compound of the two
nucleic acids -- ribonucleic (RNA) and desossiribonucleic (DNA) - is the “nucleotide”, consisting of a
carbohydrate and an azotate base, purinic o pirimidic: adenin, citosin, guanin, thymine, uracil. The
DNA of the human cell nucleus contains about three billiard nucleotides which act in triplets, the
“codons”. Though a large part is present in chromosomes,- but is extraneous to the gene acrivity, therefore not organized in triplets- the mentioned control on organic functions is very great and
articulate. But what becomes problematic is unity -- cell-unity, organism-unity, organ- unity- inside the
ocean of multiplicity on which biomedicine is called to navigate. Cells in the human organism are
supposed to be in the order of 10 to the seventeenth power. Alone the cerebral cortex is supposed to
have one hundred billion, whereby each cell can operate synaptically hundred billion connections.
Unity would require a leap similar to the one from the inertial quantity of matter, to the non-inertial
quality of “information”, a leap which cybernetics dared to take. But the step from the many to the one,
has not been taken so that a non-unified complexity shows which remains as it is, even today in the
science of life.
Does not, per chance, the new trend of ideas -to mention a preceding expression- imply abandoning the
original cellular matrix physiopathology? No, to the contrary, this physiopathology is confirmed
25 consequently to the cell transformation in laboratory showing the cell to contain the “Genetic code” at
the center of its functional synergies. Besides, riductionism is not willing to give up in favour of
structuralism, only because, from du Bois-Reymond to Schrödinger, the autonomy of meccanics has
proved unsustainable: yet structure shows an increasing number of facts in its own favour, as opposed
to the mobile material body. The new slogans are: macro molecules, double helix --of nucleic acids-,
nucleotides, triplets, ribosomes, amminoacids, mitochondrions. All of which are mentioned ever less
frequently because they upset the rationalistic scheme which has come to be. Rather, in scientific
discussion an ambigous term of ancient origin is crept in: chance. Jacques Monod, the cell-biochemist,
tries to explain in a volume published in 1970 --which does not keep the promise of its title Hazard and
Necessity[33], the order of life. Which means, in short, explaining all of comparative anatomy, with
chance mutations of the nucleotide sequence accepted and incorporated in the genoma. Geneticist
François Jacob, does not agree with him. Together with Monod he had discovered the ribonucleic acid
(RNA)action in proteine synthesis, as he writes in The Logic of Living Entity[34], of 1970, saying that
anorganism is the result of a series of organizational levels interlinked into one another
Another biologist, differently equipped intellectually, Renato Dulbecco, published the Project of
life[35], wherein he sees the “cellular machine” next as being close to DNA. In The Dream of the
Human genome and other Illusions[36], the geneticist Richard Lewontin of Harvard University,
accentuates his criticism with an ironic touch: “DNA is a dead molecule, one of the least active
molecules, and one of the least chemically active ones of the living world... DNA does not have the
capacity of reproducing itself...No living molecule reproduces itself. Only whole cells can contain the
entire mechanism required for self-reproduction, and even they, as development goes on, lose such
capacity. The linear sequence of nucleotides in DNA is used by the cell mechanism to determine
whichaminoacid sequence has to be inscribed in a proteine, and to determine when and where the
proteine has to be produced.” (pp 112 fol.)
Lowentin’s criticism seen from a positive angle could lead to state that nucleic acids belong to the
production cycle of proteins and that they represent the codified moment of structural invariance. The
recent reappearing of "proteomics” in biomedicine could be the sign of an inversion of tendency in the
molecular biology theoretic and experimental itinerary. Meanwhile, the Genoma Project, the
international initiative aimed at sequencing the about three billion nucleotides contained in the 23
chromosomes of the human cells, has ended in a spectacular way at the end of the century and the
millennium. In announcing this acheivement on June 26th 2000, the President of the United States and
the British Prime Minister, gave the impression of wanting to close the century and the millennium
with a political victory, but, incidentally, the announcement was premature.
Subsequently, causes were found thatexplained empty spaces, as the geneticists call them , and
inaccurate sequences on one or the other chromosome. A few days ago, “Nature” published news about
the advanced sequencial analysis of chromosome 11, hosts of one of the Alzheimer “loci” and coresponsible, in 5% of cases, jointly with chromosome 21, of the Down syndrome -- the so called
trisomy of chromosome 21 discovered (1958) in mongolism by the French clinician and geneticist
Jérôme Lejeune (1926-1994). The relationship between gene “loci” and function is not the same as that
between key and letter on the typewriter, except in rare instances. One function corresponds to a
structure having numerous genic, and sften chromosomic, locations. Life is structure on all levels. As
mentioned, only three to 5% of the nucleotide sequence constitute the “genes”, while origin and
function of the remaining part are still unknown. The mentioned relationship shows surprising data.
According to one hypothesis, the so called “DNA trash”, i.d. the non-genic one, is due to virus which
penetrated human cells during the long life history. Should such theory be proved, it would conferm the
existance of strong structural correlations inside the classes into which living organisms are subdivided:
types, classes, orders, kinds, species, down to the class which has one single member, the individual.
Based on the correlations mentioned, a molecular minority could coexist with an overwhelming
26 molecular majority and exert its own control upon it: in a similar way, all DNA is“packaged” into
chromatine according to a single topological invariation.
CLINICAL MEDICINE
Clinical medicine and pathology
Confirming that the cell is the chemical laboratory of life is primaty in the continuity of biomedicine
development. The electronic microscope was perfected in the last post-war period. Its use allowednanodimensional structures to be observed and describedand to show the actual structures present, for
instance of homogenous material described generically as protoplasm. The function of form as a
necessary aspect of cell function was confirmed. The way intercellular communication take place
through neuro-transmitters and hormones became clear in detail. A cell-death program, “apoptosis”,
meets with growing interest, as it seems to explain that the program’s failures allows the survival and
degenerative development of tumor cells. Virus, retrovirus, prions depend on the cell, as being the
complete expression of vitality. Physiopathology and cell-theory were intrinsically tied: in the cell
scientific life-theory found the basis of its own soundness, of its own realism. Physiopathology offered
also a safe anchorage to clinical medicine. Clinic beingthat particular kind of medicine in which single
morbid condition are observed, analysed and described, before diseases are classified. Only then the
dyagnosis of the patient’s case is fitted into the physiopathological categories.
Before completing the diagnosis, physiopathology helps clinic with what could be called the
physiopathologic approach. Which means: starting from the observation of a disturbed function and
only then looking for the cause of such disturbance, to then procede with the diagnosis and, at last,
verify the correctness of the interpretation checking the effect of the chosen therapy. In the background
of clinical medicine something remains,a precious and gelously kept posession of clinic and not of
pathology: the single individual, with his life style and his psychophysical individuality, which can in
no way be fitted into any category or classification.
Orphan diseases
The cell was revalued as being basic to physiopathology and thus to biology, such as Virchow had
conceived it and became a hypercomplex chemical laboratory in which any change, or the lack of one
single functional element causes a pathologic event or situation. This is what happens in “unusual
diseases”, or “orphan diseaes”, as the British terminology goes. We know about them through the 1989
National Commission on Orphan Diseases Report, issued by the United States Government. This report
shows how difficult rapid diagnoses are in these cases, while at times it takes months if not years
before they can be formulated. Out of about 5000 unusual diseases, 4000 are gentic. These diseases are
an economic problem as the limited sale of the necessary drugs to cure them is not profitable. However,
some of these drugs are also used in normal diseases and yeald enough profit as to make them worth
while for industry.
Clinical medicine keeps in contacts with cell physiopathology, or at least with organ-physiopathology
through specific branches, such as laboratories and Public Health medical technology as it operates in
today’s modern societies. But even in the circumstances just mentioned - which facilitate therapy,
though limiting the intuitive approach-, clinical medicine still keeps a double privilege: its relationship
with the individual as a whole, and the personal participation to the rational scientific approach not
limited to the mere application of its instruments. Nature has no duplicates: even homozygous twins
have different fingerprints. The Hippocratic conquest of the “hekastos”, the each and single, the this
and the that, still keeps its diagnostic importance, beside the necessary attempt to fit the unique case,
despite its low statistical frequency, into a more general and better defined entity.
27 Syndromes
In clinical pathology, the syndrome has acquired an ever growing importance beside the disease proper
and the morbid situation. The syndrome is part of both: part of pathology inasmuch as it concerns
anatomo-physiology, and part of the clinic due to the individual differences manifested. In the Thirties,
a Canadian of Austrian origin, Hans H.B. Selye (1907-1982) studied a “general adaptation syndrome”
which he later termed the “stress syndrome” In The Stress of Life[37], he described an alarm reaction,
a resistance phase and a state of exhaustion. The organism is involved in the syndrome through its
nervous system and through the endocrine and immunitary systems. According to the pattern outlined
by Selye, the hypothalamus releases the corticotropine release factor (CRF), which in turn causes the
release of the adrenocorticotrope hormone by the anterior hypophysis: this hormone reaches the
surrenal glands, which, again, release into the blood stream, steroid hormones that act on numerous
target organs. The two volumes Hormones and Resistence[38] ended a highly original research
program which had reformulated the generic concept of syndrome in that of reactive synergy,
highlighting one of the many unitary aspects of the organism. The recent “acquired immunodeficiency
syndrome”, known as AIDS, is caused by the retrovirus HIV, a vehicle of inverse enzyme transcriptasi,
which allows genetic information to be transferred with an inverse course from RNA to DNA. The
“Down syndrome” or Mongolism, has been attributed to chromosome 21 trisomy. Georges Devereux,
the ethno-psychyatrist, stated in the Sixties, that some specific “ethnic syndromes” had been detected as
having cultural progoms. In all mentioned cases, syndrome means the oneness of morphofunctional
multiplicity and represents the seal of complexitywhich shows as unified multiplicity, also in the
pathology of life.
ALTERNATIVE MEDICINES
All so-called alternative medicines, excepting homeopathy, stem from areas culturally remote from
Europe and the United States and show common features. The clinical aspect prevails on the pathologic
one and simulates a latent Hippocratism, provided the formula “observatio et ratio” is replaced by
another totally different one, namely “observatio et sanatio”. Hippocrates of Cos, the greatest thinker to
whom some specific and patently theoretic parts of the Corpus hippocraticum are attributed, fought the
“medicine of postulates” and its arbitrary theorizations, in opposition to a fruitful synthesis of empirism
and rationalism. What the physician sees facing him, is always a “this”, an “aech and unique one”. But,
according to what Plato’s Phaedrus, proves, Hippocrates maintained that neither the soul nor the body
can be known “disregarding the nature of the whole”. Thus a decisive step was taken from therapeutic
pragmatism to the biomedical culture of totality. Namely a culture which procedes historically through
complementary processes of accumulation and innovation and operates in increasingly broader and
more coherent cognitive syhtheses.
One of Hippocrates’ most important works is Ancient medicine (Archaie ietrikè). The title reflects the
long growth and sedimentation process which permitted, at the time, the existance of medical
categories which outlined and valued experience. There is no clinic without pathology, except in the
Baconian form of “absence and presence tables”. Critical reflection andevaluation of what has been
observed is not possible: no dialectical relationship between the observed facts and the theoretic
presuppositions take place. Evaluating experience becomes a risky task.
Let us look at “acupuncture”. Between 1948 and 1949. this therapy is registered in the Health
Regulations of the ChineseRepublic as a remedy against pain, functional disorders and numbers of
morbid states relating to obstetrics and gynecology. Acupuncture is based on a general theory of the
universe which envisages the existance of two opposed principles: Yin and Yang, and of five elements
28 representing the vital energy which flows through the whole body through a system of “channels”, or
“meridians”, which the thin needles are meant to reach at certain definite points in order toreestablish
the balance upset by the disease. A collateral practice, called “moxibustion”, uses Artemisia (moxa)
hooks instead of needles in direct touch with the skin. As Lu Gwei-Djen and Joseph Needham -founder of English biochemistry who converted to sinology- wrote in Celestial lancets. A history and
Rationale of Acupuncture and moxa[39], 1880: “Undoubtedly, acupuncture has represented a system of
cardinal importance in the history of Chinese medicine, but the objective evaluation of its actual
effectiveness has been until recent times, and continues to be to a certain extent even today, at the
center of wideranging debates. In East Asia some physicians who studied in modern universities, both
Chinese and Western, are totaly skeptical as to acupuncture’s effectiveness. Nobody will presumably
be able to fully evaluate the actual effectiveness of this method... until inquiries with modern medical
statistics will analyse adequate case records. Unfortunately the implementation of such programs may
require even more than half a century...” (pgs.7 fol.). The hypothesis of endorphin secretion is a
frequent explanation of the analgesic effect of this therapy.
In the absence of an ordered network of definitions and observations expressed in an appropriate
language, the observed material cannot represent a point of reference, of denial or inference, as relates
to presuppositions which have been determined in different ways-- this is the third, fruitful way of
scientific reasoning, beside deduction and induction. If acupuncture leads back to China,
“pranotherapy” leads back to India. In Hinduism, as we said, everything tends to become divine and
every divine manifestation lacks that which Western thought, from Aristotle on, calls the “per sé”, the
“absoluteness”. The Sanskritic term “prana” recalls the five types of energy which pervade tissues and
organs during all of the body’s lifetime.
Absorbed through breathing, vital energy is supposedly transformed into seven definite centers and
distributed through specific canals into all parts of the body. The therapist uses the right hand as a
radiating hand, and the left as an absorbing hand. “Manual medicine” is, at least partially, equivalent to
pranotherapy and chirotherapy in Western scientific tradition, its practice and categories, specially the
American one. Another Indian medicine is the “ayurvedic medicine”, the term meaning “knowledge of
longevity”, and it is widely practiced in a great number of hospitals. Tibetan and Lama medicine
deserve at least a short mention. The studies of the Benedictine Cyrill von Korvin-Krasinski, mainly
Tibetan Philosophie of Medicin. Man as a Microcosm[40], represent one of the few attempts to set up
an organic system of medical knowldge, alternative to the Western one, deeply rooted in philosophy
and cosmology. Microbiotics, in turn, leads to Japan. The term is a clumsy adaptation from ghe Greek
by the Japanese Nyoiti Sakurazawa (1893-1966), to indicate the discipline which supposedly leads to a
long life if nourishment consists only of food with no chemical or industrial additives used in
agriculture.
“Homeopathy” belongs to Western tradition. It is the most widespread and convincing, alternative
medical doctrine, despite its being limited to pharmacologic therapy. This doctrine, initiated by Samuel
F.C. Hahnemann (1755-1843), is rooted in Hippocratic tradition and aims at “a rational art of healing”.
Its widely known healing principle is: “similia similibus curantur”, meaning that when whatever causes
the disease is administered in minute doses, it produces recovery. But homeopathic dilutions of the
drug reach the point of mathematically proved inexistance of the substance: unless extreme hypotheses
are referred to, such as the “memory of water”, of French physicist Jacques Benveniste, or the “superradiance” of the Italian Giuliano Preparata and Emilio Del Giudice. These hypotheses met with firm
opposition, though they were also backed, specially the second one, by scientists of high standing.
Homeopatic and allopatic methods continue to dialogue with each other and so do the two trends of
today’s homeopathy: the humanistic one, essentially Southamerican and Italian, and the biologicalphysical one. In 1997, the important monthly “Lancet”, published a critical inquiry, or “meta-analysis”,
later criticised, on inquiries concerning the actual effectiveness of this medicine, carried out in
preceding years. The results obtained, it seemed, could not be entirely explained with the placebo
29 effect, through self-persuasion. It needs other hypotheses, which have not yet been found, to explain
the healing-effect of the healing-effect (pgs. 834-843). The American Office of Alternative Medicine
was created in 1992, as part of the National Health Institutes, under the direction of Wayne Jonas. Its
purpose is to control closely, though leaving enough lee-way for innovations, the promising field of
homeopatic medicine which, at present, still lacks cognitive foundations.
NEUROSCIENCES AND CYBERNETICS
Neurosciences belong to the Twentieth Century even though the cell, as such, was already studied by
anatomists and physiologists such as Camillo Golgi (1844-1926) and Santiago Ramon y Cajal (18521934), and the term “neuron” was coined in 1891 by Heinrich G.Waldeyer (1836-1921). But the
Nineteenth Century had achieved no lesser feat in creating the physiology of sensation, or
“esthesiology”. This term disappeared, as the basic importance of its content was vanishing. Before
Helmholtz contributed with his two works, which we already mentioned, on acustics and physiologic
optics, a so-called “Goethian era” had had great theoretical relevance. In his Theory on Colours[41],
J.Wolfgang Goethe (1749-1832), had convincingly asserted the subjective nature of the chromatic
phenomenon. According to him, this could not be reduced by the white light analysis, as Isaac Newton
maintained in his A New Theory about Light and colours of 1672[42]. Previously mentioned Müller,
transferred the Goethian subjectivity to a subjective objectivity, adding the experimentation of the
subject on himself with the work Comparative Physiology of Sight in Man and Animals[43].
In proclaiming his “ignorabimus” about the mechanical conception of the world, du Bois-Reymond
referred precisely to the turn from quantitative to qualitative, and from homogenous to heterogenous,
which took place with the law on the “specific energies of the sense organs”, formulated by Müller, his
master. This law stated that different sensorial areas cause distinct sensations, each one causing its
specific sensation, regardless of the type of stimulus. But du Bois missed the other Müller innovation
of epistemological nature, namely the passage from an objectivity, external to the subject, to an
objectivity intrinsic to subjectivity, but capable of being transformed into scientific statements by the
activity of thought. With Alfonso Corti’s (1822-1876) discovery of the inner ear spiral organ ,
published in 1851 in Researches about Hearing’s Organ in Mammalians[44], the central nervous
system --prior to the neuron discovery- had shown one of its admirable structural conformations. These
also had escaped the attention of the electro-physiologist du Bois, though they could well represent an
eighth “enigma” in the list of incomprehensible manifestations of nature, the ones that could not be
desumed from a conception of material parts in mutual interchanging movement.
What has been said so far makes it clear that neurophysiology --to speak of neurophysiopathology
would go beyond historic objectivity- has represented a markedly specific area of biomedicine wherein
to carry out thorough theoretic studies close to gnosis. In order to correlate the continuity and
connection of rational activities to the anatomo-physiological structures of the nervous system, Golgi
advocated the thesis of the interneuronal net, against Cajal’s opposite thesis which was to prevail, on
the autonomy and dynamic polarity of the single neuron. The need for oneness was to appear again
with Charles Sherrington (1857-1952), author of a classical work: The Integrative Action of the
Nervous System[45], which was published in the first years of the new Century. “Integrative”,
“integration”: the nervous system, at every level of its structure and of its functions unifies various
entities, instruments and moments acting as structural paradigm for the entire organism. The organism,
in turn, needs to unify its necessary differentiations. Neuronal units integrate thorough “synapses”,
electric transmission and chemical mediation, through agonistic muscle contraction and antagonistic
muscle relaxation, both induced via nervous paths, while peripheral innervations integrate with effector
organs. Integration conceived as unification endows Sherrington’s neurophysiology with the privilege
of being the show-case of the living organism, a privilege formerly held by embryology. Sherrington is
30 a dualist who believes that mind and brain are two different entities, but his dualism, as opposed to the
Cartesian one, contains an analogy between the two terms. The brain’s integrative, unifying function is
analogous to the mental universe’ oneness and to that which produces the latter, the unifying activity of
thought. The first can act as an instrument of the second in the psycho-physical makeup of the human
subject. One of Sherrington’s students, John Eccles (1903-1997), was to take up the mentioned
problem of dualism and the problematic but fertile need for unification.
With Eccles and his The Self and its Brain[46], written together with the philosopher Karl Popper
(1902-1994), Sherrington’s dualism converts into “interactionalism”: physical, psychical and logical
interactionalism. Cerebral events cometo be thinking subjectivity inasmuch as they are inserted in a
pure objectivity, claimed equally by mathematics. But another paradigm still, is knocking at
neuroscience’s door, namely “cognitivism”. This, M.S. Gazzaniga summarizes in a volume The
Cognitive Neurosciences[47]. Mental events are studied scientifically using the simplified model of the
“robot”, adding to it the sherringtonian synaptic plasticity. Cognitivism is now an overwhelming flood,
but mathematics still acts as a dike postulating an objectivity of an archaic, originary kinde which
watches over the mind in its quest for the truth of its own assertions. It seems impossible to fill out the
trench between logic and mathematics on the one hand,and neurology and cognitivist psychology on
the other, which goes to show the problematic magnitude of contemporary science.
By now large numbers are normal in biomedicine and in neurology itself. There is primary need for a
unifying correlation, but the interruption of the relations to metaphysics makes its implementation
difficult. Ludwig von Bertalanffy (1901-1972), an Austrian who later emigrated to Canada, broached
the subject of the“theory of systems”. He wisely deemed that the oneness of the living should be
analized and discussed before the finality, but the technological prospective seems insufficient and
limitating. However, “bionics” is created and aims at studying the motor and sensory functions of
living organisms, beside their imitation with electronic or other type contrivances. The result is a
succession of inventions: as submarine screening, ecometer, radar, sonar, sense organs similar
transductors, artificial neurons. In the Fourties, the theory of systems is followed by the “theory of
robots” and its more general and organic formulation, “Cybernetics”.
Reference to the usual simulator of conceptual evicence, evolution, does not prevent Norbert Wiener
(1894-1964), from firmly stating and admitting the immateriality of a magnitude which is about to
become ubiquitous in science: “information”. In Cybernetics[48] Wiener wrote: “Information is
information and not matter or energy. Now -a --days, no materialism refusing to admit this can survive!
(pg. 177). After the Schrödinger ”code”, Claude Elwood Shannon in his clasical essay: A Mathematical
Theory of Communication[49]-- equally issued in crucial ’48 - worked out “information”
mathematically, but did not define it, and “Information” clearly showed to what great extent
biomedicine would enrich an unlimited inquiry on the theoretical foundations of science.
Shannon and Wiener brought two different research organisatons together: “big science” of Bell
telephone laboratories , and the interdisciplinary groupwhich pool their respective organizatins.
Biomedicine, with its neurophysiologists and cardiologists, is studied in the small, friendly community
where Wiener operates at the Massachusetts Institute of Technology. Information has the typical
features of a new discovery and is still intuitive. But its becoming a primary notion in practically all
scientific axioms, some of which rest on mathematical formalism, witnesses the decisive importance of
information. But the passage to the realm of evidence simulators proved to be a serioius risk and
remains such fifty years later. Evolution, informatiion: the lack of a deep-going inquiry relating to
philosophy deprives biomedicine of participating, with enriching ontologic elements, to what we might
call the consciousness of the scientific knowledge of the world.
31 PHILOSOPHIC REQUIREMENT
In 1877, Hermann Helmholtz held a conference in Berlin entitled Thought in Medicine[50] which is a
rich source of information about the years in which the physiopathologic paradigm of biomedicine
compelled recognition, and organ physiology was accepted owing to Helholtz himself. The latter
commented: “The discovery of an idea does not restrict itself to gathering superficial similarities, but
emergesfrom a view which has captured the deep connections of the whole (...)”. Science cannot
escape the task of enucleating the conceptual foundations of theories and the central nucleuses of
assiomatics which have the function of tying moments, aspects and parts in a synthesis giving a
meaning to everything and making everything understandable. Abandoning simulators of evidence,
from whatever source they may have been drawn, goes hand in hand with the enucleation of
foundations in the sense of determinating characteristics of the observed evidence, of the implemented
analyses, of the carried out experiments. It seemed possible to consider the new cell-theory, which
emerged within the realm of molecular biology, as the foundation of today’s biomedicine and to accept
the cognitive superiority of tradition over alternative medicines. Inside the cell, the existance of a
prevailing characteristic has been supposed, namely synergy. Synergy is seen as a functional unit of a
mutiplicity of active parts so numerous and diversified as to belong to the complexity scheme, of which
it represents the most convincing example.
Besides, synergy and complexity of life are not restrained to cell-level, but precede analogous
manifestations in organ- and system- physiopathology, as well as in the organism as a whole. Synergic
unification of complex functional amd morphological multiplicity: this, in short, is “what life is”, what
nature is, which we consider living because it is capable of assimilating heterogenous substances, of
growing, of reproducing itself and of reacting to stumuli in a specific way.
Reflecting on biomedicine, consequently to the pressing importance reflected in Helmholtz’slapidary
formulation,means above all reflecting place on the possibilities, the implications and the way in which
a complex, synergic, unified multiplicity comes about. We must revert to the concept of nature, we
cannot not do so. Perhaps this reverse way may push us as far as the concept of the original reality, the
one that preceded any other determination.To disregard, to presuppose, means a severe option for an
entire culture, which risks in its choices, to detach itself from the archetype of reason --meant as an
inconditioned understanding-, and orient itself towards the attenuated formula of practice. A pictresque
expression: “coupure èpistèmologique”, by rationalist Gaston Bachelard, (1884-1962), is a reminder
that a double “epistemological cut” has divided the course of science: between modern mechanics and
Aristotelian physics, and between an informational concept of nature and meccanicism. For the neurophysiologist du Bois-Reymond, life was not included in the list of the “enigmas”: it was after all a
question of material parts having a set position in space and of movement connotations, equally set. But
information is added to two equal bodies, in the restricted meaning of du Bois, and makes them
different in terms of structure and property. The question which is also the title of Schrödinger’s
eassay, is by no means rethorical: life is a problem which intuition entrusts to analysis and analysis
returns unsolved. It is a problem which in thought becomes sharper, more exasperated, in as much as
the moment of rationality --which du Bois honestly admitted being enigmatic- faces man, together with
his non-patent evident physical vitality.
But let me come back to philosophy , after the long and constructive development of biomedicine
during the Twentieth Century. Ethics has emerged as an impellent necessity in a world of knowledge
able to face with contrasting choices the crucial moments of individual existence. It is an alarm signal,
but certainly not the solution to the metaphysical problem which living nature represents. There is an
ontological background which justifies, or refuses, the choices physician and society intend to take. In
civil life, in the legal or political realm, bioethics tends to defines its own, autonomous laws. But the
limitations of such autonomy disappear as soon as reason appears and, with its quest on life’s essence,
re-opens a gigantic cosmological and ecological, beside an anthropological scenario. The ban on
32 evidence simulators must go along with an attitude of subtle and vigilant analysis towards theories still
in the making, so that new, elusive theories will not replace the preceding ones. This applies
particularly to opinions on the “self-organisation” of physical and biological systems. Within which
limits and from what does a system auto-organize itself? Synergetics, is presumably the scientific
theory closest to synergy. It is a kind of thermodynamics of irreversible processes which concerns --as
Hermann Haken states- physical, chemical and biological systems, remote from thermic balance, where
the qualitatively new processes take place that cannot take place within balanced or almost balanced
systems. Whence the novelty originates, synergetics does not state, nor does it deem it necessary to
formulate a hypothesis. Yet, it is precisely this problem that has to be faced and choices have to be
made between dilemmas and alternative solutions proposed. Let us make an example. Alexis Carrel
(1873-1944), started organ transplantations and in vitro tissue cultures. The biophysicist Pierre
Lecomte de Noüy (1883-1974), who worked with him, stated that to consider life due to chance, equals
believing a monkey at the typewriter could create the Divine Comedy. As infinitesimal as the
possibility that this may happen is, it is not nil, and this is what matters for rational absurdity. Also if
differently formulated, de Noüy’s hypothesis could have turned out an absurdity: it sufficed to have
Dante’s poem consist not of a sequence of words, i.e. of alphabtic signs, but of a construction of
meanings, and the Primate typist as an alternative to the poet would have been out of the question to
begin with.
The answer to life, a coherent answer relating to what life has been telling us about itself, is the task of
a philosophy which is willing to take corageous choices -in logics they would be called
“counterintuitive”- and which is backed by institutions, universities, academies, congresses. Here,
overall research can be centralized, and dialogue can go beyond, whenever necessary, traditional
experiences and limitations. Bioethics, in turn, will wittness an ever incresing awe which birth,
suffering and death inspires in everyone. Philosophically substantiated, bioethics canformulate and
justify behaviour norms and inescapable imperatives.
[1] DU BOIS-REYMOND E., Gedächtnissrede auf Johannes Müller. Gehalten in der Leibniz-Sitzung
der Akademie der Wissenschaften am 8.Juli 1858, in Reden, II, Leipzig: Veit & C., 1887: 143-334.
[2] HUMBOLDT A. VON,Kosmos, Entwurf einer physischen Weltbeschreibung, (5 vol.),Stuttgart:
Cotta, 1845-1862.
[3] SCHWANN TH., Mikroskopische Untersuchungen uber die Uebereinstimmung in der Struktur und
dem Wachsthum der Thiere und Pflanzen,Berlin: Sander, 1839.
[4] VIRCHOW R., Die Cellularpathologie in ihrer Begründung auf physiologische und pathologische
Gewebelehre, Berlin: Hirschwald, 1858.
[5] HELMHOLTZ H., Handbuch der physiologischen Optik, I, Leipzig: Voss 1856; II, 1860; III, 1867;
IV, 1887; V, 1889; VI-VII, 1892; VIII, 1894; «Schlusslieferung» 1895
[6] ID., Die Lehre von den Tonempfindungen als physiologische Grundlage fur die Theorie der Musik,
Braunschweig: Vieweg, 1863.
[7] DU BOIS-REYMOND E,Die sieben Welträthsel, in Reden, I, Leipzig: Veit & C, 1886: 381-411
[8] ID., Ueber die Grenzen des Naturerkennens, in Reden, II, … p. 105-140
[9] ID., Ueber die Grenzen des Naturerkennens. Die sieben Welträthsel, Leipzig: Veit & C, 18842
[10] BERNARD C., Leçons sur les propriétés des tissus vivants, Paris: Baillière, 1866
[11] ID, Leçons de physiologie expérimentale appliquée à la médecine, (2vol.), Paris:Baillière, 1855-56
[12] ID., Leçons de physiologie opérative, Paris: Baillière, 1879
[13] ID., Introduction à l’etude de la médecine expérimentale, Paris: Baillière 1865
[14] ID., Principes de médecine expérimentale, Paris: Press Un. De France, 1947
[15] ID., Le cahier rouge, Paris: Gallimard, 1942
33 [16] FREUD S., Quelques considérations pour une étude comparative des paralysies organiques et
histériques, in Archives de Neurologie, 1899, XXVI : 29-43 e in Gesammelte Werke, I, London
:Imago, 1965: 37-55.
[17] FREUD S., BREUER J., Studien über Hysterie, Leipzig-Wien: Deuticke,1895 e in Gesammelte
Werke, I…….: 75-312.
[18] ALEXANDER F., Psychosomatic medicin: ist principles and applications, New York: Norton,
1950.
[19] BALINT M., The basic fault: therapeutic aspects of regression, London: Tavistock Publications,
1968
[20] WEIZSÄCKER V. von, Natur und Geist. Erinnerungen eines Arztes, Göttingen: Vandenhoeck &
Ruprecht, 1954
[21] AMMON G., Psychonalyse und Psychosomatik, München: Piper, 1974
[22] FREUD S., Hemmung, Sympton und Angst, Wien: Int. Psychoan. Verlag, 1926
[23] JUNG C.G., Wandlungen und Symbole der Libido, Leipzig-Wien: Deuticke, 1912. La quarta
edizione dell’opera, totalmente rielaborata, uscirà nel 1952 presso l’editore Rascher a Zurigo con il
titolo Symbole der Wandlung.
[24] JASPERS K., Allgemeine Psychopathologie, Berlin: Springer, 1913.
[25] LAVOISIER A.L., Traité élémentaire de chimie: presenté dans un ordre nouveau et d’apres les
decouvertes modernes ; avec figures, Paris: Cuchet, 1789
[26] ID., Traité…..pp.226-228.
[27] FUNK C., Die Vitamine: ihre Bedeutung für die Physiologie und Pathologie mit besonderer
Berücksichtigung der Avitaminosen, Wiesbaden: Bergmann, 1914.
[28] RICHET C., L’anaphylaxie, Paris: Alcan, 1911
[29] BURNET F.M., Auto-immunity and auto-immune disease, a survey for physician orbiologist,
Philadelphia: Davis, 1972
[30] PAULING L., The nature of the chemical bond,Ithaca: Cornell Univ.Press, 1939
[31] SCHRÖDINGER E., What is life: the physical aspect of the living cell, Cambridge: Univ. Press,
1944.
[32] WATSON J.D., CRICK F.H., Molecular structure of nucleic acids, in Nature, 1953, 171: 737-738.
[33] MONOD J., Le hasard et la necessite: essai sur la philosophie naturelle de la biologiemoderne,
Paris: Seuil, 1970
[34] JACOB F., La logique du vivant : une histoire de l’heredité, Paris: Gallimard, 1970
[35] DULBECCO R., Il progetto della vita, Milano: EST Mondadori, 1989
[36] LEWONTIN R., It ain’t necessarly so: the dream of the human genome and other illusions, New
York: New York Review of Books, 2000
[37] SELYE H., The stress of life, New York: McGraw-Hill, 1956
[38] ID., Hormones and resistance, Berlin: Springer, 1971
[39] GWEI-DJEN L., NEEDHAM J., Celestial lancets: a history and rationale of acupunture and
Moxa, Cambridge: Univ. Press, 1980.
[40] KORVIN-KRASINSKI C.von, Die Tibetische Medizinphilosophie: der Mensch alsMikrokosmos,
Zürich: Origo Verl., 1953
[41] GOETHE W.J., Zur Farbenlehre, Tübingen: Cotta 1810
[42] NEWTONI., New theory about lights and colours, in Philos.Trans.R.Soc.London, 1672, 80: 30753087.
[43] MÜLLER J., Zur vergleichenden Physiologie des Gesichtssinnes des Menschen und der Thiere.
Nebst einem Versuch über die Bewegung der Augen und über den menschlichen Blick, Leipzig:
Cnobloch, 1826
[44] CORTI A., Recherches sur l’organe de l’ouie des mammifères, in Zeitschr.f.wissenschaftl.Zool.,
1851
34 [45] SHERRINGTON C., The integrative action of the nervous system, New York: Scribner, 1906
[46] ECCLES J., POPPER K.R., The self and its brain, New York: Springer International, 1977
[47] GAZZANIGA M.S., The cognitive neuroscience, Cambridge, Mass.: MIT Press, 1995
[48] WIENER N., Cybernetics, or control and communication in the animal and the machine, New
York: Wiley, 1948
[49] SHANNON C.E., A mathematical theory of communication, in Bell SystemTechnology Journal
Urbana, 1948, 27: 379-423 e 623-656; in volume con il titolo The mathematical theory of
communication, Urbana: University of Illinois Press, 1949
[50] HELMHOLTZ H., Das Denken in der Medizin, (1877), in Vorträge und Reden, II, Braunschweig:
Vieweg, 19035: 165-190.
35 MÓNICA LÓPEZ BARAHONA
SOME RECENT ADVANCES IN MOLECULAR BIOLOGY
WITH A DIRECT IMPACT ON HUMAN LIFE
INTRODUCTION
Biology can be defined as an area of learning that deals with all the physicochemical aspects of life.
Because biology is such a broad subject it is subdivided into separate branches for convenience of
study.
Molecular biologyis one of these branches; as a matter of fact, nowadays biology is often approached
on the basis of levels that deal with fundamental units of live. At the level ofmolecular biology, life is
often regarded as a manifestation of chemical and energy transformations that occur among the many
chemical constituents that comprise an organism.
Just as the 19th century can be considered the age of cellular biology, the 20th century was
characterized by developments in molecular biology. Actually,molecular biology has been an area of
the knowledge that has experienced a dramatic revolution during the past two decades.
It is really difficult to summarize all the advances that this area has achieved. However, some of those
achievements have a special incidence on human life and therefore they are especially important for the
PontificalAcademy for Life.
Molecular genetics and cell biology are areas of molecular biology where revolutionary knowledge has
been acquired. In both fields may be found critical issues of research that directly affects human life.
Molecular genetics includes the study of the molecular nature of the gene and the method by which
genes control the activities of the cell. Based on this molecular nature of genes their sequence might be
determined and the function of the proteins that they encode may be predicted.
Cell biology is the study of the fundamental unit of structure and function in a living organism: the cell.
It may be said to have begun in the 17th century, with the invention of the compound microscope. But,
even if its major brightness was at the 19th century, the end of the 20th century and the beginning of
the 21st century have been of a great importance for the area.
MOLECULAR GENETIC: SOME HUMAN GENOME ELUCIDATION IMPLICATIONS
Probably the most spectacular advance obtained last century in the genetic engineer area was the
resolution of the sequence of the human genome[1] that was obtained some years before expected.
The fact of knowing the sequence of human genome offers a powerful tool to other bioscience areas,
and in a very special way to medicine [2].
Several laboratories all over the world are now working on elucidating the human genome map and on
the coding sequences of the genome that will encode all the different proteins that integrate a human
being. Actually the field of genomic studies is now opening tremendously interesting avenues towards
the field of proteomic studies and human proteome is expected to be deciphered quite soon.
The actual knowledge of human genome opens the possibility of predicting the behaviour of certain
diseases (mainly those that have a genetic origin).
Cancer is one of the diseases with a clear genetic origin, and there is no doubt that the understanding of
this pathology is being increased thanks to the powerful techniques of sequencing that offers the
development of the DNA-chips [3] For example, we are able to classify new different tumours
according to their gene pattern of expression and this classification allows to establish a better
diagnosis and permits to design in many cases a personalized therapy.
36 This information that concerns the evolution of a disease offers new approaches of treatment and is
changing the current medicine towards a predictive and personalized medicine.
However, the identification of genes that are implied in certain pathologies opens as well the possibility
of both classifying people based on their genome, and establishing categories of possible patients of
certain disease.
Confidentiality at that point is a very important issue, because the fact of knowing that a certain person
has certain genes mutated and therefore has an higher risk of developing, for example, a cancer might
have an effect on his insurance policy, or in his professional situation.
Discrimination based on a possible genetic determinism is a very important ethical problem that
appears as a consequence of the information that the knowledge of the human genome brings.
There are two rights that should be considered and could lead to important discrimination conflicts:
The right of the insurance company to have information about its insured or the right of the company to
have information about the health of its employees.
The right of confidentiality of the genetic information of an individual.
It is important to take into account that a human being is not only a very well coordinated group of
genes and that his history, even the clinical history of a person is not only written in its genes. Man is
body and soul, and genes do not determine one’s behaviour, not even a clinical behaviour.
The declaration of human rights clearly point out that: “A person cannot be discriminated based on
their sex, race, religion or genes”[4]
Unfortunately, weconstantly witness the violation of this principle, for example in the eugenetic
practice of the in vitro fertilization clinics that discard male embryos that may have haemophilia. Isn’t
it a discrimination based on the genes?
Another interesting question arisen by the human genome project is the possibility of patenting genes.
It is important to distinguish between two concepts invention and discovery when a patent is discussed:
invention and discovery
To invent mean to bring something new into being. To discover implies the finding of something that
preexisted but had been unkown (Newton discovered the law of gravity). To invent suggests fabrication
as a result of experiment, study, or ingenuity. [5]
Based on this definition, the human genome sequence is not an invention, but a discovery and therefore
should not be patented, because it belongs to mankind.
However, certain genes may have a therapeutical value or may be used as prognosis markers or as
diagnosis markers. The actual utility of the genes is not longer a discovery, it is an invention and it
should be treated as any other compound that acts as a marker for the diagnosis or the evolution of
certain diseases and therefore it could be patented.
Together with the human genome project other genomes of different species have been sequenced, and
the possibility of trangenesis is something that has been object of many debates.
Organisms that had genes from other species inserted into their genome (the full complement of an
organism’s genes) are called transgenic. By using these techniques several plants, animals and foods
have been generated. For example the production of pathogen resistant transgenic plants has been
achieved through this method, or human proteins that have a therapeutical use are been produced by
animals.
As we have already mentioned we cannot reduce a being to its genes, especially in the case of human
persons where the spiritual component has the importance that we all know. Whereas the use of
animals as biofactories does not have major ethical concerns.
The concern about possible dangers of transgenesis is very often polarized for different economical or
political interests. With proper regulation, this technique holds great promise for making substantial
advances, especially at the agrobiotechnology field.
37 Based in the knowledge of the sequence of some genes of the genome of laboratory animals, now days
the generation of knock out animals is a well established technique that has offered the possibility of
studying the function of a concrete gene in vivo by eliminating it of the genome of the animal .
CELL BIOLOGY: CLONING IMPLICATIONS
The manipulation of the genome and the techniques used for the generation of knock out and transgenic
animals are tools that have been used in the generation of clonic animals.
This generation of clonic animals is probably one of the most spectacular experiments in last century
and has been a real revolution for the classical cell biology.
We consider that the possibility of generating human embryos by using the techniques already used in
animals has a direct incidence on human life and has a very important ethical implications, therefore
we will describe in some detail the cloning issue.
Cloningmeans generating genetically identical structures.
Although there are different ways to clone, we will analyse here the cloning by nuclear transfer.
The technique of nuclear transfer has been used since 1938in embryology, but was not until 1997,
when these technique acquired a universal meaning with the publication by Wilmuth et al. of the
generation of the first sheep –Dolly- cloned by using the above mentioned technique. [6]
The nuclear transfer technique consists in generating a zygote by non-sexual reproduction. Using an
ooocite where the nucleus is removed and transferring to the enucleated egg the nucleus from either a
somatic or a embryonic cell that contains the full genome. The genome is re-programmed at the inner
of the oocite and is able to direct a full embryonic development when this zygote is transferred to a
uterus.
It is important to remember that the genome is the same in all the somatic cells that integrate the
different tissues and organs and it is also the same as the genome of the zygote that generated all those
organs and tissues, however not all the genes that integrate the genome are equally expressed in all the
cells, each cell only expresses the genes that the cell needs for its function.
The percentage of success of this way of reproduction is not high and varies from specie to specie.
As an example, to generate Dolly was necessary to use 277 oocites.
This possibility of reprogramming the genome is not exclusive of the zygote.
It has been shown that the environment is essential for the activation of the expression of genes and
there are several important works showing how adult stem cells could be reprogrammed to generate
cells that are not cells of their own cellular lineage. It was generally believed that adult stem cells were
only able to generate cells of their own lineage, and therefore were multipotent, however many
experiments demonstrate that its potency is higher than believed and that they act in many cases as
pluripotent stem cells.
That has been shown –in vitro- by adding to them different differentiation and/or growing factors [7-8];
or –in vivo- by transplanting them in a different tissue or
organ. [9-10-11-12]
The above-described fact has opened new possibilities for treatments of some degenerative diseases,
where the regeneration of tissues may be essential.
However, adult stem cells are not the only type of cells whose differentiation may be induced, but can
also be done with embryonic stem cells as has been already described. [13-14]
All the issues mentioned have established the bases for the possibility of the so-called therapeutical
cloning.
The therapeutical cloning would consist in generating human embryos –in vitro- by nuclear transfer in
order to keep them alive for 7 days (at that point the embryo acquires the status of blastocyst) and
destroying them after this time to obtain the embryonic stem cells of the blastocyst and differentiate
38 them in vitro trying to obtain different types of tissues that will be inmunologicallly compatible with
the donor of the genome that fecundated the egg by nuclear transfer.
This practice would be an example of not only destroying human lives, but generating them determined
by a certain genome with the only purpose of utilizing them. It would be a clear example of utilitarism.
It is necessary to mention here that in many countries there are several frozen embryos generated for in
vitro fertilization purposes that could also be used for research where law allows it. Those embryos are
obviously a source of embryonic stem cells.
In addition to the ethical implications described about cloning we should also mention that this
technique opens also the possibility of generation of inter-species hybrids.
The molecular biologist’s role in society as well as his moral and ethical responsibility in the discovery
and development of new ideas has led to a reassessment of his social and scientific value systems. A
scientist can not longer ignore the consequences of his discoveries. All science has to be for the benefit
of all human being; otherwise it will be a type of science that will degrade mankind instead of helping
it to evolve. Basic science is called to look for the truth in an honest way without attempting against
essential human values as life: the most precious gift that we have.
[1] J.C. VENTER, M.D. ADAMS, E.W. MYERS, et al, The Squence of the Human Genome. Science
Vo. 291, 16 February 2001. Pag. 1304-1351
[2] D.R. BENTLEY, P. DELOUKAS, A. DUNHAM, et al. , The physical maps for ssequending
human chromosomes, 1,6,9,10,13,20 and X, Nature VO. 409, 15 February 2001. Pag. 942-958.
[3] O. ERMOLAEVA, M. RASTOGI, K. D. PRUITT et al. Data management and analysis for gene
expression arrays.Nature Genetics 20, 23 September 1998, 19-23.
[4] HUMAN RIGHTS DECLARATION. 1997
[5] Webster`s New Encyclopedic Dictionary. 1993
[6] CAMPBELL, K.H.S., Mc WIR, RITCHIE, W. WILMUT, I., Sheep cloned by nuclear transfer from
a cultured cells line, Nature, vol. 385, 810-813, 27 de febrero de 1997.
[7] PITTENGER et al., Multineage potential of adult mesenchymal stem cells. Science, 284, 143-147.
1999
[8] COLTER, D. et al.,Rapid expansion of recycling stem cells in cultures of plastic-adherent cells
from human bone marrow”, Proceedings of the National Academy of Sciences, 97, 3213-3218. 2000.
[9] BJORNSON, C.R., RIETZE, R.L., REYNOLS, B.A., MAGLI, M.C. y VESCOVI, A.L., Turning
brain into blodd: a hematopoietic fate adopted by adult neural stem cells in vivo. Science, 283, 534537. 1999
[10] MEZEY, E., CHANDROSS, K. J., HARTA, G., MAKI, R. A. y MCKERCHER, S.R., Turning
blood into brain: cells bearing neuronal antigens generated in vivo from bone narrow”. Sicence, 290,
17779-1782. 2000
[11] BLACK, I.B., PROCKOP, D.J. et al., Adult rat and human bone marrow stromal cells differentiate
into neurons. Journal of neuroscience Research, 61, 364-370. 2000
[12] CLARKE D.L., JOHANSSON C.B., WILBERTS, J., VERESSE, B., NILSSON, E.,
KARLSTROM, H., LENDAHL, U. Y FRISEN, J., Generalized potential of adult neural stem cells.
Science 288 (5471):1660-3. 2000 jun. 2
[13] EVANS, M.J., KAUFMAN, M.H. Establishment in culture of pluripotential cells from mouse
embryos. Nature, 292, 154-156. 1981
[14] THOMSON, J.A. et al., Embryonic stem cell lines derived from human blastocysts. Science, 282,
1145-1147. 1998
39 ANGELO VESCOVI
NEURAL STEM CELLS:
FUNCTIONAL STABILITY, PLASTICITY AND THERAPEUTIC POTENTIAL
The finding that the central nervous system (CNS) embodies neurogenetic regions enriched with neural
stem cells (NSCs) has spurred a flurry of studies, which investigate on both the basics of NSCs’
biology as well as on their perspective application for the therapy of neurological disorders. NSCs are
multipotential precursors that grow and self-renew in culture in response to growth factors for
extensive time. It has recently been argued that NSCs undergo rapid transformation in vitro and that, in
turn, this would represent an obstacle to the use of cultured NSCs in therapeutic applications for
neurological disorders. Furthermore, it has been concluded that the capacity of NSCs for transdifferentiation may not be an inherent property of these cells but may, in fact, arise from their random
transformation.
This paper will discuss recent data from our group, which describe the systematic investigation of the
functional properties of NSCs upon long-term culturing and show their lack of transformation and their
actual ability to give rise to non-neural cells. NSCs do not display any sign of transformations neither at
early nor late and extensive culture stages. The self-renewal capacity of NSCs –i.e. their ability to
generate new stem cells– does not change over time and no chromosomal abnormalities are observed
up to passage 30 in NSCs.Following removal of mitogens, NSCs display steady growth potential for
many months and stop dividing and promptly differentiate into neurons and glia with reproducible
frequency. Notably, a survey of the effect of cytokines on NSCs differentiation shows that it is possible
to bias their spontaneous differentiation into neurons, favoring the acquisition of a neuronal phenotype
in well over 50% of their mature progeny by means of exposure to specific cytokines. It will then be
shown how we have lately confirmed previous findings showing how NSCs do possess the ability to
give rise to non-neural-derivatives – i.e. mesodermal cells – a phenomenon that, therefore, does not
depend on the in vitro transformation of NSCs. The lack of any tumorigenic potential of NSCs and
their striking capacity for engraftment in the CNS and their utmost clinical efficacy in the context of
cell based therapy for neurological disorders will also be discussed briefly.
After many years of heated debate, it is now well accepted that certain neuronal populations do
undergo cell turnover in the CNS of adult mammals. This provides clear evidence for the persistence of
protracted neurogenesis throughout life – a process taking place by the occurrence of neural stem cells
(NSCs) in some adult brain regions.
In the adult mammalian brain the genesis of new neurons has now been consistently documented
within the hippocampus and the olfactory bulb. Particularly, in the olfactory bulb, new cells are
produced by NSCs located in the forebrain’s sub-ventricular zone (SVZ), which reach their final
destination after long distance migration (Lois and Alvarez-Buylla, 1994).Due to the novelty of the
concept of persisting neurogenesis throughout adulthood, as well as to the attractive therapeutic
implications that relate to the existence of stem cells in the mature CNS, this area of investigation has
been expanding at an increasing pace. However, significant technical difficulties have been
encountered by working with such a complex tissue as the CNS. To date, many relevant aspects of the
physiology of NSCs remain to be unraveled. In particular, although it has recently been shown that
acutely isolated adult NSCs can be identified by the expression of selective markers such as peanut
agglutinin, heat stable antigen, SSA1 andtigen (Rietze et al., 2001; Capela and Temple, 2002), their
univocal identification remains rather difficult. At least initially, this has forced researchers to
investigate NSCs mainly by assessing their behavior by means of specific culture systems. This
approach revealed the existence of brain-derived cells that are endowed with self-renewal ability and
multi-potentiality, typical of bona fide stem cells (see Gritti et al., 2002). However, although NSCs
clearly share some characteristics with tyhe other somatic stem cells responsible for the maintenance of
40 renewing adult tissues, peculiar functional features have been attributed to NSCs. Quite unexpectedly,
unlike their hemopoietic counterpart, NSCs do possess an extensive proliferation and expansion
capacity under rather simple, serum-free culture conditions.
This allowed for the establishment of continuous NSCs lines – even from humans – which are widely
used to investigate the NSCs’ prospective therapeutic use in neurological disorders. Intriguingly,
similar approaches have also unveiled how NSCs may not manifest their full differentiation potential in
vivo. In fact, several evidences suggest that cultured NSCs possess a higher degree of plasticity than
expected, which may be partly silenced in the brain microenvironment, under normal conditions. An
impressive example of the such extreme plasticity has been provided by studies in which cultured
NSCs generated blood and muscle cells or integrated into almost any kind of bodily tissue, following
transplantation into the regenerating hemopoietic system, into skeletal muscle or into developing
mouse blastocysts (Frisen, 2002). This suggests that the full developmental potential of NSCs might
encompass the ability to undergo trans-differentiation to generate cells that belong to developmentally
unrelated tissues.
In 1999, we provided the initial evidence that trans-germ layer differentiation can occur in adult
mammals by reporting that clonally derived adult NSCs could give rise to hematopoietic cells, in vivo
(Bjornson et al, 1999). In these experiments, the progeny of genetically tagged, single NSCs (i.e.,
constitutively expressing galactosidase, the product of the bacterial lacZ gene) were injected into sublethally irradiated mice. Not only did NSCs integrate into many of the host hematopoietic tissues,
including spleen, thymus and bone marrow, but they also gave rise to most types of blood progenitors.
These progenitors did eventually differentiate into a wide range of blood cells, including
megacariocytes, granulocytes, macrophages and B- and T-lymphocytes, although erithroyd cells were
not observed. Furthermore, though not described in the initial study, NSCs increased viability in
recipient animals suggesting that non-hemopoietic NSCs may partly reconstitute and rescue lethally
irradiated animals (unpublished data). It is worth noting that neurohemopoietic conversion has now
elegantly been documented also using human NSCs. These cells have been transplanted into Scid-Hu
mice, which carry transplanted human fetal bone and thymic fragments, thus providing physiologically
relevant human bone marrow and thymic microenvironments. Under these conditions, human NSCs
were able to establish long-term hemopoiesis, as shown by serial reconstitution experiments (Shih et
al., 2001).
An equally fascinating extension of the above finding came from the observation of how, upon
injection into the mouse blastocyst, NSCs could integrate into many different tissues derived from the
three main germ layers (Clarke et al., 2000). Intriguingly, in this work, the contribution of NSCs to
some major mesodermal lineages, such as blood and the skeletal muscle, was not observed. However,
soon thereafter, it was demonstrated that NSCs of both human and mouse possess the ability to
differentiate into skeletal muscle, both in vivo and in vitro (Galli et al., 2000).
Rather peculiar circumstances appear to be necessary for the expression of what seems to be a latent,
generalized developmental potential(s) in NSCs. Two main conditions have been identified as
necessary for neuro-mesodermal trans-differentiation. First: it appears that only bona fide stem cells
can undergo trans-differentiation. As described by Galli et al. (2000), only SVZ cells, but not cells from
regions that do not appear to contain stem cells, such as the striatum and the cerebral cortex, undergo
neuromyogenic conversion. This was confirmed by Rietze et al. (2001) who enriched their cultures for
NSCs based on the expression of cell surface markers (PNAlo /HSAlo) and showed how this resulted
in an increased neuromyogenic conversion rate from the original 2.5% (Galli et al., 2001) to an
amazing 57%. Furthermore, when the differentiated progeny of NSCs were exposed to cues that induce
the myogenic phenotype in enriched NSCs cultures, almost no conversion to skeletal muscle was
observed. These findings are supported by the recent observation that the developmental totipotency of
neural cells is gradually narrowed as cell differentiation progresses.
41 It can be speculated that to undergo trans-germal differentiation, NSCs ought to be exposed to
microenvironments that contain rather peculiar, instructive cues. Since CNS stem cells have been
shown to repopulate both the early developing gastrula (Clarke et al., 2000) as well as the regenerating
hemopoietic system (Bjornson et al., 1999) and muscle (Galli et al., 2000), while bone marrow cells
regenerate the damaged muscle and liver (Ferrari et al., 1998; Theise et al., 2000), it can be assumed
that such cues may become available specifically during the regenerative phase that follows an injury
in target adult tissues or, alternatively, during embryonic development. Unfortunately, very little is
known as to the identity and nature of the factors responsible for the peculiar transition in NSCs fate.
One significant hurdle in the identification of these cues depends on the fact that most of the models
used rely on in vivo assays. Yet, in vitro models of neuro-mesodermic conversion are available that
now allow for some tentative hypothesis to be drawn. Using these systems, it has emerged that neuromesodermal conversion could only be observed when NSCs were co-cultured with C2C12 myogenic
cells or with primary myoblasts – and never with non-myogenic cells. Notably, conversion required
direct cell-to-cell contact and did not take place when neural and myogenic cells were physically
separated by a porous membrane, nor when NSCs were exposed to muscle cell-conditioned medium.
Furthermore, it is evident that a fine interplay between antagonistic cues must occur during the
phenomenon of neuromyogenic conversion. In fact, the induction of the muscle fate elicited upon
NSCs is counteracted by some type of “neuralizing” signal occurring between neighboring neural cells,
a phenomenon that may be interpreted as a classical “community effect” (Gurdon et al., 1993). Thence,
a cohort of instructive signals rather than a single effector may control the shift from a brain specific
fate to a mesodermal one. In vivo, these signals can be found in the extracellular microenvironment that
has been perturbed by an injury and may be elicited through a direct cell-to-cell interaction between the
host and the donor cells.
A legitimate concern in trans-differentiation studies regards the issue of whether transdifferentiated
cells do actually acquire a terminally differentiated, functional phenotype or, rather, are only limited to
express some lineage-specific morphological and antigenic traits (Weissman et al., 2001). While this
issue clearly requires further investigation, examples of bona fide conversion of NSCs into functionally
mature mesodermal derivatives are available. In fact, it has been shown by ultrastructural analysis that
NSC-derived myotubes are poly-nucleated sincitia, a clear sign of terminal differentiation.
Furthermore, these myotubes contain sarcomeryc structures that display M- and Z-bands (Galli et al.,
2000).
While the concept of cells of a given tissue giving rise to cells from a different one is slowly being
expanded to many adult cell types (Frisen, 2002), this phenomenon is also being challenged by some
recent studies (refs). Particularly, a recent investigation by Morshead et al. (2002) reported the inability
to generate hematopoietic progeny from NSCs in irradiated mice. Although this study was described as
being identical to our initial investigation, the functional characteristics of the NSCs cultures described
by these authors clearly underlined that the cultures that they used were almost devoid of NSC and that
the latter consistently transformed.The report of Morshead et al is in open contradiction with a plethora
of previously published work showing how neither human nor mouse NSCs undergo transformation
with subculturing, rather exhibiting strict growth factor dependency, unaltered growth kinetics and
prompt differentiation upon growth factor removal (Reynolds et al., 1996; Gritti et al., 1999; Vescovi et
al., 1999; Galli et al., 2002) . As mentioned above, the actual content of NSCs as defined by classic
clonogenic assay was at least 20 times lower in Morshead et al.’s study than in our report.Therefore,
the combination of low NSC number and significant transformation found in these authors’ cultures
lead to the transplantation of a negligible number of NSCs and explains their failure in achieving the
same neuro-hemopoietic conversion, which has now been reported by three independent groups NSCs
(Bartlett, 1982; Bjornson et al., 1999; . Shih et al., 2002)
Lately, it has been shown that both NSCs or bone marrow cells possess the capacity to fuse with other
cells and to give rise to tetraployd cells that may express markers of cell lineages other than neural or
42 hemopoietic (Ying et al., 2002; Terada et al., 2002).In this respect it should be noted that in both cases,
adult cell fusion was observed with ES cells, which are not present throughout adulthood. Furthermore,
the frequencie of the fusion event was quite low, ranging between 10-5 and 10-6.Thus, it may indeed
be possible that the acquisition of a non-neural phenotype by adult neural stem cells may in some case
be the result of cell fusion. However, given that the frequency of many of the reported
transdifferentiation phenomena appears to be of two order of magnitude higher than that observed for
cell fusion, and since cell fusion is not a prerequisite for neuromyogenic conversion (Galli et al., 2000),
it is most unlikely that transdifferentiation as a general process can be explained only in terms of
formation of tetraployd cells.
In conclusion, it is clearly emerging that the field of investigation on adult stem cells and their
intriguing biology is an exploding area of investigation that leads us to challenge many long standing
dogmas of biology. Whether such challenges will hold up to the increasingly stringent investigations
remains matter for the heated and stimulating debate(s).
References
BARTLETT P.F., Pluripotential hemopoietic stem cells in adult mouse brain. Proc Natl Acad Sci U S
A 79, 2722-5 (1982).
CAPELA A. and TEMPLES., lex/SSEA-1 is expressed by adult mouse CNS stem cells, identifying
them as non pendymal. Neuron 2002; 35:865-875.
CLARKE DL, JOHANSSON CB, WILBERTZ J, et al. Generalized potential of adult neural stem cells.
Science. 2000; 288(5471): 1660-3.
FERRARI G., et al., Regeneration by bone marrow-derived myogenic progenitors. Science 1998;
279(5356): 1528-30.
FRISEN J., Stem Cell Plasticity? Neuron 2002; 35:415-418.
GALLI R., et al., Skeletal myogenic potential of human and mouse neural stem cells. Nat. Neurosci.
2000; 3:986-991.
GALLI R., et al.,Emx2 regulates the proliferation of stem cells of the adult mammalian central nervous
system. Development, 129: 1633-1644 (2002).
GRITTI A., VESCOVI A.L., GALLI R., Adult neural stem cells: plasticity and developmental
potential. J. Physiol. Paris 2002;96:81-90.
GRITTI. A., et al., Epidermal and fibroblast growth factors behave as mitogenic regulators for a single
multipotent stem cell-like population from the subventricular region of the adult mouse forebrain. J
Neurosci 19, 3287-97 (1999).
GURDON J. B., LEMAIRE P., and KATO K., Community Effects and Related Phenomena In
Development. Cell 1993 75: 831
LOIS C., ALVAREZ-BUYLLA A., Long-distance neuronal migration in the adult mammalian brain.
Science 1994; 264:1145-1148.
MORSHEAD C.M., BENVENISTE P., ISCOVE N.N., VAN DER KOOY D. Hematopoietic
competence is a rare property of neural stem cells that may depend on genetic and epigenetic
alterations.Nature Medicine 8, 268-273 (2002).
REYNOLDS B.A. & WEISS S., Clonal and population analyses demonstrate that an EGF-responsive
mammalian embryonic CNS precursor is a stem cell. Dev Biol 175, 1-13 (1996).
RIETZE R.L., BROOKER G.F., THOMAS T., VOSS A.K., BARTLETT P.F., Purification of a
pluripotent neural stem cell from the adult mouse brain. Nature 2001: 412:736-739.
SHIH CC, WENG Y, MAMELAK A, LEBON T, HU MC-T, FORMAN SJ. Identification of a
candidate human neurohematopoietic stem-cell population. Blood 2001; 98:2412-2422.
43 TERADA N. et al. Bone Marow cells adopt the phenotype of adult cells by spontaneous cell fusion.
Nature 2002; 416:542-545.
THEISE, N.D., et al. (2000) Derivation of hepatocytes from bone marrow cells in mice after radiationinduced myeloablation. Hepatology 31:235-240.
VESCOVI A.L.et al. Isolation and cloning of multipotential stem cells from the embryonic human
CNS and establishment of transplantable human neural stem cell lines by epigenetic stimulation. Exp.
Neurol. 156; 71-83 (1999).
YIING Q., NICHOLS J., EVANS E.P., SMITH A.G., Changing potency by spontaneous fusion.
Nature 2002;416:545-548. to come.
44 IGNAZIO MARINO
ETHICS OF BIOMEDICAL RESEARCH:
FOR A CHRISTIAN APPROACH
INTRODUCTION
Research is crucial to scientific advancement, and consequently to the work of physicians. However,
the progress made in recent years, particularly in genetic engineering and biotechnology, opens the
door to practices and therapies that often call into question fundamental principles of traditional
medicine, and raise troubling ethical issues. As a result of this upheaval in biology, our stance vis-à-vis
nature – and, indeed, life and death themselves – is undergoing a dramatic transformation.It is
imperative, therefore, that we shine a renewed ethical light on the science and practice of medicine.
It is not by chance that the term “bioethics” was coined in the United States in the early ‘70s, by the
oncologist Van Rensselaer Potter, at a time of revolutionary advances in our understanding of the inner
workings of DNA, the promise of gene therapy, and the widespread use of organ transplantation, i.e.
when the urgency emerged to bring together both a humanistic approach and scientific knowledge.
Potter maintained that bioethics was to be a discipline that combined biological knowledge and human
values, as he was concerned that the disjunction of the two areas – humanistic and scientific – was
potentially responsible for the destruction of our ecosystem. Therefore, he realized that it was crucial to
bring together science and ethics into one new discipline – bioethics – and that the new discipline had
to comprise everything involving human life (“global bioethics”[1]).
Potter’s exposition, together with the initiatives of such institutions as the Hastings Center (founded in
1969 by the catholic philosopher Daniel Callahan and the psychiatrist Williard Gaylin) and the
Kennedy Institute of Ethics (founded in 1971 by the renowned Dutch obstetrician André Hellegers)
culminated in the definition of a brand new intellectual area or, better yet, of a terrain that up to that
time had never been consciously explored in connection with the practice of medicine. The publication
of the Encyclopedia of Bioethics in 1978 marked a significant milestone in the developing discipline.
Nowadays it would be inconceivable to ignore the ethical issues raised by the inexorable advance of
science. The multidisciplinary nature of bioethics is what makes it both rich and complex.
The commitment of the Pontificia Academia Pro Vita confirms that a tangible contribution to solve
ethical matters can only come from the continuous dialogue of researchers and scholars with different
backgrounds: physicians, biologists, theologians, jurists, psychologists, sociologists, economists. The
multidisciplinary characteristic simultaneously stresses and underscoresthe role of reason (central and
marginal at once) in ethics, an area where the impossibility to bring together opposite stances is never
argumentative impasse but, rather, occasion to start public debate. By “public” one should not only
mean the restricted group of multidisciplinary experts listed above, but the much wider audience of
non-professionals, the public opinion. The following pages stress how the ethical debate should be
spread in a more professional, honest and responsible fashion.On the one hand, in fact, experts need to
posses the necessary knowledge that not only enables them to argue on ethical matters, but also to
present them to non-experts in the right way. On the other, one should hope that the ethical debate
becomes a common practice for public opinion, and act accordingly, so that it earns the means and
sensitivity required for a reasoned evaluation that condemns empty sensationalism. The commitment of
physicians and researchers and their “duty to make brave choices”[2] remain crucial, which sometimes
implies also the hard assumption of responsibility whenever a finding or a new therapy is not presented
to the public if conscientiously judged of difficult ethical interpretation. Possibly the only available
way is that of individual responsible-ness for scientists as well as for patients, who will be able to
ponder on important moral matters that might influence and affect the future of humankind, and who
will pause and decide in/with conscience. The non-cultural and non-religious concept of individual
45 responsibility could be the first, fundamental step for the difficult definition of such a thing as universal
ethics and for the mitigation of differences among, say, catholic, protestant, and orthodox
bioethics.Nowadays this is absolutely necessary as medicine means no longer just life ‘care of’ but also
‘intervention upon’ life: we can create it in vitro, for example, or postpone death beyond natural
boundaries by resorting to the extraordinary technology of intensive care units.
BIOETHICS AND PUBLIC DEBATE
As mentioned above, the extension of bioethical debate to the public is a fundamental need even
though it requires dedicated modalities, times and means. Interestingly, a historical analysis of the
doctor-patient relation shows how slowly this belief has become commonly accepted and, conversely,
how hard it has been to eradicate commonplaces, prejudices and mistrust from the same relation.A
clear example for this can be the development of the concept of informed consent.This provides an
interesting insight for two reasons: first of all, it proves that the realm of bioethics is of paramount
interest for patients and the one that today more than ever needs their direct intervention. Secondly, the
history of the idea of informed consent stresses the arid ruling supremacy of legal reasons on moral
ones.
Hippocrate’s oath is often used to justify more or less ‘traditional’ medical stances and practices.From
the historical point of view it is easy to notice how in the Middle Ages Hippocrate’s oath stressed the
hierarchical doctor-patient relation. After the only (Platonic) attempt to establish a more open dialogue
between doctor and patient and following the early Christian phase of medicine, when physicians were
not only healing the body but also the soul, the role of patients is again devalued if compared to the
charismatic and unquestioned status of physicians, who are seen as both technicians and priests. What
is still completely missing is patients’ autonomy, the very concept of free choice that only recently has
provided the basis (even the legal one) for the elaboration of the idea of informed consent. The concept
of responsibility begins to emerge with the Renaissance, and becomes more and more crucial with the
Enlightenment through the contributions of such thinkers as Locke, Kant, and Stuart-Mill. Patient
access to medical information developed along with it but it has been a long process. Suffice it to say
that the first ethical code of the American Medical Association (AMA –the main US medical society),
published in 1847, still allowed for the physician’s paternalistic lie ‘with the best of intentions’. Only in
the 1980 edition the need to abide by legal requirements on informed consent was eventually stressed.
Therefore, the fact that the idea and practical application of informed consent entered medicine initially
for reasons that are strictly legal, not ethical, is important and illuminating. Only recently has informed
consent become a moral right of all patients, allowing the ill to participate in (or, conversely, to reject)
treatments or research protocols suggested by doctors. This is a perfect example of how a practice that
is nowadays commonly and universally recognized as a moral right developed initially as a mere legal
requirement. As far as informed consent is concerned, the historical analysis of the doctor-patient
relation (from ‘priest-like doctor’-‘ignorant patient’ to ‘professional physician’-‘informed patient’)
proves how crucial the direct involvement of every single individual is. In other words, the bioethical
debate must involve every citizen and not just a restricted group of field experts. This in order to not
repeat the dangerous paternalistic approach adopted by ancient medical art.
ONE MORAL, SEVERAL BIO-ETHICS? A “MODEST PROPOSAL” TO OVERCOME
ETHICAL PARTICULARISM
The most crucial moral issues nowadays stem from the fact that research allows for a quasi-omnipotent
intervention on care and prevention of diseases but also on life itself, its origin and end. The taboo (not
46 only Christian) of the human temptation to master life and nature is violated. More and more often the
risky consequences of such attitude are cast away in the name of scientific advance. The so-called
moral neutrality of research seems to turn into a sad illusion. It is then mandatory that science and
technology respect basic ethical principles. The real debate involves the universal (or simply
international) definition of such crucial criteria. Given the many different personal and cultural
interpretations of the same ethical matters, the hard task to define a single, universal deontological code
justifies the scope of the Pontificia Academia Pro Vita and our present role within it. On the one hand,
one feels the need to formalize universal guidelines; on the other, the field of investigation seems to
prevent this very attempt. The direct consequence of this impasse or, better, its usual solution
(unfortunately totally unsatisfactory) is often a purely legal one (see “Bioethics and public debate”).It is
useless to observe how this choice is often influenced –if not directly guided- by political and economic
reasons. This is what His Holiness Pope John Paul II in the third chapter of the Evangelium Vitae
Encyclical defines as “ethical relativism.” A social or parliamentary majority, the moral evaluation of
which cannot always be taken for granted, often ratifies this. The duty of civil law is different and more
restricted than that of moral law, so that one can sometimes talk of abdication of ethics.Even
Monsignor Sgreccia, in the latest edition of the second part of his Manual on Medical and social
aspects[3], is aware of the necessary specificity of ethical values.Indeed we argue about bio-ethics, not
about bio-morals. The issues discussed in the book outline an etiologic process showing the growing
social discomfort and lack of values responsible for weakening the ethical comprehension and
evaluation of both individuals and institutions. What is needed to break the vicious circle is a strong
positive will, a sincere yearning for the truth of the people and the society that they build together
through the continuous reweaving of values and an appeal to the conscience of us all, legislators
included. Also, preventive medicine and education are fundamental for the same goal.
As already stressed in the introduction, science must necessarily undergo a process of apperception.
Although rational evaluation remains the necessary starting point to the moral dimension, we need to
acknowledge the dishonesty of what Giovanni Berlinguer defines as “justificative bioethics”[4], i.e. the
fake morals of the rule that makes allowable and doable whatever is technically feasible. The will of
the researcher must be ruled by a sense of responsibility, always balanced by the farsighted evaluation
not only of the risks but also of the consequences. This is feasible on a rational and technical basis and
not only for particularly sensitive moral consciences or for fervent religious believers. Therefore, it is a
concrete possibility, a goal that any scientist (religious or not) can and should pursue. Indeed, only in
this way (i.e. by practicing a reasoned and conscientious self-discipline), can scientists prove that they
understand and are able to manage the enormous power placed in their hands by recent technical
innovations.It is important to stress that this approach would not repeat the ancient paternalistic attitude
of the physician/priest; quite the contrary, it would promote awareness and a sense of responsibility
towards the cognitive means available to men. This can be seen as a new anthropologic approach that
lies beyond cultural and religious categorizations and that can really constitute the solution to the
problem of ethical particularism: the strength and power to pause, to avoid, to stop before it is too late,
to not surpass the point of no return. This is far different from the bigot’s will to stop scientific
progress, as it stems from the preoccupation with the most precious gift of all: human life and the love
for it –values recognized and shared by all cultures.The role of scientists is even more relevant now, as
their responsibility is no longer restricted to hospital and laboratory. It now involves not only research
activities but also their farsighted evaluation, and their willingness to be a part of a debate that includes
not just a close circle of experts. We are no longer facing the attitude that Pope John Paul II defines as
“promethean…[typical] of men who believe that they can master life and death because they can make
the ultimate decision on both”[5].The responsible and farsighted choice of scientists will have full
moral value independently from the fact that it might stem from and be fed by Christian faith.“The
obligation to make brave decisions”2 cannot be imposed only on the representatives of the state, but
must be shared sincerely by every single individual inhabiting the scientific community.However, as
47 scientists might not be compliant with their duty of reasoned monitoring, the man on the street should
conscientiously evaluate the same issues with the means, practice and knowledge that state and society
will have provided to him. For this reason the official entrance of bioethics into medical professional
curricula, on the one hand, and among the topics publicly discussed, on the other, is of crucial
importance. This would help build moral awareness about biomedical research, and would make the
debate more mature and efficacious, not only among experts but also among those who are usually
excluded from any phase of the decision-making process, although they are directly affected by its
practical consequences.
FOR A CHRISTIAN BIOETHICS
A typical problem that undermines the definition of a Christian bioethics is the inevitable dialogue with
secular professionals and disciplines, on the one hand, and the existence, on the other, of a number of
bioethics inspired by different faiths (protestant bioethics, orthodox bioethics, etc.).The starting
argument of the Christian approach is that the true human nature is both corporal and spiritual, and that
human beings refer to a natural moral law.The direct consequence is that any intervention on human
beings involves not only their bodies but also their spirit.Hence, the huge responsibility of physicians
and researchers that increases when one considers man as divine creature and incarnation of God.Men
are “corpore et anima unus”[6]: this is the essence of the so-called anthropologic thought from where
we depart whenever we try to answer questions posed by new biomedical findings. It can help
Christianity decide on ethical issues, even in the presence of personal values and meanings that often
affect the moral sense of biomedical interventions on man.
The role of the Church can and should be acknowledged not only by its believers, but also by anyone
recognizing in life the ultimate goal.The evangelic mission and apostolic duty of the Church are what
allow it to play a fundamental role in the search for and evaluation of ethical answers to issues raised
by biomedical research. The getting over of the dangerous ethical particularism through a universally
acceptable moral vision becomes a crucial duty for the Church, the occasion for a renewed
‘evangelization’, rather than for the deletion of a fertile pluralism of views.The Church’s key
awakening role of a ‘culture of life’ is exemplified by the fundamental explanation of the delicate
balance of social and individual responsibility.This happens when an intact conscience pursues what
Pope John Paul II sets against the ruling “culture of death”[7] promoted by some recent medical
therapies (see chapter on “From organ market to suicide clinics”). Such values cannot depend on
religious faith, as they involve a reasoned and farsighted concept of responsibility; a responsibility
equally shared by experts and citizens –both aware of the possibility of a courageous act of
renunciation in the name of the love for life.
The practical realization of such a renewed mission of the Church calls for the joined collaboration of
single individuals and public institutions which share the ultimate universal goal: their own survival
and the chance to play a key role in its defense.
THE CASE OF THE SIAMESE TWINS AND LIVING DONATION
The importance of public debate, ethical relativism and particularism, justificative ethics and Christian
bioethics becomes apparent when one looks at a true story that took place recently, and its general
consequences. In May 2000, Italian public opinion animatedly debated the tragic story of two newborn
Siamese twins, both cerebrally intact, and who shared a common heart.Some believed one of them
could survive, by means of harvesting cardiac tissue from the other: a kind of “living donation”
implying the sacrifice of one of the babies, chosen because of her physiological weakness compared to
48 her sister. A critical analysis of the story allows not only for a reflection on which practices are
nowadays both technically and morally acceptable, but also for a consideration on the importance of
public debate and of the so-called justificative ethics. In May 2000 the focus of the debate was on the
lawfulness of “killing” one of the two babies in the operating room, by separating her body from that of
her little sister while donating part of her heart, just like in a regular transplant, possibly allowing her
sister to survive.At the time, a heart surgeon volunteered to perform the surgery, and I was asked to
participate in my capacity of expert of liver surgery and transplantation (the liver shared by the two
unfortunate twins also had to be divided). I refused. Aside from the technical aspects, the operation
raised a fundamental ethical issue: is it right to bring two cerebrally intact individuals into the operating
room having already decided that one of them will be killed and her organs and/or tissues will be used
to allow for the survival of the other? Is it right to sacrifice one life to save another? Is it acceptable to
take two sick individuals into the operating room, knowing already that only one of them will possibly
survive while the other will inevitably be transferred to the morgue?Before we answer in the
affirmative, let’s consider the following scenario: two 45-year-old identical twins, one of which is
about to die unless he undergoes an urgent heart transplant, the other with a perfect cardio circulatory
system but suffering from a painful brain tumor that will bring him to certain death in less than 2
months.Why shouldn’t we turn the brain tumor patient, who is willing to donate, into a living heart
donor for his twin brother?Why not take both of them into the operating room, harvest the heart from
the brain tumor patient (killing him in the process and, therefore, putting an end to his suffering), so we
can prolong the life to the other through a successful transplant?From a technical point of view this is
not only feasible but also less difficult than usual. In fact, no immunosuppressive therapy would be
needed for the transplant recipient, as the donor would be completely compatible (having been his
identical twin).This would ensure an excellent quality of life to the transplant patient.The live donor
would simply die 60 days earlier than expected, suffering less and certainly glad to have saved his
twin’s life. Why shouldn’t we allow this?
To go back to the true story of the Siamese twins, the extensive public debate, the justificative ethics
supported by the media and, eventually, the decision of the Ethical Committee of Palermo Civico
Hospital brought to the approval of the surgery that tragically ended with the death of both
babies.Nevertheless, this tragic conclusion should not affect our ethical evaluation of the story, nor did
it influence my personal stance back in May 2000, when I refused to evaluate and operate on the little
patients.From the practical point of view the surgical act would have been feasible and, consequently, it
would have been possible to perform it again and again with success. But, is it acceptable to sacrifice
one life to save another?
If one interprets the Evangelium Vitae Encyclical rightly, the answer is simple. “Human life is always
sacred and inviolable.”This sacred character is not exclusive of Christian doctrine, but can be and is
indeed shared also by a non-religious bioethics that promotes the concept of life beyond a supernatural
vision.
One understands the relevance of bioethics as a topic not exclusively belonging to scientists and
scholars, not only debated on panel discussions of targeted symposia.It is relevant to the involvement
of single individuals, and it requires the extraordinary commitment of experts who must explain the
meaning and consequences of a surgical act or of a new drug, so that everyone can understand and
come to a personal opinion, to an “informed” point of view.
This does not happen often in contemporary society, with the heavy influence of media and of a
scientific journalism that is seldom managed by capable professionals who would never opt for the
consumerist justificative bioethics.Both scientists and communication experts share a huge
responsibility: their irresponsible conduct could create false expectations in people in general, and in
individual patients in particular. Scientists have a duty to explain, and this activity can no longer be
considered of secondary importance or simply complementary.On the other hand, media experts should
always verify with rigorous seriousness the meaning of the information they divulge.Maybe both
49 categories (science and media experts) should train in bioethics and become responsibly aware of the
importance of information in building up a pluralistic society that is able to make decisions on how to
deal with technical innovations.
The Siamese twins story described above shows connections with another compelling bioethical issue:
the intrusion of a market of organs into the practice of living donation.Living organ donation, when
lawfully and scrupulously performed, i.e. respecting the generous will of the organ donor, is extremely
safe for kidneys and quite safe for livers. It is nonetheless mandatory that it be constantly monitored
and evaluated from the bioethical point of view[8] so that the technical feasibility does not turn into a
good enough reason to perform the operation.Indeed, living donation is a singular surgical act
involving a totally healthy person who is selected for the operation precisely for his/her perfect
conditions. Still, the operation has morbidity and mortality risks.For this reason the informed consent
and the selection process of the donor/recipient couple must be managed with extreme care.
Spontaneous living donation is an act of love and generosity that allows a sick person to regain an
excellent quality of life.This laudable act has become increasingly corrupted by the opportunity to
organize a market of organs, as recently reported by a scientific paper that quantifies the economic and
health impact of this illegal traffic in India[9].Three hundred and five inhabitants of Chennai (a 6million population town once known as Madras) were interviewed after having donated a kidney for
money. Ninety six percent of them acknowledged having agreed in order to pay debts, and that both
their health conditions and financial status got worse after the organ donation.In particular, their family
income went down from 660 dollars to 420 dollars per year, making their lives even more miserable
than before.
In recent years several western publications have tried to justify the implementation of an organized
market of organs from a scientific point of view and its immediate application in such countries as
England[10]. Furthermore, the American Medical Association has suggested that samples of US
citizens be tested to understand whether the introduction of monetary incentives could affect their
views about organ donation.In essence, the scientific community wonders whether it is ethically
acceptable to receive money in return for organs destined for transplantation.The issue has rapidly left
the closed rooms of ethical committees to end up on the front pages of such major newspapers as
TheWall Street Journal. The debate clearly calls for a thorough bioethical analysis.
Although cautious, the step taken by the American Medical Association confirms the general tendency
toward a strong link between healthcare and economy, well being and money, bioethics and physical
wellness.
Going back to the original topic, i.e. the ethical acceptability of paying for organs, the issue is raised to
face the growing need to find new ways to promote organ donation and therefore save the lives of the
many sick patients who die every day while waiting for a transplant.Data are alarming (15 and 3
patients die every day, respectively, in the US and in Italy while waiting for a suitable organ). For this
reason the ethical committees of the American Medical Association and, more recently, that of the
American Society of Transplant Surgeons have decided to explore new ways to fill the gap between
‘demand’ (waitlisted patients) and ‘supply’ (actual donors), and they have suggested that organs for
transplant could be paid for.
This allows for an analysis of transplant medicine and the close, complicated relation linking
healthcare, bioethics, politics, economy and religion. Medicine in general always lends itself to reflect
important characteristics of a given historical period, particularly because in no other field are all
individuals so personally involved as in the care of their own health.
When observed against the background of modern healthcare and of its inevitable tie to profit and
economy, transplantation offers the perfect chance to define human beings as “commodity,” as matter
(raw and/or as by-product).The availability of surgeons with no scruples in such countries as Turkey,
India, and Peru has made it possible to start an illicit traffic of organs, probably limited to kidneys, that
disgraces both medicine and the states where this practice is tolerated. The traffic exploits poor and
50 desperate individuals who agree to sell a kidney for little money (one thousand dollars in Bombay, two
thousand dollars in Manila, three thousand dollars in Moldavia, ten thousand dollars in Latin America).
The organ is then sold along with the transplant surgery that is performed in a clandestine way for
about one or two hundred thousand dollars.
The phenomenon should be considered as a real crime against humanity and, as such, it should be
prosecutable and punishable everywhere in the world.Whoever decides to exploit someone else’s
weakness and poverty, no matter how sick, is guilty of a most serious crime.
Bioethics and laws cannot ignore the problem only because it happens somewhere “else.”A popular US
television show (CBS “48 Hours”, broadcasted on February 11, 2002) has proved that transplant
patients’ trips to exotic destinations can no longer be considered as urban legends and that something
needs to be done to stop the existing illegal market of organs. American Federal law (National Organ
Transplant Act) maintains unequivocally that “nothing valuable can be exchanged with an organ (…)”
Therefore, it condemns any ways of compensation –direct or indirect- including those mentioned
above. Nevertheless, this same federal law is already and continuously broken from the ethical point of
view when we look at the selling of cells and tissues. The most common example is that of human
eggs. Their market value can reach seventy thousand dollars in the United States where they are
regularly sold for reproductive purposes.Another good example is the Pennsylvania law that reimburses
part of funeral expenses to the family of an organ donor.
One wonders how easy it could be to move from these kinds of incentives to more convincing
mechanisms for organ donors’ relatives, such as tax reductions, payment of school fees, or even direct
money transfers that will be used without specific indications.After all, if one accepts the idea of
“money for organs”, why should one care if that money comes from a dead person rather than from a
healthy one?Indeed, it could be even fairer to compensate people who are still alive and sell a part of
themselves, making it possible for other people to recover.Accordingly, it would not be wrong to judge
as “improvement of life conditions” some aberrant experiments such as the recent transplant of ovary
(performed in Saudi Arabia) and uterus (happened in China) for reproductive purposes. Both organs
were procured from living donors, and surgery was performed in a non-clandestine way; quite the
contrary, both operations were reviewed on prestigious scientific journals and even praised by
international researchers. It seems to me that these experiments are the apogee of individual selfishness
breaking all ethical rules.
The argument extends further and nourishes a debate that goes beyond the restricted issue of
transplantation. One might think that if, on the one hand, it is ethically unacceptable that waitlisted
patients die every day before receiving a suitable organ, then maybe the proposal of monetary
incentives that might boost organ donation is not to be disregarded. On the other hand, instead, some
boundaries seem to exist that should not be trespassed: the human body can never be considered as a
commodity, nor can it be given a fixed price for retail.To summarize, is it ethical and morally
acceptable that organ donation increases only by the “contributions” of the poor, while the rich act just
as receivers? The truth is that any solution suggesting monetary compensation must be avoided, as it
allows for an unfair organ allocation based on ability to pay, rather than on actual medical urgency and
on the priority established by regular waiting lists. Such proposals put human dignity at risk and
threaten to blur the dangerous overlapping of healthcare and market[11-13]. It is useless to deny that a
tie between them exists and that economy plays a fundamental role in the management of healthcare.
At the same time, though, the integration of the two fields should happen without crossing the
bioethical boundaries that healthcare must always respect.
51 FROM ORGAN MARKET TO SUICIDE CLINICS
A recent and well-documented article[14] reports with cold lucidity the last hours in the life of Marie
Hascoet, a woman who travelled from Paris to Zurich to undergo (obviously upon payment of a fee) an
assisted suicide. To date, the Swiss organization called “Dignitas” has assisted about 140 people since
1998, who went to Zurich to legally terminate their lives. They came from the United States, the U.K.,
Egypt, Israel, Germany and other countries. Once in Switzerland they sign an informed consent form
(called “Declaration of Suicide”) and are assisted to die in the specialized clinic. Terminally ill and
disabled patients (this was the case of a deaf musician) usually make the requests.
Assisted suicide is induced through a mixture of drugs (antiemetics and barbiturates) following a
precise pharmacological protocol coordinated by professional medical staff and specialized nurses.
Everything is managed with the same attention and care typical of a top-notch institution devoted to
saving lives and the healing of patients. Clinical charts are previously submitted to Dignitas’s
professionals in Zurich for their review and evaluation; the patient is summoned later on for a complete
physical that aims to confirm the ‘indication to suicide’. The patient can then return home, to ‘arrange
things’ before purchasing the one-way ticket for his/her last trip.
CONCLUSIONS
Can medical research and technology nowadays available to us be utilized to mutilate bodies to obtain
organs to sell for transplantation? Can it assist one who has decided to commit suicide or kill a human
being in the operating room to save another? Is such a practice as uterus or ovary transplantation
acceptable because social and economic pressure and some kind of justificative ethics allow it, even
though it can be dangerous for the life of the woman? What is the line that a member of a pluralistic
society should not cross in utilizing the means that science puts at our disposal? And what are the
characteristics of a Christian vision for this?
It is hard to bring together seemingly contrasting positions but a common denominator can always be
found. Those who believe in eternal life and live in faith certainly have a different vision, and find
consolation when they evaluate the many situations that life places in front of us. Nevertheless, the
respect for the sacred value of life and human dignity does not exclusively belong to Christians. If for
those who believe in Christ “man is called to a ripeness of life that goes far beyond the dimensions of
physical existence, as it consists of participation in the life of God itself”[15], the incomparable value
of individuals is common heritage of all members of society (at least it should be) in spite of different
religions. This should be taken into account whenever life preservation is pursued and its suppression,
reification and consumerist reduction condemned. Within a pluralistic society the goal can be achieved
by whoever cares for the essential values in life. Certainly there are fields where biomedical research
raises ethical issues on which it is hard to reach the general consensus of all social components. Still,
even in such fields there must be the constant commitment to follow research advances and to establish
rules on their utilization. It should not happen (as, instead, is often the case even in most advanced
countries) that science identifies new paths without dedicated rules having been set for their
implementation. Commitment in this area calls for intellectual engagement of dedicated experts’
committees and resources, so that citizens and governments can take part of the open debate in an
informed manner, and the concrete opportunity to make decisions. The most foolish and dangerous
attitude, for lay and Christians alike, is to forget or deny that ethical needs are a fundamental part of our
lives.
52 ACKNOWLEDGEMENTS
I am immensely grateful to Professor Karl Golser of the Brixen Studio Teologico Accademico for his
invaluable critical revision.
Claudia Cirillo and Alessandra Cattoi are thanked for their contribution to the preparation of this paper.
Howard R. Doyle, M.D. of the University of Pittsburgh is sincerely thanked for the critical revision of
the manuscript.
[1] POTTER V.R., Global Bioethics, MichiganStateUniversity Press, 1988.
[2] Lettera Enciclica Evangelium Vitae del Sommo Pontefice Giovanni Paolo II ai vescovi, ai presbiteri
e ai diaconi, ai religiosi e alle religiose, ai fedeli laici e a tutte le persone di buona volontà sul valore e
l’inviolabilità della vita umana, Città del Vaticano, 25 maggio 1995, 2, 90.
[3] SGRECCIA E., Manuale di bioetica. II Aspetti medico-sociali, Vita e Pensiero, Milano, 1996,
seconda edizione.
[4] BERLINGUER G., Evangelium Vitae: una sfida da raccogliere, Bioetica, 3,1995.
[5] Lettera Enciclica Evangelium Vitae, 1, 15.
[6] Concilio Vaticano II, Cost. Gaudium Spes, 14, 1.
[7] Lettera Enciclica Evangelium Vitae, 3.
[8] MARINO I.R., DOYLE H.R. Living donor in urgent cases: ethical hazard?, Liver Transplantation
2002,8(9):859-860.
[9] GOYAL M., MEHTA R.L., SCHNEIDERMAN L.J., SEHGAL A.R. Economic and health
consequences of selling a kidney in India, JAMA 2002, 288(13):1589-1593.
[10] HARRIS J, ERIN C. An ethically defensible market in organs, BMJ 2002, 325: 114-115.
[11] MARINO I.R., CIRILLO C., CATTOI A. Market of organs: unethical under any circumstances,
British Medical Journal, (Electronic letters published) 2002, http://bmj.com/cgi/eletters/325/7356/114
[12] MARINO I.R. Nessuno compri quegli organi. Il trapianto nasce da un dono. Va’ Pensiero, 93
(Electronic Paper), Il Pensiero Scientifico Editore Online, 18 September 2002.
[13] MARINO I.R. Health at any price, Italianieuropei 2002, 2(3):170-180.
[14] NAIK G. Assisted-suicide group makes more final exits go through Switzerland,The Wall Street
Journal Europe, Vol. XX, No. 206, 1, November 22-24, 2002.
[15] Lettera Enciclica Evangelium Vitae, 2.
53 ANTONIO BATTRO
NEW FRONTIERS IN NEUROEDUCATION
OPENING THE BRAIN
The digital revolution has “opened” the human brain for observation and action. In fact, the new
methods of brain imaging are the direct result of the ever increasing computer power that permits not
only an accurate view of the anatomical details of the living brain but also its chemical composition as
well as the identification of the functional changes embodied in neuronal networks of enormous
complexity during the most diverse perceptual, motor, and cognitive tasks (Posner & Raichle, 1994;
Spelke, 2002). Moreover, we can now, in some very well controlled experiments, “infer behaviour
from functional brain images” (Dehaene et al, 1998). This possibility could be some day expanded to
wider contexts, and become a matter of ethical concern regarding human intimacy (“ mind reading”).
By analogy to the world wide web www we could speak of a brain wide web (bww) with multiple
cortical and subcortical subsets (Battro, 2002) some of them highly modular and stable and others more
flexible and plastic, genetically programmed by biological evolution of our species, or epigenetically
embodied in the cultural evolution and the educational development of the individual (Huttenlocher,
2002). The new cognitive neurosciences are thus enabling us to devise new tools to better understand
and enhance our learning skills. This is the scope and aim of “neuroeducation”.
NEUROPLASTICITY
Perhaps the most remarkable findings of contemporary neurosciences are related to the astonishing
neuronal plasticity of the human brain (Buonmano & Merzenich, 1998, Grafman & Litvan, 1999). We
know that the adult brain is producing a constant generation of neurons. As Fiona Doetsch says “we are
left with the concept of a dynamic brain, one in which memories are perhaps formed by the addition of
new cells, and a possibility of a brain with a latent potential of self-repair” (Doetsc, 2002, Doetsch, F.
& Sharff, C. 2001). A proof of this statement is the extraordinary rehabilitation of some
hemispherectomized children, showing that “half a brain is enough” to perform at a satisfactory level in
current life and school (Vargha-Khadem et al, 1997, Battro, 2000). We still don’t have a good
explanation of the compensatory mechanisms involved in that process and these remarkable cases have
become a challenge for our standardmodel of the brain/mind.
NEURO-IMPLANTS AND NEURO-TRANSPLANTS
The first successful neuro-implant of modern medicine has been the cochlear implant, a digital
prosthesis connected to the auditory nerve that has changed the life and the education of thousands of
hearing disabled children (Giraud et al, 2001). This a good example of a humanitarian application of
neuroeducation using the most advanced biotechnology.
In the future we will see more direct interventions not only of neuro-implants of this kind, but also of
neuro-transplants in the disabled brain. In a recent book that reviews the question (Freed, 2000) it is
shown that stem cell implants can become a valid alternative to fetal tissue implants in the brain of
patients with Parkinson disease for example, but we still need to know more about how stem cells
differentiate to produce new dopamine neurons. Other cases of possible brain-repair with transplants of
living cells from animals or humans are also being studied, opening a great hope in the prevention and
care of degenerative diseases.
54 NEUROINFORMATICS
The brain is a mix of analogical and digital processes in constant interaction.
We can expect that “neuroinformatics” will someday provide a prosthetic
device for direct brain control of a "virtual mouse" in the brain, a kind of "thought translation device"
(Kubler et al, 1999). Some researchers have implanted special electrodes into the cortex of three
patients with locked-in syndrome that are alert and cognitively intact, but cannot move or speak. A
brain-computer interface, BCI, permits the patient to drive a cursor on a computer monitor when he or
she is thinking of driving the cursor to a target (Kennedy et al. 2000). The increase of the firing rate of
the implanted neurons move the cursor from left to right on the screen and the speed of the movement
is proportional to the rate of firing of the neurons. To "mentally control" this displacement (to point the
cursor) the patient must develop a specific analog skill to reach the different icons that will produce a
synthetic speech output, or point to a target letter to be printed. The digital skill, the “clickoption”, is
automatically triggered by a different pulse train from the cortex (which provides also a distinct
auditory feedback to the patient). The authors intend now to provide the patients with access to some
environmental controllers and to the Internet.This humanitarian task opens also a new world to the
study of the plastic changes that induce a "cursor cortex," as the authors said, in these extremely severe
and dramatic cases (see alsoTaylor et al. 2002, Koning & Verschure, 2002).
LANGUAGE AND THE BRAIN
In a globalized world the possibility to reach millions who speak hundreds of languages is one of our
greatest challenges in contemporary education. Automatic translation will become an increasing
important tool in the digital society that networks our planet. On the other hand,there is also evidence
that the bilingual brain shows structural and functional differences with the monolingual brain, a fact
that can support some types of early interventions in the teaching of languages in a global society
(Perani et al. 1996, Paulesu et al, 2000). Human language can be also independent of oral speech and
we know that signed language, for instance, which is a new modality, is organized in the brain in ways
that are similar to those of a spoken language (Hickok, Beluggi & Klima, 2002; Newman et al, 2002;
Petitto et al, 2001).Bimodalism (oral/signed language) plays now an important role in the life of many
deaf people. The current trend in neuroeducation is to provide a “universal design”to the educational
(digital) tools and to use many parallel paths to overcome the more frequent obstacles in the learning
process, like dyslexia, attentional deficit disorders, etc (Rose & Meyer, 2002).
To sum up, the increasing interaction of living neurons with information processing devices in a great
variety of cases opens a new field of knowledge and brings hope to many human beings of all ages and
conditions, talented or handicapped, but also may arise growing ethical concerns about the procedures,
the interventions and the aims of the new technologies.
55 References
Battro, A. M. (2000) Half a brain is enough: The story of Nico.Cambridge: CambridgeUniversity Press.
Battro, A. M. (2002). The computer in the school: A tool for the brain. In The challenges of sciences:
Education for the twenty-first century. The PontificalAcademy of Sciences. Scripta Varia, 104.
Buonmano, D. V. & Merzenich, M. M. (1998) Cortical plasticity: From synapses to maps. Annual
Review of Neurosciences, 21: 149-186.
Dehaene, S., Le Clec'H, G., Cohen, L., Poline, J. B., van de Moortele, P. F., & Le Bihan, D. (1998).
Inferring behaviour from functional brain images. Nature Neuroscience, 1, 549-550.
Doetsch, F (2002) Reconstructing the brain. Journal of the AmericanAcademy of Child and Adolescent
Psychiatry. 41:5, 622-624.
Doetsch, F. & Sharff, C. (2001) Challenges for brain repair: insights from adult neurogenesis in birds
and mammals. Brain, behavior and evolution. 58; 306-322.
Freed, B. (2000). Neural Transplantation. (2000). Cambridge, MA: MIT Press.
Giraud, A. L., Price, C. J., Graham, J.M & Frackowiack, R.S.J. (2001). Functional plasticity of
language-related brain areas after cochlear implantation. Brain, 124, 7, 1307-1316
Grafman, J. & Litvan, I. Evidence for four forms of neuroplasticity. In Grafman, J. & Christen (Eds)
(1999). Neuronal plasticity: building a bridge from the laboratory to the clinic. Berlin: Springer.
Hickok, G., Bellugi, U. & Klima, E.S. (2002) Sign language in the brain. In The hidden mind.
Scientific American, special edition, 12, 1, 46-53.
Huttenlocher, P. R. (2002). Neural plasticity: The effects of environment on the development of the
cerebral cortex.Cambridge, MA: HarvardUniversity Press.
Kennedy, P. R., Bakay, R. A. E., More, M. M., Adams, K, Goldwaithe, J. (2000). Direct control of a
computer from the human central nervous system. IEEE Transactions on Rehailitating Engineering , 8,
198 - 202.
Koning, P. & Verschure, F. M. (2002) Neurons in action. Science 1817-1818.
Lichtman, J. W., Fraser, S. E. (2001) The neuronal naturalist: watching neurons in their native habitat.
Nature Neuroscience. 4, 1215-1220
Paulesu, E., McCrory, E., Fazio, F., Menoncello, L., Brunswick, N., Cappa, S.F., Cotelli, M., Cossu,
G., Corte, F. Lorusso, M., Pesenti, S. Gallagher, A. Perani, S., Price, C., Frith, C.D., Frith, U. (2000). A
cultural effect on brain function. Nature Neuroscience, 3, 1, 91-96.
Perani, D., Dehaene, S., Grassi, F., Cohen, L., Cappa, F. S., Dupoux, E., Fazio, Mehler, J. (1996) Brain
processing of native and foreign language. Cognitive neuroscience and neuropsychology, Vol 7, N 1517, 2439-2444.
Posner, M. I. & Raichle, M. E. (1994).Images of mind. New York, NY: Scientific American Library.
Rose, D. H. & Meyer, A. (2002). Teaching Every Student in the Digital Age: Universal Design for
Learning. ASCD.http://www.cast.org/teachingeverystudent/ideas/tes/
Spelke, E.S. (2002) Developmental neuroimaging: a developmental psychologist looks ahead.
Developmental Science, 5, 3,392-396
Taylor, D. M., Helms Tillery, S. I. & Schwartz, A. B. (2002) Direct control of 3D neuroprosthetic
devices. Science, 296, 1829-1832.
Vargha-Khadem, F., Carr, L. J., Isaacs, E., Brett, E., Adams, C. & Mishkin, M. (1997). Onset of speech
after hemispherectomy in a nine-year-old boy. Brain, 120, 159-182.
56 ADRIANO BOMPIANI
EXPERIMENTAL RESEARCH IN THE FIELD OF BIOMEDICINE:
SPHERES, METHODS, VALIDITY CRITERIA FOR RESEARCH PROJECTS
INTRODUCTION
The paper which was presented at the Conference, "Ethics of biomedical research: for a Christian
vision" - 9th General Assembly of the Pontifical Academy for Life - was entitled, EXPERIMENTAL
RESEARCH IN THE FIELD OF BIOMEDICINE: SPHERES, METHODOLOGIES, VALIDITY
CRITERIA OF RESEARCH PROJECTS.
It seems almost pleonastic to begin by underlying that the modern world feels as "necessary" a
biomedical research that is always growing in advancement, intended as a factor of both cultural and
social progress, in order to guarantee, primarily, the best possible diagnosis and therapies. The practical
finality of the research effort, centered on "cure" - fundamental goal of medicine - is universally
acceptable, even though this is not the only end pursued in medicine. An observation made by C. Foster
to the effect that it is "the aspiration of every sick person to be cured in an effective and timely manner,
without collateral effects"[1], is absolutely true. A similar observation, equally truthful is that: "Each
medical doctor should work to realize this precise objective: that which can be verified sometimes, but
rarely in such a satisfactory manner".
Certainly it is not licit to abandon the pursuit of these objectives. Even if definitive cures are not
obtained today, it is still possible to practice therapies that are very effective in alleviating the condition
of the patient, notwithstanding the fact that the specific goal of medical research should be to obtain the
highest level of "prevention of sickness", more than "cures for the states of morbidity". It used to be
said that the "practical" objective is the fundamental goal of medicine, but it is not the only one.
Biomedical research advances growth in medical knowledge, a fact that is valuable in itself and which
characterizes the progressive, unstoppable but also infinite conquest of notions and data that distinguish
and contribute to the growth of modern science. The question of the researcher's "responsibility" in this
dynamic becomes immediately evident, a point to which we shall briefly return in the concluding
sections.
From the point of view of the sociology of science, the technico-methodological culture should be
joined ultimately to the sociological concept of interest, as is the case in all the other scientific sectors.
In fact, it is affirmed that since knowledge in the real world is destined, in great measure, to be used,
and not simply as an object of contemplation, this idea brings together not only the already accentuated
interests of the users (real and potential) to be better cured, but also the very interests of the researchers
(economic, prestige, carrier, but also the sentiments of altruism as opposed to egoism, etc.). It also
addresses the interests of the sponsors who provide the means and instruments needed for research
(economic interests, marketing power, etc.). In this work, some of these objectives would be clarified at
the points in which they meet in the "research project".
BIOMEDICAL SCIENCE, SCIENTIFIC COMMUNITY, CIVIL COMMUNITY
As is noted, the process of scientific evolution is entrusted to the scientific community, that is, to all the
operators who at various levels of preparation, action and responsibility, work in the research structure
and for the realization of the research objectives. The process of evolution of knowledge and research
are both similar; above all, in the sphere of applied sciences, the research that is carried out by an
57 appropriate technology is the indispensable driving principle in the evolution of knowledge, and
ultimately of science. Medicine, even with its peculiarity, shares this dynamic.
The indicated binomial, in which the term "science" in the constitutive sense of the word alludes to the
fullness of expiable knowledge in a particular historic moment, constitutes in other word, "research", a
relationship that is right, firstly because it accepts a progressive definition of the relationship between
an objectively existent reality and our possible knowledge of the same reality, according to which, the
logical structures are reflections of the ontological aristotelic structures. Secondly, this relationship is
valid because the constructive and subjective conceptions of the platonic school accept a current
process of renewal, according to which reality is an abstraction, and science is the sum-total of
changeable paradigms, elaborated by scientists in an attempt to give consistent progress to the mental
process of knowing.
Thus introduced, the relationship which we intend to analyse in detail in this brief paper could be
generally proposed, in terms of the relationship between the biomedical researcher on one hand, and
the society in all its complex dimensions on the other; nevertheless, it is immediately necessary - in our
present field of study - to offer a distinction between those researchers who work for health in
structures that do not have direct relationship with the patient, and the researchers who work on
patients or better (as is preferred today) with the patient (biomedical and clinical researchers)[2].
Especially in this last case, the relationship between science - biomedical experimentation - on the one
hand and the human person, on the other, is configured in terms of "dialogue" between an expert
imbued with his proper professional rights and duties and a human being, who is the subject of
inalienable rights among which is the all-known "right to defence of health". For obvious motives, the
considerations that I will present here shall be limited to this second aspect.
Definitely, in the present epoch and in the future we must always wait for the results of biomedical
research, and the more advanced it becomes the more the level of technological progress, with more
daring expansions toward the fundamental structures of life: genes and molecules, of which the desire
is not only a knowledge about their natural functions, but - sometimes - to modify their actions simply
to satisfy desires and goals set by the individual subjective will.
But society has not simply accepted this evolution in a passive manner. The episodes, which tend to
cross the boundaries of common ethical sentiments, offend the dignity of man and increase the emotive
pressure of public opinion, remain alarming. These activities help also to increase the level of
jurisprudent and legislative vigilance (particularly in international headquarters) of health authorities
charged with the regulation of research activities, especially where these activities risk damaging or
offending the dignity of the human person, with unsatisfactory results.[3]
New "structures", nearer to the operative reality of tribunals and parliaments, have been delineated to
give consistency to the need to protect the human subject of experimentation. The Ethical Committeeis
presented in this context as the place for necessary debate, as the "external" point of evaluation, of
guarantee and harmonisation between the actions projected by the biomedical and clinical researcher
and the need to safeguard the rights of the patient.
FREEDOM OF SCIENCE, FREEDOM OF RESEARCH AND "PROJECT OF BIOMEDICAL
RESEARCH"
The ethical committees, by virtue of their principal and natural role, must decide on "research projects",
and that is on the concrete exercise of the freedom of research in a defined and for a strictly delineated
field of the biomedical sciences; they must respond to the questions posed by researchers and presented
by same as worthy of being investigated. This poses, immediately, a general question: at what point
does the freedom of science - that is also talked about by our constitution (like the rest of some of the
other constitutional matters) - coincide with the freedom of research? This is a very important question,
58 to which one can at once respond in general ethical terms by affirming that it is necessary that the
research activity also shares the need for an anthropological integration (see for instance, Sgreccia,
1994)[4], and in juridical terms, affirming that each constitutional principle must be in accord with all
other constitutional principles. The is an intrinsically fundamental question in the case of biomedical
researches, being, as it were, concerned not with inanimate substance but with a human being
characterized by particular dignity. From the Ethico-juridical point of view it appears obvious from
common sense that research projects which, give benefits and those that cause damages or grave risks
to the human subject do not have the same value (the ancient aphorism "first do no harm" becomes
relevant in this context). Does this limit the freedom of research?
Scientific freedom (like other kinds of liberties) is, today, interpreted in the projection of the principles
of individualism, pluralism and universalism. Which (as is noted) present different meanings in
different contexts in which they are examined and in relationship with the cultural and moral
orientation of the evaluator[5]. The need to have and exercise the values of scientific freedom does not
exonerate the biomedical scientist-researcher from the general duties which, pertain to the entire human
moral community; rather, he is challenged to operate with a high sense of responsibility and prudence,
even when he must single-handedly direct activities in his particular area of specialization. The fact that
almost all the Constitutions of the more advanced countries confer particular juridical protection to
scientific research activities is not a sign of privilege, but of the particular dignity guaranteed to
whomever carries out these activities responsibly[6]. Moreover, it is well noted that beyond these
ethical principles that are applied in the course of the researcher's activities, there now exist clear norms
for the juridical protection of the subject of biomedical research[7].
A second question (whose answer, at first glance, may seem to be taken for granted) consist in asking
why also in biomedical research and experimentation projects are adopted on the basis of expressed,
specific "protocols".
This criterion addresses the specific demand of scientific methodology that - in general - was
developed in the course of the '800 and affirmed in the first half of the 20th century, more than the
great regrouping of the so-called "experimental sciences", among which - even purely with its specific
characteristics - is medicine. In synthesis, this methodology unfolds as follows: problems - theories critiques in the binomial conjecture-confutation. Recently. D. ANTISERI (2001)[8], and G.
FEDERSPIEL and co. (1999 and 2001)[9] have recalled this evolution, with references to application
in the medical field, and the reader is referred to these interesting articles and all the valuable
epistemological literature of Italian medicine.
The E.C. with an accurate examination of the "research protocols" presented by the researchers, act as
participants in the preventive judgement of the intrinsic quality of the research, and in the last analysis
operate for the benefit of the same researcher, when they express their judgements with justice, serenity
and objectivity, not simply rejecting (or requesting the revision of the) protocols that present excessive
risks to the research subject; they are also useful in separating the scientifically reasonable protocols
from those suspected of being products of simple improvisation or - worse - of fraud.[10]
It is widely discussed, at national and international levels, if the judgement of the scientific quality of a
protocol should be left to a single group that will also evaluate the ethical worthiness of the same
protocol, or rather share these dual roles between two distinct bodies. Even the recent conference of the
European Council on human rights did not take any position in this regard, but left the faculty the right
to choose from the unique or two-fold models.
A judgement about the scientific validity and innovative contribution of any proposed research protocol
is always re-emphasized as the necessary condition for its approval, even in the text of the additional
research protocol of the Convention of Oviedo - by way of an advanced edition - according to the well
known dictation that "no research is ethically valid if it fails to present in each case intrinsic scientific
qualities".
59 Naturally, the examination of the scientific and ethical practicability of a proposed research is much
more a complex process, as will be clearly shown following the discourse of the theme that has been
given to me.
RESEARCH AND EXPERIMENTATION
In our present field of interest, these two words are often used interchangeably. According to the Italian
Encyclopedia, by research - with a more circumscribed meaning as against the general "activity of
researching, finding, discovering somebody or something" - should be intended "all the studies and
investigations that are undertaken in the field of the scientific or humanistic disciplines in order to
characterize documents or determine sources, reconstruct events or situations, discover phenomena,
processes, regularity, laws etc." More precisely, research is each study activity carried out
systematically and not casually with the aim of acquiring new knowledge: it is said to be scientific,
when it is conducted with scientific understanding and methods.
The same Encyclopedia defines the word "experimentation" as the activity of experimenting (derived
from the Latin experimentum): and that is "to apply, use, put something to test in order to ascertain and
verify the functional capacity, validity, efficacy, performance, etc...". In the field of scientific research
it means, "to proceed according to the norms of the experimental method".
Strictly speaking, also in biomedical research, a distinction should be made, in using the terms under
consideration between the generalizing and all-knowing posture of research carried out by biological
medicine, based on the observation of the physical characteristics and pathologies of the human
organism and the position of experimentation, which, expresses more adequately the modifications
induced in the organism (healthy or sick) in order to derive information both for "knowledge in it self"
of the organic reactivity, and usefulfor applicative, diagnostic and therapeutic activities. Further, it is
obvious that with regard to the possibility of generalization of information[11], their meaning cannot
remain restricted to the single individual from whom they are derived, but can be extended to other
individuals who constitute a category, in which is inserted, also the subject that gave the information.
One final general remark: the question both from inductive and deductive argumentation about the
nature of the medical reasoning and the intrinsic value of medical "observation"[12] was also discussed
in the past. Observation - considered as "methodology" - is applied in biomedicine to whatever
meaning one wishes to give to the terms "research" and "experimentation", and biomedical technology
does nothing else but amplifies the ultra sensorial sphere and most of the time qualifies it.
In reality, re-emphasizing the need for a correct and accurate "observational empirical basis", it is
accepted today that the mind of the doctor - more so if he is a researcher - operates in diagnostic and
therapeutic researches through a gradual and progressive exploration which, proceeds by way of
conjecture and refutation. Therefore, applying the Popperian scientific "paradigm" that is prevalent
today, this long introduction now permits me to begin an analysis of the singular modalities by which
biomedical research is generally classified.
METHODOLOGIES OF BIOMEDICAL RESEARCH
They are numerous and complex and their preferential usage should be premised on the objective to be
achieved, using the best means to confer scientific validity on the protocol and scientific value on the
study project being considered. This is not a simple demand of "good science", but also an "ethical"
requirement[13]. The choice requires "competence" on the part of the researcher and a strong ethical
commitment. Generally, there are three principal ways through which biomedical research is carried
out.
60 Controlled randomised trials
Observational research
The so-called "quality" research
These modalities can be applied in the prenatal, neonatal, paediatric, adolescent, adulthood and old age
stages of human life in relation to particular "objectives" proposed for realization: diagnostic,
therapeutic, epidemiological, etc.[14] Generally, the following is affirmed:
The controlled randomised trials represent the most suitable method for excluding cases of
interferences with the evaluation of the results as a result of preferences or errors.
The observational research is particularly appropriate in the epidemiological field, characterised in the
narrative sense (as descriptive of phenomena without specifying on causes and effects) or in the
analytical sense (in searching for the causes and effects of observed phenomena, there
interrelationships, through some varieties: the cohort studies, the case-control studies, etc...).
The quality researches aim at interpreting the thinking of the people, with respect to some determined
phenomena or problems, and they have a vast articulation: methods that are purely observational on the
part of the researcher, qualitative interviews, structured more or less in questionnaires, operative
reflections by experts ("consensus methods"), interaction groups for particular problems ("focus
groups"); examination of case records, etc...
Systematic Revisions and Research
Generally, each researcher enters into the trend of an already cultivated research, of which it is
necessary that the researcher, before beginning the draft of the protocol and specifying the work
hypothesis, should understand its content as much as possible.[15] Summaries and analysis of studies
published in the past results are available in different sectors of medicine, and these continue to help
the further spread of "systematic revisions and practical guidelines", that constitute the basis of the socalled "evidence based medicine". This would derive from a vast critical analysis, which is possible
when the examined works can confront each other and respond to precise needs for the solution of
explicit problems.[16] The systematic revisions, also called "metanalysis", are aimed at constructing a
consistent basis of the comparable studies, thereby improving the level of assessment precision
regarding, for instance, the effect of an etiological factor, the predictability of a test, or the efficacy of a
treatment etc. The revisions further aid the numerical growth of the patients considered in clinically
relevant subgroups, provides solutions to problems relative to contrasting results and also indicate the
opportunities provided by new studies.
The methodology used in arriving at these revisions is rather complex (therefore, reference must be
made to specialized publications); however it is worth underlying that the intuition of ARCHIE
COCHRANE (1972)[17] on the heuristic and practical value of the systematic revisions and of the
metanalysis was, and continues always to be more, enriched with results that are the goals of the
research formulation, the routine nonetheless, that is the clinical decisions of each doctor,
characterized, moreover, in many cases as a true and proper "autonomous research".
The Methodologies of Research in Diagnosis
The attempt to prearrange methods that are always increasingly set to achieve discovery with
procedural easiness, rapidity, security of results, coupled with a comfortable investment and low cost
pathologies, or predisposed conditions, in the human subject is one of the perennial goals of biomedical
research and related experimentation today, especially with reference to the sensibilities to the
requirements of the so-called medicine that is based on data furnished - in some circumstances - from
genetically conducted inquiry (that has become for some the actual "paradigm for development" of
biomedical research as viewed by Kuhn).[18]
61 The procedures for evaluating a new diagnostic test or screening[19] are based fundamentally in the
sub grouping of persons - and this is taken to be adequate - both for the administration of an already
confirmed diagnostic standard (the so-called gold standard) and for a new test. The interpretation, or
report of the standard test should be done without knowledge of the results of the new test and vice
versa. This means, in the first place, stabilizing the sensitivity and the specificity of the new test also in
the presence of the gold standard. Other "valuable" measures of a test consist in appreciating both the
positive and negative predictable powers.[20]
In the research on new tests, various ethical questions converge: beyond those regarding correct
verification of the proportion of seemingly positive and seemingly negative results that the new test can
offer as against the standard procedure (wrong evaluations can notably influence the conduct of the
agent, and/or the decision of the patient), they must also recognise the risks connected with the invasive
nature of some diagnostic procedures (both the "gold standard" and experimentation procedures).
Obviously, the norms of "Good Clinical Practice" are relevant in these case and to them we shall
briefly return.
SOME INDICATIONS ON CONTROLLED CLINICAL STUDIES (CONTROLLED CLINICAL
TRIALS; CONTROLLED RANDOMISED TRIALS) AND THEIR USE PARTICULARLY IN
THERAPEUTIC EXPERIMENTATION
As is well known, a great part of clinical experimentation (clinical studies) takes place in the
pharmacological sector.
Definitions and Phases of Pharmacological Clinical Studies
Generally, clinical studies are classified in I, II, III, IV phases. It is not possible to delineate the precise
boundaries between the individual phases, inasmuch as there exist diverse positions (sometimes
incorrect and/or ethically non acceptable).
Phase I is concerned with a drug and a healthy volunteer and is aimed at furnishing the
pharmacokinetics profile (absorption, distribution, metabolism and elimination: ADME) and to have a
confirmation, in the case of a healthy subject, of the verified responses in animals (pharmacodynamic
activity). It is not part of the goals of this phase, inasmuch as it is ethically unacceptable, to conduct a
research on the toxicity or tolerant ratio of the drug; it is only possible to acquire some preliminary data
on the tolerability by observing the appearance or not of subjective symptoms (nausea, headache, etc.)
that are not verifiable using laboratory animals.
The studies on ADME are useful for a comparison of the verified data both with regard to man and
those relative to laboratory animals and so be able to trace an initial profile on the security of the drug:
the toxic effects verified in animals (not traceable to the pharmacodynamic activity of the active
principle) may be possible, when the two ADME are identical or very close in similarity; they are also
possible in man, for some determined dosage levels and/or in particular conditions (hyperactivity); on
the contrary they may not be possible if the ADME data are diverse. In this phase, the experimentation
is generally not conducted using the "blind", but in the "open", and both the researcher and the subjects
know all they are being administered.
Phase II has to do with the interaction between the drug and the patient (effects of the drug on the
organism: pharmacodynamic) and has the aim of demonstrating the activity of an active principle in
patients affected by a sickness or a clinical condition that justifies the proposal of the active principle.
In this phase also security elements are briefly acquired. The studies are carried out with a relatively
limited number of subjects, often according to a comparative scheme (confrontation of drug with
placebo). It is possible in this phase to determine an appropriate interval of doses, the tolerable dose (on
62 the basis of the appearance of collateral effects, connected that is, with the pharmacodynamic activity)
and to identify a dose/response relationship. It is possible that phase II does not have the scope of
ascertaining a therapeutic activity, but only a pharmacodynamic activity.
Phase III regards the interaction drug-patient (effects of the drug on the sickness: drug-therapy) and has
the scope of determining, on an elevated number of patients, enlisted in diverse centres, the therapeutic
efficacy and the security (limitedly to the number of samples) of the medicine being examined. The
experimental design is almost always a double blind, randomised in confrontation with a placebo or
with a drug with an ascertained efficacy.
In this phase many adverse effects can be gathered, particularly the more visible effects that appear
after a treatment of three/six months after the administration of the drug, as long as these however,
happen with a major frequency of once each one hundred administration. The important toxic effects
under the medical aspect that manifest with a certain lateness or re-occur with less frequency once
every thousand administration may therefore, not be revealed before the authorization to commercialise
its usage.
The Phase IV of clinical experimentation begins after the drug has obtained permission for
commercialisation. This phase is concerned principally with the interaction treatment-patients, effects
of the drug in the real conditions of use, eventual appearance of undesired effects (pharmacovigilance)
and secondly the observation of possible therapeutic effects not indicated in the commercialisation act
of the product. Clinical studies aimed at confirming or ascertaining new indications should be
considered as studies on new medical products and so fall back to the categories of studies in phases II
and III. It is necessary to underlie that there is no complete agreement with regard to the definition of
this phase.
The Characteristics of Controlled Clinical Trials
In 1998, on the occasion of the 50th anniversary of the first controlled randomised clinical study
published in Great Britain on the use of streptomycin for tuberculosis, a big international conference
was organised under the title: "50 Years of Clinical Trials", with themes very indicative of the
historical progress of this method of technical experimentation.[21] Certainly it is not the aim of this
present discourse to offer an exhaustive analysis of this complex material; nevertheless, some brief
recall of the major arguments would serve especially to present a glimpse of the responsibility that
belong to the promoters, programmers, and the same executors of these methodologies, those that have
the objective of evaluating any potentially innovative treatment using rigorous criteria, as much as
possible.[22]
J.P. BOISSEL and A. LEIZOROVICZ (2000)[23] underlie the "nature" of controlled clinical studies,
considered a fundamental progress in the history of the development and of the efficient therapies with
the following expressions: "They are scientific experiments and for this reason they can be universally
known and their results can be globally applied, as long as they are designed and conducted according
to currently well-codified principles...
"The concept of controlled clinical study is essentially the same for each branch of medicine. It is
applied both in the evaluation of drugs and in surgical procedures, in physical and psychical therapies.
It can be extended to the evaluation of diagnostic tests. Finally, the controlled clinical studies can be
used(and they shall always be) to evaluate diverse medical strategies. A strategy is the sum total of
interventions, possibly in combination with different diagnostic procedures. Diverse examples of
evaluation of different strategies in medicine have been published: for instance, an invasive approach
as against a conservative approach, or a pre-hospitalisation pharmacological treatment as against a
hospitalisation one" (page 1).
Further, they argue that: "a controlled clinical study is an experiment in the course of which different
data are collected. Their analysis, according to the design of the study, produces information that is
63 scientific in nature. A clinical study must therefore satisfy the fundamental requisites of a scientific
experiment. The methodology of the clinical studies is based on principles of the experimental method,
as was initially indicated in the 19th century and codified today. These principles can be summarized as
follows:
The hypothesis for evaluation must be proposed in writing before the beginning of data collection; the
hypothesis is verified through the modifications registered in the system, object of investigation (for
example the patient, the unit that provides the therapy, etc.).
The system, object of investigation and the experimental unit
The experimental design must be such that the verification of the hypothesis depends on the meeting
between a group of the modified experimental unit and a group of non-modified control unit; this
comparison is, for the researcher, the access key to the results of the experiment.
The number of experimental units must be sufficiently great to minimise the risk of having excessive
adverse effects on the results from the singular idiosyncratic reactions of the experimental units.
With the aim of establishing a causal relationship between the modification of the system and the
result, the two groups, apart from the intervention, must be administered in an identical way, before,
during and after the intervention that determine the modification, until the completion of data
collection".
In the first periods of development of the experimental method these principles could not be directly
applied in the field of research with full efficiency. Subsequently, they were improved with the
adoption of the statistic model and with the concept of "mixed up factors". Following these authors, the
"setting up" of a controlled clinical study, in extreme synthesis, must make provision for:
A priori hypothesis that must be proved. Usually this is relative to the efficacy of a certain intervention
on an event, a symptom, or on the quality of life of the patientwith a specific pathology and peculiar
eligibility profile. This hypothesis represents the product of a long and complex process and is
gradually constructed within a system of reasoning based on available knowledge, on intuition, on
observed or presumed functional relations and on an accurate analysis of the health problems about
which the experimenter is interested.
The assessment of the so-called "mixed up factors", necessary because of the fact that numerous factors
can interfere with the evolution of the condition of the patient after the administration of a therapy. The
effect of the therapeutic intervention is only one of the factors, and cannot be separated from the others
solely by observing the course of the patient. Other considerable factors are the so-called regression
toward the middle, the spontaneous improvement or worsening of the sickness condition, the
concomitant effects of the therapies and the placebo effect. The effects of all these factors are
correlated with time[24].
Regarding the placebo effect, it is noted that this factor interferes with the evolution of a patient's
sickness; in many of the cases this interference is positive. It is an unavoidable component of all the
therapies. Even though it is difficult to determine with precision the manner of the "placebo effect", no
one can deny its existence {see also G. Folli (1994); L. Candia (1994)}. Its intensity and the weight of
its components are most likely (the trust of the patient in the doctor or in the administered drug, the
positive expectations with regard to the sickness or one's convictions regarding medical "miracle", etc.)
unpredictable. It is supposed that many drugs function only through the placebo effect.
3)Randomisation is the criterion by which the subjects who accept to participate in an experiment are
classified in different study groups using a method of assignment that is not subject to external
influences (that is, it does not allow for any personal preferences neither of the researchers nor
patients). It is proven that generally casual assignment (random) is the best method needed to achieve
the objectives of medical research, yet this criterion is also the subject of various ethical objections that
shall be later indicated.
4) Masking of Membership of Different Groups (Blinding). ANN MC KIBBON, A. EADY and S.
MARKS[25] express this process as follows:
64 "In the studies relative to treatments, beyond the casual assignment, patients, healthcare workers and
persons participating in the research programme should not, as much as possible, know the group to
which the patient is assigned. This method is known as blinding, and helps to avoid what is commonly
referred to as measurement bias. Considering the reality of human nature, the expectation of the
patients and healthcare operators are strong, and often they can influence the manner of evaluating
results. In fact, all too often and with the best intentions, people consider as truthful that which they
believe must happen or that which they believe others think should take place. In order to reduce, as
much as possible, these wrong perceptions, neither the healthcare operators nor the patients should
know what treatment the patients are receiving" (page 46).
Many authors are convinced, and we share the same convictions, that the blinding procedures are
complicated and often present grave ethical difficulties, especially in the "double" or "triple" blind
formulas, even without a lack of the basis for their rationality.[26]
5) The Follow-up. The importance of this factor for the evaluation of the controlled randomised studies'
results is evident, not only during and at the end of the studies (the moment correctly foreseen in the
original protocol; but which is often modified for various reasons in the sense of anticipation or
lateness in the closure of the experimental phase) but also with regard to the evaluation of the effects
into the future. A very short observational period has the danger of not discovering all the perverse
long-term effects. It is agreed that at least 80% of all the participants that were enrolled and randomised
at the beginning of the study must be analysed at the end of the same study in order that the results be
considered valid or "true", at 90% probability. This means taking into account all the participants (and
their numbers should be in the least possible) who interrupt their treatment, and all others who are lost
in one way or the other. Rightly A. MC KIBBON et al affirm that maintaining a good follow-up can be
easy or difficult, according to the study[27] and S. Galbraith and I. Marshner (2002) while evidencing
the rise in the cost that is determined with the reduction of the data "in the course of the work", have
elaborated statistical criteria to confront the various situations.[28]
In each case, it is necessary (technically) and proper (juridically and morally) to follow and strictly
monitor the treatment in all phases of development, with the aim of establishing if the approved
protocol must be maintained unaltered or modified. This implies adhesion to rules of appropriate
observation of the record cases, based on timeliness of the report of the adverse effects, the completion
of the same, competence and professional experience of the one conducting the monitoring and his
freedom of judgement in the face of possible wrongful interferences.[29]
6) Correct Use of the Methods of Statistics. According to B. PITT and others (2000), the use of the
statistical model has the goal of resolving three interrelated problems:the variability between one
observer and another, or in the same patient at different times (intra-patient variability) or in different
patients at the same time (variability between patients); the casual variation in results of the same
experiment repeated many times; and the foreseeing of successive events based on a series of observed
data in the past. The two statistical instruments, which, present a solution to these problems, are the test
of significance and early assessment with its trustful limits. The test of significance gives arbitrary but
reasonable rules, for deciding if the results of a study, that is, the observed difference between the
behaviour and changes in the two groups is caused by the case or can be accepted as fruit of a different
reality.[30]
Once the difference between the changes in treated patients and those in the control group has been
calculated and the statistical meaning has been evaluated, the next point that the researcher must
consider is the question of the treatment effect, especially if the value of probability is small.[31] As
Calamo-Specchia et al (1994)[32] further argue, researches carried out by Meinert and others (1984)
have brought to the fore the fact that many published works in the international literature of that time
were neither calculating the amount of necessary samples, not planning the evaluation of results with
the statistical significance criteria; obviously, much has changed in this regard today.[33]
65 In conclusion, the indications (obviously not completely exhaustive) presented in this section show the
complexity, both methodological and interpretative, of clinical trials. This complexity puts to the test
the experimenter, the sponsor and generally the "technicians" of the clinical research, and also the press
and the question of exact understanding of the results on the part of public opinion (R. Morton,
2001).[34]
RESEARCH ON AXIOLOGY, ON CAUSES AND DAMAGE
These are very important researches with both clinical and health implications (clinically, there is also
the use of the concept of "damage" in an aitrogenic sense). These studies, which, are also aimed at
evaluating the risk produced for a determined subject, or for a determined population, from exposition
to known or supposed singular or associated causes, are very complicated and have diverse capacities
of reaching a similar objective according to the diminishing order of efficiency: controlled randomized
studies; cohort studies; case-control studies; transverse studies with statistically arranged groups.
It is not possible, in this paper, to profoundly go into all the "technical" aspects: it will be enough to say
that the cohort studies are actually retained to be "valid", even though they are not the most specific in
the results they produce, as are the randomized clinical "perspective" studies (but also for some
disturbing ethical reasons). Moreover, the cohort studies are also difficult to conduct and require very
long periods of time and relatively high cost; these are also very pronounced characteristics in the
randomized perspective studies.
The case-control studies are considered "weak" from the methodological viewpoint, but are often used
in clinical practice to study, for instance, the rare collateral effects of treatments because they have the
merit of being able to be realised with relative rapidity and a less cost. The case-control studies are
based on the anamnesis regarding the exposition of the individual object of evaluation with respect to
the causal agent (known or foreseen) for the sickness.
The transversal studies with statistically arranged groups are very fast and easy to complete as
"indication" of an axiological cause, but they are retained to be "invalid" in constructing a credible base
for clinical decisions.
THE RESEARCH OF "NATURAL HISTORY" AND THE DETERMINATION OF PROGNOSIS
As we have already accentuated, the observation of "natural history" intended as the progression of an
untreated sickness, constitutes, also from the ethical point of view, a particularly important chapter. On
the other hand, if and when the sickness is subjected to treatment, then we talk of prognosis, generally
from the moment of diagnosis. Rightly, it is noted that the "clinicians need to have a rapid access to
information regarding the natural history and the prognosis to be able to respond to the questions asked
by their patients. One of the first questions asked by patients when they are informed about a new
diagnosis is: What will now happen to me?". They want to know the implications of the sickness or
conditions just diagnosed in terms of their survival, progression of the pathology and lifestyles, even
before beginning to evaluate the available options and the problems associated with a treatment of
palliative therapy" (ANN MC KIBBON et al, page 131, 2000).[35]
To monitor a sickness by abstaining from a treatment known to be valid, in order to observe the
progression and consequences of the sickness with time (as was the case with the well known Tuskegee
Study of Untreated Syphilis in the Negro Male (BRAWLEY, 1998)[36], is clearly immoral if it takes
place without the knowledge of the patient because it betrays the patient's trust in his doctor that the
latter will always act for his good, to cure him. To make an evaluation of the "prognosis" in the field of
research is an entirely different concept; this can be done by, as much as possible, sampling patients
66 with a determined sickness for insertion at an early phase of the sickness (the so-called inception
cohort), and then follow with time using determined treatments at least 80% of the initially enrolled
patients.[37]
FINAL CONSIDERATIONS
Ethical currents and clinical experimentation
At the end of this exposition, it seems important to me to develop some further positions, recalling in
the first place the terms with which the research activity is conducted and "lived" by the researcher, in
relation with the ethical currents to which he prevalently aspires. It is widely convenient that, the
clinical experimentation constitutes a basic theme that is dense with cultural, moral and juridical
implications.[38] It puts to test both the professional preparation and the sense of ethical responsibility
of the doctor-experimenter, and the sentiment of social solidarity of the participant in the research.
It is worthwhile that research and experimentation in medicine (biomedicine) be founded on the use of
reason and the senses (this idea includes the technologies that implement or substitute the use of the
senses), as in each branch of applied natural science. The description and adequate measurement of the
biological phenomena that are spontaneously observed or of those induced with various techniques,
must be necessarily conducted according to well-defined procedures and rules that, from experience,
guide the researcher toward justified affirmations from evidence, even in a "falsifiable" future in
relation to successive different evidences. These affirmations constitute the "objective" concept to
which therapeutic researches, conducted with the methodologies that we have already recalled,
refer.[39]
The ethical reflection on the individual "relationship" that is established in the experimentation
between motivations, values and diverse interests can be carried out from the utilitarianconsequentialist, deontological, autonomy and personalist viewpoints.
Utilitarianism brings to the debate the criterion of "greater good for the greater number of people"
(actual or in the future) that will benefit diagnostic and therapeutic progress against the risk and
suffering of the few used for experiment, thereby favouring the attainment of desired results. In this
extreme mode, utilitarianism is obviously unacceptable; its positive aspect is in the fact that it invites
all to reflect on the moral justification of the "research project", on the fact of achievable benefit and on
the consequences of actions.
The deontological criterion, or ethics of duties, is concerned not so much with analysis of the objective,
as with appreciation of the morality of the methods with which the experiment is carried out, conscious
of the truth regarding medical activity, that must always act in favour of the best interest of the assisted.
In the case of conflict of interests between the goals of the research and protection of the patient, the
latter must prevail.
Deontologism - inspired by the ethics of "obligation" of the Kantian school - has a positive effect with
respect to risk evaluation in the face of the two-fold conditions in which the research can be presented:
direct interest for the health of the patient, or a lack of any immediate interest to the patient.
As is known, the evaluation of risk represent the "modern" formula for confronting the evolving
problem present in the first Helsinki document that banned all non therapeutic research without the
consent of the subject, including in the ban those who were not in position of giving consent. The
evolution has led to the actual formulations of the fact of "delegated consent", in association with
particular norms for the protection of subjects incapable of expressing consent. In any case, this
problem (which will be addressed by other speakers at this Conference) constitutes one of the most
controversial subjects of the bioethics of experimentation (Della Torre, 1994).[40]
67 The potential "split" of the medical researcher between his role as one who cures and his role as an
experimenter creates an obligation in each case of a balancing act which takes into account the best
interest of the patient more than those of science and society (World Medical Association, 1996;
concept accepted in the Convention of Oviedo, 1997).
The ethics of autonomy is based on the "rights of the person" (even before that of"the patient") and
represents - in the case of medical experimentation - application of the theories of "choice" and
"interest". The first, beyond its association to the fundamental right to liberty, restricts the rights to
choose to those conditions in which others have moral obligations to respect. Waldron[41] applies this
criterion, for instance, to the delicate question of non-therapeutic researches, where the balancing is
between the ethical obligations of the experimenter not to cause risks to the subject, and the faculty of
the subject that consents to make risky choices. The second, which, goes back to J. Bentham, restricts
the protection of the interests of the subjects to conditions in which it is possible in anticipation to
define in the public domain the beneficiary of another's obligation, and is applied, for example, to the
so-called social rights of the person, among which (with the particular modalities established by the
State) is the "protection of health". In whatever way it is argued, the result leads to "autodetermination" of the person called to participate in the research, an auto-determination, which, - in
literature - is framed in the Kantian principle of freedom of reason.
If the question is simpler to address with the principle of interest in the case of therapeutic research that
has direct potential advantages for the sick, the decision is obviously more delicate and requires the
acceptance of the "principle of auto-determination", in the case of non-therapeutic research without any
direct personal interest. Auto-determination, aware of the risks inherent in the known procedures of
truthful information and in the voluntarily nature of consent in a competent person, should be counterbalanced in the dual relation to the supremacy of knowledge that characterize the person of the
experimenter as against the subject who accepts "trustingly" (that is, by believing and accepting the
given information) to participate in the research, thereby justifying it.
Concluding, it appears evident that - concretely - all the ethical theories, which, have been recalled up
until now are applicable, even though in different measures - to the various modalities of research that
we have illustrated, without taking away, especially in the case of utilitarianism, some absolute
limitations. On this question, we remain firm in asserting the great importance of all that has been
established from copious norm processes in national and international headquarters that was gradually
elaborated for the juridical protection of the subject participant in experimentation; now we would like
to offer some examples of the indicated limitations.[42]
Some proper methodological limitations in clinical experimentation and the contribution of the
personalist ethics
The questions of major ethical commitment revolves (limiting our present considerations only to
questions of methodologies) around the criteria of randomisation (with the question of blinding) and
the use of placebo in controlled clinical studies. Putting aside isolated Pioneristic signals (for example
P. Martini "Methodulehere der Therapeutischen Untersuchung" verlag von J. Springer, Berlin, 1932)
the thematic of controlled clinical studies was developed between the last years of the 70s and 90s of
the 20th century, also with regard to ethical aspects with numerous contributions, that cannot be
analytically examined in this paper. We, therefore, refer to the cited studies of A.G. Spagnolo (1994),
Folli (1994), L. Candia (1994), Foster (2001), B. Pitt et al (2000), A. Mc Kibbon et al (2000), etc.
One extremely rigorous line of clinical experimentation, as that based on the "ethics of result" fully
sustained by utilitarianism and expressed by some authors, among whom is RAPAORT (2001), affirms
the exclusive value of controlled randomised clinical studies with placebo in the most controversial
therapeutic cases because it is the only method with the capacity to greatly eliminate instances of
bias.[43] From the evidences they produce can derive "guidelines" that can, once they are opportunely
68 diffused among doctors, lead to better results both for the singular patients and the entire arena of
public health care. What do we think of this strategy?
It is intuitive to make every possible effort at eliminating those factors that distort the clinical
efficiency evaluation of a treatment. That "guidelines" based on these efforts can assume a role of a
reference point for current medicine is likely, and all this would represent a positive development in the
evolution of medical knowledge. It is a matter of fact, however, that randomisation and the use of
placebo with double or triple blinds meet with a lot of difficulty in usage, coupled with increased
adversity in both doctors and patients.[44]
Moreover, there is no doubt that the "paradigm" of a fully informed consent that is dominant today is
hardly compatible with the criteria of "masking" that has been adopted up till now. There remains with its non-contestable ethical force - the need to evaluate on a case by case basis the "potential
contrast" that the randomised clinical studies can assume with the interests of a particular patient. This
contrast can derive substantially from two motives:
That the risk to which the patient is put is too high for him compared to the foreseen general risk for the
randomisation category in which the patient would be inserted.
That the patient is deprived of efficient therapies that he needs if, in the randomisation, he blindly falls
into the "placebo" without any treatment.
Both eventualities, which could be seen as negative, require a careful reflection and a known
professional and moral maturity on the part of the experimenter. With regard to the first (omission of
the personalist risk evaluation), it can be observed that trusting in the case or in an automatic and
centralized system of assignment of the singular patient to one or another group of randomisation can
conflict in a clear and psychologically intolerable manner with that "best interest" that - is affirmed - as
that which medicine should offer in the protection and promotion of the health of the patient, who trusts
the doctor to heal him.[45]
To trust in a form of "partially informed consent" - and without an exhaustive oral discussion - to settle
the question on a "formal" level does not give any guarantee that the particular patient truly
comprehends the nature of the information contained in the enrolment form by which he is committed,
and the associated risks to the participation in the study. Therefore, it is necessary to leave the patient
time to reflect on the risks and benefits connected to his participation to the randomised study before
deciding, and the Ethics Committee should attentively guarantee that the information given to the
patient are, as much as possible, exhaustive and that the patient understands same.
The second motive highlighted above is equally important, and explains the grown disaffection by
clinicians toward the use of "placebo" in a pure sense when there is the existence of an already efficient
standard therapy with which patients who are not part of the experimentation are treated (TAUBES,
1995;[46] LILFORD and JACKSON, 1995;[47] ROTHMAN and MICHELS, 1993;[48] etc.).
Even though it is argued that without the help of controlled randomised clinical studies with placebo
and conducted on a high number of patients it will be difficult - if not impossible - to determine the
actual risks and benefits of a determined therapeutic strategy, many authors, nevertheless, believe that
this criterion has the potential of sacrificing the good of the singular subject. This is that which, in our
opinion, is unacceptable from the viewpoint of the personalist ethics. The priority given to operating, as
much as health is concerned, in the interest of the patient more than any other scientific interest is well
known as a "value" that should be preserved, and this finds expression even in the recent international
documents on medical experimentation (see for example Convention on Human Rights and
Biomedicine: OVIEDO, 1997; Declaration on human rights and human gene of UNESCO, New York,
1996)[49] and for this reason it appears "reasonable" not to deprive the control group of a form of
traditional therapy chosen from those commonly used for the specific form of morbidity (Candia,
1994).[50]
Definitely, in the case of therapeutic research, an optimal strategy is that of preparing the protocol in a
way to obtain the information regarding the efficacy of treatment in order to bring about the best
69 decision for future patients, while at the same time maximising the opportunity for actual cure of
patients presently being examined. This strategy is -in itself - nearer in outlook to the "adaptive clinical
trials" (ACTs) version more than the "randomised clinical trials" (RCTs) version.[51]
3. In this conclusive part of the essay, there are still some aspects in the sphere of general ethics that
merit further attention and evaluation. Going back to the general position on the ethical requirement of
biomedical research, which will be addressed in this gathering by His Excellency Rev. Mons. E.
Sgreccia,[52] I would like to only consider some points closely correlated to the theme that has been
entrusted to me. I will briefly consider the following:
Objectives of Research
One of the critical aspects regards the cautious choice of the experimental research objectives,
especially for one who follows the personalist-based ethics of the catholic school who must consider
not only the scientific quality of the protocol and the methodologies to be used in reducing to the
minimum possible limits the risk to the patient, but also the "objective" for which the research is been
conducted. We all understand why this is a thorny issue, that is not limited to cases of premature
abortions, methods of sterilization, or use of human embryonic stem cells, etc., (to give a few actual
examples), but which could extend (even though in different ways) to experimentations heavily
influenced by considerations of profits, wide spread investments in drug commercialisation, that will be
added to an already large arsenal of available options detrimental to experimentations in the "orphan"
sectors, that should be more urgent,[53] or for experimentations conducted in developing countries or
countries with very high levels of poverty, where neither the information given nor the consent of the
persons enrolled correspond to the valid principles operative in the developed countries: economically
and in healthcare. In the former case, the interested mediators can easily manipulate the will of the
singular individual.[54]
In this context, the necessity for the clinical experimentation to be for the direct therapeutic interest of
the subject and that this interest be always "charitable" (that is characterized by sentiments of human
empathy) is brought to the fore, especially if the sick is particularly in clinical conditions of emergency
or in the terminal phases.[55] To overcome the recurrent contrasts of opinions on these subjects, which
have certain ethical contents, someone has also proposed the most extensive participation of the society
to the strategies of therapeutic innovation, well beyond the role already actually exercised by hospital
Ethics Committees. This is that which appears difficult but not impossible to realize for defined
research projects.[56]
Salutogenic Effects and the "Compliance" of the Subject Participating in experimentation
These represent aspects for further clarification in the sphere of experimentation (particularly
therapeutic-drug experimentation), when it is a question of evaluating the "real" effects of a determined
treatment.
The function exercised by the binomial brain-mind in the maintenance of health is, today, always
increasingly the object of research of neuroscience, also on the basis of the concept, "salutogenesis"
proposed by Antonovsky in 1979,[57] which underlines the differences in reactions of different person
toward the same traumas of existence: some demonstrating a global internal coherence of behaviours
orientated to cure and optimism, others to depression and sickness.
Various researches have sought to demonstrate the "coping" effect - and that is to the effect that the
capacity to overcome potentially stressful conditions among different individuals is correlated with the
vision that such individuals have of such situations; the Salutogenic capacity of social support and
finally - that particularly relevant to our present considerations - the Salutogenic effect of religious faith
70 [Strang S. and Strang P. (2001);[58] Murphy et al (2000);[59] Cina (1998);[60] A. Bompiani
(2000);[61] D. Smith (2002)].[62]
That these reactions have a neurobiological basis appear increasingly evident from some researches on
localization in cerebral areas of the regulating functions of emotions in normal and pathological
subjects; nevertheless, there remains the need to clarify what effect these individual differences in
"Salutogenic" mechanisms have in pharmacological researches and in clinical "trials".
Another aspect worthy of consideration with respect to methodologies of clinical experimentation is
that technically known as "compliance" of the patient, that is, the "quality" of the patient's participation
in his treatment, evaluated in terms of the behaviour of the patient in the face of the medico-health
orientations which the health professional retains to be useful for the health of the patient (M. La Rosa,
1995).[63]
There are many factors present in this phenomenon (that also closely regard the "capacity to relate"
created between the patient and his curer) that are present in the eventual therapeutic experimentation.
In fact, the study protocol presupposes a perfect compliance of the patient (the engagement of the
treatment to the doses and for the foreseen duration), while a bad unintended compliance increases the
variability of data and leads to an erroneous appreciation of the entire result (especially in clinical trials
with limited extensions) (see P.E. Lucchelli, 1995).[64]
Different methods have been created for the measurement of "compliance" (see for example R.
Novellini, 1995.[65] From the point of view of ethics, this issue goes back to the question of "sense of
responsibility" that the patient shows in adhering, with conviction, to the experimentation that is
proposed to him. But even more important is the need to underline the moral value of a voluntary
participation in an experimentation deprived of therapeutic interests for the participant, marked by a
conscious embrace of one's corporeal oblation within the most limited margins of risk (but not beyond
certain unpredictable limits), where this decision to participate is taken for the interest of one's
"neighbour". This is a form of "charity" that is original to Christian morality as against purely rational
moralities, in the sense developed, for instance, by F. BOCKLE.[66]
The Integrity of the Researcher
A final aspect to be considered regards that complex of behaviours which in popular slang is known as
"integrity" of the researcher. The first point concerns the question of possible conflict of economic
interests,[67] and the second his level of willingness to respect and follow the "protocol" agreed to and
approved by the Ethics Committee; the third point regards the falsification of results.
Already the lack of a conscienscious following - except in cases of clear adverse events and conditions
of urgency insurgent during clinical trials - of the processes as required in the protocol can bring about
more or less appreciable distortions of the results;[68] but much more grave are the instances of data
falsification, which compromise, as soon as they have been proved, the trust of public opinion and
negatively influence the availability of patients to willingly participate in clinical studies.
While reference is made to the last works of F. DI TROCCHIO (1993),[69] of PORTIGLIATTIBARBOS et al (1993),[70] of J. RANSTAM et al (2000)[71] for a further treatment of this subject, we
wish to also indicate - in these environments of high scientific "competitiveness" - the lack of that
traditional fundamental collaborative attitude of the researcher, based on the exchange of information
and materials among equals.
We wish to end this brief presentation by affirming the actual and notable scarcity of "specific"
processes of formation of researchers in medicine and - conversely - the great moral significance of the
rare situations in which this formation is confronted with methodically and seriously.
71 [1] C. Foster, The ethics of medical research on humans, Cambridge University Press 2001, p.1.
[2] I use the expression "patient" in the sense indicated by the document "Rights of the Patient" of the
W.H.O. European Region (Copenhagen, 1994), in which a patient is considered as whomever has
rights to healthcare in a healthcare facility. For further information on this subject, refer to A.
BOMPIANI, Italy and the Declaration of Amsterdam on the rights of the patient, Medicine and Moral
1998/ 1, 47-90 (English translation)
[3] It is opportune to warn that this present work is not concerned with questions regarding embryonic
research; this is treated in another presentation (see Roberto Colombo).
[4] SGRECCIA E. (in SGRECCIA E., Autonomy and Responsibility of Science, in SPAGNOLO A.,
SGRECCIA E., (editors), Ethical Guidelines for Clinical Experimentation, Milan: Vita and Pensiero,
1994, p.39) writes: “Science must refer it self to man as an individual and to the society, because it is
man that brings research into being, and both pure and applied scientific and experimental researches
are ordered to the realization of the good of man, and because the very field explored by the
experimental sciences represents a true but partial dimension of reality” (p.46) (English translation).
[5] I would like to underline the importance I believe should be attached to these principles also in the
field of biomedicine:
Individualism, seen as underlying the capacity and will of the researcher to undertake a function for his
personal promotion through the exercise of research and science that the constitutions often classify in
the freedom of choice and of activity together with the arts and in strict correlation with the right to
thought and practice of religion. There is no doubt that, in this context, the exercise of science becomes
an experience of a “research of the meaning” of one’s very life, conditioned obviously in the that field
which, is historically determined from the existential reality of each individual; but in this personal
journey one inevitably meets “the face of the other” and the social dimension of our common existence,
a reality in which the others are also subjects of rights but especially duties, and individualism accords
with respect for and collaboration with others for the “common good”.
Pluralism, taken to signify an admittance of differences in concepts in the course of the research
processes, aware of the duty to sincerely document one’s activities and choices for research, while
respecting the choices and activities of other serious-minded researchers.
Universalism, intended as projection of one’s sensual experience – in the exercise of research – within
the context of all the researches at the international community level, and not as a product of an
arrogant and utilitarian (exploitative) “lobby” group.
[6] LABRIOLA recalls, with reference to the Italian Constitution, this theme which is complemented in
the reading of article 33, comma 1 Cost.: “Art and science are free and their teaching is free” with
article 9, comma 1 Cost. “The republic promotes the development of culture and of scientific and
technical research”. Thus, the notion of “scientific activity” is embraced (see p. 8 of LABRIOLA S.,
Freedom of Science and Promotion of Research, Cedam Ed., Padova, 1979). A more recent treatment
that is largely concerned with the biomedical applications of the Italian constitutional principles can be
found in L. CHIEFFI, Scientific Research and Protection of the Person, Ed. Sci. Ital., Naples, 1993
(English translation).
[7] This subject is not treated in this work, because it is the analytical object of another contribution at
the conference.
[8] ANTISERI D., Contemporary Epistemology and Logic of Clinical Diagnosis, in SGRECCIA E.
(ed.), History of Medicine and History of Medical Ethics toward the Third Millennium, Rubettino Ed.,
Soveria Mannelli (Ct) 2000 edition (English translation).
[9] G. FEDERSPIEL, Scientific Knowledge and the Methodological Problem of Pain in Medicine,
…1999, 65, 679-687 (English translation).
72 G. FEDERSPIEL, R. VETTOR, N. SICOLO, C. SCANDELLARI, The Dicisional Clinical Analysis, in
Acts of the 102 National Congress of the Italian Society of Internal Medicine, 23-26 October 2001,
CEPI Ed., Rome, in Annals of Internal Medicine 16 (suppl. 1), 2001 (English translation)
[10] The question of fraud in scientific research is of great interest, as a chapter on the ethical
“transgressions” of the researcher, but it cannot be addressed in its complexities in this circumstance.
We can refer to the monograph of DI TROCCHIO F., The lies of Science, A. Mondadori edition,
Milan, 1993, and to the last work of PORTIGLATTI BARBOS M., MAGGIONA B., Illicit Behaviours
in the Publication of Results of Medical Research and their Ethico-Deontological Aspects, in Review
of Criminology IV/1 (1993), pp. 117-166 (English translation).
[11] The question of generalizing information comes with the possibility of verifying the same
information in the same stimulating condition. Moreover, it is an epistemologically complex problem
that should be confronted in clinical circles with much prudence (see for example, FEDERSPIEL G.,
The Limits of Medicine: Risk, Probability and Guideline, Congress: Atrial Fibrillation, Verbania
Pallanza, 4-6 May, 2000 (English translation).
[12] Observation is not intended, like in the past, as that unique passive “longitudinal” criterion, noninterventionist, for understanding the natural evolution of sickness. It is however, necessary that the
observation be conducted with unexceptionable analytical methodology, open to receiving those
elements that are meaningful for the proposed hypothesis by the researcher and the relative judgement
of verifiability and falsifiability. Consequently, observation as a scientific procedure of biomedicine
implies the precise “codification” of the phenomena perceived by the researcher (sensorial) or
evidenced (instrumentally) to the charge of the person subjected to experimentation and of their exact
description/memorization. This is the “basic language” of research (that is expressed in descriptive
propositions in the sense of Wittgenstein). The complex of observations constitute the “empirical
basis”, of the propositions that characterize the protocol, and consent the constitution of the “theoretical
superstructure” of the same protocol, realized in a manner that is logically valid and coherent upon the
empirical basis.
[13] The use of the expression “best means” is vague. The complex evaluation comprises of various
elements that are ordered to the specific goal of the “protocol”, as construed and articulated. Notably,
B. Freeman elaborated some considerations for use by members of the Institutional review Boards
(IRBS), distinguishing between scientific validity and scientific value of the study.
The scientific validity could be identified in the following:
Possibility of having credible information from the hypothesis to be evaluated;
the existence of priority and necessary condition for research;
non deviation from obvious knowledge, from proposed protocol and hypothesis made;
to have value in itself while the other presumed factors, like the researcher’s capacity, laboratories,
possible documentation, are irrelevant;
inability to always account for other elements ( for example, consent). As elements necessary for
evaluation, the E.C. should always consider the design, statistics, clinical background and the basic
sciences.
The value of the study could be guaranteed by the presence of the following:
The existence of a useful and interesting hypothesis;
presupposing the scientific validity;
having value in itself but also in relation to all that is already established or to the protocol
the duty of recognising the presumed factors (researcher, laboratory, documentation);
dependence on exogenous factors (cost, priority, abuses).
B. FREEDMAN, Scientific Value and Validity as Ethical Requirement for Research: a Proposed
Explication, IRIB, 9,6 (1987), pp.7-10.
Further treatment of the subject can be found in:
73 SPAGNOLO A.G., Ethical Principles and Methodologies of Clinical Experimentation, in SPAGNOLO
A.G., SGRECCIA E., (Editors), Ethical Outlines for Clinical Experimentation, Milan: Vita and
Pensiero Ed., 1994, pp.51-70 (English translation)
BIGNAMINI A., Construction of a Clinical Experimentation Protocol in Conformity with Good
Clinical Practice (G.C.P.) in SPAGNOLO A.G., SGRECCIA E. (Editors), Ethical Outlines for Clinical
Experimentation, Vita and Pensiero, Milan, 1994, pp.227-242 (English translation).
[14] It is beyond the scope of this paper to have a complete analysis of the specific applicative aspects
of the modalities of research in the various life conditions of the human subject.
[15] It is sustained that this serves to avoid duplication of researches whose results have long been
established, thereby avoiding wastage of resources. This justification is very valid, but it is also
necessary to recognise that the profound knowledge of that which was done in precedence can be
useful in helping to point out subdued doubts and gaps, and also errors that – in those cases have taken
medical progress “off the mark”. Therefore, when the available elements appear insufficient or
doubtful, it is clearly “scientific” and true to the ethics of a responsible researcher to repeat the
experiments.
[16] This account, for obvious reasons, cannot address the complex debates in clinical circle, regarding
“evidence based medicine”; rather, it limits itself to questions about experimentation that serve to
found the presuppositions. Refer to the publication of LIBERTI A. (editor), Evidence Based Medicine,
Pensiero Scientifico Ed., Rome, 1997; M. BARNI, Medicine of Choice or Medicine of Evidence?, in
Riv. Ital. Med. Legale XXIV/#-8/2002); FEDERSPIEL G.E. VETTOR, Evidence Based Medicine: A
critical Reflection on the Concept of Evidence in Medicine, in Ital. Heart J., Suppl. Vol. 2, June 2001
(English translation).
[17] COCHRANE A., Effectiveness and Efficacy., Nuffield Provincial Hosp. Trust, London, 1972
[18] KUHN T.S., The Structure of Scientific Revolutions, ChicagoUniv. Press, 1962
[19] It is a true case of diagnostic test when, applied to an individual, the employed technique helps to
reveal a morbid condition (an actual sickness or functional disorder, etc.) and – in case of genetic
testing – indicates if this individual possesses one or more genetic traits that can predispose, or
determine in the future, the development of sicknesses of functional disorders in the same individual.
[20] According to Ann MC KIBBON and co. (2000), sensitivity measures the proportion of patients
affected by the pathology or condition under examination that have a positive result. Specificity of the
test, on the other hand, measures the proportion of patients not affected by the pathology or condition
being examined that have a negative test result. Both sensibility and specificity must be elevated to
ensure the utility of a diagnostic test in the clinical field. In practice, both should surpass 80% to make
the test clinically useful. For the screening test, the performance should be near to perfection (100%) to
avoid erroneously diagnosing subjects unaffected by the pathology in the examination; the diagnostic
tests instead can function well with a lesser sensibility and specificity. No test has a 100% sensibility or
specificity. Often, if the result of the test is adjusted to maximize the specificity, this will diminish the
sensibility.
The positive predictive power is the proportion of patients that tested positive to the sickness or
condition under consideration. The negative predictive power is the proportion of patients that tested
negative to the sickness or condition under scrutiny. The predictive values are influenced by the
prevalence of the condition being examined in the population of the study object. For the evaluation of
a diagnostic test, the prevalence is the proportion of patients affected by a condition data on all the
tested patients. Prevalence is sometimes also defined as the pre-test probability of a sickness or
condition.
[21] The themes included the following:
Historical development of the systems of evaluation in medicine
International differences in approaches to evaluation in medicine
Interdisciplinary differences in evaluation
74 Politics of randomised controlled studies
Participation of consumers in randomised controlled studies
Industry, government regulation and clinical studies
Quality of randomised controlled studies
The daily labour of conducting randomised controlled studies
Particular historical and methodological studies
How clinical studies influence clinical practice
Clinical studies and health politics – priority and clinical studies
The future of evaluation in the health sciences
[22] B. PITT and COLL.; express this point as follows in the preface to the monograph “Clinical
Experimentation” (Rome: Pensiero Scientifico Ed., 2000): It is of crucial importance that this
evaluation be objective and impartial, and that every possible strategy be used to avoid all systematic
errors and distortions (bias) in the selection of patients, in the management, follow-up and evaluation of
results. The randomised controlled clinical study is the unique reliable instrument for obtaining the best
results in clinical research.
[23] BOISSEL J.P, LEIZOROVIEZ A., Design and condition of a clinical study, in B. PITT and
COLL., Clinical Experimentation, Rome: Pensiero Scientifico, 2000, pp 1-44 (English translation).
[24] The regression toward the middle is observed when a subject is selected on the basis of a value,
higher or below a physiological parameter. It is a purely statistical phenomenon, whose extension
depends on the process of the patient’s recruitment. Given that the same parameter is also measured
subsequently in the course of the study, the newly observed value will be – in general – nearer to that
of the middle class of the population. The result is that, after some time, the abnormal value is moved
toward the middle value of the population and if the evolution of the sickness is evaluating using the
change observed in the parameter, a purely statistical change could be seen as change of state in the
sickness.
Placebo is defined as “ any treatment that do not have a specific action on the subjective symptoms and
on the objective signs of a morbid process. (G. Folli, 1994, p.87); therefore, it can be a “substance
deprived of any pharmacological activity” (indolent substance, defined as pure placebo) or- much less
not provided with specific activity for the morbid condition or in the dosage in which it is applied
(impure placebo) (L. Candia, 1994, p.21). FOLLI G., The use of placebo in clinical trials: scientific
significance and experimental value, in SPAGNOLO A.G., SGRECCIA E., (editors), Ethical
Guidelines for Clinical Experimentation, Milan: Vita e Pensiero Ed., 1994, pp. 85-90
CANDIA L., The use of placebo in clinical trials: Deontological ethical considerations, in SPAGNOLO
A.G., SGRECCIA E. (editors), Ethical Guidelines for Clinical Experimentation, Milan: Vita e Pensiero
Ed., 1994, pp. 85-90
[25] ANN MC KIBBON et al., Guide to Evidence-based Medicine, Rome: Pensiero Scientifico Ed.,
2000(English translation)
[26] A. Mc. KIBBON et al describe the criterion under consideration as follows: “There are three
groups of persons that are usually involved in clinical studies: the patients, healthcare operators and the
persons working in the clinical study. The process of blinding generally refers to the fact of not
knowing the group assignment either by the patient or healthcare operators. The “double blind” in
general, refers to the fact that neither the patient nor the healthcare operators know what medical
treatment or other types of intervention the patient is receiving. The “triple blind” means that neither
the healthcare worker nor the patient nor the person that works in the clinical study, including the
person in charge of the data, know the treatments, both active and placebo or the standard treatment
until the completion of the final data analysis” (page 47)
According to these authors, the triple blind is very important for studies sponsored by pharmaceutical
industries. Cases which regard these industries are often criticized because of the fact they act to
protect and promote their interests at the expense of a correct publication of negative data relative to
75 their products, and this system of triple blinding extended to all levels helps all the beneficiaries of the
medical research to have trust in the final results that are published. The double blinding, however, is
the most common form of the blinding procedure” (page 48).
[27] “An example of an easy follow-up is a brief study designed to evaluate the relative benefits of a
standard pain relief treatment by intravenous means with an instrument controlled by the patient
through a system of injection, in the first 24 hours after a cardio surgical intervention. In this type of
study it is easy to have a 100% success rate follow-up. However, the follow-up is more difficult when
the study lasts for a longer period of time. The patients are more mobile and there are minor incentives
to sustain the interests of patients. An example of a difficult follow-up is a programme of cure and
prevention of the spread of tuberculosis among the homeless and periodic interviews of patients that
suffer from drug addiction” (page 49).
[28] GALBRAITH S., STAT M, MARSCHNER I, Guidelines for the Design of Clinical Trials with
Longitudinal Outcomes, Controlled Clinical Trials 23, 257-273, 2002
[29] For a detailed review of the conditions of monitoring refer to: CURTIS L. MEINERT, Clinical
Trials and Treatment Effects Monitoring, Controlled Clinical Trials 19, 515-522, 1998
[30] “The principle consists in establishing a zero hypothesis, which indicates that the value of the
difference between the changes is zero, and calculates the value of probability of the observed
difference with respect to the zero hypothesis. If the value of probability is high, then either the
experiment was not able to demonstrate a difference, or this difference is not really existent or the data
were not sufficient. This can be caused either as a result of minor effects or changes in major outcomes
with respect to the foreseen. In both cases the number of enrolled patients in the study was too small (to
discover an effect). It is important to underline that the test of significance does not enable a distinction
between these two alternatives. If the value of probability is small, less than 0.05, it can be concluded
that it is not probable that the difference was caused by the case. The test in it self does not say
anything regarding the causal relationship between the observed difference and the evaluated treatment.
This problem is related to the absence of bias in the design and execution of the clinical study” (page
14).
[31] The response is obtained in a two-phase procedure, according to PITT and others (2000). “In the
first place it should be demonstrated that the difference between the two groups was caused by the
intervention, and that therefore the observed dimension of the effect is a real value, an experimental
data…. Secondly, once it is established that the first phase has been concluded with a satisfying support
to the causal relation, it would be right to know the value of the effect dimension. The statistical theory
of the assessment demonstrates that the most probable value of the effect is the observed difference, but
that other values, even though they are less probable, are perfectly coherent with obtained data. With
the aim of giving the researcher a spectrum of these values, the limits of trust are calculated, for they
constitute the interval of the true values, which, are not significantly different from the observed
difference on a level of X% Given that X is a norm fixed at 5% of significance, the trust limits are
consequent upon the remaining 95%
[32] CALAMO SPACCHIA F.P., FUSCO A., LOJUDICE M.T., Ethics and Statistics in the
Management of Experimental Data in SPAGNOLO AG., SGRECCIA E. (Editors), Ethical Guidelines
of Clinical Experimentation, Milan: Vita e Pensiero, 1994, pp. 211-226)
[33] MEINERT C.L., TONASCIA S., HIGGINS K., Contents of Reports on Clinical Trials: A Critical
Review, Controlled Clinical Trials 5 (1984), pp 328-347
[34] R. MORTON, The Clinical Trials: Deceitful, Disputable, Unbelievable, Unhelpful, Shameful:
What Next? Controlled Clinical Trials, 22, 593-604, 2001
[35] MC KIBBON A. et al, Natural History and Prognosis, in MC KIBBON A. et al, Guide to
Evidence Based Medicine, Roma: Il Pensiero Scientifico, 2000 (English translation)
[36] BRAWLEY OW, A Study of Untreated Syphilis in Negro Male, Int. J. Radiat. Oncol. Bio. Phys.
40, 5-8, 1998
76 [37] Therefore, the indications of the Evidence-based Medicine Working Group for the studies of
natural history and of prognosis in their order of importance to clinicians are valid (LAUPACIS A. et
al, User’s Guides to Medical Literature: How to use and Article about Prognosis, JAMA, 1994, 272:
234-237):
Well-defined samples of patients at the same point of evolution of the sickness
Length of and completion of follow-up
Criteria of objective outcomes not subject to bias
Adjustment for important prognostic factors
[38] The National Committee for Bioethics (NCB) also did not fail, in many occasions, to address this
question. See, for example, the following “opinions”:
The Ethical Committees (27 February, 1992)
Information and consent to medical act (20 June, 1992)
The experimentation of drugs (17 November, 1992)
Experimentation on animals and health of the living (8 July, 1997)
[39] FIEDERSPIL and VETTOR write: “Today, therefore, scientific knowledge is no longer
considered as neither a “true” knowledge nor much less “certain” knowledge, but only as a knowledge
that is “founded and objective”. The idea of objectivity can however have two different senses that it is
opportune to distinguish. On the one hand it can be intended both in a strong sense according to which,
it is “objective” that which is “proper” to an object, that is, that which concerns that object. On the
other hand, it can be used in a weak sense of considering as “objective” that which is apart from tastes,
personal preferences, sentiments and from the hopes of the subject. As Michael Dummett has
underlined, “Science (….) searches for the descriptions of reality that are apart from our specific
classification in the universe and apart from our means for perceiving things”. Among the many
scientific methods that which prevails today is the second sense of the word by which objectivity is
identified with inter-subjectivity. “Things” – molecules, animal species, planets, drugs, rivers,
mountain ranges, brilliant rays – that are part of science are in reality concepts, that is objects
“constructed” through the use of some operative criteria that were first accepted by the scientific
community. By this is meant that in the construction of their know-how the members of the scientific
community stipulate from the very beginning an agreement that guides them to accept some criteria for
defining the “objects”, which, constitute the field of any particular scientific discipline”. However,
agreement on the meaning of a term is not sufficient to found scientific objectivity. As long as it is
possible to speak of objectivity it is in fact necessary that the operations to be effected and the results
be observable and recordable, at least in principle, by all and in the same manner. This way, it is not
enough that all Immunologists are agreed on the fact that an antigen is a substance that provokes the
production of antibodies, but it is also necessary that the presence of the antibodies can be clearly
demonstrated by means of a series of techniques that can be carried out by all and observable by all.
“That which determines objectivity, as Agazzi noted, is that which must be valid and applicable to all
the subject concerned with a determined object”. This simply means that, “whoever qualifies to make
use of certain instruments and carry out certain operations in similar circumstances, must achieve the
same results”. That which has been said up until now regards the objectivity of observations and
scientific concepts; nevertheless, it is also necessary to consider the objectivity of hypothesis and
scientific theories. Faced with a certain number of experimental results a researcher can always propose
different explanatory hypothesis, but does this make it possible to argue that all the possible conjectures
are objective hypothesis? To a question of this nature it would appear natural to answer in the negative,
nevertheless a negative response immediately raises the problem of distinguishing between objective
and non-objective hypothesis. To this problem of objectivity Karl Popper found a solution that has
become almost classical: In his “Logic of Scientific Discovery” he writes: “I will only say that the
objectivity of scientific assertions reside in the fact that they can be inter-subjectively evaluated”
(FEDERSPIEL G., VETTOR R., 1.c., p.681).
77 [40] DELLA TORRE G., The Protection of the Subjects of Experimentation: Informed Consent and the
Consent of one incapable of Consenting, in SPAGNOLO AG., SGRECCIA E. (Editors), Ethical
Guidelines for Clinical Experimentation, Milan: Vita e Pensiero, 1994, pp. 141-170 (English
translation).
[41] WALDRON J. (Ed.), Theories of Rights, Oxford: OxfordUniversity Press, 1995
[42] We refer here to the presentation of Professors MAY and especially A. LORETI BEGHE and A.
SPAGNOLO for the juridical and operative aspects.
[43] E. RAPAPORT (2001), writes: “The controlled randomised clinical studies with placebo produce
the most valid and actually available scientific approach for establishing if a particular diagnostic,
preventive or therapeutic choice can modify a particular result. Once the correctness of the research
design has been established, these methods of clinical studies create not only the possibility of
verifying the existence of any benefit, but also help quantify the level of efficiency that can be reached
in relation to one or more pre-defined primary or secondary objectives. The choices made by doctors in
charge of patients’ care depend more often on results furnished by randomised clinical studies. Even
though the experience accumulated in the cure of a particular sickness is important, the randomised
clinical studies help to demonstrate and bring to fore the goal upon which each doctor should base his
own choices. If the randomised clinical studies for the evaluation of important therapies are not realized
on a vast scale, the Clinician could find himself in a difficult position, incapable of establishing the best
cure for a particular patient.
[44] S.D. HALPERN (in HALPERN S.D., Prospective Preference Assessment: A Method to Enhance
the Ethics and Efficiency of Randomised Controlled Trials, Controlled Trials 23, 274-288 (2002)
underlined this difficulty, which results often in very few enlistments, limitation of the study efficiency
and have induced various proposals for resolving the question. Moreover, the principle of adaptive
clinical trials: (ACT) by which a patient is put in a branch of a treatment in relation to available
information, continues to spread. This criterion is nevertheless very limited, at least in the United States
of America, for various logistical and statistical motives and for the considerable weight they carry in
favour of bias. But according to PULLMAN D. and WANG X. {in PULLMAN D., WANG X.,
Adoptive design, Informed Consent and the Ethics of Research, Controlled Clinical Trials 22, 203-210
(2001)} this principle should be the criterion of choice in the face of the most difficult clinical
situations.
[45] Most authors have insisted on this aspect. Among them are: BEAUCHAMP, CHILDRESS J.F.,
Principles of Medical Ethics, 4a ed., New York: Oxford University Press, 1994; DAUGHERTY CK,
Hope and Limits of Research, Hastings Centre Rep. 26, 25-29, 1996.
[46] TAUBES G., Use of Placebo Controls in Clinical Trials Disputed, Science 257, 25-26, 1995
[47] LILFORD RJ, JACKSON J., Equiposis and the Ethics of Randomisation, J. Royson. Med. 88,
532-539, 1995
[48] ROTHMAN K.J., MICHELS KB, The Continuing Unethical Use of Placebo Controls, New Engl.
J. Med. 331, 394-398, 1993
[49] For a detailed treatment of this subject, refer to the discourse of A. Loreti-Begue at this Congress
[50] CANDIA L. (Op.cit).
[51] Beyond the cited contribution of D. PULLMAN E.X. WANG (2001), see also BERRY D.A.,
EICK AG., Adaptive Assignment versus Balanced Randomisation in Clinical Trials, Stat. Med. 14,
231-246, 1995.
[52] SGRECCIA E., The Politics of Biomedical Research: Values and Priority (at this conference)
(English translation).
[53] It has been indicated that, often researches on a wide range of randomised clinical trials try to
wrest small points of advantage on the basis of the actual “golden standard”, and therefore they require
very high case records and long periods for their realization, to the detriment of the investments in the
obscured sectors and with less frequency in the economically advantageous countries in terms of
78 economic goals, but with high frequency in the economically disadvantaged countries (questions of the
so-called orphan sickness and orphan drugs). In any case, it is not matter-of-factly guaranteed that the
“advantages” assured from these trials are actually spread, with sufficient reach and rapidity, in the
sphere of practical medicine, in such a way as to bring concrete benefits in improving healthcare
assistance.
[54] On this subject, see D. ROTHMAN, The Shame of Medical Research, New York Review, Nov 30,
60-64, 2000; National Bioethics Advisory Commission: “Ethical and Political Issues in International
Research”, Bethesda NBAC, 2001
[55] Examples of the use of terminal sicknesses or of patients in permanent vegetative states for
experimental activities, as much as they are rare, have been presented to us in recent American
literature (see J. COUZIN, Study of Brain Dead, Science 295, 1210/11, 2002). In the first case, respect
of the will of the patient is suggested, and in the second respect of the “indirect consent” of the
relatives. For further reading on the subject, refer to the presentation of A. Spagnolo in this conference.
[56] PITT (2001) recalls the recommendation of LEVIN and others (1991) on the question of “social
consultation” that involves the potential subjects, social organisations, the financial agencies, and all
the groups that can have a role in the preparation of a clinical study. Sutherland and others, cited by Pitt
(2001), underline the importance of the social context in the in the projection of a study. They
emphasize the potential benefits in social consultation and even suggest a wider participation of the
society in the design of a study. They also itemized the points in which consist the general
considerations, those scientific and those ethical that could be useful to the experimenter in planning a
study, to the local ethics committee in given its approval and to the journals in making decisions about
its publication.
Recently, S. HALPERN (in S. HALPERN, Prospective Preference Assessment: A Method to Enhance
the Ethics and Efficiency of Randomised Controlled Trials, Controlled Clinical Trials 23, 2002, 274288) in the face of the proven, increased difficulty in enlistment for clinical trials in the USA, shows
that a preliminary discussion with those enrolled has the advantage of increasing their interest to
participate in the research, and there is further advantage in modulating the methodologies on their
compliance, without compromising or sacrificing the efficiency of the research. Now, there exist a
discreet literature on these requirements (see also P. PEDUZZI et al., Research on Informed Consent:
Investigator-developed versus Focus Group-developed Consent Documents, A VA Cooperative Study,
in Controlled Clinical Trials 23, 178-197, 2002
[57] ANTONOVSKY A., Health, Stress and Coping. New Perspectives on Mental and Physical Well
being, San Francisco: Jossey-Bass Publ., 1979
[58] STRANG S., STRANG P., Spiritual thoughts, Coping and Sense of Coherence in Brain Tumour
Patients and their Spouses, Palliat. Med. 152, 127-134, 2001
[59] MURPHY P.E. et al, The Relation of Religious Belief and Practices, Depression and Hopelessness
in Persons with Clinical Depression, J. Consult. Clin. Phsychol. 68(6), 1102-1106, 2000
[60] CINA G., Introduction, in CINA G. (editor), Medicine and Spirituality: An Ancient and Modern
relationship for the Cure of the Person, Rome: Ed. Camilliane, 1998 (English translation).
[61] BOMPIANI A., Medicine and Man: Human Ecology, in AA. VV., The Human Search for Truth:
Philosophy, Science, Theology, Vatican Intern. Conf. Sc. Faith, 23-25 May, 2000, Philadelphia: St
JosephUniversity Press, 2002
[62] SMITH D., Functional Salutogenic Mechanism of the Brain, Perspectives in Biology and
Medicine, 45(3), 319-328, 2002
[63] LA ROSA M., Health, Relationality and Compliance, in V. GHETTI (editor), The Participation of
the Patient in his Treatment, Milan: Smith-Kline Foundation, F. Agneli Ed., 1995, pp. 7-14 (English
translation)
[64] LUCCHELLI P.E., Compliance and Clinical Experimentation of Drugs, in V. GHETTI (editor),
ibid., pp 45-48, (English translation).
79 [65] NOVELLINI R., Instruments and Measurement of Compliance in Clinical Studies, in V. GHETTI
(editor), ibid., pp 67-68 (English translation).
[66] BOCKLE F., The Fundamental Moral Concepts, Brescia: Quiriniana Ed., 1991 (English
translation)
[67] Most are agreed that there exist conditions of potential conflict in that “difficult alliance” that
characterizes the relationship between the university researcher and the pharmaceutical industry (see
for example R. MORTON, The Clinical Trial: Deceitful, Disputable, Unbelievable, Unhelpful, and
Shameful: What Next? Controlled Clinical Trials 22, 593-604, 2001; T. BODENHENMER, Uneasy
Alliance: Clinical Investigators and the Pharmaceutical Industry, New Engl. J. Med. 342, 1539-1544,
2000). The American Medical College (AMMC) has recently produced guidelines aimed at impeding
the conduction of clinical trials by researchers who have economic interests in the sponsoring
pharmaceutical industries (Protecting Subjects, Preserving Trust, Promoting Progress: Policy and
Guidelines for the Oversight of Individual Financial Interests in Human Subjects
Research, www.aamc.org/member/coitf), (see also J. Kaiser, Science, 295, 246/247, 2002
[68] “The experimenters, as is affirmed in the recent studies on cancer, could decide not to follow the
inclusion and exclusion criteria of a randomised protocol, while the inclusion of ineligible patients
could compromise the validity and interpretation of the results. On the other hand, if it is known that
ineligible patients have been included in the study, it will not be easy to exclude them from analysis
without compromising the presuppositions of a balanced randomisation. An analysis: intention-to-treat,
that represents the approach less exposed to potential systematic errors, requires that all the randomised
patients be included in the final analysis. The insertion of ineligible patients in a randomised study for
the purpose of increasing the numbers or because the experimenter desires to make available a new and
potentially lifesaving therapy to a given patient, threatens the interpretation of the results of the study,
and is therefore an unethical act. The risk to which the patient is exposed, the effort of the
experimenter, the use of public and/or private fund, could have been wasted from the moment in which
the results of a clinical study may not be interpretable or are interpreted erroneously because of the
insertion of ineligible patients. This trick on the part of the experimenter has always been obscured or
minimised, even though it is as serious as the falsification of data. The incomplete collection of data
can endanger the capacity of a randomised study to demonstrate the safety and efficiency of a given
therapeutic strategy. The lack of adherence to protocol and the fact of incomplete data collection, are
motivations that should be used to impede the participation of such experimenter in successive studies.
The participation of an experimenter in a clinical study should be considered a privilege more than a
right, and implies the responsibilities that must be taken seriously in order to justify the risks to which
the patients are exposed” (PITT, pp 112-113, 2001)
[69] DI TROCCHI F., (Op.cit).
[70] PORTIGLIATTI-BARBOS M., MAGGIONA B. (Op.cit).
[71] E. STOKSTAD (in STOKSTADE, Data Hoarding Blocks Progress in Genetics, Science 295, 599,
2000) gives the results of an inquiry conducted in the Institute for Health Policy, USA on 1240
geneticists and 60 other researchers of 100 Universities that receive public funding from NIM. A good
84% say that they have asked for information or materials from other colleagues, but 47% report of not
haven received any response in the three years considered; provoking 28% to renounce collaboration
and 21% to abandon the promised research lines. The reason for a lack of response and collaboration
are cited for 90% to the necessary commitment to producing the material and requested information,
for 64% to the protection of the work of the collaborators; 50% to the protection of the capacity for the
publication of the data; 28% to distrust in being able to enjoy reciprocity of treatment; 27% to the
protection of the interests of the sponsor, etc.
80 GONZALO HERRANZ
SOME CHRISTIAN CONTRIBUTIONS
TO THE ETHICS OF BIOMEDICAL RESEARCH.
A HISTORICAL PERSPECTIVE
INTRODUCTION
Studies dealing with the short but eventful history of ethics of biomedical research (ebmr)[1] are indeed
not scarce. It is interesting to point out that, regardless obvious differences in outlook and approach,
many of those studies show a marked leaning towards a convergent, if not uniform, interpretation of
their subject matter. The coincidence is marked enough to make one suspect that an informal agreement
had been attained among the authors not only on the main facts to be included and emphasized in their
accounts, but also on the secularist and scientist outlook from which the history is interpreted and
constructed. It appears as if a consensus has been reached on the place and time of birth of the ebmr, on
the main milestones signalling its evolution, on its leading thematic issues, and, above all, in the
internal forces that drive forward its progress[2].
The result of this dominant interpretation is the widespread diffusion of what could be called the
standard history of the ebmr, a history which tends to highlight some events as significant and
momentous, and, at the same time, to eclipse some others as trivial and irrelevant.
Among the elements that appear diminished or absent in this standard history of ebmr are some
pioneering contributions from Christian ethics. In consequence, they are never mentioned.This article
intends to be an initial effort to identify and collect the Christian contributions to the early development
of ebmr, to redeem them from oblivion, and to offer them for discussion.
THE DOMINANT VERSION OF THE HISTORY OF EBMR
A brief characterization of the prevailing description of the history of ebmr is not out of place here.
Only against that background, the significance and worth of the elements Christian ethics has brought
to the building of the ebmr can be better understood and appraised.
Among the characteristic features of the dominant standard version of the history of ebmr, the
following are of particular relevance to our context:
a. The attribution to the Nuremberg Code of the merit of being the starting point of the history of ebmr.
b. The labelling of the time prior to Nuremberg as a dark age.
c. The conviction that only after the publication of the Helsinki Declaration and the Belmont Report it
was possible to recognize an autonomous ebmr, emancipated from the common ethics of medicine.
d. The leading and exclusive part assigned to secularist ethics in the development of the ebmr.
The Nuremberg Code, an epoch-making event
It is frequently affirmed that ebmr was born in Nuremberg on August 20th 1947, the day when the
sentence was pronounced in the trial against the Nazi doctors guilty of performing inhuman
experiments on war prisoners. As it is well known, the sentence of the American Military Tribunal
contained a section, named afterwards as the Nuremberg Code, where ten clauses were enumerated as
basic principles that must be observed in order to satisfy the generally accepted moral, ethical and legal
requirements for the practice of experimentation on human subjects. The promulgation of the Ten
Points of the Nuremberg Code is considered the germinal event, which marks the change from an old
and dark prehistory to a new and enlightened time.
81 Such a glorification of Nuremberg is not fully justified. It is rather the result of an artificial and
politically interested re-writing of history. The Code was plainly ignored or received with indifference.
Actually, the legitimacy of the Code as a legal referent for the condemnation of the Nazi doctors in the
Nurembergmedical trial, as well as the ethical contents of some of its articles, have been the object of
well-founded criticisms[3].
But far more important is another fact: the Nuremberg Code did not exert any immediate influence on
the ethical conduct of medical research. The message of Nuremberg had no impact on the medical
profession because it was held as specifically addressed to punish the perpetrators of war crimes, and
thus without implications for the well-intentioned doctors working in democratic and free countries.
Only two decades later, when the Code was rediscovered, the breadth of its ethical contents was openly
acknowledged. In particular, its doctrine on voluntary and free consent achieved recognition when it
was transferred to two influential later documents, the Declaration of Helsinki (1964) and the Belmont
Report (1979).
The reception of Nuremberg principles into the Codes of Ethics of the national medical associations
followed also a slow, haphazard and almost lethargic course. It acquired impulse only after 1975, when
the World Medical Association published the second version of the Declaration of Helsinki[4].
The time before Nuremberg, a dark age
It is not just to relegate the time prior to Nuremberg to the category of a dark age. It was a period
contrasting substantially with ours in many aspects. No pressing need was felt then to regulate formally
the ebmr, because, among other reasons, no clear separation was recognized then between ordinary
practice and clinical experimentation, the greatest part of the research done was descriptive or
observational in type, research did not perturb the common doctor-patient relationship and, therefore,
ethical reflection could be set aside without remorse. It is true that prior to Nuremberg more
consideration was devoted by scientists to the ethos of research (the calling and the specific virtues of
the researcher, the selection and education of young researchers, methodological strictness, social
responsibilities, counselling, role models) than to the ethics proper[5]. But it is also true, as it will
shown further on,that a few doctors, from the circle of the French Morale Médicale, considered some
of the basic questions of the ebmr and were able to forward some pioneering, and surprisingly modern,
ethical concepts.
The darkness unjustly attributed to the time preceding Nuremberg is more the consequence of a
perhaps involuntary inattention to some historical sources than to the absence of authors and valuable
contributions.
The conviction that only after the Helsinki Declaration or the Belmont Report a genuine ebmr was
identifiable
It was not until recently that a specific and explicit regulation was established for the ebmr. Before
1947, only a few formal normative documents were published on the ebmr and they were practically
ignored[6].
The lack of normative ethics documents during this period is mainly due to the fact that until relatively
recent times the separation between daily medical practice and experimentation was fuzzy or not
recognised. Claude Bernard, , the leading figure of experimental medicine, in his interest to give a
moral justification to human experimentation, grants an experimental character to any medical or
surgical intervention and blurs any clear separation between them. Summarising the general opinion of
his time, Bernard wrote: “Physicians make therapeutic experiments daily on their patients, and
surgeons practice everyday vivisections on their subjects. […] There is, therefore, a duty to submit
82 oneself to experimentation, and a corresponding right to perform it whenever such a procedure can save
someone’s life, cure his disease, or bring him a personal benefit.”[7]
This view appears to us as peculiar of long bygone days. But it is opportune to remember that, a
century later, it was a common medical opinion that since anything the doctor decides to do on behalf
of his patient is based on partial and unclear knowledge, every clinical act partakes many of the
features of a clinical experiment.[8]
The leading and exclusive part assigned to secularist ethics in the development of the ebmr
Two factors can be invoked to explain the subordinate role of Christian contribution to the ebmr.
On the one hand, in the time before 1950, the bibliographic sources of Christian origin pay an almost
exclusive attention to issues connected with the moral problems and spiritual needs of sick people.
More than on medical ethics, Catholic authors wrote on pastoral medicine. Their main interest was on
the effects of medical care on the observance of God’s commandments and on the administration of the
Sacraments of the Church, on questions such as the sacredness and transmission of human life, abortion
and euthanasia, contraception and sterilization, the care of dying patients, professional secret, cooperation to evil, and marriage. The interest on ebmr was secondary, in such a way that in the majority
of manuals it is not treated at all, or it is alluded to only in a cursory way.[9]
On the other hand, the deep changes operated in the field of contemporary bioethics have brought
about, as a side effect, the progressive silencing and exclusion of Christian contributions to the ebmr.
Along the 1950s and 1960s, Christian principles and standards were part and parcel of the articles and
directives regarding eibm[10]. In later decades, under the influence of a number of factors (the
rebellion against authority, the open and public debate on some egregious examples of research abuses
and misconduct, the intense judicialization of bioethical issues, the growing influence in theory and
practice of situationist and utilitarian ethics, and the claiming of activist groups acutely critic of
religion) gave bioethics a strong secularist character[11].
Today, health care ethics is subjugated by the famous four principles of bioethics, which are a direct
derivation of the three principles contained in the 1979 Belmont Report[12]. Many ethical and legal
regulations of medical research have been built on the foundations of those principles, and
consequently the deliberations of the institutional review boards turn around some fixed and recurrent
topics, such as the protection of the subjects’ autonomy, the securing of their informed and free consent
in accordance with law, the balancing of risks and benefits, the just distribution of the ethical burden of
research among the members of society, and the protection of interests of research subjects,
researchers, sponsors and society. In fact, the principles of bioethics monopolise in practice the activity
of many Boards. No other alternative is at present deemed satisfactory[13]. So, the practical influence
of Christian values in the ebmr has been weakened and forgotten its historical meaning.
THE GENESIS OF THE STANDARD VERSION
As it will be shown in the next section, the Christian moral tradition held a clear and strong view on the
participation of human beings in biomedical experimentation: because that participation is a human
deed, it was required, on one side, that the experimenter had to request previously the indispensable
consent of his subject; and, on the other, that the subject could enjoy both the information and freedom
needed to consent in a truly human and morally responsible manner. This tradition, as noted above, is
absent from the standard version on the history of ebmr.
Two factors have contributed to efface the memory of this tradition. First, the narrowing of the area and
time of inquiry usual among Bioethics historians, who ordinarily restrict their studies to what happened
in the United States after the World War II. So, frequently the history of the ebmr does not pay due
83 attention to events that took place outside America in the time prior to Nuremberg[14]. And second, the
application of specific markers to ascertain what is, and what is not, consent to research, following
those provided exclusively by American court cases or American bioethicists. The expression
“informed consent” becomes thus a sort of registered mark of which only a restricted and authorised
use can be made. It is not a common descriptive term, but a qualified one, different in substance and
superior in quality to similar things used in other times and places.
Nothing reveals more the intent to transfer the ebmr to the American heritage than the distinction Faden
and Beauchamp made between two different types of informed consent[15]. One, labelled as the
effective type, refers itself to the mere formalistic procedures demanded by law or institutional policies
to inform and document the patient’s permission to undertake research, by which the consent becomes
formally valid. It is the mere filling of a form, by virtue of which the subject accepts the suggested
research. This type of consent involves an effective, bureaucratic and formal procedure that materially
fulfils the minimal requirements prescribed by law, the professional customs or institutional rules. The
second form, named the autonomous authorisation type, defines informed consent as a subcategory of
autonomous action by a subject to authorise a researcher to undertake a particular research intervention.
It is precisely its quality of autonomous authorisation that makes such consent substantial and ethically
genuine, because it manifests the nuclear core value of respect for persons. This type of consent reveres
the sovereignty of subjects, their values and beliefs, and it is equivalent in point of fact to a transfer of
authority and accountability actively performed by the subject into the researcher. These two types of
consent correspond closely to the two models, of beneficence and autonomy, Beauchamp y
McCullough have devised in their description of physician’s moral responsibility[16].
In the review Caplan wrote on the book of Faden and Beauchamp[17], he affirms that only the
substantial type of informed consent is, in contrast to the effective one, true consent, and affirms also
that it is a typical and necessarily American product. Caplan reproaches Faden and Beauchamp with a
glaring flaw in the book: that despite their attentive historical analysis, they omit a very significant and
decisive, fact: that the notion of autonomy-oriented informed consent is not only born and grown in the
United States, but also it is rooted in the value of autonomy, a peculiarly American insight. By contrast,
in other places and times, the practice and writings on informed consent concerned almost exclusively
with the formal and procedural aspects of its effective variant. That genuine consent is a modern and
radically American phenomenon is proved by the amazement non-Americans experience with the role
autonomy plays in American medical practice[18].
In this way, a new vision of informed consent is introduced, a view that breaks with the past. It is
original and exclusive of the American mind, the resulting conceptual changes occurred during the past
few decades in moral theory, law, and economics, and in cultural attitudes about individualism and
personal choice that extend far beyond the realm of medical morality”[19]. In contrast to the moderate
view of Faden and Beauchamp on the difficulties of valuing the consent practices of the past[20],
Caplan adopts the more radical one of measuring past and present consent procedures with the
yardstick of the autonomous authorisation type, what implies a strong risk of axiological imperialism.
The new concept of autonomous authorisation consent rests on judicial criteria born inside American
law, and presupposes that the subject is regularly endowed with sound intellect and cultivated
autonomy. And what is more: the new concept has been raised to the condition of a universal model.
Such theoretical magnification brings discredit or belittlement on the pre-Nuremberg customs and uses
related to consent.
Furthermore, the new paradigm severs all ties of the ebmr with Christian ethics. Whatever the medical
and Christian tradition had affirmed on the moral rights of the research subject, on his responsibility
and his freedom, on the power to administer his own life and his body, his capabilities and deeds, is
brought into disrepute or diminished to the condition of a rudimentary or obsolete precedent.
In front of such a bold self-attribution of historical importance and ideological superiority, it is a duty
for all to wonder whether that version of the history of informed consent takes account of all the
84 available data and analyzes them with fairness. I think that it is not the case, because such interpretation
does not take into account an important part or the history of the ebmr[21].
In what follows, I will present some data to show that the standard version of the history of the ebmr
has neglected the exploration of authors and works that many years before Nuremberg proposed, with a
surprising maturity and anticipation, very advanced ideas on the ethical criteria for informed consent
and on the position biomedical research must occupy in our society.
SOME CHRISTIAN ETHICS ORIGINAL CONTRIBUTIONS TO THE EBMR
This is a not easy topic. There are very few publications on medical ethics from the time before
Nuremberg. Besides, a number of those publications are not easy to find and, as noted previously,
many of them do not deal with the ebmr.
Despite those difficulties, pre-Nuremberg time appears to be an interesting and peaceful period, when
problems were relatively uncomplicated and medical ethics was cultivated principally by people with
deep religious convictions. Many of them were Catholics. For moral theologians and doctors as well,
the main topics of interest were in great measure the legacy of pastoral medicine, concretely those
related either to the Sacraments of the Church, or to those Commandments of the Decalogue concerned
with the preservation of life and body, and human sexuality. On the other hand, physicians, theologians
and moralists, creatures of their own time, were imbued of the incertitude of the border separating
medical practice and medical research.
Next, a presentation is made of two interesting findings, until now unknown to the bioethical literature.
One is related to the respect for the person of the research subject in the specific situation of
physiological (non-therapeutic) research, as the source of an energetic claim for the practice of
informed consent. The other finding, dealing with the relationships tying science, society and the
individual, is in the origin of a meaningful clauses present in many modern documents on the ebmr.
An early claim for free and informed consent
In the Catholic tradition, doctors and patients, researchers and subject must be guided by a spirit of
moral rectitude, brotherly love, sincerity and freedom. All are equally human beings, in the image of
God, installed in identical worth, done by divine grace capable of maintaining a direct, personal and
filial relationship with God.
Therefore it can be deduced that, in the peculiar circumstances of biomedical experimentation, there are
some specific relationships of researchers and subjects with God, relationship that are shaped by the
respect for the dignity and freedom of persons who are simultaneously brethren and creatures of God.
To rob the human being of his responsible freedom to decide about his health and body, or to grant or
decline his consent to research, is not only a distasteful abuse, but a sin, because it enslaves one’s
neighbour and deprives him of the moral merit to consciously help science and humankind.
Free and informed consent are part and parcel of the researcher-subject relationship in the Catholic
tradition[22]. It emerges, as a radical and obligated requirement, clearly articulated by authors
belonging to the practically ignored school of the French 19th century Morale médicale[23].Such is the
case of Georges Surbled.
When Surbled discusses physiological experimentation, protests with energy agaist the insensitivity of
certains colleagues who do not acknowledge the limits imposed on research by sane morals. For
Surbled, “charitable love is the first and last word of science”. He regrets that many scientists who do
not believe in God and are therefore unable to love their neighbor in God, cannot forget that they are
compelled by the imperatives of justice enforced to all.Surbled is convinced that there is a way to
abjure from inmoral or abusive experimentations: the unmistikableaffirmation of “the rights of man,
85 and, therefore, of the rights of the patient.. […] Every man has the right to be respected in his body
[…], has the absolute rightof not being offended or tortured. So, it is not permitted to the doctor to
experiment on man without his formal consent. And never was it known that patients have authorized
the practice of the dangerousand risky experiments recorded by history and condemned by the right
conscience. Such experimentshave been performed surreptitiously, in unacquainted subjects, with the
perverse pretxt of a medical treatment. Let us hurry to affirm, to make things clear, that neither the
patient himself is endowed with the absolute right to dispose of his […] The patient never can be used
as a cheap object for experimentation.”[24]
When dealing with the consent for the ordinary clinical encounter, Surbled does not show so much
energy, but he has also very important ideas on the matter. Adopting an attitude which deviates in some
points from the beneficient and paternalistic approach of his contemporaries. Certainly, he follows in
first place “the ancient and supreme rule enfonced on the conscience of the doctor and governing all his
practice: primum non nocere”, a rule in force the same in experimentation as in clinical treatment. But,
in both circumstances, Surbled affirms that the patient has the right to refuse whatever treatment or
experiment, “since it is enough for him to barricade himself behind his will, without any obligation to
explain the reasons of his decission […]. He is the only master of his body to use it in freedom. He only
must submit himself to God’s will”. Surbled does not doubt in labelling as criminal ans mostruous the
behavior of those researchers who deceive their subjects, healthy or ill, when they inject in their
unknowing victims pathogenic microrganisms.
Surbled’s concept of informed consent does not yield in ethical depth to the notion of consent
enshrined in the more advanced documents of today. It includes those requirements of respect for the
autonomy of the subject Faden and Beauchamp consider indispensable for an ethically flawless
informed consent: the assent to participate in the research based on the full understanding of the
relevant information; the deliberate and conscious authorizaton granted for the research intervention;
the absence of duress or external incentives that could vitiate or predetermine the subject’s choice[25].
There is, however, a meaningful difference between both concepts, a difference that reveals the long
distance intervening between the Christian and the secularist interpretation of man. In effect, instead of
the absolute autonomy of the subject of the secularist ethics leading him to an isolated, immanent and
individualistic decission, the autonomy of the Christian subject, a man who lives in the presence of God
and enjoys the help of His grace,realizes lucidly that he is not the absolute master of himself, bur a
prudent and responsible administrator of his life and his body, gifts borrowed and that must be traded
with wisdom and responsibility. Exactly the same can be said of the gifts received by, and the duties
imposed to, the researcher, who maintains an lively and active relationship with God and his
subjects[26].
Man’s mastership on himself is a dominion of use, not of self-property,a stewardship subordinated to
God, that everyone must exercise with freedom and in the service of others[27]. Christian humanism
professes a strong belief in the man’s worth and freedom, in human rights, and in the task, assigned by
God to man in the Garden of Eden, of governing and improving this world [28].
The idea of free and informed consent coined by Surbled appear in posterior writings belonging to the
French tradition of the Morale médicale under different appearances, frequently, and curiously,
subsumed under the dominant principle of doing no harm[29]. In other occasion appears clearly stated:
Bon[30], for example, states among the requirements forlegitimate research that “The subject, after
being fully informed of the incurred risks, must lend himself to the research absolutely free and and of
his own will”.
Science, society and the individual: ethical relationship
The Declaration of Helsinki, not in its 1962 original wording, but in subsequent versions from 1975 on,
includes a clause of deep moral meaning: that that affirms the ethical superiority of the interests of the
86 individual over the interests of science and society. During 25 years, from 1975 to 2000, this lofty
concept was reiterated: “Concern for the interests of the subject must always prevail over the interests
of science and society” read clause I,5, echoed by clause III, 4. In the current version, up-dated in
Edinburgh in 2000, the clause 5 of the Introduction insists on saying: “In medical research on human
subjects, considerations related to the well-being of the human subject should take precedence over the
interests of science and society.”
The prevailing background of the person over other human values is a constant in the Catholic ethics of
medicine. Surbled stated unambiguously that patient’s best interest imposes itself with such strength on
the physician’s conscience that it determines his behaviour. “The love of science, so deep and energetic
it can be, never can prevail in our heart over the love to our suffering brethren in need of our help.”
But, many years before Surbled, Max Simon affirmed with determination and clarity this same
principle of superiority of persons over the more valued interests of science. As early as 1845, he
wrote: “Neither the concern for science, nor the decision to solve an important theoretical problem or
the craving for adding a new agent to the medical armamentarium, can lead experimenters to lose the
touch with the immediate interest of the individual who is the subject of their studies. Nothing can
release doctors from their humanitarian duty to assure the suffering patient the whole benefits of their
art”[31]. And some lines further, Simon adds: “But, at last, it is not possible to over-emphasize this
principle: the most indigent and worthless patient, the more useless to society, cannot be subjected to
risky or dangerous experiments. Perish rather science than this principle!”[32]
Simon argues in favor of concentrating medical research in the larger hospitals and under the
leadership of highly capable and eminent academics, since only in this way it becomes possible to
perform numerous enough series of observations and, above all, to ensure that those doctors will never
use their privileges to sacrifice the interest of the individual to the interests of society and still less to
personal enhancement[33].
It would be of great interest a search for the path linking Simon to Helsinki, to see how a French book,
written in mid-19th centuryFrance in the circle of the Morale médicale, made its way to the 1975
Declaration of Helsinki, a product of the secular post World War II medical ethics.Some intermediate
points can be identified. One is the well-known discourse Pius XII delivered the 14 September 1952. In
it, the Pope analysed the ethics of biomedical research around three principles: the interests of medical
science, the interests of the individual subject, and the interests of the community. He expressed,
among other important ideas, that science is not the highest value to which all other values are to be
subordinated; that the human person cannot be used as an object by the community; and, finally, that
the patient is not the absolute master of himself: he cannot, therefore, freely dispose of himself as he
pleases[34].
These ideas were probably carried to the Declaration of Helsinki by the intermediate of a Symposium
on religious views on medical experimentation, organized by the World Medical Association in its
protracted incubation of the Declaration of Helsinki, published in 1960. The representative of the
Protestant confessions, Jacques de Senarclens, after affirming that neither the interest of science nor the
interest of society is sufficient to justify any experiment on man that contradicts the principles of
medical ethics, wounds the dignity of human beings or breaks the most elementary precepts of the
Christian faith, adduces the moral authority of the Pope as expressed in his 1952 discourse: that man
“in his personal being must not be subordinated to the community; on the contrary, the community
exists for the man”[35].
It is evident that the current Declaration of Helsinki retains in its integrity, although certainly with less
emphasis than in previous versions, the precious legacy of Simon. The commitment to give precedence
in any circumstance to the well-being of the human subject over the interests of science and society is
worth the place of honor the injunction occupies in the Declaration. Its meaning, not easy to define
with precision, is open to diverging interpretations[36]. In its vagueness, it can be understood as a
valuable tool to ascertain the limits of acceptable risk in very particular research situations or as a
87 preventive disapproval of perilous experiments. But it can be also apprehended as a parenetic
exhortation to sharpen our ethical sensitivity for the protection of the research subject or as a basic
moral attitude that gives wholehearted preference to the integrity of the human being over any other
consequentialist consideration. This topic has been developed with profundity by Jonas in a study that
has become a classic[37].
[1] The bibliography on this topic is copious. Here are offered only a few references presenting a
panoramic view on the history of the ebmr: Beecher H.K., Research and the individual. Human Studies,
Boston: Little, Brown, 1970:5-15. Brieger G., History of human experimentation, in Reich W.T. (ed.),
Encyclopedia of Bioethics, New York: The Free Press, 1978:684-92. Bynum W., Reflections on the
history of the use of human subjects in research, in Spicker S.F., Alon I., de Vries A., Engelhardt H.T.
Jr, (eds.), The use of human beings in research. Dordrecht: Kluwer; 1988:29-46. Howard-Jones N.,
Human experimentation in historical and ethical perspectives, in Bankowski Z., Howard-Jones N,
(eds.), Human experimentation and medical ethics. Geneva: C.I.O.M.S.; 1982:453-95. Ivy A.C., The
history and ethics of the use of human subjects in medical experiments, Science 1948;108:1-5. Jonsen
A.R., The Birth of Bioethics. New York: OxfordUniversity Press; 1998:125-165. Katz J.,
Experimentation with Human Beings, New York: Russell Sage Foundation;1972. LadimerI., Newman
R.W. (eds.), Clinical Investigation in Medicine: Legal, Ethical and Moral Aspects. An Anthology and
Bibliography, Boston: Law-Medicine Research Institute, BostonUniversity; 1963. Lock S., Research
Ethics – a Brief Historical Review to 1965. J Intern Med 1995;238:513-520.Rothman D.J., Strangers at
the Bedside. A History of how Law and Bioethics Transformed Medical Decision Making, New York:
Basic Books; 1991:15-100. Rothman D.J., Research, Human: Historical Aspects, in Reich W.T. (ed.),
Encyclopedia of Bioethics. Revised edition. New York: MacMillan; 1995: 2248-2258. Vaux K.,
Schade S.G., The Search for Universality in the Ethics of Human Research: Andrew C. Ivy, Henry K.
Beecher, and the Legacy of Nuremberg, in Spicker S.F., Alon I., de Vries A., Engelhardt H.T. jr (eds.),
The Use of Human Beings in Research, Dordrecht: Kluwer; 1988:3-16.
[2] With variations, this standard version of the history of ebmr is found not in academic research
papers or the chapters of monographs or books, but in short editorials, encyclopedias and publications
for the general public. A typical example is: Booth C.C., Clinical Research. In: Bynum W.F., Porter R.,
eds. Companion Encyclopedia of the History of Medicine. Vol. 1. London: Routledge, 1993:205-229.
It is also present in many influential tutorials used in the Internet for the initial education of future
members of Institutional Review Boards. In thus way, the persistence and dissemination of the message
are perpetuated.
[3] On the artificial origin of the Nuremberg and on its improvised nature as a legal referent, see:
Grodin M. E., Historical Origins of the Nuremberg Code.In Annas G. J., Grodin M. E., The Nazi
Doctors and the Nuremberg Code. Human Rights and Human Experimentation. New York:
OxfordUniversity Press, 1992:121-144. On the internal inconsistencies of the Code, see: Deutsch E.,
Der Nürnberger Kodex. Das Strafverfahren gegen Mediziner, die zehn Principien von Nürnberg un die
bleibende Bedeutung der Nürnberger Kodex, in Tröhler U., Reiter-Theil S., Ethik und Medizin 19471997. Was leistet die Kodifizierung von Ethik, Göttingen: Wallstein, 1997:103-114.
[4] Herranz G., The Inclusion of the Ten Principles of Nuremberg in Professional Codes of Ethics: An
International Comparison, in Tröhler U., Reiter-Theil S., Ethics Codes in Medicine. Foundations and
Achievements of Codification since 1947. Aldershot: Ashgate, 1998: 127-139.
[5] As examples of the old literature on the ethos of biomedical research, see: Cannon W. B., The Way
of an Investigator, A Scientist’s Experiences in Medical Research.New York: W.W. Norton & Co,
88 1945: Gregg A. The Furtherance of Medical Research, New Haven: Yale University Press, 1941;
Albareda J.M., Consideraciones sobre la Investigación Científica, Madrid: C.S.I.C., 1951; Ramón y
Cajal S., Reglas y Consejos sobre Investigación Biológica (Los Tónicos de la Voluntad), 6th ed.
Madrid: Imprenta Pueyo, 1923.
[6] For example, in the United States (Cannon W.B., The Right and Wrong of Making Experiments on
Human Beings, Journal of the American Medical Association 1916;67:1372;1373) or in Germany
(Volmann J., Winau R., The Prussian Regulation of 1900: Early Human Experimentation in Germany.
IRB: a Review of Human Subjects Research, 1996;18(4):9;11; Reich Minister of the Interior,
Regulation on the New Therapy and Human Experimentation, February 28, 1931. In: Annas G.J.,
Grodin M.A., The Nazi Doctors and the Nuremberg Code: Human Rights in Human Experimentation.
New York: OxfordUniversity Press, 1992:129-132.) The most flagrant case was probably the 1946
Resolution of the American Medical Association, which after an accelerated approval to serve as an
ethical referent during the Nuremberg Trial, fall on deaf ears and and slipped into oblivion (American
Medical Association, Requirements for Experiments on Human Beings, Journal of the American
Medical Association 1946;132:1090).
[7] Bernard C., Introduction à l’étude de la médecine expérimentale, Paris: Garnier-Flammarion, 1966:
151-152.
[8] Before the introduction of the controlled clinical trial and the acceptance of the evidence based
medicine mentality, it was held as common wisdom that practically all medical interventions were in a
certain sense experimental. Ivy, for example, affirmed that “even after the therapy of a disease is
discovered, its application to the patient remains in part experimental. Because of the physiological
variations in the response of different patients to the same treatment, the therapy of disease is, and will
always be, an experimental aspect of medicine”. (Ivy A. C., The History and Ethics of the Use of
Human Subjects in Medical Experiments, Science 1948;108:1-5). And Shimkin, a few years later,
considered that “medical experimentation on human beings, in its broadest meaning and for the good of
the individual patient, takes place continually in every doctor’s office” (Shimkin M.B., The Problem of
Experimentation on Human Beings, Science 1953;117:205-207).
[9] A substantial number of the most used manuals do not include the ebmr among the matter treated,
for example: Bonnar A., The Catholic Doctor, 4th ed., London: Burns Oates & Washburne, 1944;
Marshall J., The Ethics of Medical Practice, Darton, Longman & Todd, London, 1960; Peyró F.J.,
Deontología médica, 5a edición, Madrid: Marbán editor, 1954. Pazzini A., Il Medico di Fronte alla
Morale, Brescia: Editoriale Morcelliana, 1950.
[10] In those years, it was customary to invite Christian theologians to take part in debates or collective
works on the ebmr. In 1960, the World Medical Association sponsored a symposium of representatives
of the main religions as a necessary step to the development of the future Declaration of Helsinki
(Human Experimentation. A World Problem from the Standpoint of Spiritual Leaders, World Medical
Journal 1960;7:80-83, 86). In the monographs and anthologies then published (Beecher H.K., Research
and the Individual. Human Studies, Boston: Little, Brown and Co, 1970; LadimerI., Newman R.W.,
eds., Clinical Investigation in Medicine: Legal, Ethical, and Moral Aspects. An Anthology and
Bibliography, Boston: Law-Medicine Research Institute, 1963; Katz J. Experimentation with Human
Beings. The Authority of the Investigator, Subject, Professions, and State in the Human
Experimentation Process,New York: Russell Sage Foundation, 1972) are regularly included articles by
moral theologians, as well directives on research from Catholic health care institutions and also
magisterial pronouncements, particularly of the Pope Pius XII.
[11] Callahan D., Religion and the Secularization of Bioethics, HastingsCenter Report 1990;20(4
Suppl):2;4.
[12] National Commission for the Protection of Research Subjects of Biomedical and Behavioral
Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects
of Research, Washington, D.C.: Government Printing Office, 1979.
89 [13] As Veatch affirms, “autonomy stands between us and a moral abyss”. Veatch R. M., From
Nuremberg through the 1990s: The Priority of Autonomy. In: Vanderpool H. Y., The Ethics of
Research Involving Human Subjects. Facing the 21th Century. Frederick, MD: University Publishing
Group, 1996: 44-58.
[14] Faden y Beauchamp, in dealing with the historical evolution of the requirements of consent in the
field of biomedical research, declared that their main purpose is to show how consent emerges and
matures in the United States. They affirm furthermore that, in contrast with what happened in the richer
field of common clinical care, in the research ethics context and before the World War II very few
interesting facts occurred moral. Scientific rigorous research on humans took place in the States only
after the War, and moral criticism on biomedical research began to arise there in the mid-1960s:Faden
R.R., Beauchamp T.L., A History and Theory of Informed Consent. New York: OxfordUniversity
Press, 1986:150-151.
[15] Faden R.R., Beauchamp T.L., O. c. : 274-297.
[16] Beauchamp T.L., McCullough L.B. Medical Ethics: The Moral Responsibilities of Physicians.
Englewood Cliffs, N.J.: Prentice Hall, 1984.
[17] Caplan A. L.,A History and Theory of Informed Consent, by Ruth R. Faden and Tom L.
Beauchamp. Book Review. JAMA 1987;257:386-387.
[18] Caplan’s reaffirmation of the American exclussive citizienship of the substantive -and nor merely
formalistic- understanding of the rationale for informed consentreaches a exultant tone when he speaks
of the “total befuddlement exuded by Europeans, Asians, Middle Easteners, and South Americans at
our seeming onsession with autonomy”, a feature unnoticed and unremarked by Faden and Beauchamp.
Caplan A.L., A History and Theory of Informed Consent, by Ruth R. Faden and Tom L. Beauchamp
(Book review). Journal of the American Medical Association 1987;257:386-387.
[19] Caplan, o.c.: 387.
[20] Faden R.R., Beauchamp T.L., A History and Theory …: 55.
[21] It has been a frequent object of complaint the attitude of some American bioethicists, who for
justify their claim to the title of founders of modern medical ethics tend to ignore the contributions, old
and new, of authors belonging to other areas and times. The annoyance some Europeans feel is sincere
and, in my view, partly justified. Serres wrote rhetorically some years ago: “Novelties are frequently
made of things we have forgotten. We import, at great expense in translations, books on ethics made of
crumbled plastic, and, at the same time, we fail to remember that our European tradition has been
carving ethics along two millennia on granite and gold”. Serres M., Préface, in Testard J., L’Œuf
Transparent, Paris: Flammarion, 1986:11-12.
[22] Soane B., Consent and Practice in the Catholic Tradition, in Dunstan G.R., Seller M.J., Consent in
Medicine. Convergence and Divergence in Tradition, London: King Edward’s Hospital Fund, 1983:3744.
[23] It is surprising to check that neither in France nor in other countries has no investigation been
made on the 19th century French authors of books on medical morals and deontology. None reference
has been found in the articles and books devoted to the history of the ebmr in France to the
contributions of Surbled and Simon, the two authors who are studied next. See, for example:
Ambroselli, C. L’Éthique Médicale, 2nd ed, Paris: Presses Universitaires de France, 1988. FagotLargeault A., L’Homme Bio-éthique. Pour une Déontologie de la Recherche sur le Vivant, Paris:
Maloine, 1985. Hoerni, B. L’Autonomie en Médecine. Nouvelles Relations entre les Personnes
Malades et les Personnes Soignantes.Paris: Payot, 1991. Moulin, A.-M., Medical Science and Ethics
before 1947, in TröhlerU., Reiter-Theil, S., Herych, E. eds. Ethics Codes in Medicine. Foundations and
Achievements of Codification since 1947. Aldershot: Ashgate, 1998. Moulin, A.-M., Medical Ethics in
France, Theoret Med1989,9:271-285.
[24] This proclamation of the human rights of the patient in the special circumstances of being the
subject of an experiment, is taken from the 1905 edition of:Surbled G., La Morale dans ses Rapports
90 Avec la Médecine et l’ Hygiène, Paris: V. Retaux et fils, 1905, Vol. 3 : 216-217. It has not been
possible at this time to obtain the previous editions of this work, patrticularly the first of 1981. The
transcribed Surbled’s words precede in almost a decade the so frequently quoted of Judge B. Cardozo,
where the famous clause is contained: “Every human being of adult years and sound mind has a right to
determine what shall be done with his own body; and a surgeon who performs an operation without his
patient’s consent commits an assault, for which he is liable to damages”. Schloendorf v. Society of
New York Hospitals (1914), as appears in Katz J., ed., Experimentation…:526.
[25] Faden R. R., Beauchamp T. L., O. c. : 241-262.
[26] Full of wittiness and religious belief is the advice of Witts to the researcher:“[…] there is no stock
formula which the physician engaged in therapeutic trials can use to guide his actions. Instead he must
have a tender conscience and be prepared to justify all his actions before his Maker. He should also be
ready to defend them at an earlier date in the law courts”. Witts L.J., The Ethics of Controlled
ClinicalTrials, in Hill A.B., ed., Controlled Clinical Trials, Oxford: Blackwell Scientific Publications,
1960:13.
[27] On the Christian view on the mastering of man of his life and his body, from a personalist
standpoint, see:Sgreccia E., Manuale di Bioetica. I. Fondamenti ed Etica Biomedica, 2ª ed, Roma: Vita
e Pensiero, 1994:153-199. Of much interest are also the ideas on prudential personalism in: e Ashley
B.M., O’Rourke K.D., Health Care Ethics. A Theological Analysis, 4th ed., Washington, D.C.:
GeorgetownUniversity Press, 1997:166-169.
[28] On the deep human and Christian value of the attitude of intelligent and faithful acceptance of
God’s will, as manifested by divine revelation and specified by the Church Magisterium, see: Smith
J.E., The Introduction to the Vatican Instruction, en McCarthy D.G., ed., Reproductive Technologies,
Marriage and the Church, Braintree, Mass: The Pope John Center, 1988:13-28.
[29] Payen G., Deontología médica según el Derecho Natural, Deberes de Estado y Derechos
Profesionales, Barcelona: Sucesores de Juan Gili, 1944:164-183.
[30] Bon H., Compendio de Medicina Católica, Madrid: Ediciones Fax, 1942: 480. (French original:
Bon H., Précis de Médecine Catholique, Paris: Félix Alcan, 1936).
[31] Simon M., Déontologie Médicale ou des Devoirs et des Droits des Médecins dans l’Etat Actuel de
la Civilisation, Paris: J.B. Baillière, 1845:335.
[32] Simon M., O. c., 337.
[33] Simon M., O. c., 334.
[34] The discourse to the First International Congress on the Histopathology of the Nervous System,
September 14, 1952, on the ethical limits of human experiments and medical interventions was
published in the Acta Apostolicae Sedis (AAS 1952;44:779;789). It was also reproduced and
commented upon by many medical journals. An English translation can be found in Linacre Quart
1952;19:98-107, and also, an almost complete version, in LadimerI., Newman RW., O. c.: 276-286.
Some select fragments appear in Katz J. Experimentation with Human Beings: 731-733 y 549-551. The
discourse is object of a detailed review in Beecher H.K., O. c.: 189-200. More or less extensive
comments are included in the President’s Advisory Committee, Final Report, The Human Radiation
Experiments, New York: Oxford University Press, 1996: 88; Ford J., Human Experimentation in
Medicine: Moral Aspects. Clin Pharmacol Therap 1960;1:396-400; Jonsen A.R., O. c.: 149; O’Donnell
T.J., Medicine and Christian Morality, New York: Alba House, 1976:91-93. and in: Vallery-Radot, j.,
Lenègre, J., Milliez, P., Étude des conditions Morales d’Exploration Clinique en Médecine. I Congrès
International de Moral Médicale, Vol. 1, Rapports. Paris: Ordre National des Médecins, 1955: 123.
[35] Giuseppe B.M., De Senarclens, J., Groen J. J., Human Experimentation. A World Problem from
the Standpoint of Spiritual Leaders. World Med J 1960; 7:80-83, 96. The three contributions are
reproduced in LadimerI., Newman R.W., O. c. : 267-270.
91 [36] Schaupp W., Der etische Gehalt der Helsinki Deklaration. Eine historisch-systematische
Untersuchung der Richtlinien des Weltärztebunds über biomedizinische Forschung am
Menschen.Frankfurt am Main: Peter Lang, 1993:243-245.
[37] Jonas H., Philosophical Reflections on Experimenting with Human Subjects, en Shannon T.A.,
ed., Bioethics, 3rd ed, Mahwah, New Jersey: Paulist Press, 1987:253-279. Of particular interest in this
connection are the sections examining the polarity of individual versus society, between private and
public welfare, on one side, and, on the other, the suggestive analysis of the contrasting components of
sacrifice and social contract implied in human experimentation.
92 ADRIANO PESSINA
THE RELATION BETWEEN BIOMEDICAL RESEARCH,
ANTHROPOLOGY AND ETHICAL PHILOSOPHY.
NOTES FOR A METHODOLOGICAL REFLECTION
INTRODUCTION
Interdisciplinary relation has become a widespread requirement today: that is, the need for unity in the
face of the excessive fragmentation of knowledge, made possible by the progressive subdivision of
labour, duties, and areas of study. In some aspects, this means a reversed movement with regard to that
grafted in the modern era with the birth of the experimental sciences, when the problem was properly
that of safeguarding the autonomy of each singular discipline.
In the sphere of biomedicine, this necessity to establish a common perspective (even if not univocal) is
traceable to the very origins of bioethics itself. Although the need for interrelation among disciplines is
often talked about, it is important to recognise that it is not always easy to understand what it really
consists of, the introductory theories that make it possible, and the type of interaction it intends to
promote.
In fact, it seems that interdisciplinary relation can be discussed in various modes, or on different levels.
On one part interdisciplinary relation can be thought of as means for a determined practical or cognitive
finality that cannot be pursued through a single disciplinary approach. This is present, for instance, in
medical practice when the formulation of a diagnosis is the result of different cognitive data, obtained
with different cognitive instruments. Therefore, this relation is often more "experienced", "practiced"
than adequately theorized (and this fact is easily evident in biomedicine, where studies and
methodologies rooted in disciplines peculiarly autonomous intertwine, like in chemistry, mathematics,
biology, statistics, physics, etc.
Interrelation of disciplines can also be seen as a mere communicative interaction, which aids the
integration of different information to better define an object of interest. A common place example is
the fact that, the patient for whose good the doctor works is the man that philosophy talks about and
also the contributor in whom the economy has interest or the father of a family who is the object of
study of sociology; further he is the depressed under the care of a psychoanalyst, and above all he is
Charles, that is a unique unrepeatable individual, who can never be adequately expressed by any
science. The convergence of various definitions to better indicate the object of discussion, gives a
holistic vision that could also be useful in the operations of the singular disciplines.
In talking about interrelation of disciplines, the greatest need is that of finding a unifying perspective
able to coordinate the various human activities, including those that are cognitive, in view of a morally
good end. Here, this relation becomes necessary in furnishing moral philosophy with the needed
information for a proper evaluation. In classical language, we can say that interdisciplinary relation is a
necessary platform for the formation of minor introductions of an eventual practical syllogism.
All these aspects cannot be neglected when we inquire into the interdisciplinary nature of bioethics. But
first, it is necessary to briefly state the origin of modern science in order to understand some problems
inherited from the past, which renders difficult the need for interrelation among disciplines.
AUTONOMY AND HETERONOMY
As is noted, the origin of the experimental sciences, and the progressive determination of the
methodological identities that characterize them, happened through articulated complex historical
processes[1], which do not allow for an easy synthesis. The interpretation that they tend to polarize this
93 history on the basis of the polemics and disputes between them, humanistic and scientific[2],
undoubtedly risks becoming reductive, but they can at least serve to illumine some "categories" which
make it difficult to "think" today correctly in terms of interdisciplinary relation, especially where there
is the "moral" question.
The reference to ethics seems, in fact, to undermine some meta-scientific notions that have
accompanied the birth of the sciences, particularly the ideas of autonomy, research liberty and the
axiological neutrality proper to each science. The fear of a wrongful interference of morality in the
multidisciplinary practices has both theoretical motivations and historical roots. From the point of view
of history, we may recall that the sciences were progressively established through a process of
"emancipation" from theology and philosophy, from their contents and methods and that, recently, they
have been forced to "free" themselves from both political and economic ideologies. From the
theoretical view point, interdisciplinary relation seem to critically evaluate the cardinal principles upon
which science is itself based, from theology (known as sacred science in the middle ages), to
philosophy; from the so called exact sciences to the experimental ones (disciplines included among the
profane sciences in the medieval period).
It may be interesting to recall that St. Thomas Aquinas was already establishing clear distinctions
between the various forms of knowing, based on the autonomy of their specific procedures and trust in
the use of the "natural light":
The sacred doctrine is science; but there is need to understand that there are two classes of sciences.
Some proceed in fact from basic principles with the natural light of the intellect, like arithmetic,
geometry, and the like. Others instead begin from basic principles in light of a superior conscience,
concerned with the knowledge of God and the blessed. Just as music believes in the principles offered
it by arithmetic, so the sacred doctrine believes the principles revealed by God.[3]
This quotation reminds us that for Thomas the intellect can correctly operate on the basis of the
principles it can grasp alone and that the sacred doctrine neither substitutes the profane science in its
field, nor aids the intellect to function rightly, but rather provides that superior vision necessary for man
to better live his life and adequately realize the goals for which he is created. This idea helps us to
understand how science (and for Thomas it was mainly the question of the autonomy of philosophy) is
not subordinated, as science, to other forms of knowing, not even the sacred doctrine, which is
nevertheless judged to be indispensable to having an adequate vision of man's finality.
From these observations we can draw an indication: if interdisciplinary relation is not a mere
juxtaposition of forms of knowledge, then there is need for a clarification of the specific meaning of
"science" and "autonomy". Already in Thomas emerges an analogous use of the scientific concept,
which returns to the idea, often neglected or negated today, of the analogy of the term human
"reason."[4]
If we reread the long and troubled history of the dawning sciences, their bond with technology, and
their relationships, often problematic, with modern philosophy and theology, we can understand the
"fear" (often evoked today) of reducing scientific research to a mere disciplinary "heteronomy". This
"fear" also expresses the need to safeguard a "value": that is, the fear that if the sciences lose their
autonomy, they will be betraying their specific vocation, though restricted, to "truth", realized through
the research of the causes of the phenomena they study. The reference to the "true" provides, after all,
but we shall return to this later, the basis for agreement and disagreement between the various forms of
knowing, both because it is often forgotten that the notion of truth is not univocal but analogous, and
because the ways of determining the truth about a specific object of research are diversified according
to the reference points and the ultimate goals being pursued by the various sciences.
To establish the essential nature of the relationship between biomedicine, anthropology and ethical
philosophies it is necessary to remember that medicine tends today to think of itself in terms of "natural
science" and, therefore, makes problematic that connection with ethics, which has been evident for a
long time. Further, while it is easy to talk of a biomedicine, it seems impossible today to talk of an
94 anthropology and ethical philosophy. From the same philosophical side, the idea has been theorized
that it is impossible not only matter-of-factly, but also on the basis of principles, to affirm a unity of
method or content with regard to ethics and anthropology. The breaking up of philosophy in
"philosophies", makes evident both the almost habitual discourse on ethical pluralism (the inability to
measure ethics), and the internal debates on the notion of "person", and complicates the realization of
interrelation among disciplines.
MEDICAL SCIENCE AND MEDICAL ART
We can distinguish different levels in that which we call "medicine": on the one hand there is the sum
total of all scientific knowledge which, acquired by different instruments and with the contribution of
the specialized disciplines (from biology to statistics) constitute what is known as "medical science";
on the other hand exists medical practice which, in the modern age, has extended its proper goals
beyond the therapeutic end, to include diagnosis and prevention, as well as experimental activities, all
of which are situated between the therapeutic plan and that of scientific research. These two "macro
levels" can be distinguished in the goals they pursue: medicine as "science" has the acquisition of
knowledge as its primary goal, while medicine as "art" or professional medicine has as it primordial
end cure, healing or the "care" of the person as a real or potential "patient"[5] It is beyond the scope of
the present discourse to articulate in detail this distinction, which already contains in itself moreover
some elements that can help us understand the level of complexity inherent in a reflection on medicine
in its modern outlook.
However, not all are disposed to recognize these differences in levels. H. Jonas, for example, writes:
To medical science, as general science of the body, both sick and healthy, is not therefore suitable...
that which is otherwise valid for science, and that is to have its scope in knowing: with this knowledge
it intends fundamentally to help the doctor in his capacity to cure. Hence, it is neither without a goal
nor neutral. Once again that which distinguishes medical art from the ancient art of humanity is that
from antiquity - from Hippo crates - it is intimately connected to a science by which it is essentially
constituted.[6]
Jonas pretends to negate this distinction both to show the peculiar relationship that exists between
medical science and medical art (a relationship that would be completely different with respect to that
which can exist between a science, for instance physics, and its possible practical applications), and to
demonstrate that in medicine seen as science and art the object is not any kind of body, but the body of
a human person. Although Jonas' position is understandable, yet it is possible to retain his view without
eliminating the distinctions we already made. Simply looking at the intention of the scientist, in fact,
cannot delineate the goal of scientific knowledge.[7]
The researcher who studies the human body may have as his goal the practical application of his
knowledge, but the goal of his research is not the application itself, but the discovery, for instance, of
how the human physical features function. In this sense, we can then distinguish medical science from
medical art. Only the second is in itself concerned with cure and healing: the first, in fact, can exist
outside the possibility of application. In the same manner, for example, the knowledge of anatomy is a
necessary but not sufficient condition for the exercise of surgery, and will remain a valid knowledge
even in the absence of the operating instruments. That which determines, in fact, the axiological nonneutrality of a science (its moral relevance) is not its scientific character but its method for obtaining
knowledge. The experimental sciences are really not "neutral" simply because their manner of
obtaining results, as opposed to what happens in other speculative sciences (like mathematics,
philosophy) is "practical", that is, it involves a transformation and an intervention on the object of
study.
95 Medicine like science requires an ethical evaluation not because it would have, as Jonas argues, the
same end like medical art, but because (and this is evident in its experimental characteristics, where
there is a combination of the need to benefit a patient and the desire to understand the effects of a drug)
to obtain the knowledge one must intervene almost always (there are also aspects of pure observation in
the same medical science) on his "object of study".
It is with reference to the "object of study" of medicine that the peculiarity of this "science" emerges. In
fact, both science and medical art both deal with the human body, that is, the body of a human person.
It is pertinent to quickly add that, because of the multidisciplinary structure of medical science, many
times research is on parts of the body (on cells and organs) and not always on the living body of the
person (as is the case, for example, in the final phases of pharmacological experimentation).
Regarding medical science, therefore, we can affirm that it can correctly claim axiological "neutrality"
and its autonomy from ethical considerations only if its goal is acquiring knowledge. By neutrality is
meant that, when we consider a science as such, the ethic is with regard to the activity of the researcher
(who must be honest, truthful and respect the very methods of the research itself), and not the science
itself. This observation is valid for each research activity of man, but it is not sufficient where the mode
of knowing is realized through a practical intervention on a reality that already has its own intrinsic
value, as in the case of the living body of the human person. Medical science and medical art share a
common moral responsibility where research is carried out in a practical manner on a concrete human
person, who is unique and unrepeatable.
This ethical relevance becomes clearer when we examine medical art. Here it is useful to extensively
cite the views of Jonas again, because they seem to be extremely pertinent:
An essential feature of the medical art is therefore that the doctor each time deals with his fellow
human being and each time typically singular. The patient while he waits must trust in the fact that his
cure is entrusted only to him. More specifically, however, if we leave out psychiatric considerations,
the medical art is concerned with the body through which man belongs to the specie of animal
organisms, it is a natural thing among other natural things, and in this sense it re-enters into the realm
of natural science. But it is the body of a person. To allow one the possibility of living, the body must
be helped. The body is the objective element, but it is also the subject in action.[8]
The body (both healthy and sick) is the object of medical consideration, but it is a particular "object",
because the living human body is always the sign of the human person, that is, of his subjectivity. The
living human body expresses very well the original meaning of the word "person", that is of that
"mask" which while it makes possible the identification of a subject, also hides the profound identity,
his human "personality". From this point of view, it is undoubtedly obvious that it is not possible to
care for a sick person without passing through his corporeity: the living body is a "sign", more or less
opaque, of the human person who, going beyond corporeity, is never without the body. Each act of
violence on the human body is, therefore, an act of violence on the whole human person.
The human body, it can be said, is the meeting point between pure materiality and pure spirituality:
situations and limits well expressed from the possibility of considering it solely in the light of
biochemical processes that connote it or through the excess of human activities (that are not only
mental activities) that qualify it. It is precisely this human structure that makes it possible to view the
medical art in terms of an interpersonal relation also when the professional exercise is on the body and
toward the body.
Further, the "body" studied by medical science and anatomy is never, in the final analysis, only "a
body", even if its structures can be variously examined by different disciplines that "dissect" it
according to the logic of the different forms of knowledge (from biochemistry to physiology), as if it is
any kind of body. It is precisely on this level that we discover the intrinsic necessity for medicine as
well as the art of medicine to establish a clear relation with anthropology and ethics. Medicine, in fact,
requires a certain level of competency in anthropology and philosophy precisely because its object is
the human body and the "objective" knowledge of the body should not be negligent of the "subjective"
96 components that specify the body as human body. Furthermore, the same "sickness" carries with itself
the two levels of bodily pain and of psychological and existential suffering. To better appreciate the
phenomenon of "sickness" reference must be made to the "lived" experiences of the sick person.
The psychophysical unity of the concrete man impedes the medical ability to establish a neat boundary,
a point of demarcation between the point where the spirit begins and where the body finishes and
imposes on the doctor a need for an anthropological knowledge that transcends what he learnt in the
field of "natural" science. On the basis of this knowledge, medicine can consider the living human body
in all its phases, from generation to death, as sign of the human person.
But the anthropological question, (the "who is he"? man) and the moral question, (what is the good or
licit action necessary to better appreciate the human body and take care of this man?) does not only
regard the "object" of science and medical art, rather some moral evaluations are also exercised with
regard to the "subject" of research and of medical art. This is at least for two fundamental motives.
Firstly, it is necessary to recognise as a moral "good" the dedication to one's concrete well being to be
able to dedicate oneself to the care of others. Secondly, because there is no cure or study of the body
that does not also imply interaction with the human person, not every method of knowing and curing is
respectful of the living human person.
We can further affirm from the above point of view that the specific source of the medical art is always
of the extra-scientific kind. The medical art is not actualised by means of experimental knowledge on
man's corporeal structures, but in the recognition of the intrinsic values of the living man and,
therefore, of the value of good health as a condition which contributes to the right expression of human
personality.
Fundamentally, medicine is obviously the greatest anti-Darwin project in history, in that it operates
against the pretext of "natural" selection that favours the coming of the strongest and healthiest. It
would be interesting, but it is beyond the scope of this reflection to show the difficulty and
irreconcilability of a "naturalistic" theory of the Darwin or Neo-Darwin schools with the goals of
medical art. Rather we can say, in conclusion of this first analysis, that the relationship between
medical art and medical science is, from the chronological point of view, opposed to the
methodological stand point: it was a practical gaol that always made the need for a scientific approach
to man necessary, even though it is evident today that no practical end is possible without scientific
premises.
In general this observation can be made: the gaol of research is knowledge; knowledge is a moral value
in itself, but knowledge is always about something: therefore, the value of knowledge cannot collide or
eliminate the value of the "known" without also eliminating the moral value of knowledge itself. The
value of the known requires that the means by which it is adequately known also respect its characters.
All these become evident when this "known" and "knowable" is the body of a human person. Medicine,
as both art and science, therefore, implies the knowledge also of the man whose body is being studied.
THE METHOD OF BIOETHICS, BETWEEN DESCRIPTIVE AND PRESCRIPTIVE
The interdisciplinary character of bioethics was expressed from the very beginning from the now
celebrated definition given in 1978 and found in the Encyclopaedia of Bioethics: "systematic study of
human behaviour in the field of the life and health sciences, in the light of moral values and
principles."[9]
As is noted, the definition of bioethics still remains an open problem, as long as its epistemological
statute remains to be clearly defined[10]: particularly, the question about whether bioethics can absolve
a prescriptive role or simply be limited to the descriptive aspect or the clarification of the issues it
confronts remains open. To decide for a bioethics that is only descriptive or also prescriptive means,
97 ultimately, deciding if bioethics can overcome the impasse in which a great part of modern moral
philosophy was found, when it took as its proper theoretical model the analytic system.
The fact however remains that, while on the level of medical science interdisciplinary relation can take
on a descriptive role, in the realm of medical art there emerges the inevitable problem that regards what
must be done. Medical art naturally requires a prescriptive moment. And it is precisely when bioethics
must confront problematic contents that the need emerges to establish a method necessary to indicate
that, which must be done, and not simply that which is being done as a matter of fact.
With regard to the method of bioethics, it is worth examining the position of E. Sgreccia, now set out as
point of reference for the researches of the Centre of Bioethics of the CatholicUniversity of the "Sacro
Cuore" Rome. This method was presented using the image of a triangle: exposition of the biomedical
fact, deepening of the anthropological significance, and characterization of the values at play. The
image of the triangle,[11] in its geometric clarity allows the characterization of what we can define as
the "emergency" theories of bioethical question: represented precisely by the three sides of the triangle.
The image, moreover, expresses the necessity for the presence of the three theoretical points, as a lack
of even one means a lack of the entire image. A correct interpretation of Sgreccia's position will be
that, drawing on the symbolic significance of the triangle, the bioethics is not defined solely by the
presence of these basic theoretical "points", but also by the connection between them, that allows the
possibility of outlining an itinerary.
If we examine the methodology proposed by Sgreccia, represented by this image, in the light of the
concrete thesis he developed in his Manual, different aspects of interdisciplinary relation emerge, upon
which it is opportune to reflect. The "triangular" relationship between biomedicine, anthropology and
ethics is ordered on two levels: firstly, it permits the clarification of the theme (descriptive moment)
that is the objective fact of bioethical reflection, then follows a prescriptive moment, in which, the
conclusions are gained by a discussion of the meta-empirical perspectives which are matter-of-factly
present in two of the triangular aspects. In this perspective bioethics has both a critical and an
evaluative connotation. Evaluative, because the goal of bioethics is not simply to describe all the data
more or less problematic in a relation, but also to find and propose solutions to these very problems:
that is, solutions of natural ethics, and hence prescriptive.
The ethical propositions in bioethics, therefore, are not the products of an impossible deductive logic,
but thanks to a systematic interaction of the diverse forms of knowledge that find a common ground for
their conclusions in the judgement of the human conscience (judgements with regard to proper and
right actions), that is in an evaluation of that, which is good to be done here and now. This method is
distinguished from other procedural theories both in its content, which has its pivot in a substantial
conception of the human person, and in its critical or dialectical structure. If we have been faithful in
presenting the arguments of Sgreccia, we cannot fail to affirm that the ethical and anthropological
conception that he proposes is clearly of the cognitive school, and therefore thrives in the conviction
that it is possible to discover some truths in the very being of man and in his actions, and this is
recognisable by all persons in principle.
Further, in this "triangular" image emerges the analogical meaning of truth, which remains the basis for
making an ethical evaluation. The three sides of the triangle can be outlined because there is something
that unites them and makes communication possible between them, though in their differences: and it is
precisely the analogous meaning of truth. If the human image, the value of his existence and his
practices (that is the anthropology and ethics) were simply the historical and cultural fruit of options
taken by individuals and communities, then it would not be known the basis for possibly advancing the
claims present in scientific activities, that would remain the unique anchor for establishing the criterion
of what is true and false. But precisely because all three disciplines, according to their characteristic
methods, are necessarily concerned with the truth, they are able to understand one another and interact
in the evaluative processes of the issues treated in human practice.
98 In Sgreccia's view, bioethics is not the product of a sum total of competences, but emerges as a
discipline in the establishment of an itinerary (the triangle) that is realized when the judgement of
conscience is formulated on the basis of acquired and integrated truth. The prescriptive moment, which,
undoubtedly retains that the formal object of bioethics has an ethical value, is not, therefore, fruit of a
mere deduction from moral principles, but appears within a complex theoretical itinerary that
recognises the different approaches to reality, made possible by the knowing activities of man. This
reference to the practice of knowing that unites these disciplines is the foundation for the legitimacy of
ethical evaluation. Ethics, in fact, always has as its object human actions and, hence, it is not "out of
place" when it intervenes to determine the "goods" under consideration: goods which also concern
science, because it is always and however an expression of man's humanity and of the truth about man's
condition.
The dynamic character of this process allows us to witness the dialectical capacity: the same truth about
man, in his multiple dimensions, is, in fact, also a theoretical gain, and not only a mere inheritance of
classical thought. In this perspective, then, it becomes understandable the effort at rediscovering the
reasons which, justify anthropology and ethics as forms of knowledge, ordered by discussing, debating
and seriously evaluating contrasting thesis in this itinerary. This theoretical model makes bioethics a
theoretically dynamic enterprise not only because it collaborates with scientific researches proposed
from time to time, but also because it appreciates the various modalities with which modern man
perceives, more or less adequately, his human identity and all the values that make him a human being.
Now, it is important to underline that this system of argumentation is methodologically characterized
by the capacity to confront both the instances of atheism and secularisation, and with the propositions
of faith and theology, catholic and non- catholic. It is about a methodological system and not simply
the will of the author: in fact, in the dialectical and argumentative structures of the human reason
resides its capacity to evaluate all that is presented to it as contributory factors in the discovery of truth.
This methodological capacity of not excluding a priori any element, and the capacity to distinguish the
source of a thesis from the value inherent in the thesis as such, enables the presentation of a precise
indication regarding the vexata quaestio of ethical pluralism, that would lead bioethics to a province of
the single territories in which the ethical map would be divided. There is no doubt that ethics provides a
terrain for disagreements and differences: but this fact cannot become normative, rather, it should be
overcome. This is because the moral good concerns our common humanity, and when we act morally
we act in the name of humanity and therefore each man is consulted as a moral subject. From here
derives the thrust for confrontation and discussion, animated by the spirit of research of truth and not
from the desire for dominion and mere consent.
Anyone with an empirical scientific formation may consider this imposition to be self-conflicting, in
view of the ways by which scientific results are transmitted: but it is an erroneous impression, which
fails to take into account the specific methodology of philosophical knowledge and forgets that this
dialectical dimension is analogous to the logic of the hypothesis and of the process of verification that
characterizes experimental knowledge.
Maintaining this methodological awareness may be an optimal antidote in view of the possible
ideological drifts that could condition the transmission of some bioethical contents: in fact, in this
transmission process, it is necessary to care about indicating also the supporting reasons, and the
dialectical principles upon which they are formulated. Certainly, this is not an easily realizable
enterprise in a cultural context that seems today to be the preserve of hermeneutics, which, in the name
of an inventory of the possible and indefinite reading of reality, refuses to think of the same possibility
of the solutions to ethical problems. But this is a theme that we cannot address presently.
CONCLUSION
99 In the first place it is useful to recall that there is an intrinsic connection between all human activities
and the moral question, to use the thomistic expression: idem sunt actus morales et actus umani.As is
noted, for Thomas, human acts are those acts that are free and conscious, of which we can "add", that
they progressively determine our moral personality and our capacity not only to do good and evil, but
also the capacity to be good or bad.
From here derives a fact: all human activities, considered from the point of view of the subject, have
moral underpinnings. The existence of deontology finds its foundation both as means for obtaining
suitable results for the specific goal of medical research (the values of intellectual honesty, of precision,
etc.), and as a means, which enables the singular agent, to respect and promote his very moral identity
through his works. This "immanent", deontological aspect can neither be the only the fundamental
theme to be addressed with regard to interdisciplinary relation. In paradoxical terms we could express
the limits of the reduction of ethics to professional deontology by recalling that in order also to obtain
evil goals the virtues can be requested (that is, the moral ability): hence there is need for seriousness,
commitment, precision even for the construction of a lethal arm, but this profusion of virtues does not
make the end good in it self and this opens the question of the responsibility of the acting agents and of
their extension.
Interdisciplinary relation presents another need, that of evaluating both the means and gaols of
biomedical activities: here the ethical question transcends the research as such, and is formed according
to an "architectural" content. The moral evaluation does not threaten the autonomy of a discipline as
such, but it considers it as representing another disciplinary perspective. This position is already tied,
for instance, with the widespread conviction that not all acts that are concretely possible are morally
good. It is also noted that a different relationship is possible, that is, it is possible to give a moral
evaluation of a moral action, as an extrinsic evaluation, that is not detrimental to moral autonomy, as
such. We can pose, as an example, the legitimacy of an inquiry into the health-worthiness or not of a
prolonged fast, dictated by religious criteria, or carrying a risky pregnancy to term. A morally "good"
action can also be noxious (harmful) to the health: on the level of knowledge it is so possible to invert
the relations between the various disciplines. The interdisciplinary character, in fact, permits the
exchange of parts, without violating (in principle) the autonomy of the singular disciplines that are
correlated.
The need for moral evaluation, as we have tried to prove, derives from the practical characterization of
science and medical art.Until now the arguments made on the side of morality, can be easily extended
to the anthropological realm, while distinguishing, also in this case, an intrinsic and extrinsic relation.
On the one hand, in fact, the research on the human body requires a right conception of man and not
only knowledge of his biological, anatomical, chemical and physical structures. This is for the simple
motive that these structures do not exist in the abstract, but are qualified by the human condition itself.
The human peculiarity is also the peculiarity represented by man's corporeity.
A final annotation, historical in nature, becomes necessary. For a long time medicine, as art and as
science, has failed to point out the necessity of a structural connection with the philosophical
disciplines simply because it was assuming from the cultural stand point where it was operating, the
anthropological and ethical categories. For much of the time medicine was "naturally" Christian simply
because it was formed and developed in a Christian Weltanschauung. Today the situation is profoundly
different because different forms of secularisation mark the cultural context and because we can no
longer, on the sociological level, speak of an unquestioned supremacy of Christian humanism. There no
longer exists, on the sociological level, a common reference point for all: the "good sense" cannot take
the place of specific anthropological and ethical knowledge. From this historical and environmental
situation derives the necessity to acquire theoretically most of the categories that, for a long time, have
formed the natural "background" for western biomedicine. The future of science and medical art
requiresa new level of awareness in the field of knowledge and of ethical and anthropological
competences.
100 [1] Among the numerous studies dedicated to the history of the sciences and their relationship with
philosophy, we recall some texts: A. Koyrè, From the closed world to the infinite universe, Feltrinelli,
Milan, 1970; A.C. Crombie, From St. Augustine to Galileo. History of Science from 17 century,
Feltrinelli, Milan, 1970; P. Rossi, The philosophies and the machines (1400-1700), Feltrinelli, Milan,
1972 (English Translation).
[2] A reprint of this polemic, in our century, was realized beginning with the reflection on technology
and its relationship with the humanistic culture.
[3] Thomas Aquinas, Summa Teologiae, 1.q.1,a 2.
[4] It may be useful to reread the synthetic and interesting contribution of M. Lenoci, The human
reason between science and philosophy, in S. Zaninelli, Science, technology and respect of man. The
case of stem cells, Vita e Pensiero, Milan 2001, pp. 27-38 (English translation).
[5] On this issue ref. D. Callahan, The Impossible Medicine, Baldini & Castaldi, Milan 2002 and the
recent opinion of the National Committee for Bioethics in Ends, Limits and Risks of Medicine, 14
December, 2001 (English translation).
[6] H. Jonas, Technology, Medicine, Ethics, Einaudi Turin, 1997, p.110 (English translation).
[7] If we look at the intentions of the knowing subject we cannot distinguish between practical and
speculative sciences: from the fact, for example, the fact that the intention of a mathematician is that of
obtaining the Nobel price through his research does not evidence anything about the nature of
mathematics in itself(English translation).
[8] H. Jonas, op. cit., p.111
[9] Cf. W. T. Reich (editor), Encyclopedia of Bioethics, Vol. 4, New York: The Free Press, 1978,
Introduction, p. XIX.
[10] For a synthetic analysis of the problem I refer to A. Pessina, Bioethics. Experimental Man, B.
Mondadori, Milan 1999 (English translation).
[11] Cf. E. Sgreccia, Manual of Bioethics, Vol. 1, Vita and Pensiero, 1999 (3rd edition), pp. 63-64. The
same method is used in the analysis of the relationship between the rights of the sick and those of the
doctor (cf. p. 244ff)
101 ROBERT SPAEMANN
ARS LONGA, VITA BREVIS
Today’s concept of science does not correspond with the notion of science used until the 16th century.
It is advisable to be conscious of this difference if one wants to attain an appropriate conception of the
activities of modern science. The Greek and Latin nouns “episteme” and “scientia” were the
nominalized forms of the respective verbs of “to know”. Yet, knowledge is a relational state of the soul,
it is the habitus of a human being. A habitus. To know something does not mean that one has to
actually think of what one knows. It rather means to think with certainty of it in the right way when
thinking of it. With a certainty indeed, which knows its own reasons as definite ones. This distinguishes
knowing from thinking and believing. As a relational concept, knowledge is not something purely
psychological. That means, it cannot be accessed by mere introspection. From a psychological
perspective, it cannot be distinguished from a wrong conviction. There are wrong convictions, wrong
opinions, and wrong beliefs. There are errors of science, but there is no wrong knowledge, for truth, the
adaequatio rei et intellectus, belongs to the definition of knowledge. If I believed I knew something,
and afterwards arrive at another conviction, then this new conviction implies that the earlier conviction,
although also being a conviction, was no knowledge.
Knowledge is actualized when we consciously think of what we know. But it is also actualized by our
behaviour, even when we do not think of it. We go to a particular place by a particular route, because
we know that this route leads to this place. When we often take this route, we do not need to become
aware of this knowledge every time we take it. Knowledge in general makes it possible for us to attain
what we want, provided that we know what we really want.
Practical knowledge, in the classical sense of the word, was neither only, nor even primarily, knowhow, but knowledge about what the human being as human being really, and basically desires. And
since all human beings really desire to be happy,they need to know what happiness, eudaimonia,
beatitudo consists in. Aristotle taught that the highest form of happiness itself consists in the
actualization of the highest theoretical knowledge, i.e., in theoria, the contemplation of the eternal,
necessary and invariable, instead of the earthly, contingent and variable.
Instead of being the servant of practice, it is theoria itself which is its highest form. For Plato, this
highest knowledge was the knowledge of the Good. After all, all knowledge is only knowledge, if it is
grounded in the knowledge of the Good as the source of reality and of the knowability of all things.
One only knows what a crocodile is if one knows what distinguishes a well-formed crocodile from a
malformed one, a healthy from an ill one. And someone who would say that he knows what a knife is,
whilst not being able to distinguish a blunt one from a sharp one, does n o t, in fact, really know, what a
knife is. The classical concept of knowledge presupposes a teleological conception of reality. Real
knowledge is the understanding of a teleological context. And we have understood what the indefinable
“Good itself” is, only when it determines our actions. As Plato says, he who does evil, apparently really
does not know the Good. Thus, Saint Thomas also still taught that no-one does bad things, that is, the
undesirable, voluntarily. The blame for the bad action is always preceded by a culpable error about
what here and now is the desirable, i.e. the good. Dante still wrote of hell that it was the place of those
who had lost “the good of the intellect”. It therefore belongs to the tradition of classical philosophy that
“prudentia” is the highest of the cardinal virtues.
The decisive factor among all these characteristics of science is that knowledge always remains the
state of an individual, real human being. “One” cannot know a thing. People can have a commonly
shared conviction but only in a concrete human being can such a conviction turn into knowledge. Only
a concrete human being can be wise. Knowledge in the traditional sense, in fact, culminates in wisdom.
The desire for knowledge is a fundamental characteristic of human beings. “All man by nature desire
knowledge”, says Aristotle in the first sentence of his “Metaphysics”. As an empirical instance of this
102 characteristic, Aristotle refers to the fact that Man finds pleasure in seeing, independently of any
practical use and any reference to action. However, as an end in itself, this desire for knowledge is
severely criticized by the Fathers of the Church. The critique of curiositas became most influential
through Augustine. This criticism can be interpreted as the radicalization of the Platonic theory of the
knowledge of “the good itself”, that is, the highest good. For Plato, there can only be talking about
knowledge in the strict sense if the reason for what is known leads to the ultimate foundation, to the
good itself. This can only be realized by a few, namely the philosophers. The others have to be taught
the right opinions and follow them without any deeper insight, if the State is to be run orderly.
Christianity has democratized Platonic philosophy: Everyone is called upon to attain the knowledge of
truth, i.e. the knowledge of God. Belief is not doxa, opinion in the ancient sense, but a knowledge
based on the self-revelation of God which is of a certainty surpassing the individually acquired
knowledge. For we can, and we have to mistrust ourselves. However, “Scio cui credidi”, holds for
belief. Therefore, as opposed to Plato, Augustine condemns the earthly desire for knowledge as an end
in itself, as curiositas.
The desire for knowledge is only justified if knowledge is useful, either for human survival, or as a
means for the knowledge of God. For the knowledge of God is an end in itself insofar as God is an end
in himself and this knowledge leads to the frui deo, the loving devotion. Yet, knowledge of the finite,
insofar as it is not useful in the stated sense, ultimately leads to self-indulgence, that is to amor sui
usque ad contemptum Dei.
St. Thomas attempts to reconcile Aristotle and Augustine. Not only does he recognize the desire for
knowledge as an anthropological constant, but he sees it as the realization of the godlike character of
human beings. In this respect, all knowledge as such naturally already refers to God as the origin of
truth. The vice of curiositas therefore only consists in cutting off this reference, that is to say, in
striving for knowledge which right from the start dissociates itself from any reference to this origin.
In this case, the motive of the researcher is primarily superbia, vanity, personal ambition, and not love
of truth. It is interesting that St. Thomas once described curiositas as a form of acedia, spiritual
lethargy. To keep the ultimate end of the human being in mind requires the exercise of the deeper
powers of the human being. Without this exercise, hence, as a consequence of the fuga finis, the human
being aimlessly roams around, so to speak, in the infinite quantity of what can be known.
In his book “Legitimität der Neuzeit”, Hans Blumenberg described the rehabilitation of theoretical
curiosity as a fundamental characteristic of modern times. This thesis is only right, if we take into
consideration that, at the same time, the concept of science has significantly changed. I will
characterize this change in four ways. 1. The objects of science are no longer teleological structures of
reality but causal connections following a set pattern. 2. Knowledge is neither practical knowledge nor
theoria in the sense of contemplation of what is known. Instead, what is theoretically known either
forms the basis for practical application, or is a stage on an infinite path of inquiry. 3. Scientific
knowledge is not knowledge at all in the classical sense of the word, but a hypothesis, a more or less
well-founded opinion, which can be theoretically falsified, since it is founded not on essential insights
but on a theoretical ordering of empirical facts on a trial basis. 4. Science is not knowledge of concrete
human beings, but a collective undertaking providing information which can be acquired by concrete
human beings according to demand, be it for the purpose of further research, or for the purpose of
practical application.
I will briefly elucidate these characteristics:
1. Classical ontology is biomorphic. Reality consists of things along with their attributes and relations.
The paradigm of the being of a thing is the living being. The paradigm of being in the sense of
existence is life. Aristotle says “Vivere viventibus est esse”. First of all, however, we know from
ourselves what a living being and what life is. The paradigm of the living being is the human being,
and therefore, in the end, this ontology is anthropomorphic. “Being” does not first of all mean being an
103 object but being-a-self. Yet, it is typical of all the living “to be after something”. As long as we live, we
strive for things, be it only for survival. Knowledge of the living therefore is knowledge of its
teleological structure. Whoever ignores what a lung is good for, and why birds fly south in winter, does
not know anything about the organism of mammals, and nothing about migratory birds. Modern
science starts with a programmatic denial of teleological contemplation of reality. It is, as Francis
Bacon wrote, “sterilis et tamquam virgo Deo consecrata quae nihil parit”, infertile as a virgin dedicated
to God, who does not bear anything. Later, in the Age of Enlightenment, all virgins dedicated to God
were, in fact, expelled from their nunneries if they did not do something useful, that is to say, teaching
children, or nursing the sick. But in these words of Bacon we can already make out the new ideal of
science: Science must be useful. Knowledge must be of practical use, or to be such that it generates
new knowledge. As opposed to this, teleological knowledge is suspected of being an asylum
ignorantiae, a pretext for the ignava ratio, idle reason. The insight as such, that lungs are necessary for
the supply of oxygen, is not interesting. It is, at best, of heuristic value for research programs studying
the microbiological processes by which lungs are formed and by means of which they work. The same
holds for the flight of birds. Yet, in contrast to the teleological perspective, the knowledge of causal
laws leads to apeiron, infinity. It cannot be brought to an end. Therefore, it cannot orientate action, but
only make it more efficient.
2. That is why modern science is not contemplation but research. As such, however, unlike ancient
theoria, it is not the highest actualization of the being of Man, that is, the highest form of practice.
Instead, it is the servant of a practice directed towards a progressive subjugation of Nature.
Teleological knowledge is of no use for the mastery of Nature, even more, it is rather an obstacle to it.
One can carry out animal experiments much more easily if one overlooks the suffering of animals.
Causal knowledge, however, teaches us how we can manipulate Nature. And this knowledge can
normally only be acquired through such interventions, that is, through experiments. To know a thing no
longer means to understand it from the inside, so to speak, but means, as Thomas Hobbes says, “to
know what we can do with it when we have it”. Aristotle (this is what I understand by “biomorphic
ontology”) believed that he was able to understand w h y stones fall. Modern natural science only
determines the laws which lie behind the fall of stones. At the same time, it disregards a biomorphic
understanding of the living and an anthropomorphic understanding of the human being. The latter is
left to humanistic hermeneutics, the former does not occur at all. Life is not understood as proceeding
from human experience, but as a special case of physical processes, for we can only intervene in
processes which are understood in such a way. That is why only this sort of knowledge is useful.
The transition from “understanding” to “calculatory” science can be demonstrated by an example
which has already led Leibniz to a clear insight into this relationship, namely the example of
movement. In the classical tradition, mathematics did not have the means to deal with movement as
continuum. That is why physics could not be mathematized, in contrast to optics, where movement can
be disregarded. Modern mathematized physics only became possible through differential and integral
calculus simultaneously developed by Leibniz and Newton. On this basis, movement can be reduced to
stationary states with ever smaller intervals, the sequence of which can now be calculated. Yet, the
price of computability is the disappearance of movement a s movement, i.e. as continuum. Leibniz was
clearly aware of this fact, and as a consequence, he introduced the notion of conatus, which replaces the
Aristotelian notion of dynamis and tries to understand movement from the inside, so to speak. Such an
understanding cannot do without the idea of anticipation. An object in movement at a given point in
time t1 differs from a motionless object at the same point in time because its presence at another place
at the point in time t2is already included in the definition of its actual state. This idea might seem
paradoxical. But it can be based on experience, namely the experience of our own actions. One can
only define actions in such a way that the beginning is already characterized by the intended end. Any
definition of movement a s movement therefore already includes a hidden anthropomorphism. The
latter, in turn, can only be avoided by denying any such thing as movement, and by defining movement
104 in the way, the infinitesimal calculus makes it calculable, i.e. as a succession of static states of short
intervals.
On the basis of this insight, Leibniz developed two kinds of natural sciences, which could be described
as “physics from the outside”, and “physics from the inside”, i.e. as a philosophy ofnature dealing with
reality not from the viewpoint of its objectification, but with reality in itself. This, in turn, cannot but
mean from the viewpoint of its similarity to us. Unlike modern natural sciences, this science is not
anthropocentric, but anthropomorphic.
Neither anthropocentric nor anthropomorphic are merely two kinds of knowledge, which for Plato
therefore ought to be closely connected: Pure mathematics and metaphysics. Yet, in the knowledge of
nature, mathematics has found a field of application which is not a priori deducible but rather belongs
to the greatest miracles. As opposed to that, there has been left but little scope for metaphysics. The
most important metaphysical work of the 20th century was probably written by a mathematician,
Alfred North Whitehead. It stood and still stands alone. Where, in modern scientism, is there room for
serious, responsible metaphysical speculation? Descartes clearly expressed his viewpoint on this
matter. The aim of science is application in order to increase human happiness. The fields of
application are: mechanics, medicine, and psychology. They are the fruits from the tree of science. The
trunk of the tree is physics. Its roots, however, are metaphysics. That is an interesting turn. Classical
metaphysics understood itself as the epitome of the theoretical efforts of Man. As Aristotle says,
theoria originally is something more divine than human. For the Fathers of the Church it was a foretaste of the visio beatifica. For Descartes, it is the medium of self-assurance and self-stabilization
which we need when we tackle the adventure of science. Without fundamental ontological insights, the
things we do are not grounded. But these questions are not the object of a lifelong preoccupation. One
has to settle this matter once and for all, and at best, recall the attained insight from time to time
throughout the year. As for the remaining time, one should turn to “life”, to which, for those capable of
dealing with it, science belongs. The pursuit of science, however, becomes a moral duty for Descartes.
For, we can only afford methodical doubt, if, by means of science, we try to systematically remove
doubt and promote the happiness of mankind.
3. As far as this point is concerned, however, the evolution of European science has departed from
Descartes. The ideal of Descartes was the replacement of only probable and plausible knowledge by
certainty. Science was meant to proceed from certainty to certainty, and eventually lead to a closed
deductive system. European science, in fact, has rather followed the point of view of the Empiricists. It
has done without any metaphysical foundation, it has done without the ideal of certainty, and it has
done without the idea of closure. It does not know any absolute and thus definite knowledge, but only
hypotheses which, by means of vain attempts to falsify them, become increasingly well-founded and
more and more reliable. Yet, at the same time, these hypotheses remain in constant danger of becoming
relative, or even overturned.
4. The disregard for knowledge in the sense of certainty ensues with necessity of the fact that science
becomes a collective undertaking based on the division of labour. Only concrete human beings are
capable of knowing and of being certain. Knowledge is a state of reason. Yet, reason only exists as
individual reason. Heidegger once wrote: “Science does not think”. One could also say: “Science does
not know”. For, science is an abstraction of the activity of many people. These people might reach
some major agreement. However, this agreement can still be based on erroneous assumptions. It forms
the basis of a prejudice. But it will always need an individual act in order to turn this agreement into a
truth as certainty. This, incidentally, is the basis for an ever present potential conflict within science
itself. What, from a scientific point of view is, strictly speaking, simply a hypothesis which can be
falsified, can have turned into a certainty for the individual scientist. (J.H. Newman dedicated his
“Grammar of Assent” to this transition from objective probability to subjective certainty). In such a
case, the scientist will defend this hypothesis with a bias in contradiction of Popper’s scientific ideal.
And since the works of Kuhn and Lakatos, we also know that the process of the evolution of science,
105 especially the process of the change of paradigms, does not happen in a way that would be in
accordance with Popper’s ideal, but rather in a Darwinian way. In general, hypotheses cannot be easily
refuted. They are supported and immunized by help of additional assumptions on the part of those who
adhere to them, until a new generation of scientists emerges which comes up with new ideas and for
which, in relation to its efficiency, it is no longer worth defending the old paradigm. As for paradigms,
their status differs from that of theories. They form the theoretical background frames which theories
with a demand for serious examination have to respect. Thus, today, the theory of evolution has the
status of a paradigm. As a consequence, empirical gaps, theoretical objections from the field of
biochemistry etc., do not result in a revision of the paradigm and in an attempt to develop alternatives.
The assumption, in principle, is that open questions will be answered one day within the framework of
this paradigm. The greatest strength of the paradigm lies in the fact that the raised objections are not
based on alternative theories which, in turn, could claim to possess similar explanatory power. Yet, the
history of science shows that theories which have attained the position of paradigms can, in almost all
cases, only be forced to give up by alternative theories which can claim to have similar or higher
explanatory power, but not by an “ignoramus”. The arguments against the claim of the theory of
evolution to explain the genesis of life and the emergence of consciousness do not offer any
alternatives on the same level, but just an “ignoramus”. Therefore, their prospects of succeeding are
small. Yet, as far as Freudian psychoanalysis is concerned, things are slightly different. Although it has
a perfect strategy of immunization against theoretical objections, it was nevertheless powerless against
empirical statistics on therapeutic successes. Since the latter are not more frequent than spontaneous
healings, analysis as a therapy is disqualified, regardless of the attainment of partial insights involved
in its studies.
The case of Galilee is a good illustration of what has been said. Inquisition had a better understanding
of the principle of modern science than Galilee himself when it demanded of him to call his theory a
hypothesis. Any modern astronomer would immediately agree to this. He would only claim that the
formulae obtained when assuming the orbit of Earth around the Sun, are much simpler and “more
beautiful” than in the opposite case. For the assumption of the Sun’s orbit around the Earth so many
additional assumptions are needed that they are only worthwhile when the truth of revelation is at
stake. The cardinals, in fact, thought it to be possible that the latter was not at stake. But in order to
conceive of this possibility as being real, one would also have to revise a number of previous
assumptions. This, in turn, would have only been taken into consideration by the cardinals if Galilee’s
insights had been conclusive. Thus, this resulted in a stalemate. Galilee won, because in the face of the
enormous explanatory power of his theory, interest in continuing to support the opposite theory by
means of the highly artificial epicycles, petered out. Since then, the “new science” has become the most
important means of human domination of Nature. It has made human work easier, improved health,
increased life expectancy, made life more comfortable, and increased the production of material goods
beyond measure. However, due to its non-teleological character, it is not capable of providing human
beings with an orientation with regard to their actions. With the knowledge it provides, power, not
wisdom can be attained. It is therefore only natural that besides this science which allows the
exploration and systematic ordering of facts and laws, another form of academic research established
dealing with those facts which cannot even be perceived without an understanding “from the inside”,
that is without an understanding of their meaning, namely human expressions and human actions. In
German, one speaks of “Geisteswissenschaften”, in English of “human sciences” or“humanities”. The
description of a human action from the perspective of physics would not even make it identifiable as an
action, but produce a rather funny effect, instead. In this context, Pascal spoke of the “esprit de
finesse”, in contrast to the “esprit de géométrie”. Today, we speak of “hermeneutics”, but there should
also be talk about a “hermeneutics of Nature”. The notion of “information” seems to be appropriate to
forging links between the humanities and biology. As to this, I will not go into further details. Instead, I
would like to raise the question of the moral implications of the modern concept of science.
106 First of all, one thing is clear: a non-teleological science quite fails to be what early positivism
proclaimed it to be: a guidance in life. However, today, scientists are still regularly consulted when
ethical or political questions are being dealt with in the public domain. In this regard, one should
become aware of the fact that modern natural sciences are not only hypothetical in the sense that their
answers are provisional and falsifiable, but also in the sense that they can inform us, at best, on how to
attain an intended end, and on how high the costs for it will be. We ought to be cautious when they try
to tell us what ends we should pursue and what price we should pay in order to attain them. We should
not forget the different advice scientific pedagogics has already given, only to realize later on that it
had been wrong, in fact. Herein lies a very fundamental problem which refers to the sentence of “ars
longa, vita brevis”. Science does not “know”, for it is not an individual person. It is a collective
undertaking with no limits in time. Errors are nothing negative for it. On the contrary, it can learn more
from them than from trivial truths. Its method is: trial and error. As for the finite, mortal yet real
persons who are actually affected by the consequences of these errors, things look quite different. I
remember the happy reaction of a nurse when I was once diagnosed as having psittacosis: “Our head
doctor will be surely pleased to finally get to see a real case of psittacosis!” As for me, I was less
pleased. A wrong diagnosis is not a disaster for science, but it is for the patient and the doctor. I am
thinking here of the doctor as a doctor, not as a medical researcher. For the interests of medical science
do not coincide with medical arts and treatment which is oriented towards the patient. The medical
ethos involves, of course, an awareness of this discrepancy.
It is important to become aware of the fact that science has not, and cannot have any ethos, because
science is not a person. Only the individual scientist or a concrete community of scientists consisting of
individual persons can be ethical. And this ethos of the scientist proves itself in his or her loyal services
to science as well as in the limits set to these services. These limits are not limits to the desire for
knowledge. The urge to know seems to be an elemental force which seeks to overcome the limits it
encounters. This elemental force is not to be idealized. It is, first of all, morally indifferent. The
mastery of Nature is part of the self-assertion of human beings. Christians especially know, however,
that being subjugated to original sin, the power of humanity is ambivalent. However, modern science
provides us with power. Its interconnections with technology become more and more difficult to
dissolve. The scientific perspectives of research are dictated, to a large extent, by the developments in
research. In many cases, the verification of a scientific theory consists in a great event, such as the
explosion of an atomic bomb. As stated by Carl Friedrich von Weizsäcker, the first reaction of the
German atomic researchers to the atomic bomb of Hiroshima was fascination: “So it does work, after
all!” If today there are calls for allowing the use of embryos for research purposes, it is due to the fact
that certain knowledge cannot be obtained in a different way. “Science” cannot do without such
knowledge, because it cannot do without anything at all. But the human being who is engaged in
science, can and must be able to do without.
There is knowledge, though, the attainment of which is intrinsically immoral. This does not apply to
purely theoretical scientific knowledge, though, but to practical-technical knowledge, which we call
“know-how”. The theoretical foundations of the production of means of mass extermination themselves
remain morally indifferent. But the “art” of production of these means is not an object of knowledge
which anyone would be allowed to acquire. There is one tragic exception, though: Where such
knowledge already exists, it might become necessary to acquire it, too, in order to know how to protect
oneself against the new evil.
The virtues of vita brevis in dealing with ars longa, also and above all, involve the knowledge that the
two are in a certain way incommensurable. The French president Pompidou used to say that there were
three ways to ruin oneself: gambling, women, and the advice of experts. The scientific expert is
concerned with experimental conditions. It is necessary for him to reduce the complexity of the
individual case. His information is important for the concrete decision in question, but his advice can
107 be wrong. As a scientist, this need not bother him. For it is satisfactory enough for him to be able to tell
in retrospect why the advice was wrong, and why everything differed from his prediction. Science,
which observes and orders facts, is incommensurable with the singularity of every particular event.
Up to now I have mainly dealt with the moral and cognitive limits of science. Ethics is, above all, the
teaching of the limits of our action. There are no general ethical limits of theoretical knowledge. In the
story of paradise, God does not command abstention from any particular knowledge, but from an
action. Yet, the violation of the commandment results in a particular kind of knowledge which would
not be possible without such an experience, namely the knowledge of the difference between good and
evil. Scientific knowledge in the modern sense by nature cannot, as I tried to demonstrate, be closed. It
does not have any immanent limits, there are just some dimensions closed to it, like colours are closed
to the colour-deficient, or musical qualities to the unmusical. The ethical limits laid down for science,
are, in reality, no limits of knowledge, but limits of action which indirectly de facto also set limits to
the desire for knowledge. It is the question of the limits of what we are allowed to do in order to attain
knowledge, on the one hand, and of that which we are allowed to do, in order to apply already attained
knowledge, on the other. These two limits become, incidentally, more and more fluid. At first,
technology was an application of scientific knowledge. Since then, it has become more and more
technology which decides on the further acquisition of scientific knowledge, since this knowledge can
only be acquired by means of great technical efforts. In medicine it has, incidentally, always been the
case that a hypothesis can only be verified or falsified by the application of presumed knowledge. And
here one can, at the same time, attain an exemplary insight into how such ethical limits are being laid
down. It follows from the person’s being an end in him or herself. Kant formulated the categorical
imperative in such a way that he said that one must never use a human being only as a means. The
“only” is important in this context. For, we constantly need each other, of course, as a means for the
attainment of our ends. And every experimental subject is instrumentalized, i.e. used as a means to an
end. But the decisive thing is the limit to this use. First of all, it excludes someone being used in such a
way without his consent. It largely excludes e.g. children and mentally retarded people as subjects of
experimentation, if the experiment in any way is detrimental to this person. It, of course, excludes that
someone’s life and health is sacrificed in favour of the life and health of others, as in the case of the
Nazi doctors who carried out hypothermia experiments with the prisoners in concentration camps, the
results of which were expected to be of benefit to the soldiers in the Russian winter. It also excludes
any gain in knowledge which involves the so-called “consuming” embryo research. Yet, this problem
also arises in the everyday experimental practice in the context of mass screening of drugs. There are
repeatedly cases in which already before the actual end of the mass screening the doctor arrives at the
conviction that the tested drug would in fact be highly effective for the fight against a specific illness.
The moment he arrives at this conviction, he has to stop the experiment and administer the drug to all
the patients, including the control group which, up to then, had received the placebo. Salus aegroti
suprema lex. This, in fact, refers to the concrete patient of a concrete doctor, who must not be sacrificed
to the salus of an undefined group of later patients by an anonymous medical science.
I would also like to say a few words about the so-called ethics committees which, for a few years now,
have been springing up like mushrooms. This is a sign of crisis. It shows that the professional medical
ethos, which is almost identical with the lex artis, no longer fulfils its function of guaranteeing such a
thing as ethical normality and of relieving the agent of the burden of reflection. Too many new
possibilities have opened up for the rules of thumb of this ethos to cope sufficiently. The doctors were
not prepared for a reflection based on principles, and thus left this reflection up to ethics committees.
Yet, it is illusionary to think that professional moral philosophers would guarantee good and right
decisions. On the contrary, the most radical opponents of the European ethical traditions are
professional professors of moral philosophy, for example Peter Singer. To trust in them because they
are professors of moral philosophy, would be almost like handing over decisions about justice to
108 professional advocates only because they can formulate any decision in a professional language of legal
terms and justify it with arguments in legal terms.
Today, in the face of complicated problems, the doctor needs the help of people who are trained in
moral reflection. But he must not suspend his own judgement in favour of committees, and such
committees must always remain advisory bodies and never become decision-making bodies. I would
never put my fate into the hands of a doctor who would not be willing to listen to competent advice.
The doctor has to make his decision taking account of the points of view of competent advisers. Yet, he
must only follow the advice if he himself is convinced of its correctness. Thus, I would in fact trust
even less a doctor, who would, in case of emergency, hand his own judgement over to a committee. It
is true that there are objective moral norms. But only an agent who has transformed these objective
norms into his personal conviction, is moral.
Apart from that, the scientific discourse is subject to moral norms. It has to promote the discovery of
truth. This can be disturbed by different factors. Such a factor is personal ambition which, as it is
known, has repeatedly led to the faking of the results of research. However, there are also more subtle
sources of friction. One of these factors can presumably not be eliminated at all: the researcher’s
interest in a particular result. This interest can be of an ideological nature. The most glaring example is
perhaps the biology of Lyssenko with its theory of the passing on of acquired characteristics. Behind
this was the Stalinist ideology. But there are more recent examples of political correctness, e.g. the
attempt to silence the English psychologist Eysenk who presented empirical results of the research on
the relation of race and certain cognitive capacities. Precisely because of its non-teleological character,
modern science is value-free. Its results are always open to different responses and applications. But
when we are told that the Japanese have a higher intelligence quotient on average than the Europeans,
then we have to note this, if the result was attained lege artis. Whether we come to the conclusion to
increase immigration of Japanese, or to protect ourselves from such immigration, instead, is by no
means prejudged by the mere establishment of the facts. There is often a strong bias in human sciences,
above all in historical research, the results of which are often used for the purpose of legitimatization or
discrimination. It therefore belongs to the ethos of the scientific discourse that special interests, who are
committed to a predetermined outcome, are disclosed and that, whenever possible, those representing
such interests, exclude themselves for reasons of bias. One example for this is the discussion of the socalled brain death. There is a strong and incidentally honourable bias among transplantation surgeons
in favour of the removal of living organs for transplantation. The recognition of the failure of all brain
functions as the death of a human being is in keeping with this bias. The recognition of brain death in
Germany would have never been achieved without the great influence of the transplantation surgeons.
There are too many phenomena that speak against this. Anaesthetists and nurses often try in vain to
convince themselves of the death of a patient who breathes, stretches his arm, sweats and releases
hormones when one cuts into his skin and who is therefore anaesthetized before the organ resection. To
certify the death was always a matter for the relatives who s a w that the dying had ended and that the
dying was dead. A doctor had to be consulted in order to confirm this prima facie judgement, or to
confirm that the patient was still alive. Now, when the burden of proof is reversed and a human being,
whom all the people standing around see is living, is declared dead in the name of science, then the
interests of Transplantation Medicine, which in themselves are legitimate, lie behind this. This,
however, is not right. It makes the establishment of the truth more difficult. The research of the
American neurologist Shewmon and other scholars have shown that the brain is no more than the heart
the organ which alone is responsible for the integration of a living organ. When a young boy whose
cerebral functions have entirely failed, continues to live for years and who during this time is going
through his adolescence, then it is inconsistent with reason that this boy is designated as dead. The
same holds for the woman in the Erlangen university hospital who, according to the Harvard criterion,
was dead but still gave birth to a child months later. Certainly, these people would have long before
died if one had not kept them artificially alive. And I will not discuss the question at this point whether
109 it would not have been better to let them die peacefully. However, since one did not let them die, they
were in fact not dead but alive. Pope Pius XII explicitly declared that a “human life continues for as
long as its vital functions – distinguished from the simple life of organs – manifest themselves
spontaneously or even with the help of artificial processes.”
It would be contrary to all experience of life to claim that the definition of death would purely by
chance coincide with the new possibilities of organ transplantation. Transplantation surgeons who like
to work with a good conscience, should therefore refuse to play a part in the forming of judgements on
the question of brain death. Precisely because their interest objectively coincides in such an immediate
way with the interest of charity – can there be a nobler thing than an organ donor saving someone
else’s life? –, it can weaken all counter-arguments right from the start.
Yet, there is still another conflicting interest which taints the discovery of truth in the research process
and which can hardly be eliminated, but at least neutralized: the researcher’s interest in the
corroboration of his theory. Popper insisted that science had to defend, above all, improbable theories,
for it could learn more from their falsifications than from their corroboration which would always be
but provisional. In fact, there is the conflicting interest of the researcher in finding his theory
corroborated. This, however, is harmless insofar as there are, in general, enough other researchers who
are ready to undertake the respective attempts of falsification. Only where the scientific community as
a whole agrees to a particular theory, does it become difficult and often impossible for the individual
outsider to gain a hearing and to find a publication outlet at all for his counter-arguments. It is in the
ethos of research to counteract this mechanism.
Eventually, I will mention the problem of relevance in this context. Ars longa vita brevis. Yet, without
the vita brevis, the ars longa is just something virtual. It has its reality only as an activity of finite
human beings. Not only are the lifetimes of human beings finite, but also their material resources
limited. In the field of medicine, the consequences of these limited resources are that, despite the
incommensurability of each person, society has to refuse some persons a therapy which it gives to
others, and this on the basis of criteria which do render the incomparable comparable, after all. It is not
for me to talk about this problem here, I only wish to mention it. For research, there is a similar
problem. We cannot look into everything, firstly because life is short and secondly, because our means
are limited and research is becoming increasingly expensive. The money which is made available for
scientific research, therefore is not available elsewhere. And the money which is made available for
research in one discipline, hence is not available in another. The problem of establishing priorities is a
political and therefore always a moral problem as well, although ethics leaves a lot of scope for
argument here. In the late sixties the problem of the relevance of research was intensely discussed. All
research was expected to prove its social usefulness, while the criteria for what is beneficial were
strongly ideologized. Fortunately we have moved on from this. However, the problem, of course, still
remains. It is, as far as the scientific research is concerned, largely a part of the more extensive problem
of the relationship of short-term and long-term interests. So-called pure research often produces but
long-term gain, and this gain is not even guaranteed. However, all advances in technology and
medicine of the last centuries are due to research which, when it was undertaken, could not promise
this gain with any degree of certainty, and which did not even have its eye on such gain. Wise politics
differs from populist politics on the one hand, and Stalinist politics on the other, in always seeking to
keep a balance between the interests of those living today and the interests of future generations. Our
first obligation to them is not to live at their expense, not to exhaust their resources and not to run up
debts to their detriment. However, there is no similarly strong obligation to make huge investments for
them.
Yet, especially with regard to medicine, there is still another and more unambiguous side to the
problem of the relevance of research. There are questions in medicine the answering of which is of
highest therapeutic interest, and which can also be solved with a relatively low financial expenditure.
110 Yet, precisely because of the simplicity of the matter, no good scientific reputation can be made
through these kinds of research; One cannot make a name for oneself with them. And research
institutions are often not willing to give money to them, although many patients could be helped by
them. It is symbolic that the first in vitro fertilization was carried out in Calcutta, in a city thus, in
which abandoned babies are dying in the streets. Whoever helped one of these children to get foster
parents, would remain unknown. The doctor who carried out this spectacular operation in a
neighbouring, highly affluent part of the city, has gone for ever down in the annals of history.
It seems to me that Thomas Aquinas addresses the heart of the matter when he names superbia, thus
craving for admiration and vanity, as the motive which corrupts the desire for knowledge. Once more it
becomes clear that the moral and the immoral first and foremost consist in the vices and virtues of
individual persons. These vices and virtues have far-reaching consequences for other human beings,
and for the world. But it is important to remember: the supreme interest of the Church lies not in the
earthly consequences but in the souls of those who act and those who suffer. What happens is only
marginally within our own hands. However, we can avoid doing wrong.
111 WILLIAM MAY
HUMAN DIGNITY AND BIOMEDICAL RESEARCH:
THE RESPECTIVE POSITIONS OF THE SUBJECT OF RESEARCH
AND THE RESEARCHER
INTRODUCTION
After initial reflections on the meaning of human dignity, I will consider the meaning of biomedical
research on human subjects, its necessity, nature, and kinds. Next I will examine relevant scientific
criteria for such research and then take up in more detail basic ethical or moral principles and norms
governing research of this kind, seeking to relate these principles and norms to the respective positions
of the subject of research and the researcher. In concluding, I will focus attention on the legitimacy of
“proxy consent” in the non-therapeutic situation, a subject of serious debate.
HUMAN DIGNITY
The Catholic tradition[1] recognizes a threefold dignity predicable of human persons: (1) the first is
intrinsic, natural, inalienable, and an endowment or gift; (2) the second is also intrinsic, but it is an
achievement, not an endowment, an achievement made possible, given the reality of original sin and its
effects, only by God’s unfailing grace; (3) the third, again an intrinsic dignity, is also a gift, not an
achievement, but it is a gift far surpassing man’s nature and literally divinizing him; it is, moreover,
given to him as a treasure he must guard and nurture and which he can lose by freely choosing to sin
gravely.
The first dignity proper to human beings is the dignity that is theirs simply as living members of the
human species, which God called into being when, in the beginning, he “created man in his own image
and likeness…male and female he created them” (Gn 1:27). Every human being is a living image of the
all-holy God and can therefore be rightly called a “created word” of God, the “created word” that his
Uncreated Word became and is precisely to show us how much God loves us.
This first, inalienable, dignity of human persons is relevant for both the subject of research and the
researcher, but it is of paramount significance for the subject of research. It is, as will be seen, the
ultimate foundation underlying basic moral principles of biomedical research on human persons.
Henceforth I will call this our dignity precisely as persons.
When we come into existence we are, by reason of this intrinsic dignity, persons who surpass in dignity
and value the entire created universe. The human person is in truth the “only creature whom God has
willed for its own sake” (Gaudium et spes, 24). As persons, we are endowed with the capacity to know
the truth and to determine our lives by freely choosing to conform our lives and actions to the truth. Yet
when we come into existence we are not yet fully the beings God wants us to be. And this leads to a
consideration of the second sort of dignity proper to human persons, a dignity that is intrinsic but is an
achievement (made possible only by God’s never-failing grace), not an endowment.
This second kind of dignity is the dignity to which we are called as intelligent and free persons capable
of determining our own lives by our own free choices. This is the dignity we are called upon to give to
ourselves by freely choosing to shape our choices and actions in accord with the truth, i.e., in accord
with God’s eternal law in which we participate through the natural law. As Vatican Council II affirmed,
“man finds in his heart a law written by God [the natural law]; his dignity is to obey this law, and by it
he will be judged” (Gaudium et spes, 16). This dignity, as will be seen, is of great relevance both for
the subject of research and for the researcher, but is, I believe, of more paramount significance for the
researcher. Henceforth I will refer to this kind of dignity as our dignity precisely as moral agents.
112 The third kind of dignity is ours as “children of God,” brothers and sisters of Jesus, members of the
divine family. This kind of dignity is a purely gratuitous gift from God himself, who gives this to us
when, through baptism, we are “re-generated” as God’s very own children and given the vocation to
become holy, even as the heavenly Father is holy, and to be co-workers with Christ, his collaborators in
redeeming the world. This dignity, which we can call our dignity precisely as God’s children, is a
treasure entrusted to us, and we can lose it by freely choosing to do what is gravely evil. There is a
close bond between this kind of dignity and our dignity precisely as moral agents. In what follows,
however, I will focus on the first two kinds of dignity, namely, our dignity precisely as persons and our
dignity precisely as moral agents.
BIOMEDICAL RESEARCH ON HUMAN SUBJECTS: ITS NECESSITY, NATURE AND
KINDS
The need for biomedical research on human subjects is widely recognized by the medical
community[2] and by the magisterium.[3] Such research is necessary if medical science is to acquire
and expand the knowledge and techniques needed and/or helpful in diagnosing, preventing, and
treating human persons in need of health care and in ameliorating their suffering. Human
experimentation in the practice of medicine is as old as the practice of medicine itself, although it has
only been during the last century or so, since the time of Louis Pasteur and Claude Bernard, that those
practicing medicine have become acutely aware of the need for deliberate and scientifically sound and
planned experimentation and research.[4] The World Medical Association succinctly identifies the
purpose of such research: it “must be to improve diagnostic, therapeutic, or prophylactic procedures
and the understanding of the aetiology and pathogenesis of disease.”[5]
Research may be defined as “any systematic activity undertaken for the purpose of gaining new
knowledge, understanding, or confirming current knowledge.”[6] Although some authors sharply
distinguish experimental research on human subjects from therapy insofar as the primary purpose of
research is not to heal but to learn,[7] it has become customary to classify research either as therapeutic
or non-therapeutic. The former studies the effects of using diagnostic, prophylactic, or therapeutic
methods that depart from standard medical practice but have reasonable expectation of success,
whereas the latter is not carried out for the benefit of the research subject but in order to gain
knowledge or develop techniques that may be of benefit to other persons.[8]
SCIENTIFIC CRITERIA FOR BIOMEDICAL RESEARCH ON HUMAN SUBJECTS
The questions biomedical research on human subjects seeks to answer must be addressed in such a way
that the answers can be accepted as sufficiently grounded scientifically. This is basically an issue of
good science but it is also an ethical or moral issue.[9]
Several provisions of the Nuremberg Code give directives regarding scientific criteria for research on
human subjects. The following principles set forth in the Code are of this nature:
2. The experiment should be such as to yield fruitful results for the good of society unprocurable by
other methods of study, and not random and unnecessary in nature.
3. The results should be so designed and based on the results of animal experimentation and a
knowledge of natural history of the disease or other problem under study that the anticipated results
will justify the performance of the experiment.
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of
skill and care should be required through all stages of the experiment of all those who conduct or
engage in the experiment.[10]
113 The World Medical Association articulated many similar criteria in the Declaration of Helsinki. Among
the “Basic Principles” governing research on human subjects set forth in the 1975 revised edition of the
Declaration are the following:
1. Biomedical research involving human subjects must conform to generally accepted scientific
principles and should be based on adequately performed laboratory and animal experimentation and on
a thorough knowledge of the scientific literature.
2. The design and performance of each experimental procedure involving human subjects should be
clearly formulated in an experimental protocol which should be transmitted to a specially appointed
independent committee for consideration, comment and guidance.[11]
3. Biomedical research involving human subjects should be conducted only by scientifically qualified
persons and under the supervision of a clinically competent medical person. The responsibility for the
human subject must always rest with a medically qualified person and never rest on the subject of
research….
4. Biomedical research involving human subjects cannot legitimately be carried out unless the
importance of the objective is in proportion to the inherent risk to the subject.
5. Every biomedical research project involving human subjects should be preceded by careful
assessment of predictable risks in comparison with foreseeable benefits to the subject or to others.
Concern for the interests of the subject must always prevail over the interests of science and
society.[12]
I italicized one passage in the fifth criterion of Helsinki that is primarily ethical or moral in character
and not scientific. But even the “scientific” criteria of this document and of the Nuremberg Code have
moral implications insofar as the medical doctors and scientists involved in the research are morally
obligated to observe these scientific requirements. Here we are viewing research on human subjects
primarily from the position of the researcher. It is, moreover, evident that the kind of human dignity
primarily at stake here is researcher’s dignity precisely as a moral agent.
ETHICAL PRINCIPLES AND NORMS FOR BIOMEDICAL RESEARCH ON HUMAN
SUBJECTS
The dignity of human beings precisely as persons is the cardinal principle governing biomedical
research on human subjects. As Pope John Paul has said, “the ethical norm, founded on respect for the
dignity of the human person, should illuminate and discipline both the research stage and the
application of the results obtained from it.”[13] Prior to his election as pope Karol Wojtyla had, in his
book Love and Responsibility, formulated what he termed the “personalistic principle” or “norm,”
which, “in its negative aspect, states that the person is the kind of good which does not admit of use and
cannot be treated as an object of use and as such the means to an end,” and “in its positive
form…confirms this: the person is a good toward which the only proper and adequate attitude is
love.”[14]
The Principle of Free and Informed Consent
The fundamental principle governing biomedical experimentation on human persons is the “principle
of free and informed consent.”As Gonzalo Herranz has emphasized, this principle was clearly
recognized and affirmed by Catholic authors in the 19th century long before it was articulated in the
very first article of the Nuremberg Code in 1949. Herranz calls attention to the work of the French
Catholic medical doctor George Surbled, who clearly expressed this principle in the first edition (1891)
of his La morale dans ses rapports avec la médicine et l’hygiene, and to the vigorous affirmation by his
114 predecessor Max Simon of the principle of the supremacy of the human person over scientific research
in his 1845 volume, Déontologie Médicale ou des Devoirs des Médicins dans l’Etat Actuel de la
Civilisation.[15] This principle, as noted, was clearly affirmed in the first article of the Nuremberg
Code, and it is important to recall that this code was formulated when the memory of the atrocities
carried out by the Third Reich in the name of scientific research was fresh in the minds of men. The
magisterium of the Church is very clear on the need for free and informed consent if biomedical
research is to be justified. Pope Pius XII issued numerous statement on the requirement of free and
informed consent.[16] As Pope John Paul II has said, “the doctor has only that power and those rights
which the patient himself gives him.”[17]
The Nuremberg Code spells out the requirements of this principle by declaring:
This means that the person involved should have legal capacity to give consent; should be so situated
as to be able to exercise free power of choice, without the intervention of any element of force, fraud,
deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient
knowledge and comprehension of the elements of the subject matter involved as to enable him to make
an understanding and enlightened decision. This latter element requires that before the acceptance of an
affirmative decision by the experimental subject there should be made known to him the nature,
duration, and purpose of the experiment; the method and means by which it is to be conducted; all the
inconveniences and hazards reasonably to be expected; and the effects upon his health or person which
may possibly come from his participation in the experiment. The duty and responsibility for
ascertaining the quality of the consent rests upon each individual who initiates, directs, or engages in
the experiment. It is a personal duty and responsibility which may not be delegated to another with
impunity.[18]
I italicized the final two sentences of this article of the Nuremberg Code because they show that the
primary responsibility for a free and informed consent rests with the researcher and directly bears upon
his dignity precisely as a moral agent and his obligation to respect the subject’s dignity precisely as a
person.
The subject of the experiment also has the responsibility, rooted in his dignity precisely as a moral
agent, to form his own conscience properly and to refuse to participate in any experiment of an
immoral nature or designed to further immoral ends. The subject’s dignity as a moral agent requires
this of him. As a moral agent the subject must refuse experimentation if, as the Catechism of the
Catholic Church puts it, “it exposes the subject’s life or physical and psychological integrity to
disproportionate or avoidable risks” (no. 2295).
Many authorities, among them Henry K. Beecher,[19] recognized for his studies on medical research,
have noted that it is very difficult, at times almost impossible, to secure fully free and informed
consent. What the principle requires is a “reasonably” free and “adequately” informed consent.
Ultimately, what is at stake here is trust between researcher and subject, trust that the researcher will
not propose any experiment without communicating to the subject sufficient information to enable him
to make an informed and intelligent decision.[20]This requirement is absolutely basic, for it is rooted in
the subject’s dignity precisely as a person, and it bears directly on the researcher’s dignity precisely as
a moral agent.
The principle of free and informed consent is necessary in every kind of biomedical research,
therapeutic and non-therapeutic, whether carried out on competent subject (able to give free and
informed consent for themselves) or on non-competent subjects such as children, born or unborn, on
“voiceless” patients. I will consider of “proxy” consent in depth later on. Before doing so, however, it
is important first to note an “exception” to the requirement of free and informed consent and then some
other basic norms governing biomedical research on human subjects.
An “Exception” to the Principle of Free and Informed Consent
115 If we are considering medical treatments there is one clear exception to the requirement of expressed
consent, an exception, however, which in no way weakens the normative demand requiring the
patient’s own personal consent to medical treatment. This is the kind of case in which consent is
reasonably presumed or implied when a person is in extreme danger and cannot give consent either
explicitly or implicitly nor when there is opportunity for “proxy” consent. As the Charter for Health
Care Workers says, in extreme cases of this kind, “if there is a temporary loss of knowing and willing,
the health care worker can act in virtue of the principle of therapeutic trust…. Should there be a
permanent loss of knowing and willing, the health care worker can act in virtue of the principle of
responsibility for health care, which obliges the health care worker to assume responsibility for the
patient’s sake.”[21] I will return to what the Charter calls the “principle of responsibility for health
care” below, in considering problems of “proxy consent.” The dignity primarily at stake here is the
researcher’s dignity precisely as a moral agent, who has the duty to care for the life and health of the
subject, whose dignity precisely as a person gives him the right to receive the care needed to protect his
life and health when these are endangered.
Other Ethical Principles/Norms Governing Biomedical Research on Human Subjects
Free and informed consent is not the only relevant moral principle to justify biomedical research on
human subjects. Another key principle/norm is known as the “principle of descending order.” The
philosopher Hans Jonas suggested this principle in selecting subjects of research. It requires researchers
to select the least vulnerable people as subjects.[22] The primary obligation is to protect vulnerable
persons and to prevent taking advantage of them in “selecting” subjects of experimentation. Such
subjects, of course, must give free and informed consent to the research project for which they are
“selected” and for which they then volunteer. There are two major categories of “vulnerable persons.”
The first includes persons unable to give consent to experimentation: babies, born or unborn, and older
persons who are mentally incompetent; the second group includes people vulnerable to manipulation or
coercion (perhaps of a very subtle type) by others, for example, prisoners, residents of institutions, the
poor, students attending institutes conducting research, etc. The criterion of descending order does not
mean that vulnerable persons can never be rightly chosen or volunteer as subjects of biomedical
research; it simply requires that research subjects be selected on the basis of justice. Benedict Ashley,
O.P., and Kevin O’Rourke, O.P. offer the following general criterion relevant to this principle:
“subjects should be selected so that risks and benefits will not fall unequally on one group in
society.”[23] This requirement falls on the researcher and is as such directly related to his dignity
precisely as a moral agent.
Two other good sound subsidiary principles are formulated in Articles 9 and 10 of the Nuremberg
Code. Article 9 states that “during the course of the experiment the human subject should be at liberty
to bring the experiment to an end if he has reached the physical or mental state where continuation of
the experiment seems to him to be impossible.” Article 10 declares: “During the course of the
experiment the scientist in charge must be prepared to terminate the experiment at any stage if he has
probable cause to believe, in the exercise of good faith, superior skill and careful judgment required of
him that a continuation of the experiment is likely to result in injury, disability or death to the
experimental subject.”[24] Relevant here are both the dignity of the subject precisely as person and the
dignity of the researcher precisely as a moral agent.
Voluntary Consent in the Non-Therapeutic Situation: Can This Ever Be Morally Required?
Before considering “proxy” consent to both therapeutic and non-therapeutic experimentation, it is
necessary to consider the question whether there can be an obligation or moral responsibility for
competent persons to volunteer as subjects in such experiments. For years I thought that there could be
no such moral obligation and that volunteering to participate in such experimentation was an act of
mercy, in the nature of a gift.But in preparing this paper and after discussing the matter with others, in
116 particular Germain Grisez, I now believe that the principle of fairness can at times require a competent
adult to choose freely to participate in biomedical non-therapeutic experiments under certain
conditions. For instance, if one’s personal physician asked one in the course of a routine medical
examination to give a urine sample in a program designed to compare the urine of healthy adults with
those suffering from a particular disease in order to test some hypothesis regarding treatment of the
disease or of its symptoms, it seems that in fairness one could have a moral obligation to help out. In an
instance of this kind one can easily do something of benefit to fellow human persons with no cost or
minimal cost to oneself. The situation is analogous, it seems, to that of a vigorous adult who sees a frail
elderly person struggling to carry a suitcase across the street; fairness, rooted in the Golden Rule as
understood in the Christian tradition, would normally require the vigorous adult to come to the frail and
older person’s aid. Although such a responsibility could not be legally mandated, it is reasonable to
think that a moral obligation can exist for a competent adult to participate in non-therapeutic
biomedical experimentation in situations of this kind. If, however, the non-therapeutic experiment
imposes more than significant burdens or inconveniences, then fairness would not require one to
volunteer as a research subject; one’sfree and informed choice to be a participant would indeed be an
act of mercy, a “gift” of oneself.
The Issue of “Proxy” or “Surrogate” Consent in the Therapeutic Situation
There is no serious debate among authorities—ecclesiastical, moral, medical, and legal—that proxy or
surrogate consent can be justified when the experiment/research/treatment in question is therapeutic,
i.e., intended for the benefit of an incompetent or “voiceless”[25] subject’s life and health. Frequently,
the responsibilities of those who give proxy consent for therapeutic procedures are described as making
choices in accord with the incompetent person’s own preferences, if these are known and are morally
upright, or else of making these choices in accord with the “best interests” of the individual if he or she
had never expressed his preferences, for instance, if one is acting as a proxy for a baby (born or
unborn), a child, or an adult who has never been able to exercise moral responsibility because of some
anomaly. Thus the bishops of the United States declare that decisions made on behalf of a person by a
designated surrogate or responsible family member should “be faithful to Catholic moral principles and
to the person’s intentions and values [so long as these are compatible with Catholic moral principles],
or, if the person’s intentions are unknown, to the person’s best interests.”[26]
What, however, is the ultimate justification for giving “proxy consent” on behalf of individuals whose
“intentions” are unknown? I think that “proxy consent,” when made on behalf of those who have never
been able to articulate their own preferences with respect to the kind of therapeutic procedures they are
willing to accept, is not so much “proxy” consent, i.e., consent made in the name of another person (as
godparents give “proxy consent” for infants in baptism) as it is the personal consent required of the
person(s) morally responsible for the care of “voiceless” human beings. If the health or life of a fellow
human person—in particular, one for whom we have special responsibilities (as parents do for their
children)--is in danger or is suffering from some malady and there are means that can be taken to
protect and/or enhance that person’s life and health and/or ameliorate his condition without imposing
grave burdens upon that person, then we are morally obligated, by reason of our dignity precisely as
moral agents to authorize research/experiment/treatment in the therapeutic situation. It seems to me that
the Charter for Health Care Workers correctly identified the moral ground for so-called “proxy”
consent in this situation when it spoke of the “principle of responsibility for health care.”[27]
Proxy Consent in the Non-therapeutic Situation: Is This Ever Justifiable?
Can “proxy” consent be justified in the non-therapeutic situation, i.e., when the proposed
research/experiment/treatment is not intended to benefit the human subject of such procedures but
rather to gain knowledge that may in the future be of great benefit to others? Here I will first review
117 arguments advanced to justify and to oppose proxy consent in the non-therapeutic situation. I will then
examine relevant magisterial teaching.
Arguments for and against
A major argument advanced to justify proxy consent in the non-therapeutic situation was proposed in
the 1970s by the late Richard McCormick, S.J. His basic argument was that proxy consent in the
therapeutic situation is justified precisely because parents and other surrogates can presume that the
subjects themselves would, if they could, consent because they ought to consent by virtue of their
moral obligation to protect their own life and health. Similarly, he argued, in non-therapeutic situations
posing no significant risk or minimal risk and in which great good is promised, proxy consent for
children and other non-competents is justified inasmuch as one can reasonably assume that the noncompetent themselves would consent if they could because they would realize that they ought to
consent to such experiments because of their social nature and obligation to promote the common good
of society when they can do so with little effort and no danger or minimal risk to themselves.[28] Paul
Ramsey and I rejected McCormick’s argument justifying proxy consent in both the therapeutic and the
non-therapeutic situations precisely because there are no grounds for presuming that children and other
non-competents would, if they could, consent in both situations because they would realize that they
ought to do so. There is no need to infer, as did McCormick, that children and other non-competents
have any moral obligations.[29] Precisely because they are non-competent, they are notmoral agents,
but they are persons who ought never to be used as mere means to ends extrinsic to themselves.[30] To
treat them as if they were moral agents who had moral obligations to carry out, among them, to
participate in non-therapeutic experiments promising great good at minimal or no significant risk, is to
fail to recognize them for what, in truth, they are, namely, vulnerable, helpless human persons totally
dependent on others. I think that these considerations clearly show that McCormick’s argument for
justifying proxy consent to non-therapeutic experimentation is not at all valid. Although, as I noted
earlier, competent adults could, under certain conditions, have a moral obligation to participate in
certain kinds of non –therapeutic investigation, noncompetent, “voiceless” persons can have no such
obligation precisely because they have no moral obligations by reason of their condition.
With Ramsey I found McCormick’s apologia for proxy consent in the non-therapeutic situation
repugnant. In fact, from the 1970s until September 2002, when I presented an early draft of this paper
at a meeting sponsored by the Pontifical Academy for Life in preparation for the plenary session of
February 2003 and found my position sharply challenged, I firmly held the view that it is never morally
right for others to give so-called “proxy” consent for non-competent, voiceless human persons to nontherapeutic research/experimentation. Basically, the argument supporting this conclusion—advanced in
the 1970s and subsequently by Ramsey and me--holds that incompetent or “voiceless” human persons,
by reason of their dignity as precisely as persons, ought never be used as subjects in procedures that are
non-therapeutic and are undertaken not for their benefit but for the benefit of others. According to this
argument, even if the procedures may not “harm” them and may pose no significant risk, they are
immoral because they violate their dignity as persons. Ramsey well expressed this position when he
said:
To experiment on children [or other noncompetent subjects] in ways that are not related to them as
patients is already a sanitized form of barbarism; it already removes them from view and pays no
attention to the faithfulness-claims which, as a child, simply by being a normal or sick or dying child,
places upon us and upon medical care…. To attempt to consent for a child to be made an experimental
subject is to treat the child as not a child…. Nontherapeutic, nondiagnostic, experimentation involving
human subjects must be based on true consent if it is to proceed as a human enterprise. No child or
incompetent adult can choose to become a participating member of medical undertakings, and no one
else on earth should decide to subject those people to investigations having no relation to their own
118 treatment. That is a canon of loyalty to them. This they claim simply by being a human child or
incompetent.[31]
As I have indicated already, I was led to change my position unalterably opposing all proxy consent to
non-therapeutic procedures because of the objections raised against it at the September 27-28 2002
meeting and also as a result of discussions I subsequently carried out with Germain Grisez. I came to
realize that although McCormick’s argument to justify proxy consent on behalf of “voiceless” subjects
in the non-therapeutic situation may be severely criticized for the reasons given, the position he took
can be defended on other grounds. Some participants in the September 2002 meeting referred to
previously suggested one line of reasoning used to justify such “proxy” consent. The basic claim is that
it would not be unreasonable—and therefore not contrary to objective moral standards—if parents, for
instance, were to allow experimentation involving their children for the benefit of others if the
experiment involves no significant risk. After all, parents frequently take their children, including
babies, on automobile trips not undertaken for their benefit (e.g., to purchase some clothes for the
mother), and such journeys surely involve some risks, but, after all, risks of this kind are acceptable
both for oneself and for those for whom one cares. And other examples could be given. Hence, if it is
not wrong for parents to act in this way in exercising responsible stewardship of their children, why
would it be always immoral for them to consent to have their children participate in non-therapeutic
research/experimentation? I believe that Germain Grisez has clearly formulated this line of reasoning:
People making decisions for someone who is not competent—for instance, parents for a child—may
not accept any significant risk (that is, any risk beyond the level of life’s common risks) to a
dependent’s health for the sake of an experiment’s possible benefit to others. For parents and others in
charge of the noncompetent have a special responsibility to act in their personal interests, not to
subordinate them to others. Nor can such subordination of a dependent’s interests be an act of mercy,
since mercy is self-sacrifice, not imposing sacrifice on someone for whom one is responsible.[32]
I wish to note some important features of Grisez’s presentation. First of all, he offers a clear
definition/description of “significant” risk. He identifies as “significant” a risk that is “beyond the level
of life’s common risks”—e.g., such risks as riding in an automobile, crossing a street, etc.—“risks”
which parents commonly take for their children when they have their children accompany them in a
host of activities that are not intended to be of any direct benefit to the children themselves. Grisez thus
provides us with a clearly defined criterion to help us determine whether a risk is “significant.”
Obviously, however, application of this criterion would vary depending on social/cultural conditions.
Thus what constitutes “significant” risk in Manhattan, N.Y. would seem to be different from what
constitutes “significant” risk in, say, Wagga Wagga Australia.
Second, Grisez clearly believes that such parental consent in no way “subordinates” their children to
the interests of others since he rejects such subordination. When conditions warrant parental consent
(or consent by other guardians) to participation by those entrusted to their care in non-therapeutic
experimentation, in other words, such consent is given in fidelity to the trust given them to protect the
inviolable dignity precisely as persons of the non-competent persons for whose well-being they are
responsible. Moreover, he explicitly rejects the claim that such subordination can be “an act of mercy,
since mercy is self-sacrifice, not imposing sacrifice on someone for whom one is responsible.” After
reflecting on the reasons advanced by those who considered my view too restrictive and not necessary
to protect the inviolable dignity of “voiceless” persons, I have concluded that it would not be
unreasonable for parents to allow their children to be subjects of non-therapeutic studies posing no
“significant” risk (as defined above) and causing no significant inconvenience or burden to their
children. They would not be treating them as mere objects of use or failing in their serious
responsibility to protect their lives and health by all reasonable means.
I now believe that the view I defended for many years was in fact an over-reaction to unethical
experiments on non-competent persons and a fear, reasonable in itself, that the intrinsic dignity of such
vulnerable persons was endangered by a desire to subordinate them to the interests of others.“Proxy”
119 consent in such situations is, of course, not true “proxy” consent, i.e., consent given in the name of the
non-competent persons themselves. It is the personal consent of the parents or guardians of voiceless
persons to permit those for whom they have a grave responsibility to participate in non-therapeutic
experimentations if, and only if, such experimentations pose no “significant” risk, promise great
benefit, and cannot be carried out on other subjects.As noted previously (see note 29 above), I believe
that children who have reached the “use of reason” can make free and informed decisions, and that if so
parents ought to give their children sufficient information for them to make a free and informed choice
in the matter and to answer any of their concerns and to retain veto power over their children’s choices
in this matter when they judge this necessary.
Relevant magisterial teaching
With respect to magisterial teaching relevant to this matter it is very important to consider (a) proxy
consent to non-therapeutic experimentation on unborn human persons and (b) such experimentation on
human persons already born.
The universal magisterium of the Church rejects as absolutely immoral proxy consent to nontherapeutic experiments on unborn human persons. A key passage in Donum vitae of central
importance regarding this matter is the following:As regards experimentation, and presupposing the
general distinction between experimentation for purposes which are not directly therapeutic and
experimentation which is clearly therapeutic for the subject himself, in the case in point
[experimentation on human embryos and fetuses] one must also distinguish between experimentation
carried out on embryos which are still alive and experimentation carried out on embryos which are
dead. If the embryos are living, whether viable or not, they must be respected just like any other human
person; experimentation on embryos which is not directly therapeutic is illicit.[33] No objective, even
though noble in itself, such as a foreseeable advantage to science, to other human beings, or to society,
can in any way justify experimentation on living human embryos or fetuses, whether viable or not,
either inside or outside the mother’s womb. The informed consent ordinarily required for clinical
experimentation on adults, cannot be granted by the parents, who may not freely dispose of the physical
integrity or life of the unborn child. Moreover, experimentation on embryos and fetuses always
involves risk, and indeed in most cases it involves the certain expectation of harm to their physical
integrity or even their death. To use human embryos or fetuses as the object or instrument of
experimentation constitutes a crime against their dignity as human beings having a right to the same
respect that is due to the child already born and to every human person.[34]
When I first read this passage in 1987 and in the years to follow, I read it in the perspective ofmy
position which regarded as immoral all proxy consent on behalf of “voiceless” persons to nontherapeutic experimentation precisely because it violated their dignity as persons. I thus assumed that
the fundamental reason why Donum vitae absolutely repudiated proxy consent to non-therapeutic
experimentation on the unborn was the same as my reason for repudiating it. Moreover, the text in
question seemed capable of being interpreted in this way insofar as it prefaced its rejection of such
consent by emphasizing the respect due to human embryos as persons equal in dignity to all other
human persons. Moreover, I assumed that both Donum vitae and Pope John Paul II in the passage cited
by Donum vitae in footnote 29 considered non-therapeutic experimentation on human embryos—and
indeed all human persons incapable of giving personal informed consent—to be immoral because such
experimentation treated human embryos and other non-competent human persons as mere “objects” of
“instruments” of use. Thus, when I subsequently discovered that the U.S. Bishops, who, with Donum
vitae and Pope John Paul II, absolutely excluded as illicit proxy consent to non-therapeutic experiments
on unborn human persons,[35] nonetheless authorized parents to give such consent to non-therapeutic
experiments on children already born if the experiments poses no “significant risk to the person’s well
being,”[36] I accused them of unreasonably holding a “double standard,” one for unborn children and
another for children already born.[37] A position similar to that of the U.S. bishops was taken by the
120 Australian hierarchy.[38] However, now, after changing my position regarding proxy consent to nontherapeutic experiments posing no “significant” risks to non-competent or “voiceless” persons, I realize
that I was reading my views intoDonum vitae and the passage from Pope John Paul II cited therein. I
was guilty of eisegesis and failed to consider the possibility of interpreting the relevant texts
differently. I now think that the fundamental reason why Donum vitae repudiates proxy consent to nontherapeutic experiments on unborn human persons is that “experimentation on embryos and fetuses
always involves risk, and indeed in most cases it involves the certain expectation of harm to their
physical integrity or even their death” (Donum vitae, 1.4, emphasis added). It is for this reason that
Donum vitae also judges that such experimentation treats a living human embryo as a mere “object” or
“instrument.” One might reasonably question why all non-therapeutic experiments on the unborn are
illicit because of the serious risks they pose and why such experiments are justifiable on human persons
already born? An unborn child cannot be a legitimate subject of a non-therapeutic experiment, but
apparently the same child, minutes after birth, can be. This seems unreasonable. In answer to this
reasonable question, I think it important to emphasize that parents and others who have responsibility
to care for voiceless or non-competent persons can not licitly consent to their being subjects of nontherapeutic procedures if these procedures pose “significant” risks. I further maintain that newborn
babies are very vulnerable subjects and that one can reasonably hold that non-therapeutic experiments
performed on them would pose more than significant risks in comparison to any benefits to be
expected.
Conclusion to “Proxy” Consent for Non-Competent or “Voiceless” Subjects to Participate in NonTherapeutic Experimentations
I maintain, as noted earlier in this paper, that “proxy” consent here is a misnomer, since the potential
subjects are, precisely because they are non-competent or voiceless, incapable of giving consent, and
no one should presume to give consent for them. The consent in question is the personal consent of
parents and other guardians. The dignity proper to human beings precisely as persons and the dignity
proper to them precisely as moral agents are both at stake. For parents and other guardians who might
give consent for those under their care to participate in non-therapeutic experiments the dignity
primarily at stake is their dignity precisely as moral agents, who must respect fully the dignity precisely
as persons of the voiceless, non-competent persons committed to their trust. If in their judgment, the
proposed experimentation would not violate their charges’ dignity precisely as persons, it would then
not be unreasonable or a violation of the trust committed to them to give the necessary consent. A
condition sine qua non if such consent is to be morally licit is precisely the requirement that the
proposed experiment pose no “significant risk” (as this has been defined) to the persons committed to
their care.
[1] SEIFERT, JOSEF, distinguished a “fourfold” root of human dignity (or four kinds of human
dignity) in an excellent and helpful essay, “The Right to Life and the Fourfold Root of Human
Dignity,” in The Nature and Dignity of the Human Person as the Foundation of the Right to Life: The
Challenges of the Contemporary Cultural Context (Proceedings of the Eighth Assembly of the
Pontifical Academy for Life, Vatican City, 25-27 February, 2002), eds. Juan de Dios Vial Correa and
Elio Sgreccia (Vatican City: Libreria Editrice Vaticana, 2003), pp. 194-215. The first, third, and fourth
“roots” of human dignity that he distinguishes correspond to the three kinds of human dignity I
describe here. The second kind of human dignity that Seifert distinguishes is the dignity human beings
have as persons actually consciously aware of themselves as subjects, possessing exercisable abilities
to know, deliberate and choose. Seifert correctly points out that actual consciousness originates a
“second and new dimension of the dignity of persons,” consisting in the “conscious actualization of the
person, in the awakened personal consciousness which is in some sense the actus of personal being” (p.
121 206). Unborn babies, neonates, and other classes of human beings, who are indeed persons with
potential and not merely potential persons, enjoy the first kind of dignity I describe and which Seifert
includes in his fourfold classification. However, those persons who enjoy personal consciousness have
rights that persons whose consciousness has not been actualized (e.g., unborn human babies) or in
whom such consciousness is absent or seriously reduced because of injury or disease do not possess.
Thus all human persons, whether actually conscious or not, have the right to life grounded in their very
being as persons, but they do not, as do human persons consciously aware of themselves, have other
kinds of real rights, such as the right to freedom of speech. This root of a distinct human dignity,
consequently, had a very important place in Seifert’s essay, which was concerned with the relationship
between different kinds of human dignity and human rights. My concern here centers on the right of all
human persons to be recognized as beings of inalienable dignity by reason of their dignity precisely as
persons and on the moral duty, not right, of consciously aware human persons to acquire their dignity
as moral agents by shaping their lives and choices in accord with the truth. Hence my focus is primarily
on the first two kinds of dignity distinguished here, kinds of dignity Seifert also clearly identifies.
[2] Thus the World Medical Association in the justly famous Declaration of Helsinki, adopted by the
18th World Medical Assembly in 1964 and revised by the 29th Assembly in 1975 declared:“Medical
progress is based on research which ultimately must rest in part on experimentation involving human
subjects”(Introduction). The text of this Declaration can be found in Contemporary Issues in Bioethics,
eds. BEAUCHAMP, TOM L., and WALTERS, LEROY, (2nd ed.: Belmont CA: Wadsworth, 1986),
pp. 511-512.
[3] See, for example, Pope Pius XII, Allocution to First International Congress of Histopathology,
September 14, 1952; in The Human Body: Papal Teachings (Boston: St. Paul Editions, 1979), nos.
637-649. See also Catechism of the Catholic Church (1994), nos. 2292-2293, and Pontifical Council for
Pastoral Assistance to Health Care Workers,Charter for Health Care Workers (1994), nos. 75-82 and
sources cited therein.
[4] Worthwhile studies of medical research and its history are provided by BEECHER, HENRY,
Research and the Individual (Boston: Little, Brown, 1977) and by KATZ, JAY; CAPRON,
ALEXANDER; and SWIFT-GLASS, ELEANOR, Experimentation with Human Beings (New York:
Russell Sage Foundation, 1972). Moraczewski, ALBERT, O.P., gives a very brief but helpful overview
of this history in his essay, “Human Experimentation and Research,” in Catholic Health Care Ethics: A
Manual for Ethics Committees, eds. MORACZEWSKI, ALBERT, O.P., and CATALDO, PETER,
(Boston: National Catholic Bioethics Center, 2001), chapter 23.
[5] World Medical Association, Declaration of Helsinki, Introduction.
[6] Catholic Health Australia,Code of Ethical Standards for Catholic Health and Aged Care Services in
Australia (ACT: Catholic Health Australia, 2001), no. 6.1, p. 49.
[7] APPLEBAUM, PAUL, et al., False Hopes and Best Data: Consent to Research and Therapeutic
Misconceptions,HastingsCenter Report April 1991, 17.2:16-30.
[8] On this see ASHLEY, BENEDICT, O.P., and O’ROURKE, KEVIN, O.P., Health Care Ethics: A
Theological Analysis (4th ed. Washington, D.C.: Georgetown University Press, 1997), pp.345-346. As
the Australian Code of Ethical Standards puts the matter: “It is…important to distinguish between
research which is therapeutic, that is, conducted with the intention of providing a direct clinical benefit
to the participant along with the gaining of knowledge, and research which is non-therapeutic, that is,
conducted not with the intention of providing a direct benefit to the participant but rather with the
intention of gaining information that may in time benefit others.”
[9] On this see FOSTER, CLAIRE, The Ethics of Medical Research on Humans (Cambridge:
Cambridge University Press, 2000), p. 21.
[10] Text in Beauchamp/Walters, p. 510.
[11] The US government requires that every institution that carries on research projects with public
funds establish an institutional review board (IRB), and the US federal government will not fund
122 research projects unless they have first been approved by an IRB (President’s Commission for the
Study of Ethical Problems in Medicine and Biomedical and Behavioral Research,I.R.B. Guidebook
(Washington, D.C.: Department of Health and Human Services, 1983).
[12] World Medical Association, Declaration of Helsinki, in Beauchamp/Walters, pp. 511-512.
[13] POPE John Paul II, Address to the Representatives of the Italian Society of Medicine and the
Italian Society of General Surgery, October 27, 1980, in Insegnamenti III/2, 1009, no. 3.
[14] Karol Wojtyla, Love and Responsibility, trans. H. Willetts (New York: Farrar, Straus and Giroux,
1981), p. 41.
[15] HERRANZ, GONZALO, “Christian Contributions to the Ethics of Biomedical Investigation: An
Historical Perspective,” an essay contained in this volume.
[16] Many of Pope Pius XII’s statements are gathered in The Pope Speaks, vol. 1, nos. 3 and 4 (1954).
Among his principal addresses on the subject were those to the First International Congress on the
Histopathology of the Nervous System (September 14, 1952), the Sixteenth International Congress of
Military Medicine (October 19, 1953), and his address to the Eighth Congress of the World Medical
Association (September 30, 1951).
[17] Pope John Paul II, Address to Representatives of the Italian Society of Medicine and the Italian
Society of General Surgery, October 27, 1980, in Insegnamenti III/2, 1009, no. 5. I believe that the
reflections of the late Paul Ramsey on the “principle” of free and informed consent are very relevant
here. After noting that other aspects of research, for instance the scientific requirements of good
experimental design and professional knowledge and competence, regard the subject as passive or as
patient, Ramsey said: “any human being is more than a patient or experimental subject: he is a personal
subject—every bit as much a man as the physician-investigator. Fidelity is between man and man in
these procedures. Consent expresses or establishes this relationship, and the requirement of consent
sustains it. Fidelity is the bond between consenting man and consenting man in these procedures. The
principle of an informed consent is the cardinal canon of loyalty joining men together in medical
practice and investigation. In this requirement, faithfulness among men—the faithfulness that is
normative for all the covenants or moral bonds of life with life—gains specification for the primary
relations peculiar to medical practice.” Ramsey put matters very well when he further said: “no man is
good enough to experiment upon another without his consent.” See RAMSEY, PAUL, The Patient as
Person (New Haven: Yale University Press, 1970), pp. 5, 7.
[18] Nuremberg Code, Article 1; text is found in Beauchamp/Walters, p. 511.
[19] See his Research and the Individual, pp. 18-19, 231f.
[20] Ramsey notes that “Sir Harold Himsworth said (1953) that the Hippocratic Oath can be given in a
single sentence: Act always so as to increase trust…This might better read: Act always so as not to
abuse trust: act always so as to exhibit faithfulness, to deserve and inspire trust.” In The Patient as
Person, p. 8, footnote 6.
[21] Pontifical Council for Pastoral Assistance to Health Care Workers,Charter for Health Care
Workers (1994), no. 73. Ramsey has clearly expressed, in my opinion, the meaning of what the Charter
calls the “principle of responsibility in health care” as follows: “we might say that if a doctor stops on
the road to Jericho, instead of passing by on his way to read a research paper before a scientific
gathering or to visit his regular, paying customers, he is self-selected as good enough to practice
medicine without the needy man’s expressed consent.” See his Patient as Person, pp. 7-8.
[22] JONAS, HANS, “Philosophical Reflections on Experimenting with Human Subjects,” in Jonas,
Philosophical Essays: From Current Creed to Technological Man (Chicago: University of Chicago
Press, 1980), pp. 105-131.
[23] Ashley and O’Rourke,HealthCare Ethics, pp. 346-347.
[24] Text of these Articles is given in Beauchamp/Walters, p. 511.
[25] The expressive term, “voiceless,” was used by Paul Ramsey to describe children and other
incompetents dependent upon others for their care in his essay, A Reply to Richard McCormick: The
123 Enforcement of Morals:Nontherapeutic Researchon Children, Hastings Center Report May 1976,
6.4:21-23.
[26] National Conference of Catholic Bishops,Ethical and Religious Directives for Catholic Health
Care Facilities (1994), no. 25.
[27] Charter for Health Care Workers, no. 73.
[28] McCORMICK, RICHARD, S.J., How Brave a New World? Dilemmas in Bioethics (Garden City,
NY: Doubleday, 1981), chapter four, “Proxy Consent in the Experimental Situation,” pp. 61-62; and
chapter six, “Sharing in Sociality: Children and Experimentation,” pp. 87-98. Chapter four had
originally been published in Perspectives in Biology and Medicine 1974, 18:2-20; chapter six had
originally been published in Hastings Center Report May, 1975, 5:3: 26-31.
[29] Here I want to note that I believe, with others, that as children grow they become capable of
exercising their intellect and power of free choice. According to the Code of Canon Law recognizes
that “minors,” i.e., individuals under eighteen years of age,“on completion of the seventh year…[are]
presumed to have the use of reason” (“Minor…expleto autem septennio, usum rationis habere
praesumitur”) (canon 97.2). Those who have reached the use of reason, I believe, can give personal free
and informed consent to be subjects of non-therapeutic as well as therapeutic research/experiments.
However, I believe that the parents of minor children can veto such authorization.
[30] On this see my essay, Experimenting on Human Subjects, The Linacre Quarterly November 1974,
41:3:238-252 and also my Human Existence, Medicine, and Ethics: Reflections on Human Life
(Chicago: Franciscan Herald Press, 1977), pp. 21-28; Ramsey,A Reply to Richard McCormick: The
Enforcement of Morals: Nontherapeutic Research on Children.
[31] Ramsey, The Patient as Person, pp. 12-14.
[32] Germain Grisez, The Way of the Lord Jesus, Vol. 2, Living a Christian Life (Quincy, IL:
Franciscan University Press, 1993), p. 534, emphasis added.
[33] CONGREGATION FOR THE DOCTRINE OF THE FAITH, Donum vitae (1987), 1.4, AAS 80
(1988), 81-83. Italics in the original. At this point a footnote, no. 29, is given. It reads: “Cf. POPE
JOHN PAUL II, Address to a Meeting of the Pontifical Academy of Sciences, October 23, 1982: AAS
75 (1983), 37: “I condemn, in the most explicit and formal way, experimental manipulations of the
human embryo, since the human being, from conception to death, cannot be exploited for any purpose
whatsoever.”
[34] ibid.
[35] See NATIONAL CONFERENCE OF CATHOLIC BISHOPS, Ethical and Religious Directives
for Catholic Health Care Facilities, no. 51: “Non-therapeutic experiments on a living embryo or fetus
are not permitted, even with the consent of the parents.” See also Charter for Health Care Workers, no.
82.
[36] Ibid, no. 31, which reads in part: “In instances of nontherapeutic experimentation, the surrogate
can give this consent only if the experiment entails no significant risk to the person’s well being”
(emphasis added).
[37] I made this accusation in my Catholic Bioethics and the Gift of Human Life (Huntington, IN: Our
Sunday Visitor, 2000), pp. 208-209.
[38] See the Australian Bishops’ Code of Ethical Standards for Catholic Health and Aged Services in
Australia. In no. 6.6 of this document we read: “Research involving vulnerable people must only be
undertaken when the knowledge to be obtained is sufficiently important to warrant involving such
vulnerable people and this knowledge cannot be obtained by other means…Non-therapeutic
experimentation must involve no significant risk at all” (emphasis added).
124 DANIEL SERRÃO
ETHICS OF EXPERIMENTAL RESEARCH IN HUMANS:
PRINCIPLES AND GUIDELINES
INTRODUCTION
Ethics of experimental research is now a main concern of civil society because biotechnology is
perceived by the lay people as a possible personal menace. This is why many international
organisations, like OMS, CIOMS and others are devoting time and resources, to discuss the scientific
and ethical aspects of the experimental research on animals and humans, including embryos and foetus.
In my presentation I will refer only to research in adult humans and in the field of healthcare. The case
for animals and plants, as subjects of research, being clearly important for humans and deserving
attention in the future is not in the scope of the present communication.
There are different kinds of research related to healthcare. According to a recent publication of the
Nuffield Council on Bioethics [1] the more important are:
basic research
clinic research
epidemiological research
social and behavioural research
intervention studies, including clinical trials and community-based trials
health services and operational research
Basic research is usually laboratory-based and includes studies at the cellular level, and of immunity
and pathogenesis. Such research is often dependent on the use of samples from patients.
Clinical research is often conducted with patients in a medical setting, such as a hospital, and is
designed to obtain better information on the natural history or pathogenesis of a condition that may lead
to improved strategies for diagnosis, treatment or prevention of a disease.
Epidemiological research usually involves population-based investigations, which may be crosssectional surveys of selected populations (case-control studies) or all members of a community, or may
involve longitudinal study of a population over time (cohort studies). Such research is conducted to
obtain an improved understanding of the natural history of a disease or to identify factors that increase
or decrease the risk of a disease in individuals. Often such investigations involve the study of large
populations and they may be observational or interventional in nature. The aim is to identify strategies
for the better prevention or treatment of disease, through an improved understanding of risk factors for
disease or for progression of disease.
Social and behavioural research is often a component of epidemiological research and focuses on the
study of behavioural and social factors that may modify risk of disease in individuals or in populations.
Such research may involve the collection of sensitive information about a person and their lifestyle
(e.g. sexual behaviour). While some forms of research may only involve observation others may
involve studying or testing ways of changing behaviour or social circumstances.
Intervention studies are conducted to evaluate the impact of specific interventions on the prevention of
disease, often in the context of community-based intervention trials, or in modifying the clinical course
of disease, often in the context of clinical trials. Such research may provide the basis for policy
decisions and priority setting. Intervention studies usually involve the comparison of different
treatment or prevention strategies in which the current intervention method is compared with another
method, often new, that may be more efficacious than the existing intervention. If there is no existing
effective intervention, a placebo or “no intervention” may be used as the comparison against which to
assess the impact of the new intervention. Ideally, individuals are randomly allocated to receive the
different interventions being compared in the trial.
125 Health services and operational research are concerned with the study of methods of delivery of
healthcare, access to treatment and quality of care, with the aim of finding improved methods that lead
to better care. Such studies often include an evaluation of the cost of providing the intervention and the
benefit it provides.
In the field of research on adults, human and women, a lot of problems deserve attention to the catholic
opinion.
There are many international documents and guidelines after de Code of Nuremberg but I will present
here the Protocol on Biomedical Research, prepared by the Steering Committee on Bioethics (CDBI)
and open to public discussion which final version will be approved in 2002 and proposed to the
signature of member-states in 2003.The Protocol covers the full range of biomedical research activities
involving any kind of intervention on human beings, but does not apply to research on embryos in
vitro; it does apply to research on foetus and embryos in vivo as well as pregnant women.
The catholic opinion is not against the research on humans providing that the human dignity and human
rights are fully respected.
In this sense the Protocols state, like the Convention, that the interests and the welfare of the human
being participating in research shall prevail over the sole interest of society and science.
To protect the human dignity and human rights the Protocol states that any research project must be
approved by a competent authority after independent examination of it’s scientific merit, including
assessment of the importance of the aim of research and multidisciplinary review of its ethical
acceptability.
The ethical revision by a independent and multidisciplinary committee is the key point for the
protection of human dignity and human rights. This point is also stressed by the Helsinki Declaration
(Edinburgh, 2000) which states “the committee must be independent of the investigator, the sponsor or
any other kind of undue influence”: The Protocol states that the members of the ethics committee shall
declare all circumstances that might lead to a conflict of interest. Should such conflicts arise, those
involved shall not participate in that review.
In order to promote a good and sound opinion of the ethics committee the Protocol detail, in successive
Articles, the informations the researchers and promote are obliged to present, the demonstration that no
undue influence, including financial gain, is exerted on persons to participate in research, with
particular attention to dependent and vulnerable persons. Also important is the information to be
presented to research participants which needs to be complete and comprehensible. This information is
a sine qua non condition to obtain the consent of the proposed research participant. The main topics of
information are: the nature, extent and duration of the procedures involved, in particular, details of any
burden imposed; the risks involved; the rights and safeguards prescribed by law for their protection;
their right to refuse consent or to withdraw consent at any time, without prejudice to their right to
appropriate and timely medical care, and without suffering any other detriment; the arrangements for
responding to adverse events or the concern of participants; arrangements to ensure respect for private
life and ensure the confidentiality of personal data; arrangements for access to information relevant to
the participant arising from the research and to it overall results; the arrangements for appropriate
compensation in the case of damage; any foreseen potential further uses, including commercial uses, of
the research results, data or biological materials.
The more difficult point is the protection of persons not able to consent to research. If the research have
the potential to produce real and direct benefit to his or her health and with safeguards prescribed by
law these researches can be acceptable. Without such benefits the acceptability is problematic and open
to discussion. Even with minimal risk and minimal burden the research in subjects not able to consent,
including minors, with a consent by representation, and with any potential to produce results of direct
benefit to the health of the person concerned appears to me as manipulation not in accordance with the
emphatic sentence that the welfare of human beings participating in research shall prevail over the sole
interest of society or science. In general the catholic opinion is not in favour of this kind of research.
126 The clinical trials promoted by the Pharmaceutical Industry are another point to be considered. There
are four separate phases of such trials:
Phase I trials
Phase I studies will be the first time human subjects are exposed to the potential novel medicine. The
objectives behind the study will be to investigate pharmacodynamics, dose-response. and in the case of
vaccines, immune response, and to determine the maximum dose that can be tolerated by participants.
In the case of most new medicines these studies will be undertaken in a small number of healthy
volunteers. It is not expected that evidence of efficacy of the medicine will be provided by Phase I
studies.
Phase II trials
Using the information regarding the safe dosage range obtained from the Phase I studies, the compound
will be administered to patients suffering from the target disease and now significant numbers of
individuals will be recruited into the trial. Almost always these trials will be conducted in a number of
clinical centres. The objective of the Phase II studies will be to seek evidence of the efficacy of the
medicine against the specific disease. More information about the safety of the medication will emerge
from these studies as larger numbers of individuals are exposed to it. In Phase II trials the patient will
often be randomly assigned to the novel treatment group or to a group receiving a placebo (a compound
possessing no therapeutic effect) or, more usually, a conventional and established treatment.
Phase III trials
Where a compound has shown evidence of efficacy without significant side effects it will enter Phase
III trials in which many hundreds, or sometimes a few thousand patients will be enrolled. These trials
will generally seek not only to confirm the clinical efficacy of the novel compound, but also to
establish its efficacy in comparison with existing treatments. These studies will often be multicentre
and sometimes undertaken on an international basis. Again. careful attention is paid to possible side
effects as larger numbers of patients are exposed to the intervention. The end-points for Phase III
studies include the demonstration of a statistically significant improvement in the efficacy of the novel
medicine over the established therapies. if any such exist.
Phase IV trials
Once a new medicine reaches the market it will be subjected to post-marketing surveillance in order to
identify side-effects and other adverse effects which would only become evident as much larger
numbers of individuals are treated with. In addition. formal clinical trials continue in order to develop a
greater understanding of the compound and its effects in a wider clinical environment, but also to
extend its use for other indications or for different patient groups, such as children or the elderly.
Special study designs may be used according to the objectives of the study to evaluate safety or
efficacy. These may include study of temporal trends. case-control studies, or the phased introduction
of an intervention in different areas. Phase IV studies may also be designed to measure the impact of
the intervention on the epidemiological pattern or transmission of an infectious disease.
When these trials are proposed to run out in the developing countries there are a risk that no true
independent and multidisciplinary ethics committees exist to do a ethical opinion after reviewing of the
research projects.
After the notice of abuses in some countries, namely in Africa, the OMS as well as some international
organizations like the World Medical Association, The Council for International Organizations of
Medical Sciences, and others have prepared a document – Operational Guidelines for Ethics
Committees that Review Biomedical Research – to support the improving of organization, quality and
standards of ethical review around the world: I think that this document can be approved by our
Academy and this approval communicated to the OMS.
The European Forum for Good Clinical Practice as well as the European Parliament and European
Commission has prepared documents to harmonize the laws and administrative provisions regulating
the clinical trials on Phase II and Phase III.
127 The Catholic opinion support the values promoted by these documents; and reinforce the disposition on
the use of placebo of the Helsinki Declaration on the “extreme care which must be taken in making use
of a placebo–controlled trial and that, in general, this methodology should only be used in the absence
of existing proven therapy”. The use of placebo can open the door to abuse of the persons involved in a
therapeutic trial which can’t be informed that they can be not taking the true medicine but a similar one
with no therapeutic action. There are some informations that certain SIDA’S therapeutic researches
running in Africa, has been doing with drugs against placebo, in pregnant women – clearly against the
Helsinki Declaration.
From a Catholic point of view what is always necessary is a clear statement of the moral imperative of
respect for human dignity. This calls upon us to recognize that each person should be treated primarily
as a person or an end in him/or herself, not as an object or as a means to an end; it means respecting the
right to make free and informed decisions respecting the exercise of individual consent. The
researchers may recognize and validate the reality that free and informed consent is a matter of process,
it is not simply a matter of getting a signature on a consent form. It begins at the initial contact with
potential participants, it includes dialogue and information-sharing, and it continues all the way through
the project.
The moral requirements for substantial understanding, for substantial absence of control by others, and
for deliberate authorisation of a researcher to do something to the participant are not susceptible to
formularise assessments by researchers or Ethics Committees like Research Ethics Boards. This is a
very sensible point and catholic institutions as well as catholic participants in Research Ethics Boards
should always scrutiny very carefully the process of information to and consent by the persons
involved in a research program. Mainly in development countries where cultural, social and political
handicaps are so troubling that the promoters inform not the persons to be involved in the trial but the
authorities, and those authorities, not the persons, will consent or not. Unfortunately, in certain
countries, money and corruption are the most effective means to obtain authorization for research in
human subjects.
Researches conducted in developing countries, on Malaria and HIV-infection, are being criticised
because they use no-treatment of HIV-infected patients as placebo group. A well-balanced discussion
on ethical questions has been presented by V. Leontis[2]. In the reference (1) a comprehensive and very
complete discussion of the ethical questions related to the research in developing countries can be
found. Catholic opinion can agree with the issues that this Nuffield Report propose; they shall be
considered when reviewing research proposals in developing countries.
In summary the catholic opinion on the ethics of experimental research in humans can presented in tree
points.
In any kind of research, the sanctity of human life as a God’s creation, and the dignity of human beings
are the main values to be respected. The principles deduced from these values are, in healthcare
research, the duty to alleviate suffering, the duty to show respect for persons, the duty not to exploit the
vulnerable. These principles must be translated into practice and for this a proper procedure may exist.
The research ethics committees with a broad field of intervention are a very important and necessary
part of a proper procedure for the control of the respect of principles. However the research ethics
committees needs to be staffing with independent and competent members, and produce opinions
clearly justified and open to democratic public accountability.
The human beings, can never be used, in experimental research, as means to a end, without respect for
their life, dignity and welfare, even if the end is presented as beneficial for the society or the health of
the humanity.
128 APPENDIX: Nuffield Council of Bioethics
Issues to be considered when reviewing research proposals
Policy issues
* Does the research need to be conducted in the particular country underconsideration?
* Can the purpose of the research be justified? Is the proposed research relevant tonational priorities
for healthcare-related research? If the research is not relevantto the national priorities, is it nevertheless
justified?
* Have the criteria for selecting the study population been outlined? Have any issuesrelated to the
gender of the study population been considered?
* Is the funding which has been allocated sufficient to complete the project?
* If favourable, could the results be implemented, either now or in the foreseeablefuture? If not, does
the research have any beneficial secondary or indirect effects (e.g. the development of expertise in
research)?
Scientific issues
* Is the researcher undertaking the research appropriately qualified and does he or shehave the
relevant experience?
* Is the researcher available for the duration of the study?
* Are the staff supporting the research and the facilities available, including technicalfacilities,
adequate?
* Is this the first time this type of research has been conducted? If not, has thescientific value of
undertaking the research been justified?
* Is the research design appropriate? Is it likely to yield an unambiguous answer to theresearch
questions which have been posed?
* Is it possible for the quality control of data and analysis to be achieved?
* Has consideration been given to issues associated with bio-safety and goodmanufacturing practice?
* Can the diagnostic, therapeutic and preventative interventions be handled safely?
* Is a control group being used in the research? If so, have details been included in theproposal of the
treatment that will be given?
* Will there be any form of follow-up for participants in research? If so, have details ofthis been
provided?
Ethical issues
* Has the research received appropriate scientific review?
* Has the project been given approval by an ethics review committee in thehost/sponsoring country?
* Have any efforts been made to consult with the relevant communities during thecourse of
designing the research? Have details been given of the measures to beused to recruit prospective
participants in research?
* Has consideration been given to who will benefit from the research?
* Has consideration been given to the risks involved in undertaking the research? Havemeasures
been taken to minimise risks to participants? Is there adequate provisionfor monitoring the data
collected to ensure the safety of subjects?
* Have details been given of the information that will be made available to prospectiveparticipants?
Is this appropriate and complete? Is it in a language and at a levei ofcomplexity appropriate to
prospective participants in research?
* Have details been given of the procedure that will be used to obtain assent at thelevel of
institutions and communities, where appropriate?
* Have details been given of the procedure that will be used to obtain consent fromindividual
129 participants? Is it appropriate to ask participants to sign a consent form? Ifnot, how will their consent
be recorded? Where verbal consent to research isanticipated, is there an appropriate process for
witnessing the consent?
* Have provisions been made for receiving and responding to queries and complaintsfrom
participants in research or their representatives during the course of a researchproject?
* Have details been given of who will be given access to the personal data of theparticipants in
research. including medical records and biological samples? Aremeasures being put in place to
maintain confidentiality and are these adequate?
* Are the standards of care being proposed acceptable? Are they appropriate for thecountry in which
the research is being conducted?
* Are there other research designs which could answer the research question beingposed? If so, why
has this particular design been proposed?
* Is a control arm to be used? If so, has its use been properly justified? If it is beingproposed that the
control group in the research should receive less than a universalstandard of care, has this been
justified? Have details been given of how theintervention will be allocated? Have details been included
of what informationparticipants in the control group will be given?
* Have any plans to withdraw or withhold standard therapies for the purpose of thesearch been
justified?
* What standard of care will be provided for participants who develop diseases orconditions other
than those being studied? If it is something less than the bestintervention available as part of the
national public health system, has this beenjustified?
* Will research participants be offered payment, gifts or other inducements in returnfor their
participation? Are these appropriate?
* Will there be follow-up and long-term review of the research? If so, have details beengiven of how
this will be carried out?
* Have provisions been made for compensation or treatment in the case of death orinjury to research
participants?
* Have researchers endeavoured to secure post-trial access for effective interventionsfor participants
in the trial? If not has the lack of any such arrangements been,justified?
* Has consideration been given to the possibility of introducing an intervention shownto be
successful to the wider community and maintaining its availability? If it is notthought possible to make
the intervention available to some or all of the population inthe country in which the research is to be
conducted, can the research be justified?
* Will regular progress reports be made to the research ethics committee? If so, havedetails been
given of how frequently these will occur? Have details been given of anyarrangements that have been
made for providing proper documentation to thecommittee?
* Have details been given of how the results of the research will be used? How will theresults of the
research be disseminated to participants and other interested parties?
* Does the research include provisions for the development of expertise in researchwithin the
developing country in which it is to be conducted? If not, is the lack of suchprovisions justified?
Research conducted with vulnerable populations
* Has the inclusion of individuals in research who cannot consent been justified?
* Is the research question posed important to the health and well-being of thisvulnerable population?
* Is the research design appropriate?
* Have safeguards been built into the research design to prevent undue coercion orinfluence of this
group?
130 [1] The ethics of research related to healthcare in developing countries. Nuffield Council on Bioethics
publication. London, 2002.
[2] VASSILI LEONTIS – Ethical challenges posed by trials of biomedical intervention on human
subjects conducted in developing countries. Information paper presented at the European Conference of
National Ethics Committee. Porto (Portugal) 1998. CDBI/INF (98)2.
131 EUGENE DIAMOND
CONFLICTS OF INTEREST IN MEDICAL ETHICS
Medicine is a learned profession that has its own intrinsic ethic.Under this intrinsic ethic, the end of
medicine is ordered to a good that is health.Technique and conduct are not value-neutral but rather are
ordered to this overarching good that is the nature given end of health.Medicine is a profession
precisely because it professes such a goal.Being a professional is more than being a technician.The
public profession of medicine as a way of life is an affirmation of the moral nature of our
activity.Medicine as a profession is a public declaration of a willingness to devote oneself to others and
to serve a higher good.The physician is a moral being who professes and affirms the moral nature of his
activity.
We have in recent years seen an attempt to convert our profession to a killing activity.Doctors aas
abortionist kill unborn children; doctors accept the responsibility to kill patients with or without their
consent as in Holland or to engage in the subterfuge of physician assisted suicide as in the state of
Oregon in America.The doctor true to his calling will not violate the taboo against killing.Ge will not
do it for love and he will not do it for money.
This is why medicine must be a profession and not merely a business.A physician guided primarily by
the profit motive will have conceded that he is willing to sacrifice the best interests of his patient in the
patient’s pursuit of health.
Recently there has been an erosion of some of the safeguards that have accrued to the protection of the
patient and the society.
Let us start with information published in medical journals.This information helps to shape diagnostic
and therapeutic decisions.For a medical journal to be of value, it must publish authoratative up to date
information that is free of commercial influence.This requires that the financial associations of authors
are disclosed and that these associations do not influence published articles.Tis is the only way to avoid
bias or the appearance of bias based on a conflict of interest.Beyond the authors themselves, this
freedom from conflict of interest must extend into the process of peer review.If those who are assisting
the editor in selecting articles suitable for publicaion are not also free from similar financial
associations, the possibility of bias is reinforced. [1]Relationships between biomedical companies and
research are growing rapidly.Beyond the direct support of research or therapeutic trials, authors may
receive consulting fees, serve on advisory boards, own equity, receive patent royalties or receive
honoraria for lectures or expert testimony.
Recently the New England Journal of Medicine [2]and by inference, [3] the Journal of the American
Medical Association have altered their policies so that authors of original articles as well as review
articles and editorials will not have any “significan” financial interest in a company (or its competitors)
that makes a product discussed in an article.The National Institute of Health [4] and the Association of
American Medical Colleges [5]have likewise relaxed their requirements regarding financial association
and resultant possible bias.The attempt has been made to quantitate what degree of association could
produce bias.The key provision is to set an upper limit on the annual sum received by an author in
order to have a relationship considered “significant”.Currently $10,000 is the de minimus level.Beyond
this any holding in which the potential for profit is not limited such as stock, stock options or patent
holdings would probably be disqualifying.
The justification for these changes in policy is said to be an inability to impanel an adequate number of
authors and/or reviewers to carry out the functions of the journal because so many academicians and
clinicians are involved in intertangling financial relationships with pharmaceutical companies. [6]
Inevitably the outcome of the policy will be an enhanced opportunity for the introduction of convlict of
interest and a reduced confidence in the reliability of published data.This will extend not only to
decision making by physicians and researchers but also to the general public.Almost every major media
132 outlet in the United States has a science editor and staff that cover current medical literature often
counting on summaries and releases published for their edification by the journals
themselves.Providing this service is a large source of income, for example, to the American Medical
Association.
Let us take one example.An article in the New England Journal on R.U.-486 (Sivestre L. et. Al. New
Eng J Med 322:645, 1990) concluded that R.U.-486 was “effective and safe”.Those who thought the
data to be excessively sanguine and reassuring could be forwarned by the revelation in a prominent
place that all six authors were employees of Roussel-Uclef which manufactured R.U.-486 and stood to
make huge profits from sales.The knowledge that the so-called “scientific” article was in fact an illdisguised promotional piece could result in a healthy cynicism on the part of readers.Not only the
manufacturer, however, promoted the unfounded enthusiasm as factual, but also by the entire publicity
apparatus of the pro-abortion lobby and its media collaborationists.
A delegation from the Catholic Medical Association met with the executive director and the editorial
staff of the JAMA to express our concern that during the previous three years approximately fifteen
pro-abortion articles were published and not one anti-abortion paper.Editorial bias was vehemently
denied.Subsequently, however, we cam into possission of an intrnal memorandum [7] leaked to us by
an AMA employee informing the editorial staff of JAMA that, in fact, their policy was as
demonstrated, that is not to publish anti-abortion studies or statistical studies unfavorable to abortion.
If this ideological bias is now to be augmented by a potential for bias based on economic gain, the
profession and the public will have been thoroughly compromised.
President Bush was recently called upon to make a Solomonic decision regarding stem cell
research.While by no means a perfect decision it did make the important distinction between
embryonic stem cells (produced from embryos created for the purpose of being killed to harvest their
stem cells) and stem cells produced from adult sources (umbilical cord blood, bone marrow, etc.).While
forbidding federal funding of the creation of any new embryonic stem cell lines the president did
concede, in his policy, the continuation of existing cell lines from embryos.These were the fruit of a
poisoned tree and, since adult stem cells had outperformed embryonic stem cells both clinicaly and in
the laboratory, it was difficlt to comprehend the dogmatic insistence by the scientific community of the
superiority of and need for embryonic cell lines.
It turned out that many of the existing embryonic cell lines that were allowed to be preserved were in
fact owned by universities and other enterprises that had every intention of profiting from the
propagation of and distribution of embryonic stem cells for research.
During the debate on cloning [8] in the U.S. Congress, it was revealed that three human cloning patents
were pending in the U.S. patent office.The sponsor of the HumanCloning prohibition act, Senator
Brownback, pointed out that the notion that we have to kill one person in order to find a cure for
another is a false trade off which disregards advances made in other non-embryonic stem cell
sources.Even more frightening is the prospect of people in corporate America owning, trading, buying
and selling people (cloned) as if they wer property.This is an issue that must be included in the cloning
debate.When Senator Brownback introduced a Human Unpatentablity Amendment to outlaw patenting
human clones [9] it was defeated.This occurred on the same day that a team from the University of
Minnesota reported on the versatility of adult stem cells and teir ability to convert and morph into
hundreds of specialized cells within the body. [10]
Jonathan Swift said “Falsehood flies and the truth comes lingering after, so that when men come to be
undeceived the jest is over and the tale has had its effect”.The culture of death has for the last thirty
years clearly controlled the pres and the media now shows a sinister proclivity toward controlling the
scientific literature and thereby the political process.Through the powerful incentive of the profit
motive derives the clear conflict of interest between objective scientific investigation and advocate
science in pursuit of monetary gain.
133 The ultimate perversion of the commercialism of medical research would be the sale of body parts for
use in experimentation.The reality of a brisk business in fetal body parts has been exposed by
numerous investigative pro-life agencies.This offshoot of the abortion industry has been demonstrated
to advertise the availability of organs from aborted babies in scientific journals.These are not merely
allegations, but ar tryly undeniable since the acual advertisements containing price linsts for human
tissues have been exposed.Such offerings as “fetal liver, second trimester fetal kidney, pancreatic islet
tissue” each with an attached price list have been discovered, having been placed by so-called
laboratories doing business with abortionist sources. [ll]
A movement is currently underway to approve the payment by potential recipients for donor
organs.Currently the National Organ Transplant Act makes it illegal for “any person to knowingly
acquire, receive or otherwise transfer any human organ for valuable consideration for use in human
transplantation.”The American Medical Association has called for a study of the possibility of paying
donors for organs. [12]The background for this consideration of a radical policy change is, of course,
the annual shortfall in the availability of donor organs.The United Network for Organ Sharing database
indicates that there are now 75,000 patients waiting for an organ.Among those waiting for a heart or
liver transplant one-third will die before an organ becomes available.
The primary source of donor organs will be the so-called Heart Geating Cadaver donors.These are
patients who have had an irreversible cessation of total brain function and are being maintaine on
ventilators in intensive care units.These will constitute a pool of 10,000-12,000 potential donors per
year.Despite extensive public awareness campaigns, the ratio of actual to potential donors has not
increased sufficiently. [13]One response has been a greater reliance on living donors (kidneys), partual
transplants (liver and lungs), and sources of dubious ethical propriety such as anencephalic infants and
animals. [14]
Another potential source of transplantable organs is patients who have been declared dead by
traditional cardiopulmonary rather than brain-based criteria.The success of transplants using organs
from these sources has been limited by problems with warm ischemia.These non-Heart Beating
Cadaver Donors fall generally into two categories:1) Uncontrolled Cardio-pulmonary Death (usually in
emergency rooms), and 2) Controlled Timing and Place of Death.This second category follows a
method commonly known as the Pittsburgh protocol. [15]
Under this protocol, families who have decided to forego life support are approached to donate
organs.Warm ischemia time is minimized by taking the patient to the operating room disconnecting life
support there and removing the organs immediately or shortly after the pronouncement of death.Ethical
issues surrounding the use of Non-Heart Beating Cadaver Donors have to do with the consent process,
the question of irreversibility and early declaration of death.There are also intuitive problems related to
thefact that the procedue seems staged or contrived in thaat the patient is declared dead after having
been removed from the company of his near relatives and into an operating room.
Market forces have begun to erode the standard of uncompensated donation from living donors by the
opportunity to obtain organs outside of the United States.Americans are purchasing organs from
strangers in China, Peru, and the Philippines and then returning to the U.S. for post transplantation
care. [16]
Another challenge to the altruistic principles underlying the Act is the increased frequency of kidney
donations by patients unrelated to the recipients since a close genetic match is no longer as
necessary.The possibility exists of illegal purchase and illegal profits beyond the control of
transplantation centers. [17]
The movement to liberalize the rules to allow for a freer market in the purchase of organs raises the
specter of a bidding war in which less deserving wealthy candidates for transplantation gain priority
over poor candidates lacking the wherewithal to purchase organs.One economist has suggested that less
affluent individuals could always take out loans to purchase organs as they now do to purchase
134 automobiles or houses.What happens, however, if the borrower is incapable of repaying the loan?Can
we have some mechanism for foreclosing on or reposessing a kidney?
The present system of providing ethical or humanitarian incentives for donation would protect the
unbiased distribution of organs based on priority of need. [18]
Brokering criteria in the United States would be impossible to control.If the current prohibition against
the sale of organs were rescinded, there would be no legal justification for preventing persons from
bypassing the regulated system to compete in an unregulated market.The potential unfairness of such a
market and the preferability of enhanced ethical incentives (public recognition, compensation of
funeral expenses or tax credits) would be the better way to sustain broad societal interest. [19]
Finally a word on bioterrorism, a fundamental conflict of interest has arisen over the issue of whether
biologists should publish work that could be misused.The National Academy of Sciences has set up a
panel to study how to prevent the destructive applications of advanced biotechnology. [20]Recent
studies on the 1918 pandemic influenza virus at the Armed Forces Institute of Pathology have
suggestested the potentials for reconstructing the 1918 virus and make it more resistent to the immune
system. [21]Similar studies have been published to demonstrate how to engineer microorganisms to
spread more readily, resist antipotics and vaccines and thus be more effective as weapons for
bioterrorism.There are serious questions as to whether such information should be made available in
journals.A conflict of interest has arisen between bioweapons experts in the government and the
American Society of Microbiology as to whether there should be special peer review.Needless to say,
scientists are highly resistant to the notion that their work or any important data should be subject to
censure for political reasons.
Though the conflicts of interest may not be as demonstrable in a socialized medical system as they are
in a capitalist system, they are unavoidable in a privately based system either fee for service or
managed care.The main protection against the intrusion of political and economic issues into medical
care is a return to the Hippocratic system of medical ethics that remains viable in all cutures and all
forms of reimbursement.
Finally, another opportunity for conflict of interest consists of so-called “advocate science”.This
consists in the propounding of so-called “scientific” claims or rejecting counterclaims based not on the
quality of objective data involved, but rather on a hidden political agenda or a desire for political
correctness.
The principal occasion for the employment of advocate science is in research regarding the etiology
and treatment of homosexuality or same-sex attraction disorder.The media have promoted the idea that
a “gay gene” has already been discovered and certain professional organizssations have dot
discouraged this assumption.If same sex attractin were genetically determined, then one could expect
identical twins to be identical in their sexual attractions.Most studies, however, show that identical
twins are discordant in their sexual attraction. [22, 23, 24]
There are, however, ongoing attempts to convince the public that same sex attraction is genetically
based.Such attempts are politically motivated by the supposition that the upblic would be more likely to
respond to changes in laws and religious teaching were they to believe that same sex attraction is
genetically determined and unchangeable.
A similar controversy surrounds the issue as to whether the homosexual state is treatable and
changeable.In the debate between essentialism and social constructionism, the believer in natual law
would hold that human beings have an essential nature—either male or female—and that sinful
inclinations such as the desire to engage in homosexual acts are constructed and can, therefore, be
deconstructed.Some members of the American Psychiatric Association have gone so far as to allege
that attempts to change homosexuals are notonly unsuccessful but unethical.There are a number of
therapists however, who have written extensively that reparative therapy is successful with about 30%
experiencing a freedom from same sex attraction, and another 30% experiencing improvement. [25, 26.
27, 28]Dr. Robert Spitzer, the renowned ColumbiaUniversity psychiatric researcher who was largely
135 responsible for the removal of homosexuality from the APA’s list of mental disorders, has now
indicated that his most recent research indicates that sustined change can be achieved. [29]
Other examples of Advocate Science would include the American Cancer Society’s refusal to admit a
relationship between abortion and breast cancer [30]despite overwhelming evidence, and the National
Institute of Health’s insistence on the effectiveness of the condom in preventing AIDS.When the
question was posed at a large international meeting of AIDS experts how many would be willing to
have sexual intercourse with an HIV positiver person while wearing a condom, no one [31]in the
audience raised their hand.
The evidence strongly suggests that the officialdom of numerous professional organizations such as
AMA and AmericanCollege of Obstetrics and Gynecology has a hidden agenda of apologizing for
abortion and upholding the homosexual rights lobby despite any evidence to the contrary and despite
the conflicting opinion of many in their grass roots membership.
[1] Parrish, D. and Bruns, D., Legal Principles and Confidentiality in Peer ReviewJAMA 287;
2839,2002
[2] Drazen, J. And Curfman, G., Financial Associations of Authors. New Eng J Med 346:1901, 2002
[3] Rennie, D. et al , Conflicts of Interest in the Publication of Science. JAMA 266:266, 1991
[4] Public Health CFR42, May 21, 2002.
[5] Task Force on Financial Conflicts of Interest in Clinical Research.Assoc. Of American Medical
Colleges. December, 2001
[6] Angell, M. and Wood, A., Authors Conflicts of Interest. New Eng J Med 341:1618, 1999.
[7] Memorandum regarding topics for publication G. Lundberg to Staff, Unpublished.
[8] Human Cloning Prevention Act.S.Brownback, M. Landrien and J. Ensign sponsors, U.S. Senate.
[9] Human Un-patentability Amendment, S. Brownback (R,Ks) sponsor.
[10] Verfaille, C.,Adult Stem Cells, Nature6/15/02.
[11] Life Dynamics, Denton, TX, Unpublished data.
[12] AMA: Study Paying for Organ Donations. Chicago Tribune, Page 4, 6/10/02.
[13] Diamond, E.F.,Ethical Issues in the Use of Asystolic Donors. Linacre Quarterly.69:33, 2002.
[14] Diamond, E.F., Anencephalic Donors. Chicago Medicine. 97:15, 1994.
[15] Policy for Management of Terminally Ill Patients, U. of Pittsburgh. 4/2/92.
[16] Scheper-Hughes, N.The Global Traffic in Organs. Current Anthropology. 41:191, 2001.
[17] Friedlander, M.The Right to Sell or Buy a Kidney. Lancet. 359:971, 2002.
[18] Delmonico, T. et alEthical Incentives for Organ Donation. N. Eng J. Med. 346: 2002, 2002.
[19] Levine, D.Kidney Vending, Yes or No?Am. J. Kidney Dis. 35:1002,2000.
[20] Speak No Evil U.S. News and World Report p. 60. June 24, 2002.
[21] Taubenberger, J. et al.Proceedings of the NationalAcademy of Sciences.On-line 8/5/02.
[22] Bailey, J., Pillard, R.A Genetic Study of Male Sexual Orentation Archives of General Psychiatry.
48:1089, 1996.
[23] Eckert, E. et al.Homosexuality in Monozigotic Twins Raised Apart British J. of Psychiatry.
148:421, 1986.
[24] Friedman, R. et al.Psychological Development and Blood Levels of Sex Steroids in Male Identical
Twins of Divergent Sexual OrientationJ. of AmericanAcademy of Psychoanalysis.8:427, 1980.
[25] Buber, J. and Buber, T.Male Homosexuality.Canadian J. of Psychiatry.24:409, 1979.
[26] McIntosh, H.Attitudes and Experience of PschoanalysistsJ. of American Psychoanalytic
Assoc..42:1183, 1994.
136 [27] Nicolosi, J. et al.Toward the Ethical and Effective Treatment of Homosexuality NARTH1998.
[28] Satinover, J.Homosexuality and the Politics of Truth Baker Books, Grand Rapids, Michigan1996.
[29] Spitzer, R.Communication NARTH, 2000.
[30] Brind, J. et al.Induced Abortion and the Risk of Breast CancerN. Eng. J. Med.. 336:1834,1997.
[31] Redfield, R.Personal Communication, 1999.
137 ROBERTO COLOMBO
THE MOST VULNERABLE SUBJECTS OF BIOMEDICAL RESEARCH
The case of the human embryo
The majority of biomedical researches involve uncertainty regarding the effects of agents, interventions
and outcomes on research subjects. For this reason, all participants in experimental studies are
vulnerable on principle. The myth of "risk-free clinical investigations" has long been pulled down, and
the category of "minimal-risk studies" that replaced it is not of easy definition or application[1].
Vulnerability is considered as a universal expression of man's condition of finitude that characterizes
his earthly life from the very beginning to death, and "the special vulnerability of the research
subject"[2] has long been recognized. However, "the conditions and circumstances that give rise to
vulnerability are a very recent focus"[3]. The word "vulnerability" is derived from the Latin vulnus, a
wound that can heal up or even be mortal. Similarly, contemporary usage of the term refers to "a state
of being exposed and unable to resist harm, illness, injury, damage, debility or temptation"[4].
Vulnerability, in this context, will be considered a condition - either intrinsic or situational - of some
individuals that put them at greater risk of being enlisted in an ethically wrongful research project.
Indeed, the concept of vulnerability points in two directions. On one hand, vulnerability is a distinctive
weakness of the subject him- or herself: "a state of being laid open or especially exposed to something
injurious or otherwise undesirable"[5]. On the other hand, the term reminds us of people "who are
disposed to capitalize on such weakness"[6], exploiting (intentionally or negligently) this opportunity
and taking unfair advantage to the subject's detriment. In most research and clinical situations, subjects
may be vulnerable either as a consequence of their limited decision-making capacity (as is the case of
children and mentally disabled adults) or restricted power of carrying out a decision (as in the case of
prisoners), or because they are especially at risk of exploitation (subjects whose moral status is not
adequately recognized or protected in a given research context or in our society). A full account of
vulnerability in biomedical research must attend to both types of concern, the second one being
connected with the concept of exploitation. Like vulnerability, exploitation has recently become a hot
topic in research ethics[7]. However, the concept of exploitation is not free from ambiguities that
require clarification in the context of biomedical research. According to Ruth Macklin, while "no one is
in favor of exploitation" and "it is easy to come to apparent agreement on this point [...], agreement
evaporates once we examine various allegations in specific cases"[8]. In a recent essay[9], David
Resnik provided a thoughtful analysis of exploitation (in general) and applied this analysis to the
biomedical research context. He argued that not all exploitative research is unethical: a study may be
prima facie exploitative yet still morally justified in some situations. Therefore, "[d]escribing a study as
exploitative, does not definitively settle questions about the morality of the study"[10]. However, one
should consider that "there exist acts which per se and in themselves, independently of circumstances,
are always seriously wrong by reason of their object"[11]. These acts include "whatever is hostile to
life itself, such as any kind of homicide, genocide, abortion, euthanasia and voluntary suicide; whatever
violates the integrity of the human person, such as mutilation, physical and mental torture and attempts
to coerce the spirit"; and "whatever is offensive to human dignity" and treats individuals "as mere
instruments of profit, and not as free responsible persons"[12]. Whenever exploitation of a research
subject entails an act that either threatens his life, integrity, and human dignity or treats him simply as a
means, and not at the same time as an end in himself[13], no clinical circumstance or therapeutic
intention can "transform an act intrinsically evil by virtue of its object into an act "subjectively" good
or defensible as a choice"[14]. The analysis of exploitation has been addressed by several authors from
different foundations. One can mention Kantian, libertarian, and Marxist accounts of exploitation, but
they are not alone[15]. Developing Alan Wertheimer's concept of wrongful exploitation[16], Resnik
argued that there are three basic elements of exploitation - harm, disrespect, and injustice - and that in
138 all cases of exploitation at least one of those three elements is involved[17]. However, while it is
convenient to distinguish between different aspects of exploitation for analytical purposes, in practice
these aspects often overlap and interact. Furthermore, there are degrees of exploitation, ranging from
highly exploitative acts, such as the practice of slaveholding or human organ trade, to less exploitative
situations, such as covering oneself with the glory of others or using spared blood samples for research
purposes without the patient's specific consent. Since biomedical research often results in a sum of
benefits and harms to subjects, situations may even be more complicated. In the case of a non strictly
therapeutic clinical protocol, where the benefit/harm ratio is not favourable to the research subject but
favourable to other patients, should this research be regarded as exploitative? According to Resnik's
argument, although some ethical considerations - such as the presence of the informed consent of the
subject and the absence of a high risk of serious damage to the life and integrity of the same subject can justify the experiment, the protocol "is still exploitative"[18]. In studies where individual patients
are not expected to benefit substantially, the moral dilemma is whether the harm to each of these
subjects can be justified taking into account the benefits to other patients. Some authors hold that "there
are good grounds to regard all research as essentially non-therapeutic" [19], any therapeutic
consequences being entirely contingent features of the research process as far as the individual research
subject is concerned[20]. Others object that in later phases of clinical trials, so much is known about
the efficacy of a new treatment that it is highly likely that research subjects will benefit from it. The
debate is still open and will not be addressed herein. However, it is noteworthy that several authors
hold that, "in the research setting, exploitation translates into an issue about risks and benefits, not
about voluntariness"[21]. Therefore, the solutions to protect potential research subjects from coercion
are different from the ones needed to protect them against exploitation. Informed consent, either
personal or by proxy, cannot prevent the possible exploitation of research subjects.
VULNERABILITY IN BIOMEDICAL RESEARCH
Risk is the likelihood that harm may occur[22], and risk assessment should incorporate probability
judgments: "[t]he quantification of risk involves an examination of both the degree or magnitude of
harm that could occur and the possibility that such harm will occur"[23]. A subject may be harmed in
consequence of an increased susceptibility to otherwise less injuring conditions, or the researchconnected harm may result from the exploitation of one or more of his or her physical and non-physical
weaknesses. On this ground, vulnerability can be classified either on the basis of the nature of the harm
of which the research subjects are at higher risk (type of risk) or according to the reason why these
subjects are vulnerable (type of vulnerability). Levine[24] classified the risks of biomedical research
subjects into four categories: physical, psychological, social, and economic. Although frequently
adopted by Institutional Review Boards (IRBs) and Ethical Committees (ECs), this list of potential
harms is not comprehensive, and leaves out two other types of harm, of a different nature: legal and
dignitary. The six categories are not mutually exclusive, and more than one type of harm might be
present in a given study. "Harm" and "injury" have distinct meanings in law, but, following other
reports[25], the terms will be used interchangeably as the ethical aspects of vulnerability are concerned.
Physical harms range from death, developmental impairment and permanent injury at one extreme, to
temporary illness, pain and discomfort at the other[26]. Psychological harms include the research
participant's negative perception of self, emotional suffering and cognitive or behavioural
aberrations[27]. Social harms refers to the negative effects on the subject's familial and social
relationships. Examples include the risk of stigmatization as a result of testing positive for HIV[28]or
the risk that genetic studies will exclude a paternity[29]. Economic harms derive from the burden of
non-refunded or underestimated financial costs (or their equivalent in terms of time and work) to
participants in a research[30]. Legal harms can be incurred in studies of possession and use of illicit
drugs, sexual or physical abuse, or other kinds of prosecutable behaviour[31]. Particular attention
139 should be paid to the so-called dignitary harms, i.e. the wrongs a subject can suffer to his human
dignity during the recruitment, operative or follow-up phase of a research protocol. Dignitary harms are
a consequence of attempts on human rights, since "the foundation on which all human rights rest is the
dignity of the person"[32]. The violation of some fundamental and inalienable human rights - such as
the right of a human being not to have his or her bodily and psychological integrity impaired for
whatever reason other than a strictly therapeutic one - has already been covered by the abovementioned categories of harms. However, human dignity is neither restricted nor reducible to the
various aspects of physical, psychological, social and economic life. As a moral agent, every human
being has personal values and preferences, a conception of good and evil, and individual commitments.
These and other spiritual dimensions of human life are deeply rooted in the "original or elementary
experience" that constitutes our identity in the way we face everything, i.e. the "complex of needs and
"evidences" which accompany us as we come face to face with all that exists. […] So original are these
needs or these "evidences" that everything man does or says depends on them"[33]. At this level, we
are faced with the "heart" of human dignity. "This "heart" is vulnerable", and its vulnerability is
witnessed by "that indefinable unease that overtakes the individual when, for example, he or she is
treated as an object of another's interest or pleasure"[34]. In Kant's words, human dignity is harmed
whenever you do not "act in such a way that you always treat humanity, whether in your own person or
in the person of any other, never simply as a means, but always at the same time as an end"[35].
Avoiding dignitary harms requires a deep respect for every aspect of human dignity, including the
religious sense, i.e. the radical engagement of the person with life and its meaning, whatever the
identity of his or her life's meaning may be. Human dignity, in turn, rests on the human proper and
primordial nature - "the nature of the human person" - which is "the person himself in the unity of soul
and body, in the unity of his spiritual and biological inclinations and of all the other specific
characteristics necessary for the pursuit of his end"[37].
The reasons of vulnerability
There are different reasons why research subjects are vulnerable, and recent years have seen an
increase in studies on the causes of vulnerability[38]. According to Kipnis[39], these ways can be
grouped into six types. A seventh type, social vulnerability, has been added by other authors[40]. The
classification is somewhat redundant, but may be useful in order to decide whether a particular
category of subjects is vulnerable or not, and to what extent. Cognitive or communicative vulnerability
is the most familiar to investigators and, probably, more common than usually reported. Circumstances
that suggest the presence of this type of vulnerability should include not only immaturity (such as
children and adolescents)[41], mental retardation[42], dementia[43], and certain kinds of mental
illness[44], but also educational deficits and unfamiliarity with the language[45], as well as situations
that do not allow otherwise competent adults to exercise their capacities effectively (such as stressful
emergencies)[46]. These cognitive or communicative impairments affect the subject's decision-making
process and limit the autonomy of prospective research participants. Juridical or institutional
vulnerability refers to an individual that is subject to the formal authority of others (e.g. parents,
guardians, warders, officers and judges) who may have their own interests (private or public benefits)
in whether the individual agrees to enrol in the biomedical study[47]. Subjects might have a deferential
vulnerability - a subtle, underestimated form of vulnerability - when their decisional subordination to
others (e.g. relatives, friends, masters, physicians, and opinion makers) results from an informal
hierarchy[48]. Medical vulnerability may concern potential participants (patients) who suffer from
severe diseases for which there are no available, effective or acceptable standard treatments (e.g. very
aggressive forms of cancer, end-stage AIDS, and some rare disorders)[49]. Due to their extraordinary
medically exigent state, exploitation of these patients through their hope for remission or improvement
is not uncommon. Research subjects present an economic or allocational vulnerability when they are
140 disadvantaged in the social distribution of goods and services such as income, housing or health care.
Payment for participation or free access to health care services might constitute unfair inducements to
enrol through exploitation of a reduced economic autonomy[50]. When subjects' enlisting requires or
presupposes the availability to them of resources or facilities (e.g. a rapid communication system, a
reliable dietary intake, skilled health care professionals) that contribute decisively to their personal
safety during the study, prospective participants are exposed to infrastructural vulnerability[51]. Lastly,
social vulnerability refers to individuals belonging to undervalued social groups or communities[52]. In
some cases, this type of vulnerability is shifty and insidious, and "is a function of the social perception
of certain groups, which includes stereotyping and can lead to discrimination"[53]. With the exception
of the first type of vulnerability, the cognitive or communicative one, that recommends against the
eligibility of such a vulnerable person as an authorized decision maker in case of an incompetent
research subject, the remaining vulnerabilities might affect the proxy as well. As far as research
involving embryos and fetuses in utero is concerned, the natural and first-choice proxy decision maker
is the decisionally competent mother, not only because she can be expected to perceive and defend the
rights of her unborn baby better than any other person (if not, an ethical and legal conflict may arise,
often very difficult to settle)[54], but also in view of the fact that nowadays any research on the living
embryo (post-implantation) and fetus passes through the mother's body and in no circumstance is this
without a risk for the pregnant woman. In this case of proxy consent, the decision maker's vulnerability
may be a consequence of the mother's submission to a formal authority (e.g. the parents, if she is under
age), or due to informal power relations, socially constructed (e.g. with her obstetrician) or more
subjective in nature (e.g. with an influential friend). As a result of prenatal diagnosis, the woman may
be aware of a malformation or a severe disease affecting the fetus, for which there are no effective
standard treatments. If the mother is asked to enter into an experimental fetal therapy protocol, medical
vulnerability can be expected due to a major weakness in her decision-making process. In another
circumstance, the mother may be alone and unemployed or belong to a poor family, or live in a rural
and underdeveloped country, with no suitable obstetrical care facilities. Finally, the pregnant woman
may belong to an undervalued social group, e.g. immigrants or refugees. In the latter cases, the
mother's economic, infrastructural or social vulnerability exposes the unborn child to a greater risk of
being enlisted in a research project that may be ethically wrongful. The incompetent eligible for a
biomedical research remains a potentially vulnerable subject even when an authorized surrogate
consent makes up for his or her cognitive or communicative defect. Apart from evidence to the
contrary, indirect vulnerability via proxy consent cannot be excluded, and ethical procedures and legal
tools should be designed to protect the incompetent from exploitation. Proxy decision makers cannot
always be presumed to have a firm grasp of the represented subject's rights or to be in a position to
protect them unconditionally.
The most vulnerable subjects
Until recently, vulnerability in biomedical research - as a distinct ethical feature of a subpopulation of
subjects eligible for experimental studies - has received scarce systematic attention. However, the need
for such reflection has been appreciated for several decades[55]. During the 1970s, in the United States,
widely discussed episodes of wrongful research (e.g. the Willowbrook State School hepatitis study in
children[56], the Brooklyn Jewish Chronic Disease Hospital cancer research in elderly debilitated and
indigent patients[57], and the Tuskegee study of syphilis in poor and ignorant African-American men
)[58], while giving birth to our current procedures for ensuring the ethical conduct of investigations in
the biological and medical sciences, pointed out that these procedures (including considerations on the
study's scientific validity and value, analysis of risks and potential benefits, and informed consent)
cannot always prevent investigators from exploiting (deliberately or not) some weaknesses of
individuals and social groups that make them more prone to be involved in elevated-risk experimental
141 and clinical trials. The above-mentioned and other cases cast doubt on the wisdom of leaving the
judgement about a subject's study participation to the discretion of investigators only. Since the early
days of bioethics, a call for special protection of vulnerable individuals and populations[59] was
present in every manual and course dealing with the ethics of medicine and research. In identifying the
vulnerable subjects of biomedical research, a special role is attributed to the analysis of risks and
potential benefits for participants and to the subject selection procedures in research protocols. A
reference is often made to the "minimal risk" concept (see above, note 1). For example, this concept is
central to the schema for the analysis of risks in research involving children and people hospitalized as
mentally infirm, proposed by the U.S. National Commission on the Protection of Human Subjects of
Biomedical and Behavioural Research[60]. However, the distinction between "research not involving
greater than minimal risk" and "research involving greater than minimal risk" is not of easy and
unambiguous application. When faced with the atypical physical, psychological or social experiences
of most vulnerable subjects, the reference made in the definition to the "probability and magnitude of
physical and psychological harm that is normally encountered in the daily lives, or in the routine
medical and psychological examination"[61] is not as straightforward and clear as it claims to be. The
Belmont Report provides little additional detail with regard to this model for the ethical analysis of
risk, but emphasizes the importance of a "systematic, non-harbitrary analysis of risks and benefits"
through "the accumulation and assessment of information about all the aspects of the research", and
invites "to consider alternatives systematically"[62]. Alternatives to an invasive or otherwise
potentially harmful study on vulnerable subjects remain the ethically ideal solution to the dilemma
posed by most trials involving these groups of participants. Nevertheless, such alternatives are not
always easy to devise and apply, and - even if available and feasible - not all investigators, companies,
agencies, governments and the public opinion are prepared to accept them, especially when the route to
the expected biotechnological and clinical results is deemed to be longer and/or more laborious and
expensive.
IS THE HUMAN EMBRYO A MOST VULNERABLE SUBJECT?
The question of the human embryo's vulnerability in biomedical research arises from the evident
condition of weakness that characterizes embryonic life, with special reference to the in vitro human
embryo. The distinctive precariousness in the condition of the human embryo developing outside the
mother's womb cannot be denied. Even from a mere biological point of view, that neglects the
humanness of the embryo as a member of the human family, the in vitro developing conceptus is
among the weakest and least self-sustaining human beings ever described in the medical literature,
whose physical state - as far as its total dependence on life-support measures is concerned - is
comparable to that of patients with acute life-threatening conditions, such as severely premature
newborn babies in incubators, surgery patients during general anesthesia, and critically ill subjects in
intensive care units. Notwithstanding the continuous efforts to improve them[63], embryo culture
media and conditions are far from ideal when compared with the natural tubal and uterine
environment[64], and in vitro embryonic development is exposed to a series of risks including delayed
growth, infections, blastomere fragmentation, partial cavitation, abnormal distribution of cells between
the inner cell mass and the trophoblast, alteration of the zona pellucida, and delayed hatching[65].
Furthermore, cryopreservation in liquid nitrogen - a procedure carried out if the embryo is not
transferred to the uterus by day 5 or 6 of culture - is not a safe condition for the storage of embryos.
Depending on the stage of the embryo's development, the techniques employed and the length of
cryopreservation, a number of embryos are irreversibly harmed or exposed to the risk of death[66]. On
the whole, the in vitro human embryo is totally dependent on the laboratory's artificial environment and
the care of biologists and technicians[67]. Any faulty instrument, altered culture medium or failure to
obey precautionary rules (such as those concerning sterility) can have dramatic consequences on the
142 embryo's life and integrity[68]. Although in utero embryonic development too is not free from risks, in
vitro circumstances are characterized by an unusual exposure to several sources of harm and,
accordingly, the human embryo in vitro is a highly vulnerable subject. Besides risks that are common
to any in vitro fertilization (IVF) and embryo culture (EC) and transfer (ET) procedure, research
protocols add further exposure of embryos to dangerous conditions. Some experiments require per se
the destruction of the developing embryo. This is the case of research on pluripotent embryonic stem
cells (ESC)[69], obtained by removing the inner cell mass of the blastocyst at 5-6 days after
fertilization and culturing the obtained cells in the presence of some growth factors[70]. Other kinds of
experiments are less destructive. Among them are the studies of cell cycle, gene expression (mRNA
and protein synthesis) and metabolism in the cleaving, morula and blastocyst stage embryos[71]. To
perform these investigations, a number of cells are either removed from the embryo or injected with
tracing substances and analyzed by microscopic, immunochemical or molecular techniques[72]. Due to
the so-called "safety reasons" - i.e. to avoid the possible birth of a newborn baby affected by congenital
defects - embryos that survive these experiments are not allowed to develop and to be transferred to the
uterus. Lastly, research on new techniques of microassisted IVF[73] and pre-implantation
diagnosis[74], while of a less invasive nature and aimed at generating normally developing embryos, is
affected by a number of failures, including embryonic malformations and deaths. "Experimentation on
embryos and foetuses always involves risk, and indeed in most cases it involves the certain expectation
of harm to their physical integrity or even their death"[75]. However, physical harms are by no means
the only type of injury a human embryo can suffer while being generated and developed outside the
mother's womb and, even more, subjected to experimental research. The human embryo's dignity as a
human individual (subject), i.e. the son or the daughter of a woman and a man endowed with their own
dignity, is threatened because other persons exercise undisputed dominion over the life and the
integrity of the developing conceptus. No matter how important the scientific and clinical data obtained
or how noble and humanitarian the aim of an experimental study, it cannot reduce the human embryo to
an "object" or "instrument". "The use of human embryos or fetuses as an object of experimentation
constitutes a crime against their dignity as human beings who have a right to the same respect owed to
a child once born, just as to every person"[76]. In the second place and in the context where we use the
term "vulnerability", it reminds us that some researcher has, knowingly or negligently, taken unfair
advantage of the human embryo's weakness, carrying out experiments on an incompetent or "voiceless"
subject. The reasons why the embryo is very susceptible to being exploited in an unethical biomedical
investigation allow us to point again to the high vulnerability of this research subject. Although the
collection of a free and informed consent is not the only ethical criterion to justify research on human
subjects, the absence of the capacity to consciously decide whether or not to participate in an
experimental study is unanimously considered to be a clear indicator of vulnerability. Cognitive
vulnerability, in the presence of a more than "minimal risk" to the subjects, would suffice to proscribe
proxy consent in a non-therapeutic experimental setting. This should be true for the human embryo as
well. "No objective, even though noble in itself, such as a foreseeable advantage to science, to other
human beings or to society, can in any way justify experimentation on living human embryos or
foetuses, whether viable or not, either inside or outside the mother's womb. The informed consent
ordinarily required for clinical experimentation on adults cannot be granted by the parents, who may
not freely dispose of the physical integrity or life of the unborn child"[77]. In utero human embryos are
under the formal authority of their parents (or the mother alone) if competent, while the in vitro embryo
may be subject to either the legal parents, who provided gametes for the fertilization process, or to
other persons, such as physicians, investigators or judges (embryos left over from ET cycles or
generated for experimental purposes only). Because of this subordination, human embryos are
juridically vulnerable: they are liable to the authority of others who may have interests conflicting with
or neglecting the "best interest" of the research subject[78]. This distinctive vulnerability calls into
question the validity of the consent to research on embryos given by their parents or by other subjects
143 involved in IVF-ET. "This is especially a concern when those in authority are also those who are
conducting, commissioning, or somehow benefiting from the research"[79]. The human embryo as a
subject of biomedical research is also vulnerable in an indirect way, i.e. via the vulnerability of the
person that is required to give the proxy consent. Such a person can be juridically vulnerable him- or
herself, as in the case of a girl under the authority of her parents or a woman subject to a guardian.
Furthermore, parents may be affected by deferential vulnerability, as a result of a powerful social and
cultural pressure in favor of the use of ESC for research on cell therapy of severe diseases[80]. They
may mask an inner wish not to consent to an experimental study or find it hard to turn down a request
from their physician concerning the so-called "embryo donation for research purposes".
An unfair way of settling the question
The most insidious and dangerous way in which the human embryo becomes a highly vulnerable
research subject results from the denial of its subjectivity. When it is not recognized as a subject of
research - as every human being involved in biomedical research is - there are no compelling reasons
for treating the human embryo according to the same criteria of respect and protection which should be
adopted regarding all human individuals to whom is commonly attributed the moral and legal status of
a person. On the contrary, "the Church has always taught and continues to teach that the result of
human procreation, from the first moment of its existence, must be guaranteed that unconditional
respect which is morally due to the human being in his or her totality and unity as body and spirit: "The
human being is to be respected and treated as a person from the moment of conception"[81]. In the
context of current biomedical research discussions, the neglect of the human embryo's subjectivity and
its ethical implications are often masked by the ethical theory of "special (or adequate) protection" that
is accorded to the conceptus. An example of this approach to the embryo research question can be
found in the European Community's Convention for the Protection of Human Rights and Dignity of the
Human Being with Regard to the Application of Biology and Medicine (Oviedo Convention on Human
Rights and Biomedicine), whose Article 18 states: "Where the law allows research on embryos in vitro,
it shall ensure adequate protection of the embryo"[82]. The expression reflects the position of those
who hold that whereas human embryos before implantation do deserve some protection, they need not
be respected as human beings[83]. Arguments in favour of this opinion vary from one author to
another, and include the supposed developmental discontinuity between the embryo in vitro and in
utero, the non- or pre-personal status of the human embryo, some weak versions of the potentiality
argument, the "conflict of interests" approach to moral and social dilemmas, and the view that the
human embryo has a "symbolic value", which precludes its destruction for trivial reasons[84]. These
arguments will not be discussed here. In the context of the research subjects' vulnerability, our
concluding remarks will focus on the obscure and ambiguous meaning of "special (or adequate)
protection" with reference to experiments with human embryos. In everyday language, as well as in
ethics and law, the phrase "protecting somebody or something" attracts people's attention to the need to
prevent or rescue the protected one from a peril, either actual or foreseeable. While the nature and the
seriousness of the peril may vary to a great extent and one can discuss which perils a subject or an
object should be protected from, there is unanimous consensus that the minimum degree of protection
to be granted to a somehow valuable entity is to prevent or rescue it from death or destruction. The
second degree is protection of its integrity and core activity. No matter how the human embryo in vitro
is considered in the current debate - either as a human subject with full personal dignity and rights or a
biological entity whose value rests in its potential to become a person - the call for protection of the
embryo in biomedical research should at least explicitly ban any experimentation which of itself and by
intention causes its death (destruction) or permanent impairment of its developmental competence.
When no respect for each human embryo's life and integrity in whatever clinical or experimental
circumstance is guaranteed, how can a "special (or adequate) protection" be granted to the conceptus in
144 vivo? One way in which this statement has been interpreted is as follows. Human embryos as a whole
deserve adequate protection from destruction, harm or exploitation in experimental research on them.
Therefore, only a limited number of human embryos, in special circumstances, can be enlisted in nontherapeutic research protocols that will end in their death or developmental impairment. This concept
of collective respect regards human embryos as a species to be protected and not as subjects to be
safeguarded from an outrage upon their individual rights. As in the case of animals in danger of
extinction, the human life's value involved in this way of applying the principle of "special protection"
does not derive from the "special (unique) dignity" - intrinsic and inalienable - of every human being
whatever his or her personal situation may be, but reflects the "special role" granted to the first stages
of the human individual's life on earth and in society. This role being linked to the birth of a child, the
so-called "spare embryos" (left-over from IVF cycles, either cryopreserved or not) - when no longer
required for ET - lose their "function" and are considered to be ideal candidates for experimental
investigations. Therefore, it is widely felt that generating human embryos by IVF solely for research
purposes is ethically unacceptable while using "spare embryos" is less questionable[85]. Others,
however, doubt whether, or even deny that, there is a moral difference between the two practices: "Not
only is the embryo used instrumentally in both cases, also the moral status of the embryos is
identical"[86]. The argument given by Annas[87] et al. that the intention of gamete providers at the
moment of fertilization is fundamentally different sounds weak. "Even in the context of regular IVF,
not every embryo is created as a "goal in itself". The goal of IVF is the solution of involuntary
childlessness - the loss of some spare embryos is calculated beforehand"[88]. A second way of
addressing the question of a human embryo's "special protection" arises from the proportionalist and
utilitarian approach to ethical dilemmas in biomedical studies from which benefits to some subjects and
harms to others result. While there is broad consensus among the supporters of this view that the only
acceptable aim of human embryo research should be to benefit human health, there is difference of
opinion concerning the application of this principle[89]. Most authors emphasize that research on
human embryos can only be justified if direct and important clinical benefits to other embryos,
newborn babies or adults are reasonably to be expected. A few others, however, are inclined to accept
basic research too[90]. In this context, the advent of human ESC research and the speculations on its
possible impact on cell therapy[91] operated as a catalyst for the diffusion of this way of thinking.
Following this, a concept of relative respect should replace the idea of "unconditional respect" for the
life and integrity of each and every human embryo[92]. A third way that is adopted to make operational
the concept of "special protection" appeals to the so-called "principle of necessity" or "subsidiarity"[93]
and results in a form of revocable respect for the life and integrity of the human embryo. According to
the principle of necessity, human embryos may only be enrolled into experimental research if there are
no valid alternatives to reach an exceedingly valuable aim in the field of medicine, such as curing
severe and life-threatening diseases. Both the Warnock Commission (UK) and a Canadian Royal
Commission indicated that "necessity" means that no other animal model is available or appropriate to
conduct the experiments and achieve the expected results[94]. A field where the "necessity" to use
human embryos has been invoked is research on cell therapy. The advocates of human ESC research as
the most promising opportunity to enter into the "regenerative medicine" era often deny that stem cells
from sources other than embryos at the blastocyst stage - such as those from cord blood, fetal and postnatal tissues - can provide an effective alternative to cell therapy. On the contrary, these is growing and
sound evidence that stem or progenitor cells isolated from different tissues and cultured in vitro,
although not of unlimited self-renewal and boundless developmental potential such as ESCs, show a
surprising capacity to differentiate or transdifferentiate into a number of cell lines (cell plasticity).
Work is in progress to confirm the functional plasticity of stem cells from several adult tissues and to
discover new sources of these cells, to demonstrate clonal repopulation of organs from the transplanted
cells, and to identify mechanisms to increase donor engraftment[95]. As John Paul II reminded in his
address to the 18th International Congress of the Transplantation Society, "this is the direction that
145 research must follow if it wishes to respect the dignity of each and every human being, even at the
embryonic stage"[96]. However much longer and more laborious the alternative way to cell therapy
may be, both its scientific feasibility on principle and the absence of absolute clinical and ethical
contra-indications argue against the appeal to the principle of necessity. Indeed, the principle itself is
not applicable in such a circumstance where to satisfy the need of one subject would require violation
of the respect due to the life and integrity of another. "Respect", understood in these ways, is reduced to
and used as a weak form of protection that is suitable for an object (however precious, things do not
have intrinsic value) but inadequate for a subject (the value of human beings is not conditional on
something other than their intrinsic value). The dissolution of the subjectivity of the human embryo
leads to a dramatic increase of its vulnerability in the context of biomedical research.
The unconditional respect that is morally due to the human being
The only form of protection that is adequate for a human embryo as a research subject is the full
protection of its individual rights as a human being: "The fruit of human generation, from the first
moment of his existence, that is to say from the moment the zygote has formed, demands the
unconditional respect that is morally due to the human being in his bodily and spiritual totality"[97].
Any weaker form of embryo protection cannot answer for his rights to "be recognized, among which in
the first place is the inviolable right of every innocent human being to life"[98]. Nowadays, the life of
the in vitro embryo is at greater risk of being threatened during experimental studies than any other
human being's life, i.e. the human embryo is a most vulnerable research subject. Vulnerability requires
care for the vulnerable, and such care must be guaranteed by the ethical conduct of scientists and
physicians and the national and international law. The vulnerable subject is a subject poor in protection,
not in rights. There is a moral and civil duty to protect the poor, and this duty cannot be forgotten in the
course of biomedical research. In a Christian perspective, according to the special care for the little
ones that is required by the Gospel, biomedical research ethics must pay special attention to the rights
of the least of the research subjects: "In so far as you did this to one of the least of these brothers of
mine, you did it to me". (Mt 25: 40)
[1] Notwithstanding the optimistic appraisal of the ADVISORY COMMITTEE ON HUMAN
RADIATION EXPERIMENTS that ";40 to 50 percent of human subjects research poses no more than
minimal risks of harm to subjects" (Final Report, Washington, D.C.: U.S. Government Printing Office,
1995, Chapter 17, Commentary following Finding 22), the debate on the so-called ";minimal risk
standard" and its impact on the ethics and law of clinical trials continues to be lively. According to the
U.S. Federal Policy for the Protection of Human Subjects of the DEPARTMENT OF HEALTH AND
HUMAN SERVICES, ";minimal risk" refers to a research setting in which ";the probability and
magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than
those ordinarily encountered in daily life or during the performance of routine physical or
psychological examinations or tests". (Code of Federal Regulations, Title 45, Part 46, §102(i) : Federal
Register, June 18, 1991, 56: 28003) Clearly, there is nothing common to everybody about the risks
inherent in ";daily life", and any interpretation of the suggested criterion is questionable. For a critical
analysis of the classification of research that relies on the minimal risk standard, see: PRENTICE E.D.
AND GORDON B.G., Institutional Review Board Assessment of Risks and Benefits Associated with
Research, in: NATIONAL BIOETHICS ADVISORY COMMISSION, Ethical and Policy Issues in
Research Involving Human Participants, Bethesda, MD: National Bioethics Advisory Commission,
2001, vol. 2, pp. L1-L16, pp. L7-L9.
146 [2] EVANS D., EVANS M., A Decent Proposal. Ethical Review of Clinical Research, Chichester:
Wiley, 1996, p. 17.
[3] BLACKSHER E., STONE J.R., Introduction to Vulnerability Issues of Theoretical Medicine and
Bioethics, Theoretical Medicine and Bioethics 2002, 23: 421-424, p. 422.
[4]FOX K., Hotep's story: Exploring the wounds of health vulnerability in the US, Theoretical
Medicine and Bioethics 2002, 23: 471-497, p. 472.
[5]KIPNIS K., Vulnerability in research subjects: a bioethical taxonomy, in NATIONAL BIOETHICS
ADVISORY COMMISSION, Ethical and Policy Issues in Research Involving Human Participants, op.
cit., vol. 2, pp. G1-G13, p. G5; see also ID, Seven vulnerabilities in the pediatric research subject,
Theoretical Medicine and Bioethics 2003, 107-120, pp. 108-109.
[6] KIPNIS K., Vulnerability in research subjects: a bioethical taxonomy, op. cit., p. G5.
[7] In recent years, many authors have addressed the topic of exploitation in biomedical research and in
clinical trials, with special reference to the developing countries and AIDS research. See, for example,
ANGELL M., The ethics of clinical research in the Third World, The New England Journal of
Medicine 1997, 337: 847-849; LURIE P. AND WOLF S., Unethical trials of interventions to reduce
perinatal transmission of the human immunodeficiency virus in developing countries, ibid: 853-856;
VARMUS H. AND SATCHER D., Ethical complexities of conducting research in developing
countries, ibid.: 1000-1005; SAVULESCU J., On the commercial exploitation of participants of
research, Journal of Medical Ethics 1997, 23: 392; RESNICK D., The ethics of HIV research in
developing nations, Bioethics 1998, 12: 286-306; MBIDDE E., Bioethics and local circumstances,
Science 1998, 279: 155; BENATAR S.R., Avoiding exploitation in clinical research, Cambridge
Quarterly of Healthcare Ethics 2000, 9: 562-565; BHAGAT K. AND NYAZEMA N., Ethics and HIV
research in Zimbabwe, Central African Journal of Medicine 2000, 46: 105-107; MULLINGS A.,
Genetic research in the Third World (developing) countries: science or exploitation?, St. Thomas Law
Review 2001, 13: 955-964; MILLER F. AND BRODY H., What makes clinical trials unethical?,
American Journal of Bioethics 2002, 2(2): 2-10; RESNIK D.B., Exploitation and the ethics of clinical
trials, ibid.: 28-30; AGRAWAL M., Voluntariness in clinical research at the end of life, Journal of Pain
Symptoms Management 2003, 25: S25-S32; LEE S. AND KRISTJANSON L., Human research ethics
committees: issues in palliative care research, International Journal of Palliative Nursing 2003, 9: 1318.
[8] MACKLIN R., After Helsinki: unresolved issues in international research, Kennedy Institute of
Ethics Journal 2001, 11: 17-36, pp. 23.25.
[9] RESNIK D.B., Exploitation in biomedical research, Theoretical Medicine and Bioethics 2003, 24:
233-259.
[10] Ibid., p. 234.
[11] JOHN PAUL II, Post-synodal apostolic exhortation Reconciliatio et paenitentia (December 2,
1984), 17, in Acta Apostolicae Sedis 1985, 77: 185-275, p. 221; quoted in ID., Encyclical letter
Veritatis splendor (August 6, 1993), 80, in Acta Apostolicae Sedis 1993, 85: 1133-1228, p. 1197 .
[12] SECOND VATICAN ECUMENICAL COUNCIL, Pastoral Constitution on the Church in the
Modern World Gaudium et spes (December 7, 1965), 27.
[13] Cf. KANT I., Grundlegung zur Metaphysik der Sitten, Lipsia: Hartknoch, 1785 (Groundwork of
the Metaphysics of Morals [trans. by H.J. Paton], New York, N.Y.: Harper Torchbooks, 1964, p. 96).
[14] JOHN PAUL II, Veritatis splendor, 81, in Acta Apostolicae Sedis 1993, 85, p. 1198.
[15] REEVE A. (ed.), Modern Theories of Exploitation, Beverly Hills, CA: Sage Publications, 1987;
FEINBERG J., Harmless Wrongdoing, New York, N.Y.: Oxford University Press, 1988; WOOD A.,
Exploitation, Social Philosophy and Policy 1995, 12: 136-150; HOLMSTROM N., Exploitation,
Canadian Journal of Philosophy 1997, 7: 353-370; CARLING A., Exploitation, in CHADWICK R.
(ed.), Encyclopedia of Applied Ethics, San Diego, CA: Academic Press, 1998, vol. 2, pp. 219-232;
147 ARNESON R., Exploitation, in BECKER L., BECKER C. (eds.), Encyclopedia of Ethics, New York,
N.Y.: Routledge, 2001, vol. 1, pp. 515-517.
[16] According to Wertheimer, exploiting someone wrongfully always involves taking unfair
advantage of someone for one's own benefit: WERTHEIMER A., Exploitation, Princeton, NJ:
Princeton University Press, 1996, p. 10.
[17] RESNIK D.B., Exploitation in biomedical research, op. cit., p. 240.
[18] Ibid., p. 243.
[19] EDWARDS S.D., An argument against research on people with intellectual disabilities, Medicine,
Health Care and Philosophy 2000, 3: 69-73, p. 70.
[20] Cf. EVANS, EVANS, A Decent Proposal, op. cit., p. 17.
[21] AGRAWAL M., Voluntariness in clinical research at the end of life, op. cit., p. S29.
[22] For a useful discussion on the concept of risk see: VAN NESS P.H., The concept of risk in
biomedical research involving human subjects, Bioethics 2001, 15: 364-370, and the literature cited
therein.
[23] BERG J.W., Legal and ethical complexities of consent with cognitively impaired research
subjects: proposed guidelines, Journal of Law and Medical Ethics 1996, 24: 18-35, p. 24.
[24] LEVINE R.J., Balance of Harms and Benefit. Ethics and Regulation of Clinical Research, New
Haven: Yale University Press, 1988: 37-65.
[25] See, for example, THE PRESIDENT’S COMMISSION FOR THE STUDY OF ETHICAL
PROBLEMS IN MEDICINE AND BIOMEDICAL AND BEHAVIOURAL RESEARCH,
Implementing Human Research Regulation: The Adequacy and Uniformity of Federal Rules and of
Their Implementations, Washington, D.C.: U.S. Government Printing Office, 1983; NATIONAL
BIOETHICS ADVISORY COMMISSION, Ethical and Policy Issues in Research Involving Human
Participants, op. cit., vol. 1.
[26] LEMBERGER L., Early clinical evaluation in man: the buck stops here, Xenobiotica 1987, 17:
267-273; WEIJER C., FUKS A., The duty to exclude: excluding people at undue risk from research,
Clinical and Investigative Medicine 1994, 17: 115-122; ELLIOTT C., Doing harm: living organ
donors, clinical research and the tenth man, Journal of Medical Ethics 1995, 21: 91-96; GROUDINE
S., LUMB P.D., At the coalface – medical ethics in practice. First, do no harm, Journal of Medical
Ethics 1997, 23: 377-378; LONDON A.J., KADANE J.B., Placebos that harm: sham surgery controls
in clinical trials, Statistical Methods in Medical Research 2002, 11: 413-427.
[27] Psychological harms also include distress, anger or guilt related to the disclosure of sensitive or
embarrassing information, and anxiety and fear upon learning of one’s likelihood of developing a
disease for which there is no effective treatment: GLASS, K.C., WEIJER C., LEMMENS T.,
PALMOUR R.M., SHAPIRO S.H., Structuring the Review of Human Genetics Protocols, Part II:
Diagnostic and Screening Studies, IRB: A Review of Human Subjects Research 1997, 19(3-4): 1-13;
MARTEAU T.M., CROYLE R.T., Psychological Responses to Genetic Testing, British Medical
Journal 1998, 316: 693–696; MEISER, B., DUNN S., Psychological Impact of Genetic Testing for
Huntington’s Disease: An Update of the Literature, Journal of Neurology, Neurosurgery and Psychiatry
2000, 69: 574-578.
[28] KESSEL E., Estimating risks and benefits in AIDS vaccine and drug trials, AIDS Public Policy
Journal 1990, 5: 186-188; INSTITUTE OF MEDICAL ETHICS – WORKING PARTY ON THE
ETHICAL IMPLICATIONS OF AIDS, AIDS, ethics, and clinical trials, British Medical Journal 1992,
305: 699-701; BELOQUI J., CHOKEVIVAT V., COLLINS C., HIV vaccine research and human
rights: examples from three countries planning efficacy trials, Health and Human Rights 1998, 3: 3858; LEIDER P.A., Domestic AIDS vaccine trials: addressing the potential for social harm to the
subjects of human experiments, California Law Review 2000, 88: 1185-1232.
[29] WERTZ D.C., FLETCHER J.C., Privacy and disclosure in medical genetics examined in an ethics
of care, Bioethics 1991, 5: 212-232; WEIL J., MACKAY C.R., Howard: paternity and Pandora's box,
148 Cambridge Quarterly of Healthcare Ethics 1993, 2: 229-237; ROSS L.F., Disclosing misattributed
paternity, Bioethics 1996, 10:114-130; RITTER M.M., Genetic testing and paternity, Lancet 2001, 358:
241; LUCASSEN A., PARKER M., Revealing false paternity: some ethical considerations, Lancet
2001, 357: 1033-1035.
[30] DIAMOND A.L., LAURENCE D.R., Compensation and drug trials, British Medical Journal
1983, 287: 675-677; GUEST S., Compensation for subjects of medical research: the moral rights of
patients and the power of research ethics committees, Journal of Medical Ethics 1997, 23:181-185.
[31] FITZGERALD J.L., HAMILTON M., The Consequences of knowing ethical and legal liabilities
in illicit drug research, Social Science and Medicine 1996, 43: 1591-1600; ID., Confidentiality,
disseminated regulation and ethico-legal liabilities in research with hidden populations of illicit drug
users, Addiction 1997, 92: 1099-1107; LOXLEY W., HAWKS D., BEVAN J., Protecting the interests
of participants in research into illicit drug use: two case studies, Addiction 1997, 92:1081-1085;
KINARD E.M., Ethical issues in research with abused children, Child Abuse and Negligence 1985, 9:
301-311.
[32] JOHN PAUL II, Post-synodal apostolic exhortation Ecclesia in America (January 22, 1999), 57, in
Acta Apostolicae Sedis 1999, 91: 737-815, p. 792. Contrary to this view of human rights as deeply
rooted in the dignity of every human being, the ";interests" theory of rights – frequently proposed in the
context of the abortion debate (see, for example, PURDY L., TOOLEY M., Is abortion murder?, in
PERKINS R. (ed.), Abortion: Pro and Con, Cambridge, MA: Schenkman, 1974, p. 144) – assumes that
a being can have rights if it is capable of having ";conscious desires" or ";interests". On this
presupposition, human embryos and fetuses are not entitled to inalienable human rights, including the
right to life, integrity and development. Following this theory, Feinberg claims that someone is harmed
only when his or her interests have been thwarted, defeated, invaded or set back (FEINBERG J., Harm
to Others, New York, N.Y.: Oxford University Press, 1984, pp. 31–64). This definition would include a
virtually unlimited number of harms that conscious subjects may complain about and exclude even the
most devastating harm to unconscious subjects. The ";interests" approach to the foundation of rights
shows its weakness when confronted by the moral question of our obligation to recognize and respect
the rights of another being. The simple fact that someone has, or is capable of having, desires and
interests of any kind is not obviously a compelling reason for each of us to comply with these desires
and protect these interests.
[33] GIUSSANI L., The Religious Sense, Montreal: McGill-Queen University Press, 1997, p. 7.
[34] Ibid., p. 11.
[35] KANT I., Groundwork of the Metaphysics of Morals, op. cit., p. 96. For an insightful discussion
of this sentence in the light of Kant’s moral theory, see HILL T.E. JR., Humanity as an end in itself,
Ethics 1980, 91: 84-90; COOPER N., The Formula of the end in itself, Philosophy 1988, 63: 401-415.
[36] SECOND VATICAN ECUMENICAL COUNCIL, Gaudium et spes, 51.
[37] JOHN PAUL II, Veritatis splendor, 50, in Acta Apostolicae Sedis 1993, 85, p. 1173.
[38] Among others, see BRAZIER M., LOBJOIT M. (eds.), Protecting the Vulnerable: Autonomy and
Consent in Health Care, New York, N.Y.: Routledge, 1991; THOMASMA D.C., A communal model
for presumed consent for research on the neurologically vulnerable, Accountability in Research 1996,
4: 227-239; BRODY B., Research on the vulnerable sick, in KAHN J.P., MASTRIOANNI A.C.,
SUGARMAN J. (eds.), Beyond Consent: Seeking Justice in Research, New York, N.Y.: Oxford
University Press, 1998, pp. 32-46; DENNIS B.P., The origin and nature of informed consent:
experiences among vulnerable groups, Journal of Professional Nursing 1999, 15: 281-287; UDO, S.,
Protecting the vulnerable: testing times for clinical research ethics, Social Science and Medicine 2000,
51: 969-977; NICHOLSON R., Who is vulnerable in clinical research?, Bulletin of Medical Ethics
2002 (181): 19-24; STEINBOCK B., ARRAS J.D., LONDON A.J., Ethical Issues in Modern
Medicine, Boston, MA: McGraw-Hill, 2003; ECKSTEIN S. (ed.), Manual for Research Ethics
Committees, Cambridge, UK – New York, N.Y.: Cambridge University Press, 2003.
149 [39] KIPNIS K., Vulnerability in research subjects: a bioethical taxonomy, op. cit., pp. G7-G12.
[40] See, for example, NATIONAL BIOETHICS ADVISORY COMMISSION, Ethical and Policy
Issues in Research Involving Human Participants, op. cit., vol. 1, pp. 90-91.
[41] GRANT V.J., Consent in paediatrics: a complex teaching assignment, Journal of Medical Ethics
1991, 17:199-204; DORN L.D., SUSMAN E.J., FLETCHER J.C., Informed consent in children and
adolescents: age, maturation and psychological state, Journal of Adolescent Health 1995, 16: 185-190;
COHEN D., FLAMENT M., TAIEB O., THOMPSON C., BASQUIN M., Electroconvulsive therapy in
adolescence, European Journal of Child and Adolescent Psychiatry 2000, 9: 1-6; DICKEY S.B.,
KIEFNER J., BEIDLER S.M., Consent and confidentiality issues among school-age children and
adolescents, Journal of School Nursing 2002, 18: 179-186.
[42] FREEDMAN R.I., Ethical challenges in the conduct of research involving persons with mental
retardation, Mental Retardation 2001, 39: 130-41.
[43] KEYSERLINGK E.W., GLASS K., KOGAN S., GAUTHIER S., Proposed guidelines for the
participation of persons with dementia as research subjects, Perspectives in Biology and Medicine
1995, 38:319-361; KARLAWISH J.H., CASARETT D., Addressing the ethical challenges of clinical
trials that involve patients with dementia, Journal of Geriatric Psychiatry and Neurology 2001, 14: 222228.
[44] BRUERA E., MILLER L., MCCALLION J., MACMILLAN K., KREFTING L., HANSON J.,
Cognitive failure in patients with terminal cancer: a prospective study, Journal of Pain
Symptomatology Management 1992, 7: 192-195; APPELBAUM P.S., GRISSO T., FRANK E.,
O'DONNELL S., KUPFER D.J., Competence of depressed patients for consent to research, American
Journal of Psychiatry 1999, 156: 1380-1384; CARPENTER W.T. JR, GOLD J.M., LAHTI A.C.,
QUEERN C.A., CONLEY R.R., BARTKO J.J., KOVNICK J., APPELBAUM P.S., Decisional
capacity for informed consent in schizophrenia research, Archives of General Psychiatry 2000, 57:
533-538; KIM S.Y., COX C., CAINE E.D., Impaired decision-making ability in subjects with
Alzheimer's disease and willingness to participate in research, American Journal of Psychiatry. 2002,
159: 797-802; KIM S.Y., KARLAWISH J.H., CAINE E.D., Current state of research on decisionmaking competence of cognitively impaired elderly persons, American Journal of Geriatric Psychiatry
2002, 10: 151-165.
[45] ASHCROFT R.E., CHADWICK D.W., CLARK S.R., EDWARDS R., FRITH L., HUTTON J.L.,
Implications of socio-cultural contexts for the ethics of clinical trials, Health Technology Assessment
1997, 1(9): 1-65.
[46] SMITHLINE H.A., MADER T.J., CRENSHAW B.J., Do patients with acute medical conditions
have the capacity to give informed consent for emergency medicine research?, Academic Emergency
Medicine 1999, 6: 776-780.
[47] TROUT M.E., Should research in prisons be barred?, Journal of Legal Medicine 1974, 2: 2-10;
DERIEMER T.A., Human research in Connecticut prisons, Connecticut Medicine 1975, 39: 387-391;
WHITE L.P., Biomedical experimentation on prisoners, Western Journal of Medicine 1976, 124: 514516; SOMERVILLE M.A., Criminality, confinement, psychiatric care and consent: a dilemma
augmenting combination, Legal Medicine Quarterly 1981-1983, 5-7: 147-159; DUDLEY H.A.,
Research ethics committees and military defence, Journal of the Royal College of Physicians (London)
1994, 28: 237-241; REGEHR C., EDWARDH M., BRADFORD J., Research ethics and forensic
patients, Canadian Journal of Psychiatry 2000, 45: 892-898 [see also the comments on this paper that
appeared in the same Journal 2002, 47: 384-386].
[48] HEWLETT S., Consent to clinical research: adequately voluntary or substantially influenced?,
Journal of Medical Ethics 1996, 22: 232-237; HARRELL J.S., BRADLEY C., DENNIS J.,
FRAUMAN A.C., CRISWELL E.S., School-based research: problems of access and consent, Journal
of Pediatric Nursing 2000, 15: 14-21; ROTHSTEIN M.A., Ethical guidelines for medical research on
workers, Journal of Occupational and Environmental Medicine 2000, 42: 1166-1171; HAYMAN R.M.,
150 TAYLOR B.J., PEART N.S., GALLAND B.C., SAYERS R.M., Participation in research: informed
consent, motivation and influence, Journal of Paediatric and Children's Health 2001, 37: 51-54; PENTZ
R.D., FLAMM A.L., SUGARMAN J., COHEN M., DANIEL AYERS G., HERBST R.,
ABBRUZZESE J.L., Study of the media's potential influence on prospective research participants'
understanding of and motivations for participation in a high-profile phase I trial, Journal of Clinical
Oncology 2002, 20: 3785-3791.
[49] SILVERMAN H.J., Ethical considerations of ensuring an informed and autonomous consent in
research involving the critically ill, American Journal of Respiratory Critical Care Medicine, 1996,
154: 582-586; CASARETT D., Beyond vulnerability: the ethics of end-of-life research, Journal of Pain
Symptoms Management 1999, 18: 143-145; SCHUTTA K.M., BURNETT C.B., Factors that influence
a patient's decision to participate in a phase I cancer clinical trial, Oncology Nursing Forum 2000, 27:
1435-1438; ELLIS P.M., Attitudes towards and participation in randomised clinical trials in oncology:
a review of the literature, Annals of Oncology 2000, 11: 939-945; BOSK C.L., Obtaining voluntary
consent for research in desperately ill patients, Medical Care 2002, 40(9 Suppl.): V64-V68;
CASARETT D.J., KNEBEL A., HELMERS K., Ethical challenges of palliative care research, Journal
of Pain Symptoms Management 2003, 25: S3-S5; KARLAWISH J.H.T., Conducting research that
involves subjects at the end of life who are unable to give consent, Ibid.: S14-S24.
[50] How the exploitation of economic vulnerability, when coupled with social vulnerability, may be
easy and stubborn at the same time, came out clearly with the Tuskegee Syphilis Study scandal (U.S.
DEPARTMENT OF HEALTH, EDUCATION AND WELFARE, Final Report of the Tuskegee
Syphilis Study Ad Hoc Advisory Panel, Washington, D.C.: U.S. Government Printing Office, 1973;
JONES J.H., Bad Blood: The Tuskegee Syphilis Experiment, New York: Free Press, 1993; PENCE G.,
Classic Cases in Medical Ethics, New York: McGraw-Hill, 1995, pp. 225-252). The study began in
1932, lasted 40 years, and involved 600 African-American men living in Macon Country (Alabama),
399 with syphilis and 201 who did not have the disease. Subjects’ high vulnerability – due to
indigence, ignorance, and racial discrimination – was exploited by the investigators in the absence of
any information on and consent to the research. In exchange for participation, the men received some
unrelated health care, free meals, and transportation, and later in the study, to encourage autopsy, a 50
dollar burial stipend. Payment of research subjects for study participation is a common yet poorly
discussed practice. For a critical reflection on this question, see DICKERT N., GRADY C., What's the
price of a research subject: approaches to payment for research participation, The New England Journal
of Medicine 1999, 341: 198-203 ; ANDERSON J.A., WEIJER C., The research subject as wage earner,
Theoretical Medicine and Bioethics 2002, 23: 359-376.
[51] JAYASURIYA D.C., Law, ethics, and biomedical research involving human subjects in
developing countries, Journal of Clinical Research and Drug Development 1989, 3: 83-88;
BEAUCHAMP T., JENNINGS B., KINNEY E., LEVINE R., Pharmaceutical research involving the
homeless, Journal of Medicine and Philosophy 2002, 27: 547-564.
[52] WEIJER C., Protecting communities in research: philosophical and pragmatic challenges,
Cambridge Quarterly of Healthcare Ethics 1999, 8: 501–513.
[53] NATIONAL BIOETHICS ADVISORY COMMISSION, Ethical and Policy Issues in Research
Involving Human Participants, op. cit., vol. 1, p. 90. Several aspects of social vulnerability are
discussed in: WEISSTUB D.N., ARBOLEDA-FLOREZ J., AND TOMOSSY G.F., Establishing the
boundaries of ethically permissible research with special populations, Health and Law in Canada 1996,
17: 45-63; DENNIS B.P., The origin and nature of informed consent: experiences among vulnerable
groups, Journal of Professional Nursing 1999, 15: 281-287; DYREGROV K, DYREGROV A,
RAUNDALEN M., Refugee families' experience of research participation, Journal of Trauma Stress
2000, 13: 413-426.
[54] STRONG C., Ethical conflicts between mother and fetus in obstetrics, Clinical Perinatology 1987,
14: 313-328; MEYER K.C., Forced medical treatment in pregnancy: resolving the conflicting rights of
151 mother and fetus, Medical Staff Counseling 1990, 4: 53-58; MATTINGLY S.S., The maternal-fetal
dyad. Exploring the two-patient obstetric model, Hastings Center Report 1992, 22(1): 13-18;
PINKERTON J.V., FINNERTY J.J., Resolving the clinical and ethical dilemma involved in fetalmaternal conflicts, American Journal of Obstetrics and Gynecology 1996, 175: 289-295;
CHERVENAK F.A., MCCULLOUGH L.B., The fetus as a patient: an essential ethical concept for
maternal-fetal medicine, Journal of Maternal and Fetal Medicine 1996, 5: 115-119; FLAGLER E.,
BAYLIS F., RODGERS S., Bioethics for clinicians: 12. Ethical dilemmas that arise in the care of
pregnant women: rethinking "maternal-fetal conflicts", Canadian Medical Association Journal 1997,
156: 1729-1732; FASOULIOTIS S.J., SCHENKER J.G., Maternal-fetal conflict, European Journal of
Obstetrics, Gynecology and Reproductive Biology 2000, 89: 101-107.
[55] Cf. KIPNIS K., Vulnerability in research subjects: a bioethical taxonomy, op. cit., pp. G1-G2.
[56] KRUGMAN S., Experiments at the Willowbrook State School, Lancet 1971, I: 966-967; ID., The
Willowbrook hepatitis studies revisited: ethical aspects, Review of Infective Diseases 1986, 8: 157-62.
[57] FADEN R.R., BEAUCHAMP T.L., KING N.M.P., A History and Theory of Informed Consent,
New York, N.Y. – Oxford, UK: Oxford University Press, 1986, pp. 161-167; MACKLIN R., Mortal
Choices, New York, N.Y.: Pantheon, 1987, pp. 167-194.
[58] BENEDEK, T.G., The Tuskegee study of syphilis: analysis of moral versus methodological
aspects, Journal of Chronic Diseases 1978, 31: 35-50; KING P.A., EDGAR H., CAPLAN A.L.,
Twenty years after. The legacy of the Tuskegee Syphilis Study, Hastings Center Report 1992, 22(6):
29-38; CORBIE-SMITH G., The continuing legacy of the Tuskegee Syphilis Study: considerations for
clinical investigation, American Journal of Medical Sciences 1999, 317: 5-8; WHITE R.M., Unraveling
the Tuskegee study of untreated syphilis, Archives of Internal Medicine 2000, 160: 585-598; ID., The
Tuskegee syphilis study, Hastings Center Report 2002, 32(6): 4-5.
[59] MORENO J.D., Protectionism in research involving human subjects, in NATIONAL BIOETHICS
ADVISORY COMMISSION, Ethical and Policy Issues in Research Involving Human Participants, op.
cit., vol. 2, pp. I1-I21.
[60] NATIONAL COMMISSION ON THE PROTECTION OF HUMAN SUBJECTS OF
BIOMEDICAL AND BEHAVIOURAL RESEARCH, Research Involving Children: Report and
Recommendations, Washington, D.C.: Department of Health, Education and Welfare, 1977; ID.,
Research Involving Those Instituzionalized as Mentally Infirm: Report and Recommendations,
Washington, D.C.: Department of Health, Education and Welfare, 1978.
[61] NATIONAL COMMISSION ON THE PROTECTION OF HUMAN SUBJECTS OF
BIOMEDICAL AND BEHAVIOURAL RESEARCH, Research Involving Children: Report and
Recommendations, op. cit., p. xx.
[62] NATIONAL COMMISSION ON THE PROTECTION OF HUMAN SUBJECTS OF
BIOMEDICAL AND BEHAVIOURAL RESEARCH, The Belmont Report: Ethical Principles for the
Protection of Human Subjects of Biomedical and Behavioural Research, Washington, D.C.:
Department of Health, Education and Welfare, 1978, Part C (Applications), n. 2.
[63] MENEZO Y.J., SAKKAS D., JANNY L., Co-culture of the early human embryo: factors affecting
human blastocyst formation in vitro, Microscopy Research Techniques 1995, 32: 50-56; DE SILVA
M., Culturing human embryos with and without glucose, Fertility and Sterility 1998, 69: 970-971;
CONWAY-MYERS B.A., Co-culture update: creating an embryotrophic environment in vitro,
Seminars in Reproductive Endocrinology 1998, 16:175-82; WIEMER K.E., COHEN J., TUCKER
M.J., GODKE R.A., The application of co-culture in assisted reproduction: 10 years of experience with
human embryos, Human Reproduction 1998, 13(Suppl 4): 226-238; MENEZO Y., VEIGA A.,
BENKHALIFA M., Improved methods for blastocyst formation and culture, Human Reproduction
1998, 13(Suppl 4): 256-265; MAHADEVAN M.M., Optimization of culture conditions for human in
vitro fertilization and embryo transfer, Seminars in Reproductive Endocrinology 1998, 16: 197-208;
COOKE S., QUINN P., KIME L., AYRES C., TYLER J.P., DRISCOLL G.L., Improvement in early
152 human embryo development using new formulation sequential stage-specific culture media, Fertility
and Sterility 2002, 78: 1254-1260; BLAKE D., SVALANDER P., JIN M., SILVERSAND C.,
HAMBERGER L., Protein supplementation of human IVF culture media, Journal of Assisted
Reproduction and Genetics 2002, 19: 137-143; BOISO I., VEIGA A., EDWARDS R.G., Fundamentals
of human embryonic growth in vitro and the selection of high-quality embryos for transfer,
Reproductive Biomedicine Online 2002, 5: 328-350.
[64] LOZA ARREDONDO M.C., HICKS, J.J., Influencia del medio tubario y uterino en el desarrollo
embrionario, Ginecologia y Obstetricia Mexicana 1990, 58: 245-250; PULKKINEN M.O., Oviductal
function is critical for very early human life, Annals of Medicine 1995, 27: 307-310; BARNES F.L.,
The effects of the early uterine environment on the subsequent development of embryo and fetus,
Theriogenology 2000, 53: 649-658; DIAZ-CUETO L., GERTON G.L., The influence of growth factors
on the development of preimplantation mammalian embryos, Archives of Medical Research 2001, 32:
619-626.
[65] COHEN J., ELSNER C., KORT H., MALTER H., MASSEY J., MAYER M.P., WIEMER K.,
Impairment of the hatching process following IVF in the human and improvement of implantation by
assisting hatching using micromanipulation, Human Reproduction 1990, 5: 7-13; HARDY K.,
Apoptosis in the human embryo, Review of Reproduction 1999, 4: 125-134; ALIKANI M.,
CALDERON G., TOMKIN G., GARRISI J., KOKOT M., COHEN J., Cleavage anomalies in early
human embryos and survival after prolonged culture in vitro, Human Reproduction 2000, 5: 26342643; BRISON D.R., Apoptosis in mammalian preimplantation embryos: regulation by survival
factors, Human Fertility (Cambridge) 2000, 3: 36-47; HARDY K., SPANOS S., BECKER D.,
IANNELLI P., WINSTON R.M., STARK J., From cell death to embryo arrest: mathematical models of
human preimplantation embryo development, Proceedings of the National Academy of Sciences USA
2001, 98: 1655-1660; PORTER R.N., TUCKER M.J., GRAHAM J., SILLS E.S., Advanced embryo
development during extended in vitro culture: observations of formation and hatching patterns in nontransferred human blastocysts, Human Fertility (Cambridge) 2002, 5: 215-220.
[66] VAN DEN ABBEEL E., CAMUS M., VAN WAESBERGHE L., DEVROEY P., VAN
STEIRTEGHEM A.C., Viability of partially damaged human embryos after cryopreservation, Human
Reproduction 1997, 12: 2006-2010; MAGLI M.C., GIANAROLI L., FORTINI D., FERRARETTI
A.P., MUNNE S., Impact of blastomere biopsy and cryopreservation techniques on human embryo
viability, Human Reproduction 1999, 14: 770-773; VAN DEN ABBEEL E., VAN STEIRTEGHEM
A., Zona pellucida damage to human embryos after cryopreservation and the consequences for their
blastomere survival and in vitro viability, Human Reproduction 2000, 15: 373-378; EDGAR D.H.,
JERICHO H., BOURNE H., MCBAIN J.C., The influence of prefreeze growth rate and blastomere
number on cryosurvival and subsequent implantation of human embryos, Journal of Assisted
Reproduction and Genetics 2001, 18: 135-138; MACHTINGER R., DOR J., LEVRON J.,
MASHIACH S., LEVRAN D., SEIDMAN D.S., The effect of prolonged cryopreservation on embryo
survival, Gynecological Endocrinology 2002, 16: 293-298; GUERIF F., BIDAULT R., CADORET V.,
COUET M.L., LANSAC J., ROYERE D., Parameters guiding selection of best embryos for transfer
after cryopreservation: a reappraisal, Human Reproduction 2002, 17: 1321-1326.
[67] SCOTT L.A., In vitro fertilization: technology and methods, Clinical and Laboratory Medicine
1992, 12: 411-428; YEUNG W.S., NG E.H., Laboratory aspects of assisted reproduction, Hong Kong
Medical Journal 2000, 6: 163-168.
[68] WIEMER K.E., ANDERSON A., STEWART B., The importance of water quality for media
preparation, Human Reproduction 1998, 13(Suppl 4): 166-172; HALL J., GILLIGAN A., SCHIMMEL
T., CECCHI M., COHEN J., The origin, effects and control of air pollution in laboratories used for
human embryo culture, Human Reproduction 1998, 13(Suppl 4): 146-155; DUMOULIN J.C.,
MEIJERS C.J., BRAS M., COONEN E., GERAEDTS J.P., EVERS J.L., Effect of oxygen
concentration on human in-vitro fertilization and embryo culture, Human Reproduction 1999, 14: 465 153 469; LOUTRADIS D., DRAKAKIS P., KALLIANIDIS K., SOFIKITIS N., KALLIPOLITIS G.,
MILINGOS S., MAKRIS N., MICHALAS S., Biological factors in culture media affecting in vitro
fertilization, preimplantation embryo development, and implantation, Annals of the New York
Academy of Sciences 2000, 900: 325-335; STRINGFELLOW D.A., GIVENS M.D., Infectious agents
in bovine embryo production: hazards and solutions, Theriogenology 2000, 53: 85-94; CATT J.W.,
HENMAN M., Toxic effects of oxygen on human embryo development, Human Reproduction 2000,
15(Suppl 2): 199-206; GUERIN P., EL MOUATASSIM S., MENEZO Y., Oxidative stress and
protection against reactive oxygen species in the pre-implantation embryo and its surroundings, Human
Reproduction Update 2001, 7: 175-189; FARIN P.W., CROSIER A.E., FARIN C.E., Influence of in
vitro systems on embryo survival and fetal development in cattle, Theriogenology 2001, 55: 151-170;
GEBER S., SALES L., SAMPAIO M.A., Laboratory techniques for human embryos, Reproductive
Biomedicine Online 2002, 5: 211-218; SCHULTZ R.M., WILLIAMS C.J., The science of ART,
Science. 2002, 296: 2188-2190; COOKE S., TYLER J.P., DRISCOLL G., Objective assessments of
temperature maintenance using in vitro culture techniques, Journal of Assisted Reproduction and
Genetics 2002, 19: 368-375.
[69] TROUNSON A.O., The derivation and potential use of human embryonic stem cells,
Reproduction, Fertility and Development 2001, 13: 523-532; GEPSTEIN L., Derivation and potential
applications of human embryonic stem cells, Circulation Research 2002, 91: 866-876; AMIT M.,
ITSKOVITZ-ELDOR J., Derivation and spontaneous differentiation of human embryonic stem cells,
Journal of Anatomy 2002, 200(Pt 3): 225-232.
SCHULDINER M., YANUKA O., ITSKOVITZ-ELDOR J., MELTON D.A., BENVENISTY N.,
Effects of eight growth factors on the differentiation of cells derived from human embryonic stem cells,
Proceedings of the National Academy of Sciences USA 2000, 97: 11307-11312; NIWA H., Molecular
mechanism to maintain stem cell renewal of ES cells, Cell Structure and Function 2001, 26: 137-148;
OGAWA M., Embryonic stem cell differentiation: the role of growth factors, Nippon Rinsho 2003,
61:401-405; LEVENBERG S., HUANG N.F., LAVIK E., ROGERS A.B., ITSKOVITZ-ELDOR J.,
LANGER R., Differentiation of human embryonic stem cells on three-dimensional polymer scaffolds,
Proceedings of the National Academy of Sciences USA 2003, 100: 12741-12746.
[71] LEESE H.J., Metabolic control during preimplantation mammalian development, Human
Reproduction Update 1995, 1: 63-72; DEVREKER F., ENGLERT Y., In vitro development and
metabolism of the human embryo up to the blastocyst stage, European Journal of Obstetrics,
Gynecology and Reproductive Biology 2000, 92: 51-56; GARDNER D.K., POOL T.B., LANE M.,
Embryo nutrition and energy metabolism and its relationship to embryo growth, differentiation, and
viability, Seminars in Reproductive Medicine 2000, 18: 205-218; HENDERSON J.K., DRAPER J.S.,
BAILLIE H.S., FISHEL S., THOMSON J.A., MOORE H., ANDREWS P.W., Preimplantation human
embryos and embryonic stem cells show comparable expression of stage-specific embryonic antigens,
Stem Cells 2002, 20: 329-337. For a few examples of such techniques, see VAN BLERKOM J.,
DAVIS P., ALEXANDER S., A microscopic and biochemical study of fragmentation phenotypes in
stage-appropriate human embryos, Human Reproduction 2001, 16: 719-729; COBO A., RUBIO C.,
GERLI S., RUIZ A., PELLICER A., REMOHI J., Use of fluorescence in situ hybridization to assess
the chromosomal status of embryos obtained from cryopreserved oocytes, Fertility and Sterility 2001,
75: 354-360.
[73] PATRAT C., WOLF J.P., EPELBOIN S., HUGUES J.N., OLIVENNES F., GRANET P., ZORN
J.R., ANDJOUANNET P., Pregnancies, growth and development of children conceived by subzonal
injection of spermatozoa, Human Reproduction 1999, 14: 2404-2410; TESARIK J., MENDOZA C., In
vitro fertilization by intracytoplasmic sperm injection, Bioessays 1999, 21: 791-801; SELVA J.,
Assisted hatching, Human Reproduction 2000, 4:65-67; HARDY K., WRIGHT C., RICE S.,
TACHATAKI M., ROBERTS R., MORGAN D., SPANOS S., TAYLOR D., Future developments in
assisted reproduction in humans, Reproduction. 2002, 123: 171-183; AL-NUAIM L.A., JENKINS
154 J.M., Assisted hatching in assisted reproduction, British Journal of Obstetrics and Gynaecology 2002,
109: 856-862; NAGY Z.P., OLIVEIRA S.A., ABDELMASSIH V., ABDELMASSIH R., Novel use of
laser to assist ICSI for patients with fragile oocytes: a case report, Reproductive Biomedicine Online
2002, 4: 27-31.
[74] WILDING M., FIORENTINO A., DE SIMONE M.L., INFANTE V., DE MATTEO L., MARINO
M., DALE B., Energy substrates, mitochondrial membrane potential and human preimplantation
embryo division, Reproductive Biomedicine Online 2002, 5: 39-42; DE VOS A., VAN
STEIRTEGHEM A., Aspects of biopsy procedures prior to preimplantation genetic diagnosis, Prenatal
Diagnosis 2001, 21: 767-780; WELLS D., DELHANTY J.D., Preimplantation genetic diagnosis:
applications for molecular medicine, Trends in Molecular Medicine 2001, 7: 23-30; BRAUDE P.,
PICKERING S., FLINTER F., OGILVIE C.M., Preimplantation genetic diagnosis, Nature Review
Genetics 2002, 3: 941-953; BUI T.H., HARPER J.C., Preimplantation genetic diagnosis, Clinical
Obstetrics and Gynecology 2002, 45: 640-648, 730-732; EGOZCUE J., SANTALO J., GIMENEZ C.,
DURBAN M., BENET J., NAVARRO J., VIDAL F., Preimplantation genetic screening and human
implantation, Journal of Reproductive Immunology 2002, 55: 65-72.
[75] CONGREGATION FOR THE DOCTRINE OF THE FAITH, Instruction on Respect for Human
Life in its Origin and on the Dignity of Procreation Donum vitae (February 22, 1987), I, 4, in Acta
Apostolicae Sedis 1988, 80: 70-102, p. 82
[76] JOHN PAUL II, Encyclical letter Evangelium vitae (March 25, 1995), 63, in Acta Apostolicae
Sedis 1995, 87: 401-522, p. 473.
[77] CONGREGATION FOR THE DOCTRINE OF THE FAITH, Donum vitae, I, 4, in Acta
Apostolicae Sedis 1988, 80, p. 82.
[78] The phrase "in the patient's best interest" is often used in daily dialogues at the bedside or in a
biomedical research setting. However, if the "best interest" is not explicit, the meaning of the statement
is obscure and sometimes deceptive. For a useful discussion of this expression in different clinical
situations, see DANIELS K.R., BLYTH E., HALL D., HANSON K.M., The best interests of the child
in assisted human reproduction: the interplay between the state, professionals, and parents, Politics of
Life Sciences 2000, 19: 33-44; COTLER M.P., The do not resuscitate order; clinical and ethical
rationale and implications, Medicine and Law 2000, 19: 623-633; ROSS L.F., Genetic testing of
adolescents: is it in their best interest?, Archives of Pediatric and Adolescent Medicine 2000, 154: 850852; SPENCER K., The best interest principle as a standard for decision making in the care of
neonates, Journal of Advanced Nursing 2000, 31: 1286-1292; ALLMARK P., MASON S., GILL A.B.,
MEGONE C., Is it in a neonate's best interest to enter a randomised controlled trial?, Journal of
Medical Ethics. 2001, 27: 110-113; PHAM H.H., LERNER B.H., In the patient's best interest?
Revisiting sexual autonomy and sterilization of the developmentally disabled, Western Journal of
Medicine 2001, 175: 280-283; MILLER G.H., The psychological best interest of the child is not the
legal best interest, American Academy of Psychiatry Law 2002, 30: 196-200; MAINOUS R.O.,
Conjoined twins: whose best interest should prevail? An argument for separation, Pediatric Nursing
2002, 28: 525-529; WASSERMAN D., Comment on "Whose best interest?" Judging and balancing the
interests of conjoined twins, ivi: 530-531; HIRSCH N.J., In the patient's best interest: a call to action, a
call to balance, Bioethics Forum 2002, 18(1-2):24-29.
[79] KIPNIS K., Vulnerability in research subjects: a bioethical taxonomy, op. cit., p. G8.
[80] For a discussion on the cultural and social pressure surrounding the ESC and cell therapy
campaign, see FRIST B., The promise and peril of embryonic stem cell research: a call for vigilant
oversight, Yale Journal of Health Policy, Law and Ethics 2001, 2: 167-176; MCLAREN A., Human
embryonic stem cell lines: socio-legal concerns and therapeutic promise, Comptes Rendus de Séances
de la Société de Biologie 2002, 325: 1009-1012; KONSEN A.H., Are we killing the weak to heal the
sick? Federally funded embryonic stem cell research, Health Matrix Cleveland 2002, 12: 507-555;
BRUCE A., The search for truth and freedom: ethical issues surrounding human cloning and stem cell
155 research, Journal of Law and Medicine 2002, 9: 323-335; NIPPERT I., The pros and cons of human
therapeutic cloning in the public debate, Journal of Biotechnology 2002, 98: 53-60; SCHMID R., Stem
cells: a dramatic new therapeutic tool, Jounal of Gastroenterology and Hepatology 2002, 17: 636-642;
FITZGERALD K.T., Questions concerning the current stem cell debate, American Journal of Bioethics
2002, 2: 50-51; BAKER R., Stem cell rhetoric and the pragmatics of naming, Ivi: 52-53; MCGEE
D.B., The idolatry of absolutizing in the stem cell debate, Ivi: 53-54; MACDONALD C., Stem cell
ethics and the forgotten corporate context, Ivi: 54-56; LONDON A.J., Embryos, stem cells, and the
strategic element of public moral reasoning, Ivi: 56-57; ROSENTHAL N., Prometheus's vulture and
the stem-cell promise, New England Journal of Medicine 2003, 349: 267-274.
[81] CONGREGATION FOR THE DOCTRINE OF THE FAITH, Donum vitae, I, 1, in Acta
Apostolicae Sedis 1988, 80, p. 79. JOHN PAUL II, Evangelium vitae, 60, in: Acta Apostolicae Sedis
1995, 87, p. 469.
[82] COUNCIL OF EUROPE, Convention for the Protection of Human Rights and Dignity of the
Human Being with Regard to the Application of Biology and Medicine (Oviedo: April 4, 1997),
Council of Europe, ETS no. 164, art. 18.
[83] See, among others, HURSTHOUSE R., Beginning Lives, Oxford – Cambridge: Blackwell, 1987.
[84] DUNSTAN G.R., The moral status of the human embryo: a tradition recalled, Journal of Medical
Ethics 1984, 10: 38-44; STRONG C., Ethics in Reproductive and Perinatal Medicine. A New
Framework, New Haven – London: Yale University Press, 1977; GREEN R.M., The Human Embryo
Research Debates. Bioethics in the Vortex of Controversy, Oxford: Oxford University Press, 2001. For
a thoughtful criticism of the "symbolic value" argument, see QUINN K.P., Embryonic stem cell
research as an ethical issue: on the emptiness of symbolic value, St. Thomas Law Review 2001, 13:
851-861.
[85] Persons who believe that the in vitro human embryo is not yet a subject with human rights but
"deserves special respect" and "serious moral consideration as a developing form of human life" are
prone to ";approve of research with embryos left over from a couple's attempts to treat infertility
through IVF, but disapprove of creating and then discarding embryos solely for research purposes. In
their view, the practice of creating research embryos instrumentalizes and demeans human life, and
should be prohibited". (ROBERTSON J.A., Symbolic issues in embryo research, Hastings Center
Report 1995, 25(1): 37-38, p. 37).
[86] PENNINGS G., DE WERT G., Evolving ethics in medically assisted reproduction, Human
Reproduction Update 2003, 9: 397-404, p. 398. Drawing such a line cannot be justified even under the
assumption that, before implantation, the human embryo is not a subject with a right not to be killed or
harmed: ";If embryos are too undeveloped physically to be harmed, it should not matter whether
researchers use embryos left over from IVF or embryos created solely for research. In both cases the
embryos are at the same stage of development". (ROBERTSON J.A., Symbolic issues in embryo..., p.
37).
[87] ANNAS G., CAPLAN A., ELIAS S., The politics of human embryo research: avoiding ethical
gridlock, The New England Journal of Medicine 1996, 334: 1329-1332.
[88] PENNINGS G., DE WERT G., Evolving ethics in medically assisted reproduction, op. cit., p. 398.
See also IGLESIAS T., IVF and Justice. Moral, Social and Legal Issues related to Human In Vitro
Fertilisation, London: The Linacre Centre for Health Care Ethics, 1990.
[89] Cf. PENNINGS G., DE WERT G., Evolving ethics in medically assisted reproduction, op. cit., p.
398.
[90] ESHRE TASK FORCE ON ETHICS AND LAW, The moral status of the preimplantation
embryo, Human Reproduction 2001, 16: 1046-1048.
[91] AHMANN J., Therapeutic cloning and stem cell therapy, National Catholic Bioethics Quarterly
2001, 1: 145-150; SHANNON T.A., Human embryonic stem cell therapy, Theological Studies 2001,
62: 811-824; HIRAI H., Stem cells and regenerative medicine, Human Cell 2002, 15: 190-198; CAI J.,
156 RAO M.S., Stem cell and precursor cell therapy, Neuromolecular Medicine 2002, 2: 233-249;
LINDVALL O., Stem cells for cell therapy in Parkinson's disease, Pharmacological Research 2003, 47:
279-287. STRAUER B.E., KORNOWSKI R., Stem cell therapy in perspective, Circulation 2003, 107:
929-934; HENNINGSON C.T.JR., STANISLAUS M.A., GEWIRTZ A.M., Embryonic and adult stem
cell therapy, Journal of Allergy and Clinical Immunology 2003, 111(2 Suppl): S745-S753; TERAI S.,
YAMAMOTO N., OMORI K., SAKAIDA I., OKITA K., A new cell therapy using bone marrow cells
to repair damaged liver, Journal of Gastroenterology 2002, 37 (14 Suppl):162-163; PARTRIDGE T.A.,
Stem cell route to neuromuscular therapies, Muscle and Nerve 2003, 27: 133-141; HASSINK R.J.,
DOWELL J.D., BRUTEL DE LA RIVIERE A., DOEVENDANS P.A., FIELD L.J., Stem cell therapy
for ischemic heart disease, Trends in Molecular Medicine 2003, 9: 436-441; HOCHEDLINGER K.,
JAENISCH R., Nuclear transplantation, embryonic stem cells, and the potential for cell therapy, New
England Journal of Medicine 2003, 349: 275-286.
[92] One of the first public expressions of this position is attributed to the Ethics Advisory Board of the
(then) U.S. Department of Health, Education and Welfare. In 1979 the Board declared that the human
embryo is "entitled to profound respect; but this respect does not necessarily encompass the full legal
and moral rights attributed to persons". (Quoted in: CALLAHAN D., The puzzle of profound respect,
Hastings Center Report 1995, 25[1]: 39-40, p. 39). When faced with the unconditional respect due to a
person, even the "profound respect" accorded to embryos sounds like a relative respect and does not
compel everyone to refrain from using the human embryo as a means to search for possible new ways
to cure persons affected by severe diseases.
[93] Cf. PENNINGS G., DE WERT G., Evolving ethics in medically assisted reproduction, op. cit., p.
398.
[94] "No one should undertake research on human embryos the purpose of which could be achieved by
the use of other animals or in some other way". (DEPARTMENT OF HEALTH AND SOCIAL
SECURITY, Report of the Committee of Inquiry into Human Fertilization and Embryology, London:
Her Majesty's Stationery Office, 1984, p. 63). See also: ROYAL COMMISSION ON NEW
REPRODUCTIVE TECHNOLOGIES (CANADA), Proceed with Care: Final Report of the Royal
Commission on New Reproductive Technologies, Ottawa: Minister of Government Services, 1993, p.
630.
[95] For a well-balanced overview of current stem cell and cell therapy research, see: COGLE C.R.,
GUTHRIE S.M., SANDERS R.C., ALLEN W.L., SCOTT E.W., PETERSEN B.E., An overview of
stem cell research and regulatory issues, Mayo Clinic Proceedings 2003, 78: 993-1003.
[96] JOHN PAUL II, Address to the 18th International Congress of the Transplantation Society
(August 29, 2000), in: Acta Apostolicae Sedis 2000, 92: 822-826, p. 826.
[97] CONGREGATION FOR THE DOCTRINE OF THE FAITH, Donum vitae, I, 1, in Acta
Apostolicae Sedis 1988, 80, p. 79.
[98] CONGREGATION FOR THE DOCTRINE OF THE FAITH, Donum vitae, I, 1, in Acta
Apostolicae Sedis 1988, 80, p. 79; quoted in: JOHN PAUL II, Evangelium vitae, 60, in: Acta
Apostolicae Sedis 1995, 87, p. 469.
157 ANTONIO SPAGNOLO
ETHICS RESEARCH COMMITTEES (ERCs):
OPERATIONAL PROCEDURES AND QUALITY OF THE ETHICAL REVIEW
THE DEVELOPMENT OF FORMALISED ETHICAL REVIEWS OF BIOMEDICAL
RESEARCH
Biomedical Ethics Research Committees (ERCs) can be defined as independent bodies composed of
people with various fields of expertise, including medical and scientific but not only those, who are
responsible for ensuring that the biomedical research projects involving human subjects conform to the
principles of biomedical ethics[1].
This need for a formalised ethical review of biomedical research derives from the fact that
experimentation is a moral experience that deeply worriedpeople during the second half of the 20th
century. Experimentation, together with making medicine technological and the ideological use of
medicine, can be included among the historical and cultural conditions that are at the origin of bioethics
as a movement and as a discipline[2].
In fact immediately after the Nuremberg trials there was disconcerting proof that apart from curing,
medical research could also be used for committing crimes. Today these crimes are well-known, they
were recorded in the proceedings of the trials and are the negative proof of what can be done by
absolute power, which has no morality or is even the presumed holder of morality itself, with the
collaboration of physicians and researchers who allowed themselves be used by political power,
considering themselves justified because they were “forced to comply”[3]. Biomedical research has
always been carried out in a more or less controlled way, and in accordance with the requirements of
experimental methods. None the less, the specific concern regarding the ethical aspects involved in
performing research became tangible just after the Second World War, with the documentation of the
atrocities committed by Nazi physicians in the name of this research. And the Nuremberg Code (1947),
with its reference to the“absolute essentiality” of informed consent from the subjects who undergo
experimentation, and their “objective” protection by the scientists, is one of the first bioethics
documents ante litteram.
From that tragic moment the regulations developed along two lines: the doctrine of “human rights”,
which culminated in the Universal Declaration ofHuman Rights of 1948, and the continuously revised
approval of specific guidelines for the ethics of experimentation issued by international organisations,
like the WorldMedical Assembly , which elaborated the famous Helsinki Declaration that was issued in
1964 and that has been revised several times since (last revision in Edinburgh, October 2000).These
international guidelines required a theoretical and justificative foundation of the ethics of biomedical
research, which came together within the field of the reflection on bioethics, exactly the new discipline
that was about to emerge.
It took some time before the Nuremberg Code was implemented in terms of formal surveillance of
research on man. So even after Nuremberg, during the 50’s and 60’s the North Americans had to face
the reality of some research that was just as awful as the research carried out by the Nazi doctors: the
systematically organised abuse of cruel experiments on man that caused deep moral suffering. In 1963,
for example, during an experiment at the Jewish Chronic Disease Hospital of Brooklyn, tumour cells
were injected into elderly patients without their consent, in order to study the ways the tumour spread.
The patients’ ages and the likelihood that no negative effects of this experiment would have time to
manifest in them, whereas it was possible to study the metastatic mechanisms of the neoplasias, were
the reasons adopted by the physicians called to answer in court.Another example took place from 19651971 at the Willowbrook State Hospital in New York, where a series of studies were carried out on
158 immunisation against viral hepatitis, by inoculating the virus into some institutionalised children who
were psychologically handicapped orphans.
Around twenty years after the Nuremberg Code, Henry Beecher, a professor of anaesthesia at the
Faculty of Medicine of Harvard University, published a famous paper with dozens of examples of
researchers who had risked the life and health of human beings without informing them of the dangers
involved in the research and without obtaining their consent first[4]. A year later, M. H. Pappworth[5]
reported hundreds of unethical experiments, many of which were published in prestigious scientific
journals.
None the less, it would be a mistake to think that no attention was given to the safety and interests of
the subjects involved in the experimentation that was carried out before the formalised introduction of a
systematic revision of research. In as long ago as 1900 Walter Reed, who studied yellow fever for a
long time, introduced real informed consent for the subjects who took part in the experimentation on
this disease, and he provided previous information on the risks and the documentation of the consent
expressed[6]. Germany, in 1931, was maybe the first country in the world to issue official guidelines
for university research centres, which the physicians were to follow for the use of “new therapies” and
in order to perform scientific experiments. What is even more surprising is that this kind of advice
concerning experimentation had already been given in instructions issued by the Prussian government
in 1900, following a heated debate about the “Neisser case”. In 1898 Prof. Albert Neisser, who had
discovered the bacterium that causes gonorrhoea, called Neisseria gonorreae, published the data of an
experiment on syphilitic patients. This publication was accompanied by heated discussions and bitter
controversies because in order to achieve his aim Neisser had injected the serum from syphilitic
patients into prostitutes and other patients, hospitalised for other pathologies, who were unaware of all
this[7].
The recommendations in the Richtlinien may be considered not less advanced and legally binding, and
in some cases even more detailed than those of the Nuremberg Code and those of the Helsinki
Declaration. None the less these recommendations were not strong or incisive enough to prevent
several physicians from being guilty of dreadful crimes against helpless people, the victims of the Nazi
outrage in the concentration camps[8]. What was missing in these experiments was informed consent
from the subjects but also a scientific rigour of the research design, protection against the excessive
risks that the subjects were exposed to, the freedom to withdraw from the experimentation at any time,
and so on. Therefore it was generally considered that these aspects should be evaluated before
beginning clinical experimentation and this is basically from where the need comes for a previous,
systemic and formal ethical review of every research project by an independent commission.
Therefore the creation and spread of the ERCs derives from the need to prevent abuse like that
committed in many past experiences through experimentation carried out on human beings, often
belonging to particularly vulnerable categories. However neither the Nuremberg Code nor the first
version of the Helsinki Declaration in 1964 mentioned review commissions. In these documents the
researcher was made totally responsible for the protection of the health and rights of the subjects
involved in the research.
THE STATUTORY VS. NON-STATUTORY SYSTEM OF THE ETHICAL REVIEW OF
RESEARCH
The formalised ethical review of research by “ethics commissions” basically followed two different
paths: one was through the statutory system that quickly developed in the United States and that
provided for the institution of these independent committees at a well codified, federal, legal level; the
other one was through the self-regulation, non-statutory system, which was prevalent until a few years
ago in Europe and in particular in the United Kingdom, and in which guidelines from scientific
159 organisations rather than laws, provided indications on how to set up and make these committees on the
ethical review of research work.
In the United States, the 1938 Federal Food, Drug and Cosmetic Act made it permissible for physicians
to test new drugs with no ethical review of the protocols. In 1962, following the dramatic damage to
foetuses caused by the experimental use of thalidomide in pregnant women, this law was amended.
Thus, for the first time in the world a legislation included the need for informed consent from the
subjects who were administered experimental drugs (although this did not prevent all the previously
mentioned unethical experiments of the ‘60s from being performed).
A first federal document that required the ethical review of research by an independent Committee had
already been issued in 1953 (Group Consideration for Clinical Research Procedures Deviating from
Accepted Medical Practice or Involving Unusual Hazard). However, these guidelines could only be
applied to research performed in public clinical centres at the National Institutes of Health (NIH)[9],
which were financed with federal funds and which were being established during those years. The
Director of the NIH set up a Committee that was to examine the most appropriate system for ethical
reviews.
However, as far as the other research institutes, like universities and private American centres are
concerned, little is known about the existence of review committees for experimentation. In 1961-62, it
was seen through questionnaires sent to AmericanUniversity departments of medicine, that a third of
those that answered had committees and a quarter of them had started procedures to set them up.
In 1966, the new Surgeon-General of the United States Public Health Service (USPHS), Dr. William H.
Stewart, issued instructions concerning the responsibility of institutions with respect to research carried
out there. In fact he considered that by accepting public funds for research, the schools of medicine,
hospitals and other research institutes also accepted to share the public responsibility for their use. He
therefore asked the institutions to guarantee the USPHS that all the research projects that were to
involve human beings would be systematically subject to an independent ethics review, and he also
underlined that this would have to involve external people, who were qualified from a scientific point
of view. This Committee was to examine the rights and the wellbeing of the individuals[10] involved,
the appropriateness of the methods used to request informed consent, and the risks and potential
medical benefits of the research[11]. A specific office was set up in the NIH in order to implement the
instructions from the Surgeon-General of the United States Public Health Service (Office for Protection
of Research Risk, OPRR).
None the less, despite these indications regarding public research, in 1972 another new shock upset the
public opinion, when the sadly famous “Taskegee Study” came to light. This research had been begun a
few decades before, and left around 300 poor, uneducated Afro-American men suffering from syphilis
without antibiotics in order to evaluate the natural evolution of the disease.
In 1974, as a public reaction to this study, President Nixon signed the Act on research[12]. In section
474 the law required the establishment of Institutional Review Boards (IRBs) wherever biomedical and
behavioural research involving human beings was carried out with public funds, in order to defend the
rights of these subjects during the research. These commissions had to be present in the institute where
the experimentation was carried out. So, a situation that was already very widespread in many research
institutes in the United States was formalised[13]. The same Act also established a “National
Commission for the Protection of Human Subjects of Biomedical and Behavioral Research” that was to
provide ethics guidelines for research (in particular on vulnerable subjects like prisoners, children,
mental patients, etc.). This Commission was also supposed to provide indications for the working of the
IRBs, which were responsible for the review of experimentation protocols and the formulation of some
fundamental ethical principles that were to guide human experimentation. The Commission worked
from 1974 to 1978 and produced the famous Belmont Report that was published in the Federal Register
on 18th April 1979[14]. The Report presented the fundamental principles that the researchers were to
160 refer to: the principle of respect of persons, the principle ofbeneficence, the principle of justice, and in
the light of which the IRBs had to evaluate the protocols submitted for approval[15].
Unlike this American system of ethical reviews of research strictly controlled by the federal
regulations, across the ocean, in particular in the United Kingdom, the constitution of Research Ethical
Committees (RECs) was the result of an initiative of the professional societies and not of regulations
from the authorities: on the contrary, the Minister of Health abstained from intervening, since he
considered it essentially an ethical-professional matter.
Within this non legal system, in 1967 the Royal College of Physicians (RCOP) had already
recommended that all the clinical experimentation was to be previously approved by a group of doctors
including experts in clinical experimentation: "all projects were approved by a group of doctors
including those experienced in clinical investigation. This group should satisfy itself of the ethics of all
proposed investigations"[16]. Over the following years committees, made up differently and working
in various ways, were established all over the United Kingdom in order to supervise the ethics of
experimentation. In 1984 the RCOP therefore considered it appropriate to publish guidelines
suggesting a certain uniformity of aims, structures and procedures so that the ERCs would work
better[17].
As far as the international bodies are concerned, the development of the ERCs also started within a
non-statutory system. The first mention of a committee for reviewing research in an international
document concerning clinical research, goes back to the Helsinki Declaration at the World Medical
Assembly, in the Tokyo revision of 1975 (whereas there was no trace of a reference to a review
committee for clinical experimentation in the first declaration of 1964). In this revision it was
established that “the project itself and the carrying out of every phase of human experimentation have
to be clearly defined in an experimental protocol that has to be subject to an independent Committee
specifically nominated for that purpose” (I,2).
As it can be seen, these committees were not yet described as “ethical”, but in most of the countries
where they were gradually being set up, they were called Ethics Research Committees (ERCs) or more
simply Ethics Committees (ECs).
In the United States, the name “ethics committee” is generally used for committees established in a
hospital, and providing ethical consultation for clinical practice, so they are a support in bedside
clinical decision making. However, the name used by the Federal Regulation (Institutional Review
Boards) indicates their exclusive authority and responsibility in authorising experimentation involving
human beings[18].
The ERCs successively appeared in all the countries where clinical research was performed, with
different names but with the precise aim of reviewing research. For example in Canada, a few years
after the United States, the Comité Deontologique de la Recherche was established (1978), with similar
responsibilities concerning the authorisation of experimentation, but also to offer “an evaluation, a
comment and a guide”[19]. In other countries the committees appeared with various names:
Commissions Facultaires d'Ėthique in Belgium (1984); Ethik Kommissionen in Germany (1984);
Comité Consultatif de Protection des Personnes dans la Recherche Biomédicale in France (1988)[20].
In Spain the committees involved in the ethics of clinical experimentation began to appear after the law
of 3rd August 1982 was issued. This law made it compulsory for every hospital to establish its own
committee for experimentation with clearly defined characteristics and functions[21].
In Italy the requirement to have clinical experimentation protocols evaluated by an ERC came from the
publication of the Ministry of Health Decree of 27th April 1992 in the Official Gazette, which adopted
the European Community Directive 91/507, regarding “good clinical practice” (GCP), and which
aimed to establish standard principles in carrying out trials for the human experimentation of new
drugs. So following this Directive, ERCs began to appear in the various research centres even though
there were no regulations for the establishment and working of these committees. None the less they
161 continued to be created in a spontaneous and improvised way, with no coordination between them until
1997-98, when new Decrees were issued, which somehow regulated the activities of the ERCs[22].
Today, as we will see, their role of reviewing research was envisaged by all the international guidelines
concerning human experimentation and it was considered essential for carrying out any
experimentation.
THE QUALITY OF THE ERCs: FROM THEIR STATUTES TO THE OPERATIONAL
PROCEDURES OF THE ETHICAL REVIEW
Therefore the fundamental aim of the evaluation by the ERCs was to protect the rights and wellbeing of
the human beings involved in the experimentations. This aim was to take place through the request for
informed consent, so the people involved would be able to participate in a conscious, free and
voluntary way, and also through the analysis of the risks and benefits. In 1978, the National
Commission added impartiality in the selection of the subjects of the research, as a further
requirement[23]. The National Commission was particularly concerned about protecting the most
vulnerable subjects with respect to the possibility of their utilitarian involvement in the
experimentations. Later, when participation in certain kinds of experimentation was perceived as
possibly beneficial (for example, in the case of the risk of cardiovascular pathologies in women of a
menopausal age or of anti-HIV drugs), the ERCs were asked to guarantee unbiased access to these
benefits for the most underprivileged categories of people and those in greatest need of protection[24].
So the ERCs’ activities have always been mainly and often exclusively dedicated to trying to guarantee
that clinical and scientific research, which is itself a positive value and is to be encouraged because of
the beneficial effects that it can have on biomedical and social progress, does not turn against the
subjects directly involved and who contribute to the research in a fundamental way, and that it
complies with a series of requirements regarding the judgement of its ethicality.
When the law on abortion was passed in the U.S in 1973[25], the committees had toestablish the risk of
the mother’s life in view of a request for an abortion. The narrow aim and binding character of these
committees’ decisions were not pursued by the ethics committees established in the United States in the
80’s, when the President's Commission for the Study of Ethical Problems in Medicine and Biomedical
and Behavioral Research, recommended that ethics committees be established in all the hospitals and
that they perform three basic activities: ethics consultation in clinical cases, the drawing up of
guidelines and recommendations and education regarding the ethical aspects of clinical practice[26].
The ERCs are an ethical guarantee to protect the safety, integrity and rights of the people involved in
the experimentations and to avoid the recurrence of scientific and economic abuse.They are also a legal
guarantee because their reviewing activities are acknowledged in national and international rules and
regulations. Actually, this kind of guarantee also has a fundamental value and positive and heralding
repercussions for the quality of clinical research in general and of each experimentation.
In 1996, the European Union, together with the United States and Japan, intended to achieve this
double aim with the guidelines from International Conference on Harmonisation – Good Clinical
Practice (ICH-GCP)[27], which were then adopted by the single countries. The aim was to promote the
development and quality of clinical research using the available resources the best way, and guarantee
the safety and protection of the rights of the subjects taking part. After the previous European
guidelines of 1991, the main applicative instrument of these new guidelines proved once more, and
even more emphatically, to be the ERC (also called Independent Ethics Committee in the document).
Therefore the ERCs are called on to perform a fundamental function, first of all for the good of the
subjects involved, then for society and then for biomedical progress, through even greater operative
effectiveness, which goes beyond the necessary official and legitimisation and formal thoroughness. So
it is important that the value of its review activities and its decisions are acknowledged on the strength
162 ofits independence and autonomy, its competence and the pursuit of its main and fundamental aim of
protecting the life and dignity of the people involved in experimentation before that of the progress of
clinical research.
The current regulations, as well as the international documents that refer to ethics, involve some
essential commitments for the ERCs: the adaptation of their statute to the fundamental principles
contained in the guidelines and an adequate operative organisation so the ERCs can work properly.
However, the recovery and promotion of the ERCs’ “ethical” role, with respect to their review
activities and also their training activities, is still extremely important.This role is to be kept separate
from the bureaucratic and administrative role, provided for and maybe emphasised by the provisions of
the law.In fact attributing binding decisional power has produced the risk of turning this body into an
administrative controlling committee rather than a place for scientific and ethical reflection on
experimentation and for support for researchers[28].
Therefore, two of the fundamental aspects of the ERC’s activities are the deed of constitution, with its
reference to the principles and aims defined in the statute, and the way it is to work, previously
organised and maybe to be perfected depending on experience and the requirements. The World Health
Organization, by issuing the Operational Guidelines for Ethics Committees That Review Biomedical
Research (WHO Operational Guidelines) in 2000,points out the need to establish procedures that
“ensure consistency and facilitate cooperation” (n.3) for the ERCs[29].
The deed of constitution of an ERC,issued by a health and research institution, could be preceded and
facilitated by a promoting commission of experts (who will not be part of the ERC), some of whom
work within the institute but most of whom do not (to safeguard its independence), with the duty of
issuing the statute (in concordance with the current regulations and with the principles of the institute)
and to identify the members with respect to the professional competence required.
The indication to proceed first of all with drawing up the statute, comes from a need for transparency
and visibility of the activity, for coherence and loyalty with respect to the reference criteria of the
promoting body and of the ERC itself.The public statement of the inspirational principles, the criteria
and reference guidelines and of the priorities to pursue, define the not only ideological but also
operative nature of the ERC. It would therefore be appropriate for this document to be issued before the
constitution of the ERC, leaving open the possibility of a later examination of the suitability of the
constitutional modalities and any proposals regarding corrections and improvements.
The references, apart from the obvious ones regarding the current national regulations, to the most
important international Documents, like the Universal Declaration of Human Rights (UN, 1948), and
above all those regarding human experimentation, like the most recent version of the Helsinki
Declaration, the European Union ICH-GCP, the CIOMS International Guidelines (2002), the European
Convention on human rights and biomedicine (1996), the professional ethics Codes and the National
Bioethics Committees documents, are an essential part for the ERCs, of the pursuit of their aims.
Moreover, in the case of a religiously inspired health institute, or one that intends to portray itself
through the respect of certain morals and principles, the statute should contain the reference to these
principles (for example, a reference to the indications of the Roman Catholic Magisterium[30] may be
appropriate in a Catholic health institution). This is not a mere formality but rather a fundamental
element that makes that particular health institute and the activity of the ERC itself stand out. It is a
specific element and is to be asserted in any litigations between the civil law and the above mentioned
principles (see below).
Apart from indicating the inspiring principles and aims, the statute should also indicate the composition
of the ERC and all the elements necessary for the members to be operative that they can not define
themselves: the economic aspects and the authority that will approve and set up the ERC. For Italy, the
Ministerial Decree of 15th July 1997 states that the ethics committees for the evaluation of clinical
experimentation are established by the administrative body of the health institutions that intend to carry
out clinical experimentations (art. 3)[31]. Together with the requisite of being multidisciplinary and
163 multi-sector, the statute should also reassert the fundamental requirement regarding the ERC’s
independence of any influence, whether within or outside the institute, so its composition should reflect
this wish. Regarding this, the European Forum for Good Clinical Practice (EFGCP) Guidelines and
Recommendations for European Ethics Committees (a proposal of guidelines and recommendations for
the European ethics committees involved in the evaluation of biomedical research) recommends that
the ethics committees not be appointed by people or institutes with a possible specific interest in the
experimentation, either as a sponsor or as experimenters (2.A)[32]. However, the WHO Operational
Guidelines require more realistically, where this conflict of interest is inevitable, transparency and that
these interests be made known (4.1.3). In any case both documents recommend providing a appointing
procedure which, apart from the name of the institute or of the person responsible for this, also includes
the procedure for selecting the candidates and the method for the choice of the candidate (for example,
whether by consent, by majority vote or by a direct choice). The appointing modalities should also
include, apart from the duration and renewal, at least the procedures for resigning, for objections and
for substitutions. Together with permanent ERC members, an important contribution to the review of
experimentation protocols can come from external and independent advisors, who may be invited ad
hoc or, as the WHO Operational Guidelines suggest, be selected and included in a permanent list.
These advisors, who may even only provide a written comment (6.1.5), may be experts in specific
aspects of the protocol or of particular pathologies or of methodologies, or they may represent
associations or particular groups of patients, and the modalities for consultation should be defined
previously (4.6). The external advisors co-opted to the ERCs are obviously also explicitly bound, as are
the ERC members, to maintaining the confidentiality of the information they will obtain while
performing their duty.
The ethical evaluation of an experimentation protocol involves providing an opinion regarding the
rights of the subjects in terms of their physical, psychological and moral integrity, the principles of
fairness and equal opportunities, the rights of the people who have access to the institute for assistance
and who, even though they are not directly involved in the protocol, may suffer the consequences, and
of the right of the physician taking part to carry out his main duty as a therapist without being
conditioned.
So one of the ERCs’ functions is also to verify the compatibility of the experimentations not only with
the current rules and regulations, but also with the cultural characteristics and ethical, moral and
religious background of the local population, with the operative conditions of the institute where the
experimentation is to take place and with fundamental human rights.
The previously mentioned EFGCP Guidelines of 1997 contain indications regarding the instructions
that should be established in advance, regarding the optimum fields of competence for a review of the
protocol, as well as the minimum quorum of the members. The EFGCP (like the ICH-GCP)
recommends that a minimum of five members should make up the quorum and it indicates that the
maximum number should not be more than twelve, since it is more difficult to reach a decision with a
large number of people. The same document recommends that the quorum represents people of both
sexes, a broad age group, the cultural expression of the local community and that there also be at least
the following members: two physicians with recent experience of clinical research according to the
GCP, independently of the institute where the experimentation is taking place, one “lay” member, a
lawyer and a paramedic (2.E)[33].
Apart from the competence and professional experience in the area specifically requested, those asked
to collaborate in the ERCs should, also for obvious reasons of external credibility, be people of
acknowledged ethical value and professional integrity.
One question concerning the ERC members is their independence with respect to the institute: a large
number of members (and maybe the Chairperson) who are not employed by the institution may be an
essential factor in protecting the ERCs from undue influence[34].This measure should not be
underestimated, since the interest in carrying out clinical experimentation is not only scientific or
164 academic, but also and above all economic (the income from the sponsors is not only for the
experimenters but also for the institution) and it could condition the decisions if the Chairpersonis
employed (above all if directly involved in the administration) by the same institution in which the
ERC is operative.
Another measure to adopt as far as the impartiality of the decisions is concerned is that no member of
the ERCs should take part in the meetings, discussions or decisions if he or she has an interest in or is
involved in the protocols or matters to be discussed.As can be seen from the EFGCP (2.C.i) and WHO
(7.1) recommendations, in the case of a conflict of interest, this exclusion procedure (and before that,
the communication and written recording of this situation) is to be established in the ERC statutes or
operating procedures, and accepted by the individual members when they accept their appointment.
One has to also consider that the conflict of interest can be direct or indirect, like involvement in
planning or carrying out the experimentation, a partnership with or being employed by the
experimenter, or a role of advisor for the manufacturers of the drug[35]. The question regarding
economic partnerships is particularly complex, above all with respect to large international
pharmaceutical companies, which are often listed on the Stock Exchange, and which have economic
investments, in the form of financial products, in which any citizen and therefore also a member of an
ERC, may participate.
Finally, the statute has to refer to how the ERC is to work, in terms of the operative procedures that will
be defined in the internal regulations.
After the statute has been approved and the members of the ERC have been nominated by the relevant
authority, a secretarial office has to be set up so the ERC can work properly, as indicated in the WHO
Operational Guidelines (4.4). This office is to be responsible for the technical organisation of the
meetings, the prompt distribution to the members of the documents to be examined, filing the
documentation, contacts with the members and with external co-opted members. The expenses are
therefore to be planned in order to provide the office with the necessary resources and the sponsor
generally covers these costs.
One important matter that should also be underlined in the ERC statute is continuing education for the
members. When accepting the nomination every member of the ERC should also formally accept to
take part in training courses and meetings. Moreover, being prepared to receive initialand continued
training in order to contribute to improving the ERC’s work is indicated by the WHO Operational
Guidelines as a condition to be accepted at the time of nomination (4.7).
After the statute has been examined and the main officers have been elected (the president and vicepresident) it is necessary to work out the operating procedures, which are defined in regulations that
will be binding for the members of the ERC and for those who submit a request for an ethical opinion
on a clinical experimentation. These procedures should be as functional, flexible, transparent and
standard as possible, and are the instrument that in a certain senserepresents all the multidisciplinary
review activity of the ERC, from when the application for review is made to the communication of the
decision. The standard application of the operating procedures also helps guarantee impartiality and
coherence in the evaluation, a continuity of reference and uniformity of work, for those who are
requesting an opinion and also for the members of the ERC themselves and for other ERCs requested
to evaluate the same experimentations.
Accepting the procedures and the continuous review of their effectiveness, makes it possible for the
ERC to work properly and take into consideration any opportunity to increase the quality of its
evaluations.
The proof of appropriate and balanced work by the ERC obviously comes from the outcome of the
discussions and evaluations, that is, from the written, motivated decision on the
specificexperimentations.
In order to issue areview the ERC has to have adopted a rigorous or bureaucratic element, the
fundamental, binding, operative aspects and the formalities, generally required by the current
165 regulations, for the validity of the meetings, the issuing of the decisions, the preliminary study of the
protocol, etc., and this is a very interesting, demanding and dynamic part of the procedures. This aspect
will have to take into consideration local requirements and characteristics, it will be able to turn the
general indications and recommendations into a flexible working guide and stimulate the ERC towards
a continuous comparison between its founding criteria and the situation in which it actually works. This
particular capacity of adaptation by the ERC will make an evolution of its qualities easier and make its
work more effective. Therefore first of all, the guarantee of protection of the patients will increase (for
example, the composition of the ERC could be modified if specific fields of expertise are repeatedly
involved) and it could perform a pedagogic role for the researchers. There could also be some useful
indications for the pharmaceutical sponsors, apart from obtaining the reviews in a reasonable time. It is
therefore important that the procedures themselves provide for a continuous self-evaluation.
The essential indications regarding the operative procedures come from the laws and regulations of the
individual countries (which generally come from the implementation and adaptation of international
guidelines), but also from the above mentioned WHO Operational Guidelines and the Guidelines of the
European Forum for Good Clinical Practice, as well as from the ICH-GCP, in the paragraph concerning
the ethics committees. Some useful suggestions may also come from associations or other bodies
involved in experimental ethics.
The fundamental points considered in these documents, which should also be an integral part of the
procedures for setting up and making the ERC work, come together in a general scheme that includes
the procedures for the meetings, the appointments and succession of the members, the procedures for
presenting the request and for the review of experimentation protocols, the procedures for the
formulation and communication of the decision, the procedures for monitoring the experimentation, the
documentation and filing procedures and, finally, the procedures for reviewing the activities of the
ERC itself[36].
The central part of the ERC’s activity consists in the examination of the experimentation protocol, the
analysis and discussion of all its aspects, particularly the problematic ones that characterise it, even
though the review is not limited to just the protocol but also includes other documents enclosed (for
example, any reviews that may already have been issued by other ERCs).
As for the procedures for evaluating the protocol, after distributing the documentation to the members
before the meeting and before the overall analysis of the ethical and scientific aspects of the protocol, it
may be useful to carry out an analysis of its contents and structure so the secretariat can make sure
nothing is missing. So an evaluation of the scientific validity and technical feasibility could be carried
out in advance (with respect to the plenary meeting) by a technical and scientific sub-committee of the
ERC, possibly with the support of external advisors. During the plenary meeting, the technical data,
although maybe not an opinion about its scientific validity, will already be available, and the overall
ethical evaluation can be reached, with an analysis of the scientific and ethical, insurance aspects, etc.,
through the discussion and individual contribution of the various members. The experimenter could
also be invited to present the research or to clarify particular aspects of the project.
A plan of the elements to consider for the ethical evaluation of the research protocol is shown in Table
1 and contains the whole of point 6.2 of the WHO Operational Guidelines.
166 Tab. 1 – Elements of the ethical review of research (WHO, Operational Guidelines for Ethics Committees that review biomedical
research, Geneva 2000, 6.2)
Scientific Design and Conduct of the Study
• the appropriateness of the study
• the medical care to be provided to research
• the adequacy, completeness, and
design in relation to the objectives
participants during and after the course of
understandability of written and oral
of the study, the statistical
the research;
information to be given to the
methodology (including sample
research participants, and, when
• the adequacy of medical supervision and
size calculation), and the potential
appropriate, their legally acceptable
psycho-social support for the research
for reaching sound conclusions
representative(s);
participants;
with the smallest number of
• clear justification for the intention to
• steps to be taken if research participants
research participants;
include in the research individuals
voluntarily withdraw during the course of
• the justification of predictable risks
who cannot consent, and a full
the research;
and inconveniences weighed
account of the arrangements for
• the criteria for extended access to, the
against the anticipated benefits for
obtaining consent or authorization
emergency use of, and/or the
the research participants and the
for the participation of such
compassionate use of study products;
concerned communities;
individuals;
• the arrangements, if appropriate, for
• the justification for the use of
•
assurances that research participants
informing the research participant’s
control arms;
will receive information that
general practitioner (family doctor),
becomes available during the course
• criteria for prematurely
including procedures for seeking the
of the research relevant to their
withdrawing research participants;
participant’s consent to do so;
participation (including their rights,
• criteria for suspending or
• a description of any plans to make the
safety, and well-being);
terminating the research as a
study product available to the research
•
the provisions made for receiving
whole;
participants following the research;
and responding to queries and
• the adequacy of provisions made
• a description of any financial costs to
complaints from research
for monitoring and auditing the
research participants;
participants or their representatives
conduct of the research, including
• the rewards and compensations for
during the course of a research
the constitution of a data safety
research participants (including money,
project;
monitoring board (DSMB);
services, and/or gifts);
• the adequacy of the site, including
• the provisions for compensation/treatment Community Considerations
the supporting staff, available
in the case of the injury/disability/death of
• the impact and relevance of the
facilities, and emergency
a research participant attributable to
research on the local community and
procedures;
participation in the research;
on the concerned communities from
• the manner in which the results of
which the research participants are
• the insurance and indemnity arrangements;
the research will be reported and
drawn;
published;
Protection of Research Participant Confidentiality
• the steps taken to consult with the
concerned communities during the
• a description of the persons who will have
Recruitment of Research Participants
course of designing the research;
access to personal data of the research
• the characteristics of the
participants, including medical records and
•
the influence of the community on
population from which the research
biological samples;
the consent of individuals;
participants will be drawn
• the measures taken to ensure the
• proposed community consultation
(including gender, age, literacy,
confidentiality and security of personal
during the course of the research;
culture, economic status, and
information concerning research
ethnicity);
• the extent to which the research
participants;
contributes to capacity building,
• the means by which initial contact
such as the enhancement of local
and recruitment is to be conducted;
Informed Consent Process
healthcare, research, and the ability
• the means by which full
• a full description of the process for
to respond to public health needs;
information is to be conveyed to
obtaining informed consent, including the
• a description of the availability and
potential research participants or
identification of those responsible for
affordability of any successful study
their representatives;
obtaining consent;
product to the concerned
• inclusion and exclusion criteria for
communities following the research;
research participants;
• the manner in which the results of
the research will be made available
Care and Protection of Research
to the research participants and the
Participants
concerned communities.
• the suitability of the
•
investigator(s)’s qualifications and
experience for the proposed study;
any plans to withdraw or withhold
standard therapies for the purpose
of the research, and the
justification for such action;
167 The ERC can also provide for procedures for an expedited review of the research projects, establishing
the conditions for applying this modality and the limits of the decision taken in this case[37].What can
not be ignored in an evaluation by the ERC is not only the scientific validity of the experimentation,
but also the adequacy of the conditions of protection of the subjects, the conformity to the GCP, to the
Declaration of Helsinki and to current regulations and its feasibility in that particular institution. In
particular, the decision regarding scientific validity involves the responsibility of the technical and
scientific opinion of various, specific figures who absolutely have to be adequately expert, because of
the decisive consequences of their opinions during the evaluation and the overall opinion.
Also in the risk/benefit analysis, in the measures to limit or avoid risk, in the criteria for the suspension
or interruption of the participation of the subjects, in all the aspects in which a specialist, technical
competence is necessary, the opinion of the “technical” members will be extremely important. The
members with non medical and scientific expertise will be called to pay particular attention to the
ethical, legal, and also psychological aspects, because of the impact that the experimentation may have
on the subjects taking part (for example, evaluating whether the participation in the experimentation
will excessively condition already difficult or precarious situations caused by the pathology) but also
on the community concerned.
The procedures should provide plenty of room to the modalities of review of the information given to
the subjects and of the consent statement.For this element of the protocol, which is often lacking, the
ERC could draw up a guide for the experimenter so the information sheets and consent forms presented
for approval contain at least the ethical elements provided by the international regulations and
guidelines. Detailed and complete information does not, on its own, equal ethical. It is necessary to
consider the cultural and subjective differences, and therefore pay attention to the clarity and
readability of the text[38], the comprehensibility of the terms, the style of language used (neither
terrifying, nor persuasive).
Apart from the aspects of the protocol itself, other aspects that are to be included in the procedures of
evaluation of the experimentation are: the suitability of the researcher, in terms of his qualifications and
experience, and of the institute, the economic responsibility that should not involve the institute, the
adequacy of the medical supervision and of the follow-up of the subjects and the insurance policy.
All these elements have to be studied before formulating an opinion, which should follow a clearly
defined and uniform method. It is certainly to be hoped that the ERC issues an opinion that expresses
the broadest consent or dissent of its members, although if an agreement is unlikely, there will have to
be a vote and a majority decision (two thirds of the assembly) and the possibility for those who do not
agree to add their opinion. If the decision is sub conditione, it will have to specify the missing
requirements and if it is negative it will have to be clearly motivated.
In the procedures for communicating the decision, the need for a clear and unequivocal expression of
the outcome of the evaluation has to be underlined. There are precise indications in the ICH-GCP
regarding this aspect, and they are to be adopted in the ERC procedures. For this procedure too, the
ERC can use a standard form for the written opinion, with all the points that have to be present: the title
and date of the experimentation, the documents examined, the name and qualifications of the members,
the explanation of the decision reached, any binding instructions for a positive opinion, any additional
recommendations, and the reasons for a negative opinion or for a suspension. It is important, also to
contribute to the improvement of the quality of clinical research, to provide all the elements of the
criteria that have led to a negative opinion, and that could successively be considered and corrected in
view of a renewed request for an opinion.
Issuing the opinion, when the experimentation has been approved, is not the end of the review work for
the ERC, so it will also have to provide some procedures that make it possible to carry out periodic
monitoring of how the experimentation is proceeding until it has formally been concluded. These
monitoring will require an efficient secretariat for keeping the documentation up to date during the trial
and for the time limitsand apart from the trial follow-up, they mainly concern the amendments, the
168 evaluation of any serious adverse events and the conclusion of the trial. The verification of the aspects
that can affect the safety of the subjects should be even more accurate. The ERC therefore also has to
carefully evaluate all the information that comes from other ERCs or experimentation centres and
renew or withdraw the approval already expressed of the protocol.
Apart from the procedures for the appropriate recording and filing of the documentation, of the
opinions regarding the experimentations and of the ERC’s minutes and correspondence, which can be
inspected by the regulatory authorities or by whoever has access, according to the modalities
established in advance, a last consideration has to be made concerning the procedures of the review of
the activity and efficiency of the ERC itself (the annual check on the frequency of the meetings, the
number of protocols examined, the time necessary for the opinion, the need to substitute one or more
members or to insert new fields of competence, etc.).The ERC should in fact have a strong stimulus for
self-criticism and an commitment towards the review of its own operative procedures and of the
activities it carries out, thanks to the professionally and morally qualified figures within it, the adequate
number of members who are not part of the institute, themultidisciplinary fields of competence covered
and in the pursue of a continuous improvement of the quality of its work.
CONCLUSIONS: TRUST BUT VERIFY
Although the ERC review system is based on trust in researchers, collaborating with them and
assuming that they are well intentioned, the ERC is responsible for verifying that the intention to
protect the subjects of the research is put into practice. George Grob, an FDA inspector, reported the
results of a few years of IRBs inspections and has provided a series of interesting observations that can
help these research review bodies understand which direction they should move in and the
transformations that should therefore take place[39].
Grob indicates six main factors that describe the present situation of the ERCs:
1) In the past research was mainly carried out in single university and hospital institutes, by a single
researcher, with a small number of subjects, so the ERCs had less work and more time to carefully
examine the protocols and evaluate the risks. Today, research is often carried out by commercial
sponsors, who urge for immediate approval from the ERCs, since these are multi-centre trials, and they
not happy about requests to modify their protocols. Research often concerns genetic data and there is
also strong pressure from the potential research subjects themselves to become part of a trial, so the
ERCs have to make sure that there is enough information to let the subjects understand the difference
between research and treatment.
2) Although monitoring the research after approval is an important way to protect the subjects taking
part, the enormous amount of work makes it impossible for the ERCs to carry out this role, and they
generally just dedicate it a few minutes during the meetings.
3) The large number of protocols to examine, and therefore the need to work quickly in order to
examine them all, produces superficial evaluations, where an expert in a specific field of research may
often not be called in.
4) Neither the ERCs nor the government bodies devote much attention to the need to evaluate the
effectiveness of the ERCs: has the information necessary for consent really improved?Have the
subjects of the research really received the best for their situation? Have the ERCs verified whether the
modifications they required have actually been put into practice?
5) Many of the ERC members often have interests of a different nature with respect to the protocol they
have been asked to evacuate and there are often too few members not affiliated to the institute to
guarantee the impartiality of the opinion.
6) The ERCs and the institutes they belong to provide too little training for the researchers and the
members themselves of the ERC.
169 As a consequence of these comments it is recommended that the ERCs reconsider their operative
procedures and all their work in order to improve the protection for the subjects of research, as well as
the value and scientific validity of the research itself. At this point it is worth mentioning the recent
debate concerning the importance of the increasingly numerous guidelines issued within the field of
human experimentation in general.Jonathan Moreno[40], in discussing this question, has pointed out
that at the beginning of the 20th century, the guidelines on experimentation, including the Helsinki
Declaration, were mainly based on the researcher’s discretion. However, over time, there has been
increasing external pressure regarding the ethical elements to be protected in research. That is, there
have been three levels of protection: 1. weak: everything is entrusted to the researcher’s moral qualities
(virtues); 2. moderate: the personal virtues were important but were not considered sufficient, so
respect for certain guidelines was required; 3. strong: protection is established by law but there is no
incentive for the researcher to put his virtues into practice.
Moreno’s question is: are we sure that increasing the protection by external bodies is the best way to
carry out research ethically? In fact, with strong protection, it appears that the subjects are more
protected, but ethics codes, guidelines, informed consent and Ethics Committees are only a starting
point. They are certainly essential, but they do not substitute the researcher’s ethical conscience, which
is the best guarantee of safety for the subjects of research. So the ERC too has to aim to educate this
conscience and part of the ERC’s activities must always be the continuing education of researchers.
[1] Foster C., Research Ethics Committees, in Chadwich Ruth (ed.) Encyclopedia of Applied Ethics,
London: Academic Press 1998, 3: 845-852.
[2] Jonsen A.R.The Birth of Bioethics, New York: OxfordUniv.Press; 1998: 125-165
[3] Spagnolo A.G., voce Bioetica, in Dizionario Interdisciplinare di Scienza e Fede (a cura di G.
Tanzella-Nitti e A. Strumia), Urbaniana University Press, Roma 2002 pp. 196-214.
[4] Beecher H.K., Ethics and clinical research, The New England Journal of Medicine 1966, 274(24):
1354-1360.
[5] Pappworth M.H., Human guinea pigs, Beacon Press, Boston 1967.
[6] Evans D., Evans M., A decent proposal. Ethical review of clinical research, J. Wiley & Sons,
Chichester 1996, p. 2.
[7] Volmann J., Winau R., The Prussian regulation of 1900: early ethical standards for human
experimentation in Germany, IRB, 1996, 18(4): 9-11; Sass H.M., Reichsundschreiben 1931: preNuremberg German Regulation concerning new therapy and human experimentation, J. Med. Philos.,
1983, 8(2): 99-111.
[8] Spagnolo A.G., Minacori R., Il consenso informato alle sperimentazioni mediche prima e dopo
Norimberga.In: A, Tarantino e R. Rocco (a cura di), Il processo di Norimberga a Cinquant'anni dalla
sua celebrazione (Atti del simposio internazionale, Lecce 5-7 dicembre 1997), Giuffrè Editore, Milano
1998, pp. 173-191.
[9] Lipsett M.B., Fletcher J.C., Secundy M., Research Review at NIH, HastingsCenter Report, 1979,
9(1): 18-21.
[10] Foster, Research Ethics Committees, p. 846.
[11] Curran W., Governmental Regulation of the Use of Human Subjects in Medical Research: The
Approach of Two Federal Agencies, in Freund P.A. (ed.), Experimentation with Human Subjects,
George Braziller, New York 1970, pp. 402-454.
[12] National Research Act Public Law 93-348, July 12, 1974
[13] U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral
Research, Institutional Review Boards, DHEW Publication No. (OS) 78-0008, Washington 1978.
170 [14] The National Commission for the Protection of Human Health Subject of Biomedical and
Behavioral Research: The Belmont Report: Ethical Principles and Guidelines for the Protection of
Human Subject of Research.U.S. Office for Protection from Research Risks (OPRR), National
Institutes of Health (NIH), Public Health Service (PHS), Human Health Service (HHS). Washington,
D.C., 1979.
[15] These principles were then extended by Beauchamp and Childress from the limited area of human
experimentation to all fields of bioethics (see Spagnolo A.G., I principi della bioetica nord-americana e
la critica del “principlismo”, Camillianum 1999, 20: 225-246.)
[16] Supervision of the Ethics of Clinical Investigations in Institutions. Report of the Committee
appointed by the Royal College of Physicians of London, Br. Med. J., 1967, 3, 429-430.
[17] RoyalCollege of Physicians of London,Guidelines of the Practice of ethics Committees in Medical
Research, London 1984.
[18] National Commission for The Protection of Human Subjects of Biomedical and Behavioral
Research, Report and Recommendations: Institutional Review Boards, Publication n. (OS) 78-0008.
Washington D.C: Department of Health, Education and Welfare.
[19] Medical Research Council of Canada, Guidelines on Research Involving Human Subjects, Ottawa
1987.
[20] Viafora C., Comitati etici: la bioetica all'interno delle istituzioni sanitarie, in A Bompiani (a cura
di), Bioetica in medicina, CIC Edizioni internazionali, Roma 1996: 434-450.
[21] Herranz G., Il Comitato centrale di deontologia spagnolo, in Spinsanti S. (a cura di), I comitati di
etica in ospedale, Edizioni Paoline, Cinisello Balsamo (Mi) 1988: 141-148.
[22] Spagnolo A.G., Bignamini A.A., De Franciscis A., I Comitati di Etica fra linee-guida dell'Unione
Europea e decreti ministeriali, Medicina e Morale 1997, 6: 1059-1098.
[23] Levine R.J., Ethics and Regulation of Clinical Research, 2d ed., Urban and Schwarzenberg,
Baltimore 1986.
[24] Levine C., Has AIDS Changed the Ethics of Human Subjects Research?, Law, Medicine and
Health Care, 1988, 16(3-4): 167-173.
[25] Access to abortion in the United States, since the Roe versus Wade sentence in 1973, has been
acknowledged as a woman’s right to privacy, and therefore not controlled by the committees.
[26] US President's Commission for the Study of Ethical Problems in Medicine and Biomedical and
Behavioral Research, Deciding to Forego Life-Sustaining Treatment, US Government Printing Office,
WashingtonDC 1983.
[27] International Conference on Harmonisation of Technical Requirements for Regulation of
Pharmaceuticals for Human Use, Tripartite guidelines for good clinical practice, International
federation of Pharmaceutical manufacturers Association, Geneva 1996.
[28] Cfr. Spagnolo A.G., Sacchini D., Torlone G., Bignamini A.A., Il laboratorio del Comitato Etico.
Istituzione e procedure operative standard, Medicina e Morale, 1999, 2: 221-263.
[29] World Health Organization, Operational Guidelines for Ethics Committees That Review
Biomedical Research, Geneva 2000.
[30] For example, the Charter for Healthcare Workers, issued by the Pontifical Council for the Pastoral
of Health Workers or the Ethical and Religious Directives for Catholic Health Care Services.
[31] Ministero della Sanità, Decreto Ministeriale 15 luglio 1997, Recepimento delle linee guida
dell'Unione europea di buona pratica clinica per la esecuzione delle sperimentazioni cliniche dei
medicinali, Gazzetta Ufficiale della Repubblica Italiana, serie generale, suppl. ord., 18 August 1997.
[32] European Forum for Good Clinical Practice, Guidelines and Recommendations for European
Ethics Committees, revised edition 1997; also translated and published in Italian in Medicina e Morale,
1998, 5:1037-1057.
[33] In Italy, ERCs“ought to included: two clinicians, one bio-statistician, with documented experience
and knowledge of randomised clinical trials, one pharmacologist, and as the ex-officio members, one
171 pharmacist, the medical director or the scientific director of the institute itself and an expert in legal
matters; the other members should have qualifications and expertise in general medicine, bioethics, the
nursing sector and voluntary work” (Ministry of Health, Decree 18.3.1998 Guidelines for the founding
and working of ethics committees, official gazette of the Italian republic, general series, n.122,
28.5.1998).
[34] This is recommended, for example, in Italy by the DM of 18.3.1998: “It is advisable to include a
large number of members who are not employed by the institute making use of the Committee and
members who are not part of the medical profession or the relative technical professions. The need to
make known the absolute impartiality of the body also requires that the presidency of the Committee be
preferably entrusted to members who are not employed by the institute”.
[35] This circumstance is explicitly stated in the Italian situation, for example, in the DM of 18.3.1998.
[36] After issuing the Operational Guidelines the WHO itself issued a new document that proposes to
provide guidelines on how the ERCs are to evaluate the ethicalreviews (WHO, Surveying and
Evaluating Ethical Review Practices. A complementary guideline to the Operational Guidelines for
Ethics Committees that review biomedical research, Geneva, February 2002). And at the same time, the
European Forum for Good Clinical Practice provided the European Guidelines for Auditing
Independent Ethics Committees, EFGCP 2002, www.efgcp.org)
[37] World Health Organization, Operational Guidelines for Ethics …, n. 6.3.
[38] Berto D., Peroni M., Milleri S., Spagnolo A.G., Evaluation of the readability of information sheets
for healthy volunteers in phase-I trials, Eur. J. Clin. Pharmacol 2000, 56: 371-374.
[39] Grob G., Institutional Review Boards:a time for reform, US Department of Health and Human
Services, Office of Inspector General, 1998.
[40] Moreno J.D., Goodbye to all that. The end of moderate protectionism in human subjects research.
HastingsCenter Report 2001; 31(3): 9
172 JUAN DE DIOS VIAL CORREA
ETHICS OF ANIMAL EXPERIMENTATION
Animals have been often mistreated to the point of cruelty.It is very often that hunting, making war,
eating, experimenting, industrial manipulation, etc. have gone far beyond any moderation and have
resulted in unnecessary and extreme suffering for animals, not to mention the wiping out of species, the
desolation of the environment and the impoverishment of all life, including of course human life.
Experimental Biology developed before even the most rudimentary methods of anesthesia were
known.To mention a single and particularly striking instance the physiological role of pain bearing
posterior root nerve fibers[1] was established in experiments in unanesthetized animals, which made
Müller remark: “Diese Versuche sind bei hoheren Thieren die grausamsten die man erdenken
kann”.Animal housing conditions have often been appalling, and to a large extent it seems that feeding
and general maintenance has been kept at the bare minimum necessary to ensure reliable experimental
results.However, from the XIX century on, great efforts have been made in many countries to curb
cruelty to animals, not only in everyday life but increasingly in animals used for experimentation.The
obvious benefits brought about by the use of experimental animals (preserving life and health in human
beings; savings of costs and time in research) are being increasingly weighted against the suffering
inflicted.As a consequence stronger regulations are being enforced and greater care is exerted, at the
same time that efforts are made to explain to the public (general public, legislators, media), the need of
having recourse to animal experimentation.
However the development of biotechnology places novel demands and stress upon experimental
animals.Cloning for industrial purposes and xenotransplants may be mentioned as issues, which have
aroused considerable interest.The general field of genetic manipulation, transgenic animals, etc. also
deserves consideration.
If only because of social awareness, we are now at a point where the ethical status of animal
experimentation should be examined in more detail than at any time in the past.
Ethics is concerned with “the reason why” of human actions, in answer to the question “what should
we do?
At the base of any ethical judgment[2] lies a moral experience which is as it were an empirical datum
apprehended by practical reason.The action may be judged as approved within my tradition,
experience, and first appreciation and feeling, in short I may be inclined to the action.A further step
corresponds to the intelligence which will refine this judgment and try to identify what is it that is
attractive, what are the positive values, what are the aspects of reality perceived which call for my
approval.This effort will also result in an identification of negative values, in the sense of attraction by
pseudorealities.The judgment by inclination is thus transformed into a judgment of values.
This approach is nearer to wisdom than to reasoning, and requires an openness to the good of reality
i.e. a disposition to let oneself be attracted or become desirous of the fullness of being.When this
disposition is deeply rooted, action flows from our experience.This fitness of the soul for right action is
what we mean by “virtue”.
In the case of the attitude to animals, we feel “inclined” to the action of caring for, respecting, even
loving the animals.Cruelty or wanton neglect of them on the other hand, evokes a feeling of
disapproval.When we submit this “inclination” to finer analysis, we discover biological, psychological,
cultural reasons that stem from the feeling and reinforce it.We discover “values” in certain attitudes
toward the animals.
By a natural extension of our vision to other fields of experience we encounter situations that share
some features with our contact with animals.Such are the attitudes before wild animals, or even living
things in general.We discover a value in the manifold reality which we call “life”, and perceive that
173 each of its manifestations poses a peculiar challenge to the attitude of man.This is intimately linked to
the discovery that somehow we have a share into every life, and that we are dependent on life to live.
However at the level of the analysis of values, the question of mistreatment of animals has become
deeply entangled with some of the most pressing and vocal, philosophical and scientific issues of our
time, namely those concerned with life in general and with environment.Practical judgment and the
search for values are replaced by ideological discourse.Under these perspectives the demand is made
for a rational elucidation of the relations between man, life and environment.Particularly pressing is the
requirement of a foundation for an ethics of human behavior in regard of living (and to a lesser degree
of non-living) beings.“Environmental ethics” and even “environmental philosophy” are becoming
topics of widespread discussion in scientific circles especially among the younger generations.Even
though this is not the occasion for a systematic treatment of the subject, it may be of value to address it
briefly because of the increasing acceptance found by positions entirely incompatible with Christian
ethics.
A judgment of values requires an elucidation of the status of animals and of living beings in
general.This is rendered more urgent from the moment that both in scientific circles and in the general
public a cultural current is active which interprets the existence of man as a product of biological
evolution within a wholly materialistic outlook.In this widely extended conception, no qualitative
differences may be rightly invoked to separate man from the rest of living things.There can be no
question that in this way the special dignity of man is done away with, and that the end result is not so
much an enhancement of the status of animals as a debasement of that of man.
The history of materialistic evolutionism sheds a light upon the meaning of some of the present day
evaluations of the status of animals.During the XIX century the surge of materialism found a powerful
hold in the idea of natural selection as the driving mechanism for the diversification within the world of
living things.The gradualism and the non-finalist character of evolution seemed to be in harmony with
a radically materialistic interpretation of reality.Non human Primates were not to be seen as
qualitatively different from man, and this became the basis for a new and presumedly higher evaluation
of the condition of animals.It is often overlooked that this pretended reevaluation of animals in the
perspective of evolution, is really accompanied by a debasement of the condition of man.This was
however perfectly clear to the great apologists of monistic and materialistic evolution in the XIX
century.Ernst Haeckel the prominent german biologist stated it thus. “[thought and reason] are certainly
found in the higher vertebrates especially in the placental mammals, the class from which man has
sprung.The consciousness of the highest apes, dogs, elephants, etc. differs from that of man in degree
only, not in kind, and the graduated interval between the consciousness of these “rational” placentals
and that of the lowest races of men (the Veddahs etc.), is less than the corresponding interval between
these uncivilized races and the highest specimens of thoughtful humanity (Spinoza, Goethe, Lamarck,
Darwin etc.)…”[3] (It is well known that ideas such as these inspired cruel ethnological experiments
such as were the exhibitions of south american indians in museums and zoological gardens in
Europe.More than that they reinforced the notion that any special consideration of the status of man
was untenable.[4]
One of the most influential of the theses proposed in this perspective is expressed in the dictum of Peter
Singer “All animals are equal”, which is meant of course to comprise man among the animals.[5]
A utilitarian approach to animals would then require the identification of a “common interest” which
might be equally counted for each and every individual.Singer dismisses as essentially irrelevant the
usual comparison between animals on the basis of their cognitive powers and adopts the idea of Jeremy
Bentham according to whom the really relevant question about animals - if you are concerned with
their receiving a fair treatment-, is “…can they suffer?” [6]
It seems obvious that animals can suffer and that they will react vigorously against some forms of pain
or suffering.But there seems to be no valid reason to equate their “kind” of suffering with that of man
174 inextricably entangled with the cognitive and moral reverberations of suffering.It seems that Singer’s
evaluation involves an unwarranted anthropomorphism.
Singer has made an eloquent case against killing animals either for food or for science, as well as
against submitting them to cruel conditions for rearing and housing.In his position animals individually
counted are assimilated to human beings, and he shows no special interest in the defense of the
species.The evaluation keeps focussed only on the individual animals and their suffering.
This position has been sharply questioned among others by Regan[7].He argues that equality of
condition is not logically followed by any obligation of equality of treatment, and beside that it will be
normally impossible to make a reliable evaluation of the good and evil that may be associated with a
definite action upon animals.If no absolute right is granted to anyone, it might well be that the suffering
of one would be a perfectly acceptable means for securing the well-being of the greater number.Regan
claims that the shortcomings of utilitarian ethics in the defense of animals may be overcome only by
the recognition of individual animal rights.
Both these positions have in common that they assimilate the status of animals, individually counted, to
that of man.
They should be considered apart from other philosophical views which place man as one of the many
components integrated to the whole of living (and even non living) beings.Such are the ethics of the
earth of Leopold[8] or the deep ecology of Naess[9] and others.These holistic approaches have no
direct bearing on the treatment of animals, if only because suffering is a part of the natural life course
of any animal.It is however important to bring them to mind at this place because of two main
reasons.Firstly they are in the background of present day ethics of the treatment of Nature; and
secondly they share with the above mentioned ethics of Singer and Regan, an outlook which in
principle deprives man from any special consideration. Leopold’s ideas demand that moral
consideration be extended to categories that had been traditionally excluded, and begin to open the way
toward a consideration of ecosystemic equilibrium.[10] Naess (ibid) goes beyond stressing biological
relations rather than biological individuals which are seen as subordinate to the network of interactions.
Notwithstanding their depersonalizing bias, ethics founded upon Nature do have a certain interest in
that they represent a mode of reaction against prevailing ethics especially those of utilitarian trend.The
whole of Nature is not seen as an object open to a grasping tendency expressed in technological
exploitation.If the good of nature is to regulate the actions of man, this means that objectively good
values are being rediscovered by many, notwithstanding the fact that these values appear to be grossly
distorted, and exaggerated.
In this sense authors like Singer and Regan seek to extend to animals – at least to higher animals – the
special consideration accorded to man, while ecological approaches incorporate man into a natural
whole, whose laws comprise those of every living being.Accordingly, while in the case of Singer
animal suffering is an evil to be minimized, in the case of Leopold it is integrated into the complex
interplay of life. Singer’s approach bears the mark of its individualistic origin and inevitably runs
counter to holistic approaches.
Utilitarian and holistic views are deformations of value systems which require to be integrated into a
renewed anthropocentric perspective, and which range from the compassion for animals and the
repugnance toward inflicting unnecessary suffering, to the participation of man in the whole of earthly
life.
However removed from a Christian view, all these ethics suggest a deeply rooted respect for life.It is
the value of life itself which emerges from the highly confusing‘philosophical foundations.Under the
form of respect for life a renewed conscience emerges that there are attitudes and action which are
objectively right or wrong.The role of Nature tends to supplant God Himself, but in so doing it
inevitably demands a search for meaning in human life. This is a hint of “natural religion” which
demands to relinquish the autocratic godless role so often assumed by man.
175 The Bible presents a view which differs greatly from that of any “natural religion”.Man was created at
the image of God with the mandate received from the Creator to subdue, to dominate the
earth[11].What was entrusted to man was the whole of the Creation wisely disposed by God’s
omnipotence[12].The works of the Creation had been seen by God to be good[13] and the power
conferred upon man could never be construed as a right to mismanage and plunder, but as a manner of
carrying out a mandate which “reflects the very action of the Creator of the universe”[14].God’s
intention is reaffirmed in Genesis when man is placed in the Garden of Eden to cultivate and to guard
it.[15] Man is responsible for God’s creation before God Himself.
Recent experimental developments, especially those concerned with the manipulation of the genome
have brought again to light the need for a particular care for animals both to avoid cruelty to them and
to preserve unwanted impacts upon the environment which might result from mismanagement of the
genome.In particular one should be attentive to the novel question raised by transgenic animals, that is
those whose genetic makeup has altered by the introduction of one or several foreign genes.In these
cases it is not only the state of the experimental animal that is to be an object of special concern,
including that necessary to avoid useless suffering, but also the state of the progeny, the care for
avoiding alteration of the biodiversity and for the possible impact upon the environment.
The Pontifical Academy For Life issued a booklet on xenotransplantation, which deals also with the
ethical problem of animal experimentation in general and with transgenesis.As stated in the document:
“….thereshould be a reaffirmation of the right and the duty of man, according to the mandate from his
Creator, and never against the natural order established by him, to act within the created order and on
the created order, making use as well, of the other creatures in order to achieve the final goal of all
creation: the glory of God and the full and definitive bringing about of His Kingdom, through the
promotion of man.The words of St. Irenaeus of Lyons still ring out with all their truth: Living man is
the glory of God and man’s life is the vision of God” (Adv. Haereses, 4,20,7)[16].
The "equality of animals and man" postulated by Singer, and the "animal rights" of Regan are
expressions employed beyond a natural and justifiable sense, in that only within the human species
could be found individuals capable of being aware of them and of acquiescing to the obligations they
might impose.Analogously, it is only man who is aware of obligations toward Nature and this
awareness puts him in a unique stance in front of the universe.Man may well feel himself responsible
for the healthy and harmonious development of life, but he truthfully claims to be the subject of rights
that may not be infringed.Man transcends the whole of living things and all analogy between his
condition and that of other beings has at most a restricted value.
As stated in the above mentioned document on Xenotransplantation (16) “….a simple look at
humanity’s long presence on the Earth is sufficient to show an irrefutable fact clearly: it is man who
has always directed the realities of the world, controlling the other living and non-living beings
according to determined purposes.In particular man has always made use of animals for his primary
needs (food, work, clothing etc.) in a sort of natural cooperation that has constantly marked the
different stages of progress and the development of civilization…”
The unavoidable conscience of this condition may certainly mislead man to transform this uniqueness
into a relation of domination of the whole of Nature.Human reason will however condemn any cruelty
or wanton ill-treatment of living things. “…the sacrifice of animals can be justified only if required to
achieve an important benefit for man….However (in every) case there is the ethical requirement that in
using animals, man must observe certain conditions: unnecessary animal suffering must be prevented;
criteria of real necessity and reasonableness must be respected; genetic modifications that could
significantly alter the biodiversity and the balance of species in the animal world must be avoided.The
theological and moral point of view …..leaves open the question of different levels of sensibilities
between animals of different species….”(16).
The proper respect for animals and the concern about their useless suffering is a way of acknowledging
the splendor of life, and suggests that not to observe it is debasing for man, and not only evil but in a
176 way self destructing.At the same time he who cares for living beings imitates the Creator in Whose
stead only, may the human person act to rule over the Universe.Care for life and for living beings is a
manner of acknowledging man’s indebtedness to God.
[1] MÜLLER JOHANNES.Handbuch der Physiologie des Menschen Ersten Bandes zweit Abtheilung
Coblenz Verlag von J Hölseher, 1833, pp. 649-650.
[2] MARITAIN JACQUES.An introduction to the basic problems of moral phiosophy Magi Books Inc.
Albany, N.Y. (1988).(Translated from Neuf leçcon sur les notions premières de la philosphie morale,
first published in Paris, 1950 by Pierre Taqui) Chapters 2 and 3.
[3] HAECKELERNST.The Riddle of the Universe.Published 1899, translatedfrom Die Welträthsel,
1899 by Joseph McCabe, Prometheus Books, 1992), p. 182.
[4] AGUILERA NELSON, CLAUDIA ESPINOZA. Presencia de indígenas de Fuego. Patagonia en
teritorio europeo. In Boletín surdelsurpatogonia.com/erase una vez/pueblos, 66n1.htm.
[5] SINGER PETER.All animal are equal.Originally published in Philosophic Exchange, vol I, n5:
243-257 (1974).Reproduced in Environmental Philosophy.Zimmermann HE, Callicott JB, Sessions G,
Waqrren Kj; Clark J. Editors.Prentice Hall, N.J., 26-40 (2002).
[6] Cit. In (5), p.30.
[7] REGAN TOM. Animal rights, human wrongs.Originally appeared in Environmental ethics.Vol 2,
n2, 99-120 (1980).Reproduced in Environmental Philosophy.Zimmermann HE, Callicott JB, Sessions
G. Warren KJ, Clark J. Editors.Prentice Hall, N. J. 41-55 (2001), p.48.
[8] LEOPOLD ALDO.Originally appeared as The Land Ethic.In “A sand country almanac and
asketches here and there”, Oxford University Press, 1949.Reproduced in Environmental
Philosophy.Zimmermann HE. Callicott JB, Sessions G. Waqrren KJ, Clark J. Editors, Prentice Hall,
N.J., 97-110 (2001), pp 109-110.
[9] NAESS ARNE.The deep ecological movement: some philosophical aspects. Originally appeared in
Philosophical Inquiry 8: 1-2 (1986).Reproduced in Environmental Philosophy.Zimmermann HE,
callicott JB, Sessions G. Waqrren KJ, Clark J. Editors, Prentice Hall, N.J., 185-203 (2001), pp 189-190.
[10] FISSO MARIA BEATRICE, ELIO SGRECCIA.Etica dell’ambiente.Medicina e Morale
1996/6:1057-1082, pp 1068 and 1074.
[11] H.H.JOHN PAUL II.Encyclical Letter Laborem Exercens n4.
[12] Gen. 1:26-28.
[13] Gen.1.
[14] H.H.JOHN PAUL II.Encyclical Letter Laborem Exercens n4.
[15] Gen. 2:15.
[16] PONTIFICAL ACADEMY FOR LIFE.Prospects for Xenotransplantation.Librería Editrice
Vaticana (2991), nn.7, 8,15.
177 ADRIANA LORETI-BEGHE’
INTERNATIONAL REGULATIONS AND BIOEMEDICAL RESEARCH
Contemporary advances and future prospects
Summary: 1. Introduction – 2. Freedom of scientific research and the defence of human rights – 3. The
Convention of Oviedo and the Additional Protocol on biomedical research – 4. Genetic manipulations
and cloning – 5. The right to physical and mental integrity in the Charter of Fundamental Rights of the
European Union – 6. Conclusions.
1. If it is true that the scientific and technological ‘revolution’ that characterised the last decade of the
past century (and will without fail also mark the years to come) is also a matter of the drawing up of
suitable legal norms (not only of national law but also and above all of international and Community
law) to govern the applications of modern technologies, jurists can legitimately bestow upon
themselves (or at least share) the title of ‘architects of the future’.
Personally, I make this observation in order to engage in a deeper reflection. I am, indeed, convinced
that the dimensions of biomedical research bring out the need to ensure effective forms of guarantees
for the fundamental rights of man. But at the same time I am also convinced that legal regulation and
jurisdictional defence do not exhaust the gamma of possible guarantees. On this point, I would like to
observe that a legal regulation brings together needs, pressures and assessments that are born before
and outside the world of law on the basis of a preliminary process of formation of social agreement. If
agreement constitutes the basis of every legal regulation, it follows that the explicit recognition of
fundamental rights and the possibility of employing jurisdictional remedies to defend them must also
be preceded (or supplemented) by specific measures directed towards guaranteeing and implementing
such rights, through the abolition of obstacles of a primarily ‘cultural’ nature as well, as is
demonstrated, for example, by the experience acquired in the field of forms of discrimination based
upon gender.
It seems to me necessary, therefore, to introduce or improve, side by side with the prohibition of
eugenic selection and the use with discriminatory goals of the techniques of genetic engineering (to cite
only a few examples), the processes of education and information designed to guarantee full
transparency in the communication of the objectives of research and biomedical experimentation and to
ensure, in a lasting way, public trust and participation in programmes of genetic investigation. In other
words, we need to stimulate and adequately explore agreement on the overall direction of scientific and
technological research because the management of technical-scientific knowledge in contemporary
society requires the increasing possibility of democratic participation and ‘sharing’.
In the above-described context, the need is especially felt to ensure forms of guarantees for the ethical
nature and legitimacy of biomedical research and experimentation that go beyond, and are different
from, the traditional forms, through, as well, the ‘association’ of public opinion and the mass media
during the stage of the drawing up of political or legislative decisions concerning the developments and
the applications of the techniques of genetic engineering. The risks inherent in an uncontrolled
development of biomedicine and biotechnologies are now increasingly perceived by individuals, and as
a result the right to know of citizens is increasingly an imperative requirement. In this perspective,
adequate modalities and procedures should be identified for the technical-scientific choices that are at
the basis of those transformations that are most perceived by society, with the aim of rendering
effective the right to information on, and participation in, the decision-making processes on questions
and issues connected with science and applied research.[1]
An important example in this sense is provided by the creation of specific work groups within the
framework of the initiatives linked to the implementation of the White Book on European Governance
presented to the European Commission in 2000. In the context of such initiatives, designed to fill the
178 complained-about democratic deficit of the Community’s method of governance, there were envisaged,
in fact, two groups of experts: one entrusted with formulating proposals in the field of the
democratisation of scientific knowledge, especially in the sectors of health and security, and another
responsible for initiatives connected with the participation of civil society.[2]
To the ends above mentioned, of great relevance as well is the spread at an international, European,
national and local level of monitoring bodies and consultative forums, of an impartial and independent
character (such as ethical committees, to which I will return later in this paper), which can make
themselves the expression of the overall ‘sustainability’ of experimentations in line with the principles
of subsidiarity (in the broad sense of drawing citizens as close as possible to the decision-making nerve
centres) and precaution. In particular, the principle of precaution, which has rapidly risen to the rank of
a general principle of law (in this case, of Community law), implies the adoption of a structured
strategy for the adoption of decisions which sees in the preventive assessment, management and
communication of formable risks, as well as the involvement of all the interested parties, its essential
elements. This principle, as has been observed, can be seen as an applicative example of a way of
interpreting scientific knowledge and is applied when the state of scientific knowledge in a given sector
does not allow the full appreciation of the risks connected with, or consequent upon, the technological
applications of scientific discoveries and the probabilities that they have of becoming a reality, from a
the point of view of time as well.[3]
A precise legal obligation, in this sense, on the part of the State parties to the Convention of Oviedo,
derives from article 28 of this agreement. It places upon the contracting countries the obligation to
supervise matters so that the fundamental problems raised by the development and application of
biology and medicine constitute a subject for appropriate public consultation and debate, in particular
in the light of the relevant medical, social, economic, ethical and legal implications. The sensitisation
and education of the public are thus positive obligations adopted by the States that ratified this
international instrument. For that matter, new forms of mediation between science and society appear
to be really necessary, especially in multicultural and multiethnic societies (of which contemporary
society is an example), because there is a widespread perception of a progressive ‘separation’ of
science and society and the absence of shared foundations regarding the ethical acceptability and
legitimacy of scientific research. Obviously, this runs the risk of undermining the bases of the
fundamental rights of man, with reference both to their recognition and to the forms and instruments of
their defence, and above all else their direct implementation by the interested person.
It can be said, therefore, that the legal regulation of bioethical questions cannot precede the maturation
within a social body of sufficiently shared and consolidated moral choices and ethical options on the
solutions to be pursued, to whose realisation the law is called to offer the support of more suitable
instruments. It will thus be possible not only to reconcile the individual needs for control over the use
of genetic material (and, especially, of the information that is contained in it) with the more general
needs for public defence of genetic resources, but also to provide a more precise content to the notions:
‘shared patrimony of humanity’ and ‘intergenerational responsibility’.
2. Freedom of scientific research is a widely upheld right both in the Constitutions of individual States
and in international instruments. It is true, however, that it is not always easy to distinguish between
pure research (which essentially involves the broadening of knowledge of the foundations at the basis
of observable phenomena) and applied research (the activity of investigation certainly directed towards
the acquisition of new knowledge but also directed towards precise objectives), given that they are two
stages of the same cognitive process, which, because of the characteristics of modern science, appears
to be necessarily experimental and from which derive, in many cases, not only practical and applicative
consequences but implications that are important for the further development of pure scientific
research.
179 It is equally true that the unprecedented results of scientific and technological progress that have
followed each other in recent years at an overwhelming rhythm seem destined to penetrate the secrets
of space, matter and life, and to increasingly affect in the future the environment, the ecosystem and the
habitat of man. From this point of view, it should be made clear that molecular biology and the
techniques of genetic engineering (the so-called life sciences) are the sectors which are most fertile in
really revolutionary innovations. Biotechnologies, in particular, are different from the other modern
technologies which have also been developed in recent years: here one only need draw attention to the
needs for raw materials that are very special and different in comparison to traditional raw materials
(genes, the so-called ‘green gold’ of the twenty-first century); the significant consequences for human
health of the application of biotechnological research; and even the possibility that biotechnologies will
influence the values at the basis of civil co-existence in the direction of developments that are not
totally in line with the principals of a state based on law, as public opinion as well seems by now to
clearly perceive. In particular, the advances achieved in this sector raise concerns, which have been
demonstrated by the European Parliament since 1989, about the possible discriminatory use of the
results of biotechnologies, in particular with the purpose of social and demographic control.[4] In this
sense can also be interpreted the observations of those who complain about the risks of a ‘second
Genesis’, conceived artificially in the biotechnological laboratories of industrialised countries and
directed towards repopulating the earth’s biosphere in line with criteria of eugenic selection.[5]
The risks connected with, and consequent upon, the improper use of the results of scientific research,
brought about by phenomena that are as famous as they are tragic (from Hiroshima to the crisis of the
‘mad cow disease’), demonstrate not only the dual character of technical-scientific progress but also the
need to govern the exercise of the activities that are at the basis of this progress so as to direct their
future developments towards the achievement of results that are advantageous for the whole of
mankind and useful in the strengthening of the bases of civil co-existence. In this context, the
international defence of human rights and fundamental freedoms has risen to occupy a place at the
centre of a broad reflection. This is because the advent of modern technologies, above all in the
biomedical field, have raised concerns and uncertainties, involving as they do new threats to the
freedom of individuals, and have promoted an intricate debate about the existence of new rights and the
need to guarantee respect for them: one need only think here, for example, of genetic modifications
whose ‘knock-on effects’ can affect not only the subjects who are directly involved but also subsequent
generations.
The needs called attention to find a greater response, as is natural, at the level of international law.
Indeed, there are numerous factors that push in the direction of a growing ‘globalisation’ of the
activities of research, in the same way as the objectives to be promoted and achieved through suitable
international norms are also many in number, Before returning in due course to the analysis of the
various aspects of the subject already indicated in this paper, it should be stressed here that the
agreements reached within the United Nations Organisation (UNO) from the end of the Second World
War onwards in order to govern international co-operation within the area of scientific research have
helped first and foremost to provide an implementation in this sector of the general obligation to
engage in co-operation contained in the statutes of the UN in the light of the fundamental objectives
identified in those statutes: the maintenance of peace and international security, on the one hand, and
respect for human rights and fundamental freedoms, on the other.
In the preamble to the Charter of the United Nations, adopted in San Francisco in 1945, the States had
already reaffirmed their faith in fundamental human rights and in the dignity and the value of the
human person. The very famous Declaration on Human Rights, adopted by the General Assembly of
the United Nations in 1948, had the merit of converting, for the first time, respect for, and the
safeguarding of, the natural, universal, indivisible and inalienable rights of human beings into an
international instrument. This instrument, even though drawn up in the form of a declaration and thus
without binding efficacy, was the first of numerous measures designed to make States adopt pact-based
180 commitments of a positive character with a view to defending human rights and fundamental freedoms.
Amongst these, the principle of the autonomy of the individual in the management of his or her own
corporeity was to take on a significant importance. On the other hand, the Pact on Civil and Political
Rights and the Pact on Economic, Social and Cultural Rights of 1977 are, instead, binding on the
contracting States. The Pact on Civil Rights established the obligation of the preventive free informed
consent of the individual to the carrying our of medical or scientific experiments on him or her (art. 7),
whilst the Pact on Economic Rights contains a precise reference, inter alia, to the rights of individuals
to enjoy the benefits of scientific progress and its applications (art. 15). Lastly, reference should also be
made, because of their different effectiveness, to the deontological norms adopted by the World
Medical Assembly (the Declaration of Helsinki of 1949, most recently modified at Edinburgh in 2000)
and by the Council of International Organisations of Medical Research (CIOMS), which established the
ethical principles to be applied to biomedical research on human beings. These are norms that have
directed and governed the applications of medical technologies in line with universal and objective
values and criteria of scientific rigour and ethical correctness, and which have today become absolutely
necessary in the assessment and approval of scientific research.
The link between scientific research and human rights has been emphasised on various occasions by
the General Assembly of the United Nations, which has adopted numerous non-binding resolutions and
other provisions on the subject. One may refer, in particular, to resolution n. 38/135 of 19 December
1983 on human rights and the progress of science and technology, by which the General Assembly
invited all States, the bodies of the United Nations and other international organisations, both
governmental and non-governmental in character, to adopt those measures necessary to ensure that the
results of scientific and technological progress are utilised exclusively in the interests of international
peace and to the benefit of mankind, promoting and encouraging universal respect for human rights and
fundamental freedoms.[6] With specific reference to the sphere of biomedical research, it is possible to
recall to mind, in addition, the resolutions adopted in March and December 1993 by the General
Assembly of the United Nations entitled, respectively, ‘Human Rights and Bioethics’ and ‘Human
Rights and the Progress of Science and Technology’. By these resolutions the United Nations
expressed the hope and wish that scientific progress could be developed in a way that respected
fundamental human rights through the creation of ‘ethics of the life sciences’ at an international and
national level. To this end, the United Nations invited governments, specialised institutes and other
international organisations, at regional and non-governmental levels as well, to inform the Secretary
General of the UN about the measures adopted to ensure the development of the life sciences in a way
that respected human rights, measures including the creation of national consultative bodies and the
promotion of exchanges of experience between institutions.[7]
3. The principal binding instrument of an international character established to defend the dignity and
the integrity of human beings in relation to biomedicine is the ‘Convention of the Council of Europe on
the Protection of Human Rights and the Dignity of Human Being in Relation to the Applications of
Biology and Medicine (the so-called Convention on Biomedicine)’, which was adopted on 19
November 1996 by the Committee of the Ministers of that organisation. It was signed at Oviedo on 4
April 1997 and entered into effect at an international level on 1 December 1999.
Although expressly dedicated to the defence of the dignity and integrity of human beings as regards the
‘applications’ of biomedicine (art. 1), the Convention of Oviedo also contains norms on the defence of
human beings in relation to scientific research, a subject which is considered on its own.
On this point, the Convention, indeed, made a clear choice of principle by upholding, in article 2, the
primary importance of ‘the interest and the good of the human being…over the interest of society or
science’. This is a relevant statement of principle, which, by being placed amongst the general
provisions of the agreement, should influence the interpretation and the application of the agreement in
the sense of guaranteeing respect for the human being at every stage of his or her formation and
181 development. This stance of committed defence in relation to the human being was restated by the
Convention within the framework of the regulation of medical and biological research (chap. V, arts.
15-18), whose ‘free exercise’ is subordinated to the observation of the provisions of different pacts and
other legal provisions ensuring protection ‘of the human being’ (art. 15)
Less strongly committed at this level were the norms of the Convention regarding the effective defence
of the embryo, such as its article 18 on scientific research on embryos in vito, which offers a level of
defence that is clearly insufficient. This provision, in fact, delegates to national legislation the choice of
authorising, or not authorising, scientific research on embryos in vitro, and limits itself to establishing
that where such research is allowed by national law such law must ensure ‘an adequate level of
protection’. It should be added that the clear inadequacy of this provision is only just counterbalanced
by the prohibition on the creation of human embryos for research purposes, upheld by article 18 itself,
which, however, does not exclude experimentation on human embryos produced by the process of
assisted fertilisation but which remain unused and frozen (so-called ‘surplus embryos’).
Reference may be made here to the policies adopted by the United Kingdom, the United States of
America and France directed towards legitimising the use for research purposes (carried out with
private funds) of surplus embryos. In particular, we should remember here the Bill on bioethics
approved by the French National Assembly, at its first reading, on 22 January 2002. The most
‘revolutionary’ element of this Bill, which should ensure for France the role of European leader in the
field of biomedical research and place her on a position of competitiveness with Great Britain and the
United States of America, is the debatable ‘green light’ given to research on so-called surplus embryos,
that is to say on embryos frozen for the purposes of assisted reproduction. This approach, according to
the views of the French Assembly, is justified by the need to allow that progress in the medical field
required to combat illnesses (such as cancer and Parkinson’s disease) in relation to which contemporary
medical knowledge appears to be insufficient.
As may be easily understood, the risk run in this decision to support this form of experimentation (socalled ‘therapeutic cloning’) is that it will begin the move, from a moral point of view and in the long
term, towards the cloning tout court of human beings (so-called ‘reproductive cloning’), which at the
present time is forbidden by international and national sources of law. This risk was stigmatised by the
resolution of the European Parliament of 7 September 2000, in which the Strasbourg Assembly
condemned the use of ‘a new semantic strategy’ designed to ‘weaken the moral significance of human
cloning’ in order to favour further developments in the production and use of embryos for research
purposes. For the European Parliament, in opposition to this strategy, ‘there is no difference between
cloning for therapeutic purposes and cloning for reproductive purposes’ (it should, however, be made
clear that the resolution in question was approved by a very narrow majority: 237 votes in favour, 230
votes against, with 43 abstentions).[8]
The other norms of the Convention of Oviedo regarding the protection of people (including those who
are incapacitated) taking part in research are those contained in articles 16 and 17. In essential terms,
these are norms designed to ensure the protection of the dignity and physical and mental integrity of the
human being through the application of the traditional instrument of the defence of the autonomy of the
individual in the medical field (free and informed consent expressed in written form) and a series of by
now consolidated principles and criteria (the proportionality of the risks and benefits expected from the
research; the preventive approval of the scientific and ethical profiles of the research by ‘competent
entities’; and the inexistence of a method other than that of research on human beings which has
equivalent efficacy).
It should not be forgotten that because the Convention is a real and authentic framework agreement
which establishes objectives and norms at the level of principle, it looks forward as regards the more
sensitive aspects of the subject to the adoption of further legal instruments. Amongst these, one may
remember the additional Protocol on the prohibition of the cloning of human beings, signed in Paris on
12 January 1998, as well as the draft protocols on the transplanting of human organs and tissues;
182 biomedical research; the defence of the human embryo; human genetics, and not least,
xenotransplantations. To this should be added the fact that in order to take scientific developments into
account the Convention envisages the possibility of re-examining the norms introduced within five
years following their implementation, that is to say by the end of 2004.
Of the draft protocols just referred to, the one dedicated to biomedical research is of especial
importance. Even though the text of the protocol (whose drafting is by now well advanced) is not final,
it seems to me advisable to observe the salient points of this international instrument, which, indeed, is
shaped by an awareness of the transnational and transdisciplinary character of biomedical research.
This draft protocol is divide into eleven chapters dedicated to its subject and field of application;
general principles; ethical committees; information and consent; the protection of incapacitated
individuals; so-called special situations; research carried out during pregnancy or maternal
breastfeeding; the safety and monitoring of research; privacy and the right to information; research
carried out in States not signatory to the protocol; and final provisions. There are many articles in this
project designed to defend human beings who participate in biomedical research, including in vivo (but
not in vitro) embryos. Special attention is paid, in addition, at the level of the guarantees that are
offered to subjects who take part in research, to incapacitated individuals: specific norms are envisaged
to defend people who find themselves in situations of dependency or vulnerability so as to avoid
unjustifiable pressures in the securing of the expression of consent to research (art. 13).
Detailed responsibilities, to these ends, are given to ethical committees, to whom is entrusted, first and
foremost, the task of carrying out a multidisciplinary examination of the objectives of the research, a
scientific analysis of the protocol, and its acceptability from the ethical point of view. To this end, the
committees are to adopt obligatory and officially argued (but not binding) opinions. As is already
envisaged by the so-called norms of good clinical practice, the draft protocol indicates the information
that must be provided to these committees, which should make special reference to the competence and
suitability of the researchers as well as listing of the subjects who are responsible at both a clinical and
financial level. The usual obligations to provide information exist as regards research methods, the
procedures of investigation and statistical analysis, which must be indicated in the research protocols
together with a summary of the project itself.
One innovation, however, is the obligation of the researcher to inform the other research centres, the
ethical committee and the responsible national authority about the developments in this area of research
that could justify its re-examination at an ethical level (art 26.) The results of the research, finally, must
be the subject of a final report given to the ethical committee or the competent national authority (art
30). In this area, it should be stressed that the draft protocol could have been more incisive if it had
envisaged the obligatory requirement to publish and disseminate the results of research even in the case
of a negative outcome, even taking into account the understandable reservations that researchers might
have expressed on the matter. As one may easily observe, indeed, the history of scientific advance is
the history of research hypotheses which find confirmation, or otherwise, in experiments. Modern
technology, in particular, is a ‘process’ in constant evolution, in which it is difficult to ‘establish’
definitive methodological and conceptual instruments.
Monitoring a path that does not lead to positive results and making the results of such research
available to the scientific community would allow, therefore, not only the avoidance of repetitive and
obsolete (as well as expensive) experiments but would also make more manifest the nature of the
‘shared patrimony’ of scientific research, where the truth (like error) is never such but only the highest
fruit that it is possible to achieve with the scientific knowledge available at a particular moment. For
this reason, we should greet with favour such initiatives as the publication of specific specialist journals
in this area. One may refer here, for example, to the Journal of Negative Observations of Genetic
Oncology (NOGO).[9]
A positive judgement may be made, however, on the provision requiring an indication in the research
projects about the use of the results, data and biological material for commercial ends (art. 12).
183 Lastly, reference should also be made to the innovations as regards research carried out in countries
that are not parties to the protocol when this is implemented in the future. According to art. 31, in fact,
the ethical norms and fundamental guarantees for safety enunciated by the protocol will also be applied
to research carried out on human beings who are citizens of non-signatory countries. One can, however,
not fail to observe that in order to guarantee a more effective legal protection for citizens of such
countries (especially if they are developing countries) it would have been advisable to introduce the
figure of the ‘cultural mediator’, a citizen of the non-signatory State, with the aim, as well, of ensuring
real and complete information about, and understanding of, the risks and benefits linked with, and
consequent upon, the research. In a different way, one can well doubt whether such consent, even when
provided in written form, will really be informed and aware consent as regards the risks of the
experiment in line with the principle of the autonomy of the individual in the management of his or her
own corporeity.
4. A subject of special bioethical relevance expressly addressed by the Convention of Oviedo is that of
research into the human genome and the potential genetic manipulations flowing from this. In this
field, in fact, fear has for some time been felt about the possible discriminatory use, and a possible use
injurious to human dignity, of the advances in biomedicine, a fear that animates, in particular, the
debate about the need to regulate the application of the techniques of genetic engineering and the
biotechnologies. In other words, there is a perception of a risk connected with, and consequent upon, a
‘return’ to the application of the criteria of eugenic selection after the dramatic episodes which took
place during the course of the Second World War.[10]
Taking these concerns into account, the Convention and the additional Protocol of Paris forbid actions
designed to modify the human genome which are not justified on the grounds of prevention, diagnosis
and treatment (art. 13).[11], as well as prohibiting the cloning of human beings.[12] This latter
technique, whose aim is the deliberate creation of a human being who is ‘genetically identical’ to
another human being, constitutes an ‘improper use of biology and medicines’ and is expressly defined
as being ‘contrary to the dignity of man’ (preamble to the protocol, point V).[13] It may be observed
that the prohibitions in question take into particular account the need, affirmed by the preamble and by
art. 13 of the Convention, to respect the human being both as an individual and as a member of the
human species, and to use the advances of biomedicine to the benefit of present and future generations.
In this sense, it can be said that the Convention accepts the principle of intergenerational solidarity,
already indicated as being of cardinal importance in so-called sustainable development in the
Convention on Biological Diversity (so-called ‘biodiversity’) which was signed in Rio de Janeiro in
June 1992.[14]
Specific indications along these lines also emerge from the needs for solidarity formalised by the
UNESCO Universal Declaration on the Human Genome and Human Rights adopted on 11 November
1997.[15] This declaration, in fact, symbolically proclaimed that the human genome is the ‘shared
patrimony of mankind’ in order to emphasise the fundamental unity of all the members of the human
family and the inherent dignity of each one of those members (art. 1).[16] This declaration also
reaffirmed the need to defend the dignity and the rights of the individual independently of his or her
genetic characteristics (art. 2) and specifically stated that the human genome, by its nature subject to
evolution, contains potentialities able to express themselves in different ways according to changing
factors, such as education, conditions of life, condition of health, and more generally the relationship
between each individual and his or her own natural and social habitat (art. 3). In this way, there clearly
emerged an approach, specifically adopted by this Universal Declaration, designed to exclude every
form of ‘genetic determinism’ that could lead to individual humans being defined in terms of their own
genetic patrimony and the information to be found in it.[17]
It should, however, be stressed that the Convention of Oviedo (art. 21) and the UNESCO Declaration
(art. 4) both forbid the commercialisation of the human body and the human genome ‘in its natural
184 states’, without, however, precluding the possibility of establishing, for example, a normative regime
for the defence of patents on biotechnological inventions, as happened in practical terms at the level of
the European Community with the adoption of the directive of the European Parliament and the
European Council n. 98/44 (which, in essential terms, employs the notion of invention, to which is
connected the traditional requirements of innovation, inventive activity and industrial application)[18]
Although I am not able in this paper to examine fully this Community measure and the questions and
issues that underlie it, it must, however, be made clear that the solemn proclamation to the effect that
the human genome is the shared patrimony of mankind sits unevenly with a reality where the enormous
economic potential that underlies the patenting of the results of biomedical research directs this last, as
may be easily perceived, in conformity with a profit-seeking logic that is not very compatible with the
need to defend the fundamental rights of man and in particular his real and authentic ‘biological
identity’.
For some time this area has involved, for that matter, a real and authentic gold rush: by June 2002
about 720,000 requests for patents on human genetic sequences had been presented (one may point out
here that an object of invention can be made up of a biological material isolated from its natural
environment or produced by a technical procedure, even though pre-existent to the natural state. The
demands of an economic nature which make up the premise for the regime defending patents can,
moreover, lead to the making of dramatic ‘errors’ as regards biotechnologies: one need only remember
the ‘accident’ caused by the decision of the European Patents Office (UPO)[19] to grant to the
University of Edinburgh, on 8 December 1996 (n. EP 0695351), a patent on a ‘method of preparing a
transgenic animal’, where in scientific English the term ‘animal’ can also be applied to human beings.
This decision was in contrast with the executive regulations of the Convention of Munich which
excluded the possibility of granting patents ‘in respect of biotechnological inventions
which…concern…processes of cloning human beings’[20], and to such an extent as to lead the UPO to
issue a declaration in which it stated that it had committed an error(sic) and to affirm that although it
was not in its powers to retract a patent that had already been issues,[21] the sphere of protection that
had been given could not be taken to include human cloning.[22]
5. After briefly examining the legal instruments designed to strengthen at a universal level the defence
of fundamental rights in the light of scientific and technological developments (the Convention of
Oviedo and the UNESCO Declaration), it is now possible to observe that at the level of Community
law the European Community has for some time followed the questions and issues connected with, or
consequent upon, developments in molecular biology and the application of the techniques of genetic
engineering, as is demonstrated by the adoption of the Charter of Fundamental Rights of the European
Union solemnly proclaimed at Nice by the Presidents of the European Parliament, the European
Council and the European Commission on 7 December 2000 (even though for the time being it does
not have binding legal effectiveness).[23]
With regard to the points that are of most interest to us here, it is first and foremost important to
observe that at point 2 of the preamble the European Union declares that it places ‘the person at the
centre of its action’ and that it is based upon the principles of freedom, democracy and a state based on
law, which had already been placed at the basis of the same Union by the Treaty of Maastricht and the
Treaty of Amsterdam.[24] To these principles the preamble to the Charter adds a reference to the
values of human dignity, equality and solidarity, expressly defined as ‘indivisible and universal’ in
awareness of the ‘spiritual and moral heritage of the Union’.[25] Another statement of principle is that
to be found in article 1, which upholds the inviolability of human dignity.
It should also be observed that article 3 of the Charter recognises the individual’s right to physical and
mental integrity as regards the application of medicine and biology.[26] This right is guaranteed not
only by the traditional instrument for the defence of individual autonomy in the medical field (free and
informed consent) but also by a series of prohibitions in relation to selective eugenic practices, the
185 reproductive cloning of human beings, and making profits from the human body and its parts. It may be
noted that the prohibition of ‘eugenic practices…whose purpose is the selection of persons’, as well as
the prohibition of the ‘reproductive cloning of human beings’ were formulated in this way to accept the
proposals of the European Group for the Ethics of Sciences and New Technologies that were contained
in its document ‘Droits des citoyens et nouvelles technologies: un defi lance a l’Europe, Rapport sur la
Charte des droits fondamentaux en relation avec l’innovation technique demandé par le President Prodi
le 3 février 2000, Bruxelles, 23 mai 2000’.
Article 21 of the Charter is also of great importance. This article forbids all forms of discrimination,
including those based upon the genetic characteristics of the individual. This prohibition is connected
in a clear way with that upheld by article 13 of the Treaty of Rome, introduced ex novo in the Treaty of
Amsterdam, which attributes to the Council of the Union the responsibility for adopting measures
designed to combat forms of discrimination based upon sex, race and ethnic origins, religion or
personal beliefs, handicaps, age or sexual preferences. It is easy to understand, in fact, that this
provision constitutes the framework at the level of ideas within which to place a future conventional
prohibition of ‘genetic discrimination’, also taking into account from this point of view the need to
incorporate into the corpus of the treaties the contents of the Charter on Fundamental Rights.[27]
6. The very rapid advance in technology is a reality that we should face up to and address in a
responsible way. Modern technology, differently from what happened in the past, does not aim at
reaching a point of equilibrium but is an opportunity for further steps forward. Today, scientific
innovation and technological development are spreading rapidly throughout the world, as a result, as
well, of the so-called process of globalisation and individual interconnections, generating worries and
uncertainties as regards both the present and the future fate of new generations.
Of particular importance, therefore, is the reawakening of ethical reflection on human life, with the
birth and development of bioethics, which fosters reflection and dialogue between believers, of
different religions as well, on fundamental ethical questions connected with human life. As John Paul II
stated in Evangelicum Vitae, we also need to mobilise and form the consciences of everyone to activate
a shared ethical effort directed towards creating a new culture of life: new, because able to confront and
solve today’s unprecedented problems affecting human life; new, because engaged in with deeper and
more dynamic conviction by all Christians; new, because it will be capable of bringing about a serious
and courageous cultural dialogue with all parties.
To generate, support and even found a sentiment in favour of humanity is thus a very important
educational and intellectual task for tomorrow’s world.[28]
1. Colloque international “Science et Societé”, Paris, 30 November 2000,
inhttp://www.recherche.gouv.fr/discours/2000/dsciences.htm.
2. For the activities of these bodies see http://europa.eu.int/comm/governance.
3. See Tallacchini M.C., ‘Politica della scienza e diritto: epistemologia della identità europea’, Politeia,
2001, 62, 6-21.
4. Cf. the resolution on the ethical and juridical problems of genetic manipulation adopted on 16 March
1989, in Guce n. C96 of 17 April 1989, p. 165.
5. See Rifkin J., ‘Il secolo delle biotecnologie’, Internazionale, n. 229, 1998: p. 17 and ss. See also
Fantini M., ‘Il fantasma dell'eugenica’, in Rodotà S. (ed.), Questioni di bioetica (Laterza, Bari, 1993),
pp. 301-331, and Santosuosso A., ‘La genetica: problemi di legittimazione medica e di controllo
sociale’, in Barni M.and SantosuossoA. (eds.), Medicina e diritto. Prospettive e responsabilità della
professione medica oggi (Milan, 1995) pp. 330 and ss.
6. As is known, the resolutions of international organisations, which in themselves have no binding
effectiveness, can acquire such effectiveness only if they are transformed into sources of general
186 (custom) or particular (agreements and treaties) international law. It is true that resolutions that can be
broadly placed in the sphere of so-called ‘soft law’ are not completely unproductive at the level of
juridical effects and are of importance in terms of the ascertaining of international law of a customary
character. On the first point see Conforti B., Diritto internazionale (Editoriale Scientifica, Naples,
2001), p. 178, who refers to a ‘legality effect’ by which is meant, in large measure, the working of the
international resolution as a cause of the exclusion of what is illegal effected by a State which, in order
to implement a resolution, adopts an approach contrary to the obligations deriving from customary
sources or which are conventionally accepted. On the second point, of greater interest here, it should be
made clear that resolutions can be authoritative expressions of the opinio juris of States and thereby
contribute, by being connected with similar elements of international practice, to the reconstruction of
the norms of general international law.
7. Reference may also be made in this context to the resolution adopted by the General Conference of
UNESCO on 16 November 1999 entitled ‘Declaration on Science and the Use of Scientific Knowledge
and the Agenda for Science – Framework for Action’
8. See the resolution in Guce n. C135 of 7 May 2001, p. 263.
9. Cf. http://www.path.jhu.edu/NOGO.
10. Yet not only this. It is well known, in fact, that attempts to manipulate the human genetic patrimony
were carried out not only in the Nazi concentration camps, as is borne out by the transcriptions of the
Nuremberg trials, but also, until recent years, in hospitals and prisons of the United States of America
and of the former Soviet Union. After, among other events, the discovery of dramatic episodes (such as
the Tuskegee Syphilis Study, an experiment connected with the spread of syphilis that was begun in the
1930s and conducted on black people in the South of the United States of America and even continued
after the discovery of penicillin, or the experiments approved by the Committee on Medical Research
created after the outbreak of the Second World War) and the launch of ethical reflection on medicine
and scientific research, the National Commission for the Protection of Human Subject of Biomedical
and Behavioural Research was established in the United States of America in 1974. As observed in its
first chapter, in the wake of the results of the deliberations of this committee a report was produced
entitled ‘Ethical Principles and Guidelines for the Protection of Human Subject of Research’ (the socalled ‘Belmont Report’), in which were laid down the principles that subsequently formed the basis of
the analysis of ethical questions and issues in the medical and health care field.
11. It should be observed that the Convention of Oviedo was also concerned with forbidding the use of
the techniques of medically assisted procreation whenever the aim of such activities is to determine the
sex of the child, with the exception of cases where the intention is to avoid a serious illness connected
with gender (art. 14) As regards the possible discriminatory use of the results of research on the human
genome, on the other hand, the Convention prohibited discrimination based on genetic patrimony
(art.11) and established regulations for the use of so-called predictive genetic tests (art. 12).
12. The aims of this protocol are clearly laid down by the preamble to the document in which the
member States of the Council of Europe, although demonstrating an awareness of the advances that the
techniques of cloning can contribute to scientific knowledge and its therapeutic applications,
condemns, on the grounds that its is contrary to the dignity of man and because of the difficulties of a
medical, psychological and social character caused by the deliberate use of this biomedical practice, the
‘exploitation of the human being through the deliberate creation of genetically identical human beings’.
To the category of consequences of the prohibition upheld by the additional protocol should be placed,
inter alia, activity directed towards the commercialisation or offer of gametes, somatic embryo cells or
other human genetic material for the purposes of cloning, as well as any connected forms of
advertising.
13. Along the same lines see also article 11 of the Universal Declaration on the Human Genome and
Human Rights’ of UNESCO, to which this paper will return shortly. It should be made clear that by
human (animal) cloning is meant the production of genetically identical human (or animal) embryos
187 obtained through non-sexual replication of a single other human (or animal) living being, at any stage
in its development or life, beginning with the zygote (the fertilised cell-egg, before the process of
segmentation begins) or after its death. On the scientific and ethical aspects of cloning the reader is
referred to Comitato nazionale per la bioetica, La clonazione (IPZS, Rome, 1997), and to the
bibliography to be found in this publication. One may remember on this point that the recommendation
of the Parliamentary Assembly of the Council of Europe 1046 (1986) of 24 September 1986 on the use
of human embryos and foetuses for diagnostic, therapeutic, scientific, industrial and commercial
purposes invited the governments of the member countries to adopt the measures necessary to forbid
the ‘création d’êtrs humains identiques par clonage ou par d’autres méthodes’ (in Textes du Conseil de
l’Europe en matière de biéthique, op. cit., p. 19). The contents of this recommendation 1100 (1989) of
26 January 1989 was taken up by article 20 of the Report on Artificial Human Procreation adopted in
1989 by the ad hoc committee of experts on the progress of the biomedical sciences of the Council of
Europe, according to whom ‘l’utilisation des techniques de procréation humaine artificielle afin de
créer des être humains identiques par clonage ou par toute autre méthode doit être interdite’ (ibidem, p.
149). Lastly, the action plan adopted at the end of the second summit of the heads of state and
government of the Council of Europe, held in Strasbourg in October 1997 also committed the member
States of the organisation to prohibit techniques of cloning, bestowing upon ministers the mandate
required to approve an additional protocol to the Convention of Oviedo (ibidem, p. 137). Within the
context of the European communities as well, human cloning has been the subject of ‘condemnation’,
in particular by the Declaration of the European Council held in Amsterdam on 16-17 June 1997 (cf.
annex IV of the Conclusions of the Presidency), which expressly refers to the opinion on the ethical
aspects of the techniques of cloning of the European Group for the Ethics of Sciences and New
Technologies (cf. the opinion n. 9 of 28 May 1997), as well as by the resolutions of the European
Parliament of 1993 and 1997 on human cloning and the cloning of human embryos (in Guce n. C315 of
22 November 1993, p. 224, and n. C115 of 14 April 1997, p. 92, to which were added the resolutions of
1998 and 2000 published in Guce n. C34 of 2 February 1998, p. 164, Guce n. C378 of 29 December
2000, p. 95, and Guce n. C135 of 7 May 2001, p. 263). In the last resolution cited, of 7 September
2000, the European Parliament incisively affirmed that so-called therapeutic cloning ‘raises a deep
ethical dilemma, is a step forward from which there can be no return as regards norms for research, and
is in contrast with the approach to public order and good custom adopted by the European Union’.
14. According to article 13 of the Convention of Oviedo, ‘an intervention whose aim is to modify the
human genome cannot be undertaken except for preventive, diagnostic, and therapeutic reasons and
only if its goal is not to introduce a modification of the genome of descendants’. It should be noted that
the Convention on Biological Diversity, together with the Declaration on the Environment and
Development, were adopted at the Convention on Climate Change and at the so-called Agenda 21 of
the United Nations Conference on the Environment and Development (UNCED) held in Rio de Janeiro
from 3-14 June 1992. These were important acts of an international nature, directed towards
formalising the will of the States taking part in the Rio conference to achieve economic and social
development compatible with the defence of the environment (for an examination of these acts see, in
relation to them all Garaguso G. and Marchisio S. (eds.), Rio 1992: vertice per la Terra (Franco Angeli,
Florence, 1993). Agenda 21, in particular, assigned to the General Assembly of the United Nations the
task of proceeding with the verification of the results achieved within the framework of the
implementation of the commitments made at Rio, dealt with by the XIX special session of the General
Assembly (UNGASS) held in New York in June 1997. For the results achieved by this assembly see
Marchisio S. et al., Rio cinque anni dopo (Franco Angeli, Milan, 1998), as well as United Nations
Environment and Development, Earth Summit II, Outcomes and Analysis (London, 1998).
15. The UNESCO Declaration is divided into a preamble and seven chapters: human dignity and the
human genome (arts. 1-4); the rights of the people involved (arts. 5-9); research on the human genome
(arts. 10-12); the conditions for the carrying out of scientific activity (arts. 13-16); solidarity and
188 international co-operation (arts. 17-19); the promotion of the principles of the declaration (arts. 20-21);
and the implementation of the declaration (arts. 22-25). It should be observed that the contents of the
UNESCO Declaration were taken up in toto by the resolution on human rights and the human genome
of the General Assembly of the United Nations of 9 December 1998 (A/RES/53/152). It should be
made clear that the UNESCO Declaration and the resolution of the United Nations, although they have
a broader range than the Convention of Oviedo (because of the different number of the member States
of the three organisations), do not have binding effectiveness.
16. The notion of the ‘shared patrimony of mankind’ is by now widespread in international law and
refers to the requirements connected with, or consequent upon, the (international and intergenerational)
responsibility to promote and achieve the use of finite natural resources to the benefit of mankind as a
whole. This notion is to be found present, in particular, in the resolutions of the General Assembly of
the United Nations and in article 136 of the Convention of Montego Bay of 10 December 1982 on the
exploitation of resources on and beneath the seabed outside national jurisdictions (so-called
‘international waters’), as well as in the resolutions of the General Assembly of the United Nations on
the use of resources in the Antarctic. For a study of this notion in the context examined in this paper see
Kutukdjian G.B., ‘Le génome humain: Patrimoine Commun de l’Humanité’, in Héctor Gros Espiell
Amicorum Liber (Brussels, 1997), I, p. 601.
17. See specifically, in this sense, art. 2 lett. b of the Universal Declaration. Article 12 of the
declaration makes clear that ‘every person should have access to the advances in biology, genetics and
medicine regarding the human genome, respecting their own dignity and rights…The applications of
research, above all of that in biology, genetics and medicine, regarding the human genome, must be
directed towards alleviating suffering and improving the health of every individual and mankind as a
whole’. Specific requirements of solidarity and international co-operation are also upheld by the
declaration in articles 17-19, according to which the States should first and foremost encourage
research directed towards identifying, preventing and treating illnesses of a genetic nature, as well as
the rare or endemic diseases that afflict an important part of the world’s population. In the relations
between industrialised countries and developing countries, the declaration envisages that the former
should encourage scientific and cultural co-operation with the latter, favouring the international
dissemination of scientific knowledge about the human genome, human diversity, and genetic research,
as well as strengthening the ability of developing countries to engage in research, thereby allowing
these last to draw benefits from the advances in biomedicine.
18. Reference should be made here to the by the by now influential case of Mr. Moore, afflicted by a
rare kind of leukaemia, whose spleen was removed at the University of San Diego (California). This
removal was followed by others (blood, skin, bone marrow and seminal liquid) in order to monitor the
illness but also for the production of cell lines that were subsequently patented by the medical team
treating Mr. Moore and offered for sale in the form of pharmaceutical products that were successful in
the treatment of multiple and grave afflictions. The judicial developments of the episode involved Mr.
Moore, in a lower court, being seen as possessing a general property right to his own cells and other
parts of his body, but in the highest court (1989) this property right was excluded and the patient was
seen as possessing a more limited right to payment for damages because the medical doctor failed in
inform him, at the moment of these removals, about the existence of his personal interest in the
treatment and the commercialisation of the removed biological materials, It should, however, be
noticed that more recently the action of pressure applied by associations and foundations which have
arisen spontaneously to defend the rights of patients, above all in the United States of America and the
United Kingdom, is directing the jurisprudence of those countries towards results markedly different
from those of the case of Mr. Moore: cf., with special reference to the ‘Terry Case’ del 2000,
Santosuosso A., ‘Il gene dell’azionariato diffuso’, Il Sole 24Ore of 10 June 2001, p. IX. In general, on
the property of parts of the human body and the defence of the rights connected with the genetic
characteristics of man, see Paganelli M., ‘Alla volta di Frankestein: biotecnologie e proprietà (di parti)
189 del corpo umano (nota a Corte di appello della California 31 luglio 1988)’, Il Foro italiano, 1989, IV,
417-421; Edelman H., ‘Discutendo il caso Moore’, Rivista critica di diritto privato, 1989, 469-482;
Martin L., ‘Le droit de tirer profit de ses caracteristiques personnelles, notamment genetiques, est-il
illimité?’, Journal International de Bioéthique, 1996, 4, 296-321.
19. It should be made clear that this is an office that is totally independent of the European Community
given that it was created in 1977 within the framework of the Convention of Munich on the granting of
European patents.
20. Cf. article 23D of the modified and added to version of the decision of the Administrative Council
of 16 June 1999, which provided for the insertion of a new heading on biotechnological inventions in
line with the regulations introduced by the Community directive n. 98/44. It should be noted that the
patent granted by the UEB was also in contrast with article 6 of this directive which prohibits human
cloning.
21. In relation to which there remained, however, the faculty to offer opposition in line with what was
provided for in the Convention of Munich.
22. On this point the European Parliament also pronounced, through its resolution of 30 March 2000 (in
Guce n. C378 of 29 December 2000, p. 95), as did the Comitato Nazionale per la Bioetica (‘National
Committee for Bioethics’) with its declaration of 25 February 2000.
23. It should be noted that during the course of the preparatory proceedings some countries (including
Italy), as well the Community’s institutions (and in particular the European Parliament), had expressed
their wish for the incorporation of the Charter into the treaties. In particular, in the last stages of the
negotiations the proposal was presented to insert an explicit reference to the Charter into article 6,
paragraph 6 of the Treaty of Maastricht, thereby formalising its position within the framework of the
Union and placing it amongst the general principles of Community law. These requests cannot but be
shared, especially when one considers the by now paradoxical fact that the Treaty of Maastricht
continues to make exclusive reference to a text (the CEDU) drawn up within an international
organisation different from the Community (the Council of Europe), whereas today the Community and
the Union have their own catalogue of fundamental rights. The failure of these above-mentioned
requests to be accepted appears just counterbalanced by the fact that the form of the Charter appears to
be formulated in such a way as to be able to be utilised in a possible future as a legally binding
instrument.
24. In addition to the preamble, the Charter includes seven chapters, dedicated, respectively, to human
dignity (arts. 1-5); equality (arts. 20-26); solidarity (arts. 27-28); citizenship (arts. 39-46); justice (arts.
47-50), and to general provisions (the so-called horizontal norms to be found in arts. 51-54).
25. It should be remembered that during the course of the preparatory proceedings a reference ‘to the
cultural, human and religious patrimony’ of the Union was proposed. However, in the view of many
States (and in particular of France) this phrase lent itself to being a factor of potential discrimination.
26. It should be remembered here that article 13 of the Charter also proclaims the freedom of scientific
research.
27. It should be remembered that the prohibition of genetic discrimination was already upheld by
article 11 of the Convention of Oviedo and by article 6 of the UNESCO Declaration examined above.
Of importance on this point is the formulation used by the Protocol added to the CEDU n. 12 of 2000
which prohibits not only discrimination based on ‘sex, race, colour, language, religion, political
opinions, national or social origins, membership of a national minority, property, birth’, but also
discrimination based upon other forms of ‘status’.
28. To employ the contemporary words of Jonas H., Tecnica, medicina e etica (Turin, 1997).
190 PIERMARCO AROLDI
THE INVOLVEMENT OF THE GENERAL PUBLIC IN BIOMEDICAL RESEARCH
THE ROLE OF THE MASS-MEDIA
THE THEORETICAL FRAME OF REFERENCE
The theme developed in these pages suggests an exercise in reflection on the boundary between two
territories, that belonging to biomedical research and its development and that of the media and social
communication systems. This is a boundary that unites more than it separates, with an abundance of
openings and passageways through which, objects, ideas and problems more and more frequently pass.
In this paper, I will try to briefly trace some of the more frequented passages and the most significant
problems that cross the two territories.
Although this intention defines from the start the limits within which my argument will be developed,
the theoretical framework within which it is placed requires a broader setting. If it is not to be reduced
to a more or less faithful description of the panorama, the eye needs reference points, mental categories
that permit one to recognize and name phenomena, to grasp similarities, analogies and differences.
From this point of view, ethical reflection on biomedicine, on the one hand, and on social
communication on the other (which is constantly urged by the Magistero), provide some indications
common to both territories which I will allow myself to succinctly delineate.
It is no coincidence that various authors in recent years have grasped significant analogies between
what is happening in the sphere of scientific and medical research and the spurt of acceleration that
telecommunications has inflicted on the global media system, proposing or debating over metaphors
that operate via a semantic shift between these two fields, often evocatively[1].
The problems raised by these changes bring an abundance of practical consequences, which are often
highly significant: to the point that, in Italy, a number of parties have suggested that Video Ethics or
Media Ethics Committees be set up, like those adopted in the biomedical sphere, whereas the political
institutions have felt the need to institute the figure of “Garante per le comunicazioni”.
Above and beyond these analogies, some of which it is perhaps worth returning to, there are rather
different – and closely connected – foundations that I would like to briefly recall as categories useful
for tackling both fields of reflection. These are central in the tradition of Christian thought: the
concepts of human person and truth. From the first derives the personalistic tradition which, as Antonio
Spagnolo reminds us, “sinks its roots into the very reason of man and into the heart of his freedom”.
Man is a person because he is capable of reflecting on himself; he is capable of self-determination, of
discovering the sense of things and putting it into his own expressions “in every human person the
whole world is recapitulated and acquires a sense, but the cosmos is, at the same time, crossed and
transcended. Every man holds the sense of the universe and all the value of humanity: the human
person is unity, a whole and not a part of a whole […] a ‘unitotality’ of body and mind that represents
its objective value, which is then taken on by subjectivity” [2].
The human being, thus conceived in the image and likeness of his Creator, can only and always be an
end and not a means. This concept, which is so familiar to the cultural tradition of this Academy, also
guides thought in the sphere of the ethics of communication. Indeed, communication, as Guido Gatti
reminds us, “is set within the sphere of interpersonal relationships, of which it is a particularly
significant kind; it is a type of interpersonal relationship which is particularly intimate and, more than
any other, specific to the condition of people and to the fact that those who take part in it belong to the
world of the spirit. In communication men enter into a relationship of mutual exchange […] thus
creating a real interpersonal unity” [3].
Even the communication produced by the mass-media can be set in this perspective, as summarized by
the Pontifical Council for Social Communications when it observes that “in all three areas, message,
191 process, structural and systemic problems, the basic ethical principle is the following: the human
person and the human community are the reason for and the measure of the use of means of social
communication. People should communicate to the benefit of the global development of other people”
[4]. Authors such as Spaemann, Abbà and Rhonheimer speak of first person ethics i.e. those governed
by ones personal responsibility, and Bettetini and Fumagalli, amongst others, in proposing their “ideas
for an ethics of communication” [5] refer back to them.
Our reference to the second principle, which is connected to the first – that of truth – must be even
more succinct. This is a central concept in bioethical thought, starting out from ontological truth, the
“truth”, or authenticity, of the person that we have just mentioned, which the encyclical Veritatis
splendor sets at the very foundation of ethics; the question of truth is perhaps still more evidently
fundamental in any reflection on communication. Here it is not only the truth of personal subjects
involved in the communication process that is in play, but also their truthfulness – not so much in the
sense of “objective correspondence of the message expressed” as in terms of “a precise, factual
reality”, that is, rather as a logical truth than as “a subjective correspondence of the message with the
thought of the one communicating it and the willingness of the communicator to express the truth of his
own thought without pretence and without erecting intentional screens” [6]. From this derives not only
the intrinsic negativity of lies, but also the pragmatic dimension of the truth of the act of
communication itself, which is experienced first and foremost as a form of inter-action between people.
Indeed, although logical truth is not always a fundamental prerequisite of communication, at least
inasmuch as a bona fide error is part of the risks of communication, the authenticity of the subjects (we
might say their deontology) and the authenticity of their personal relationship constitute a structural
element of genuine communication, even in the sphere of the mass-media [7].
Having reminded the reader of these basic references, we can now approach the universe of social or
mass communication (I would like to use these two terms as synonyms, although I am fully aware of
the historical and semantic differences between them) in order to point out, above all, their importance
as cultural environment: indeed, if the term medium means both channel and environment, we have to
say that it is now this second aspect which prevails. This is evident both at the level of the technologies
employed and at the level of their capacity to produce social meanings.
On the first level (which is, as we have seen, an element common to the communicative environment
and biomedical research) Francesco Botturi expresses himself very clearly when he observes that,
unlike the technical knowledge of former times, modern technology “precedes and exceeds the subject
and his intentions. The subject certainly uses and innovates the techniques, but he has limited control
over them; he is rather – and to a greater degree – controlled by them, because technology is less and
less sectorial. It now consists of an enormous collection of devices and apparatus which, with their
pervasiveness and capillary distribution, shape much of life’s context for modern man, together with
his mental orientation: in other words, technology makes up the environment” [8] within which man
experiences himself, others and the world. Using a series of particularly evocative metaphors, Cardinal
Carlo Maria Martini spoke, in this connection, of “an atmosphere, an environment in which we are
immersed, which envelops us and penetrates us from all around. We are set in this world of sounds,
images, colors, impulses and vibrations like primitive man was immersed in the forest, like a fish in the
water. It is our environment, […] a new way of being alive” [9].
Precisely because they are the place where we live out our daily experience, even if this is mediated,
the various means of communication end up forming a hotbed for the production and reproduction of
culture: a thick network of public and private discourses within which it becomes difficult to isolate
individual messages or individual texts and which is easily seen as a real, though symbolic, horizon,
within which we can place the paths of sense attribution, of value recognition, of coordination of
individual and collective action. From this point of view, obviously without wishing to reduce the
cultural riches of our societies to the mass culture expressed by the media, we inevitably grasp deepseated consonances between the forms of thought that have appeared in the radicalized modernity and
192 the cultural forms represented by the communication flows which cross the information, entertainment
and disseminating networks. This means, for the ends of our discussion that although, on the one hand,
as Claudio Giuliodori observes in connection with bioethics, the media are the place in which specialist
topics attain dignity and social citizenship [10], on the other they define the main cultural context and
the set of possible languages within which the issues that are most relevant for the individual person
and the community are conceived, tackled, represented, discussed, valued and judged.
This consideration brings with it some notable and problematic consequences, which I shall attempt to
delineate in the second part of this paper. However, but before doing so, I would like to stress this last
analogy or continuity between the territories of biomedical research and mass communication. Both are
places where culture is produced rapidly and radically changed by the various technologies, within
which reflection on some decisive topics, such as the concept of natural and artificial, the perception of
our physical body and its limits, the knotty problem of identity, both biological and cultural, is
developed in the light – a rather crepuscular inevitability – of the decline of neutrality. Now that the
myth of the neutrality of science and technology is behind us, and that of the neutrality of information
has been set aside, the media can easily become a symbolic space in which, owing to the large number
of subjects involved, we find ourselves – although not always consciously - up against divergent
paradigms, contrasting and sometimes contradictory axiologies, and development and control
strategies. Suffice it to think, for example, that television information is, at least in Italy, one of the
most socially important spheres, in which voices and trends which might be called “naturalistic”
(environmentalism, animal protection, biologism etc….) live side by side on a daily basis, together with
opposing “artificialist” impulses (biotechnologies, control of reproductive processes etc…).
Thus, the media culture, seen not so much as a system but as a collection of social discourses that cross
and organize it, proves to be profoundly and unconsciously contradictory. The contradiction inherent in
positions which do not accept experimentation on animals, but would accept experimentation on human
embryos, or a fear of the biotechnologies that coexists with the assumption that they are useful for the
purpose of discovering treatments for various illnesses are two examples of this.
However, precisely because they are a socio-cultural environment, the media are thus not only the
place where the contradictions and tensions that cross the various fields of knowledge and social acts
are principally manifested, but also a space where they can be negotiated, the sphere of the construction
of agreement: the agorà in which different skills come face to face with one another. They are, in short,
the arena in which public opinion is ‘up for grabs’, but here, public opinion is no longer seen as a
rationally-set-out-judgment acting as an instrument of control and a stimulus for the government’s
operations, but as a doxa, common feeling, a play of mirrors in which to recognize oneself or set
oneself at a distance.
Moreover, owing to the growing complexity of the system, the opposing phenomena of selfreferentiality and interactivity suggest that the media can also be subjects or privileged places not only
for words or discussions, but also for intervention, for action, for change: the former explain how a
piece of false information can circulate for years, drawn from one medium by another, notwithstanding
official denials; or how what are actually minority positions can enjoy a greater media success than
they do in what is known as “actual fact”. In their turn, the more or less indirect answers triggered by
the communication flows cause actions and reactions, changes in direction, the taking of stands. In this
connection, The italian Di Bella case is, perhaps, an example from which all the necessary lessons have
not yet been learned.
For all these reasons, it may be useful to observe more closely, if schematically, a few key problems of
the relationship between the media and medical-scientific research.
193 TOWARDS A SYSTEMATIZATION OF THE QUESTION
In order to tackle the question appropriately it may be useful to proceed by referring to a schematic
formula which breaks down the system of mass communications into its basic elements: here, for the
sake of brevity, to Lasswell’s paradigm. Indeed, it is well-known that this occupies an important place
in the tradition of communication research precisely because, by providing a static description of the
communications chain, it has allowed various specific sectors of research to be isolated, thus helping to
organize studies on communication in a more proficuous and complex way. As Mauro Wolf observes,
“Lasswell’s schema has organized the nascent communications research around two of its longestlasting core themes – analysis of effects and analysis of content – and, at the same time, has identified
the other development sectors in the field” [11].
In this context, the lack of processuality and the reduction into a one-way, intentional and transmissive
model of communication hardly matters, having been well overtaken both by media technologies and
by the theories of communication that have been developed since the Sixties in the wake of the
contributions of linguistics and semiotics. For our purposes, it only lends us a matrix for isolating the
various disciplinary and processual spheres of communication in which the theme dealt with in these
pages proves to be particularly pertinent and rich in consequences.
In Laswell’s words, as you will remember, an appropriate way of describing an act of communication
is to answer the following questions:
who
says what
in which channel
to whom
with what effect?
Scientific study of the communication process tends to concentrate on one or other of these
questions[12]. Starting out from this schematic rendering of the process it is therefore possible to
isolate the area of the emitters (the first “who” in the model), which has been historically investigated
by sociology, the area of content (says “what”), traditionally the subject of content analysis, the area of
the medium used (the “channel”), which has been analyzed first and foremost by the so-called media
theorists – from Innis to McLuhan and de Kerckhove, the area of the audiences (the second “who”), the
territory of audience studies, to end with the long sequence of theories on the effects of the media on
the individual and society.
In the next few pages, I will seek to analyze some of the most awkward problems in the relationship
between biomedical research and mass communications on the basis of this systematization, describing
first the means and then the consequences of the workings of the media.
“Who ?”
The first sphere of analysis is thus that studied by the sociology of broadcasters. In this research
tradition we find research methodologies that are sometimes very different aiming to understand, on the
one hand, the processes involved in the professional training and socialization of those who work in the
communication field and, on the other, the negotiation mechanisms which take precedence in the social
construction of news.
Clearly, both topics have a very close connection with the involvement of public opinion in highly
complex questions, such as those implied by biomedical research. Indeed, from the first point of view,
the important thing is the cultural background and the professional knowledge – general and specific –
of the journalist or communicator acting as mediator between the scientific community and the public
at large, whereas, in the second case, the productive routines within which his daily professional duties
are set and the relationships he is able to establish with his sources take precedence.
194 To start out with, it will also be useful to recall that the collection of studies in this sphere tends to be
polarized around two interpretations of the phenomena analyzed; we shall define them – again for
simplicity’s sake – as plot theories and involuntary distortion theories. The first interpretation tends to
emphasize the ideological dimension of control over the media carried out by an elite (known under
different names depending on the occasion, but always able to superdetermine, in practice, the
homologated production of information); the second tends to devalue the weight of the intentions of the
subjects involved to the benefit of a structural and operative conditioning incorporated within the
information production routine. In the next few pages, the two perspectives will be dialectally
considered in order to avoid either the risk of an ingenuous vision of the power plays which underlie
the information process, or that of oversimplifying and thus reducing the importance of the
phenomenon.
The first important question would thus seem to be connected with the negotiative nature of
communication, and of information in particular. Indeed, according to a well-known joke, the answer to
the question “What is a piece of news?” is “Whatever a reporter thinks is one”. However, as all
research on newsmaking [13] has stressed, the aleatory nature of this answer accounts for a complex
process whereby the news item is socially constructed, in which a number of different factors and
subjects come into play.
We can list some of these factors in order to gain a better understanding of the various levels of
negotiation at work. They include professional factors, dependent on the process of socialization
journalists are subject to within their own work group (professional culture and practices, the game of
role expectations etc.); more or less obvious criteria of newsworthiness (relating to the facts and
subjects involved, the product, the competition, the audience etc.); the production routines (mix of
time, media and access to sources, role of agencies, strictness of deadlines etc.); consequential
procedures (selection, editing, thematizing etc.).
But, as Carlo Sorrentino reminds us, “before it is defined by professional and organizational logics,
every fact is turned into a news item by a social process, a negotiation carried out between a number of
social actors who set in play political, economic and cultural resources […] an intense process of
exchange between a number of social actors involved in different ways: those who have lived through
the event, sources, media-men and readers” [14].
Some phases of this negotiating process deserve further investigation, in particular the relationship
established between journalists and their sources.
In connection with the production routine, it should be remembered, as Sorrentino mentions, that “the
intrinsic unpredictability of the material dealt with by the information machine requires that precise
procedures be identified” [15], a sort of bureaucratization of the journalists’ profession based on
standardized operations and work organization. It is this organization that allows us to tackle
improvisation and the discontinuity of what is real, by means of rational, practical constrictions. All
this translates into a management of the news production chain which, often unnoticed by the insiders
themselves, ends up structurally conditioning the task of selecting and representing the results of
scientific research.
In the sphere of the studies on newsmaking processes, the contribution of the sociologist Dorothy
Nelkin [16] is a reference point. Nelkin clearly shows the pertinence of some of the production
mechanisms of information spreading, together with the ways in which the sphere of science and
biomedical research are covered. In particular, Nelkin observes that the ideology of news – although it
seems to be coherent with the vision of the praxis of scientific research as a source of discovery, that is,
of novelty from the information viewpoint - actually contradicts some fundamental features of the
research itself, starting out from the fact that science usually produces its innovations over a lengthy
period of time which is not always predictable, in the wake of investigations and hypotheses destined to
remain such until they receive recognition (which, again, is not immediate) from the scientific
community. Instead, the fine timing required, the hunger for constant updating and the need to be up to
195 the moment characteristic of the informational apparata often prevent scientific arguments from being
properly processed and, also imply the risk of spreading news that is overhasty or totally untrue.
Likewise, the expectations held by journalists as regards the characteristics a scientific fact must have
before becoming a news item (the so-called criteria of newsworthiness) tend to favor whatever might
seize the public’s attention or imagination, either due to its eccentricity or because of the controversies
it can unleash at the level of social issues. Moreover, from this latter viewpoint, the author identifies
two opposing behaviors: on the one hand the tendency to minimize the precautions normally adopted
by researchers in disseminating the results of their work, thereby stressing the certainty of the scientific
discovery with the conviction that the public is interested in facts and not hypotheses; on the other
hand, in the case of a controversy, we witness the praxis of presenting all possible opinions, basically
setting the best-founded ones on a level with those devoid of all legitimacy in the name of a debatable
interpretation of the criterion of objectivity. Thus, often, the content of the news ends up being the
controversy itself although the public is left without any parameter for evaluating it.
One last aspect regards the dependency of journalistic work on its sources; we will return to this topic
further on, but for now, it will be helpful to mention the observation of Gabriel Galdòn Lòpez [17],
according to whom the sphere of scientific popularization is particularly exposed, owing to the low
number of authoritative sources, to the risk of homogenization, standardization and reiteration. The
need to keep attention levels high on a given scientific topic (either because it encounters public favor
or because the pages devoted to research have a fixed periodic schedule which does not correspond to
any real possibility of having something new to report every day) plus the need to avoid missing
something the competitors have found thus sometimes lead to continuous repetition or artificial
stressing of the topic.
However, probably the most thorny question regards precisely the dependency on information sources.
As we shall see, this is a question with a large number of consequences, both for the work to be
published, and for the formation of public opinion. Indeed, it is well-known that sources are the first
link in the information chain, the place in which the first selection of facts and the first codification of
material destined to become news takes place. In the case of the media destined for the general public,
the coverage of information on scientific– in our case biomedical - research depends almost exclusively
on the sources and their accessibility within the restrictions mentioned above of publishing routines.
Moreover, in the media system, what a source is depends on the medium itself and on the type of
product it has to package. Prime examples of sources are: the national and international information
Agencies (which, in turn, have the problem of finding newsworthy items through their network of
correspondents, international magazines and journals, or other Agencies), external collaborators
(researchers or science journalists), the Press offices of the Institutions presiding over scientific
research and of associated companies, the Internet. As can be noted, some sources are active, others
passive [18]: the former produce informational material of their own initiative, the latter confine
themselves to responding to publishing demands. As one can imagine, seeing the conditioning imposed
by production routines which leave little time for forms of investigative journalism or reportage of a
scientific nature, the active sources will be the most advantaged. The initial selection will thus be made
firstly out of those institutional, public or private subjects endowed with power and which thus have
great negotiating power with the publishers, so they can push information towards the media apparatus
following a principle of convergence between its own interests and professional routines.
The role of the sources proves to be decisive not only in the selection phase but also during that process
of negotiation with the information apparata which start up the social construction of the news item.
Indeed, the institutional relationships are flanked by the personal relationships between individual
journalists and representatives of the various institutions. Just to give an idea of the complexity of the
negotiation, it is sufficient to think that, when the journalists frequent their own sources – and not only
the scientific ones – they are criticized by observers, and even by insiders, because this results in too
much socialization: a full-scale social convergence that might turn into “a relationship of trust that may
196 be useful but is also potentially dangerous” [19]. Responding to accusations that they basically just
reiterate the positions of their sources, the journalists tend, on the other hand, to justify close contacts
by saying that they need to go beyond the official façade and properly understand the institutional
reasonings precisely in order to avoid the risk of being instrumentalized [20]. Within this relationship
based on trust, which is continually renegotiated, a typical “strategic ritual” repeats itself. This consists
in resisting the interpretation suggested by the sources and shifting the level towards borderline or
marginal spheres, while deviating the sources’ preferred meaning into an emotional, curious or
sensational register. Probably, the increase in soft news of a scientific nature, also recorded when
serious crises in the health or food sector occur [21], is partially explained by this phenomenon.
Finally, it should be remembered that the more journalists frequent their sources, the less subject they
are to processes of professional socialization activated by the publishing industry. Their familiarity
with the world of scientific research, its problems and specialized subjects increases, but the more
easily they lose sight of the sense of the communication product as a whole and their relationship with
the public. Their main points of reference become the sources themselves and colleagues from
competitive publications [22].
In the case of scientific popularization, moreover, the chain of sources includes a very important
intermediate passage: the specialized international science publications. These are intended for an
audience of specialists, researchers or doctors and constitute the real reference point in the sector for all
those involved in popularizing the results of biomedical research through the media. The centrality of
these publications in the process of new construction also makes them one of the best places for
identifying the limits and risks of communicative praxis.
The most obvious risk is called conflict of interest: in the words of D.F. Thompson, we can define it as
a series of conditions in which the professional judgment concerning a primary interest (such as a
patient’s health or the validity of a research project) tends to be unduly influenced by a secondary
interest (such as a financial gain or personal advantage) [23]. As has been remarked on more than one
occasion, this is a condition rather than a behavior and, as such, it can be replicated in different
environments. In this context, what interests us in particular is the conflict which can occur when a
piece of medical research is published in a scientific journal. As Drummond Rennie, editor of the
prestigious Journal of American Medical Association remarks, “scientific information does not exist
until it is published and made known”. In other words, publication is the time when the study and its
results are effectively assigned a value. It is, therefore, also the time when it is most exposed to a risk
of conflictuality which involves researchers, their colleagues, sponsors and their financers, health
Institutions and the universities with which they are associated, and even the editors of publications.
All these aspects are particularly accentuated when the pharmaceutical industry invests enormous
financial resources in clinical research, actually often replacing public intervention.
Various cases of a conflict of interest that bound the researchers to their sponsors, conditioning the
integrity of the results published, have been reported over the last decade. Sometimes these were
sensational cases that created a scandal even outside the scientific community; sometimes they
consisted in systematic studies that highlighted the spread of this potential condition to a large number
of scientific publications [24]. The “continuum between a potential conflict which, due to its limited
size, does not interfere with one’s own judgment, and an actual, financially significant conflict which
heavily conditions ones judgment” [25] can be expressed in very different forms and may reach the
point where of research data is manipulated in order to obtain publication, in the awareness that
positive results are more favorably viewed than negative ones. In this connection, Drummond Rennie
lists, “commercial influence owing to the existence – for the researcher – of direct financial interests in
the pharmaceutical industry, direct payment for the recruitment of patients in clinical trials, the
debatable criteria with which the names of editors and revisers are included or eliminated, sponsorized
symposia and the proceedings of the same, transparency in the way in which the results of clinical trials
are reported and the subsequent sharing of data, the frequent lack of transparency in the financial
197 assessment of drugs and technologies, the selective publication of results of positive studies and the
influence wielded over, and intimidation of, authors of studies whose results are not appreciated by the
sponsors. These are all possible facets of a conflict of interest in the process of publication of results”
[26].
Obviously, the most interesting thing in this connection is that the centrality of scientific publications in
the information chain causes a “contamination of the sources” which reverberates, amplified,
throughout the whole communication system: the media will have access to the source and spread the
damage to a wider public and other, more popular media.
A similar situation is repeated further along the information chain, when publications destined for the
general public find themselves in the position of, for example, offering information about drugs and
treatments and, at the same time, giving space on their pages to the advertising campaigns of the
companies which produce those same drugs.
The argument above suggests that we should see the sphere of news negotiation as an uneven terrain, in
which overall phenomena of “involuntary distortion” do not exclude individual, local and personal
responsibilities. Within this process, there is room for what has elsewhere been defined as “conflicts of
interest” to develop. Indeed, it seems evident that, both at the macro- and micro-structural levels, there
are a multiplicity of points of contact and interweave between media system, industrial pharmaceutical
system, advertising system, research system, hospital system and political system, all of which are
potentially places where the news item can be negotiated. When the so-called “paying third party” (to
keep within the realm of information), whoever it is, comes between researcher and reporter, the
communicative consequences are hard to predict.
“What ?”
As concerns the area of content of the communication, the research tradition on the media would
suggest we pay attention to a particularly interesting phenomenon which goes by the name of agenda
setting; in the train of this hypothesis, the power of the media lies not so much in “telling people what
to think” as in “telling people what to think about”. If we were to phrase it more precisely, we could
say that people tend to include or exclude from their knowledge what the media include or exclude
from their content [27].
So, while, on the one hand, the agenda setting hypothesis is fully entitled to be placed amongst those
theories of effects which will be dealt with below, on the other hand, it calls our attention to the content
of the media (which is, in turn, the product of that work of selection, bestowal of hierarchy and writing
that we have preciously looked at) as a strategic place for the construction of social visibility and the
discursive legitimization of the topics of scientific research and medical practice. As, again, is
summarized by Mauro Wolf, “ever new aspects of reality are placed at the center of our (momentary)
attention, becoming issues which form a passing focus for public debate, reference points for the
incessant becoming of climates of opinion” [28].
The most interesting aspect in all this, beyond the social construction of reality, is perhaps to be sought
in the innovative dynamic which supports the ideology of news and which is, per se, particularly
consistent with the progress of science (or of a social representation of it which is particularly common
and effective): advancement by successive conquests. In this sense, the temporary emergence of topics,
issues, tensions and collective subjects supported by the media constitutes not only “a movement that
coagulates interests and organizes contrasting and conflicting perspectives, revolving around opposing
values” [29], but, first and foremost, an impulse which can accelerate social change by means of its
representation. The media help to make this change possible “because they construct the conditions via
which this change becomes visible, thus becoming a publicly-known reference point, a legitimate
social goal” [30].
198 Once it has into the discursive content of the media (and into the related social arguments that cross the
communication system and its audiences), a topic thus tends to be socially legitimized, according to a
mechanism of mutual reinforcement offered by the various means of communication. Indeed, the place
visibility is constructed is not only of an informative genre (daily press, television news, medical and
scientific communications etc.): from this point of view, fiction and entertainment, especially that
centered on words, like the talk-shows, play a still more important role because they incorporate the
specialized themes into the fabric of daily experience or view them as branches of practical knowledge,
useful for dealing with crisis situations (for example, illness) or as narrative cues or dramatic situations
around which to arrange the production of stories.
This last aspect is worthy of special comment: the fact that the media constitute the main story telling
system of modern times makes them one of the most important forms of symbolic apparatus, thanks to
which groups and societies are placed in a position to think about themselves, to recognize, confirm or
change their own value systems, to plan their own development. “Common narration” implies
references as to identity and belonging; it suggests stereotypes, codifies emotions, legitimizes behaviors
and mediates social change. From this point of view, the success of much TV fiction set in medical
surroundings whose characters are members of the medical and nursing professions is probably not
only the legitimate product of kinds of particularly felicitous alchemy reduceable to the logics of
grammar and narrative syntax (closed environment, large set of characters, with fixed main elements –
doctors – but a continuous variety of secondary ones – patients - topics of human interest etc.), but can
be interpreted as a symptom of the need for social discourse on matters concerning health, illness, pain,
the doctor-patient relationship, death (and the sense it has). And in this case, it takes the form of a
diffuse and serial narration. Topics such as euthanasia, transplants or the prevention of Aids, to give a
few particularly dramatic examples, probably gain more social legitimization from this kind of
treatment than from specialized information, scientific publications or the ethical-political debates that
accompany the opening of new frontiers of research. Indeed, it is no coincidence that the attention of
lobbies and pressure groups has historically been concentrated around cinema and television fiction
perhaps still more massively than it has around information [31].
“To whom ?”
The public is a particularly interesting variable within the communicative process, even if – at least
from the point of view which concerns us in these pages – it is perhaps less of a problem than the
others. Its pertinence in conditioning biomedical information seems relevant at two different levels.
The first level is, so as to speak, structural: the construction of an audience of readers, listeners,
spectators or users is the first aim of every informative apparatus; the more the information organ
operates in a competitive financial regime, the more important this aim is. From this point of view,
information providing is a sector of the cultural industry which feels the effects of all the laws of the
market in which it operates.
For any means of communication, to gain an audience, to maintain and increase the numbers with time,
means wrestling with its interests, its passions, its tastes, its requirements and the particular uses it
makes of the information offered. The success (the attention, the curiosity, the ever-increasing financial
investment etc.) that the audience decrees for themes and subjects of a scientific and health nature does
not only entail a quantitative expansion of publications and spaces devoted to research, health and
medicine (although this is one of the most significant publishing phenomena of the last few years). It
involves, first and foremost, a qualitative definition of some thematic areas, which are favored to the
detriment of others; it facilitates the establishment of true cultural fashions even in the sphere of
scientific popularization; it helps to trace out the conditions for the public relevance of certain branches
of research rather than others and delineates a communicative environment which is more or less
favorable for the circulation of the respective results. In other words, the public constitutes – as in other
199 spheres of information – one of the criteria of newsworthiness through which the selection and
hierarchical ordering of scientific facts destined to become news takes place.
However, the audience is also an important variable at another level. Indeed, while the public helps to
close the information circuit by attributing sense to the news and interpreting the contents of
communications, we have to consider that different segments of the public produce different meanings
in the wake of their cultural background, their skills and abilities and their experience. This means
especially, for the purposes of our argument, that there do exist audiences which, due to concomitant
circumstances, are particularly sensitive to communication on the subject of health, medicine,
treatments and therapies. Suffice it to think, for example, of the sick and their relatives who, on the
basis of their own direct experience, may tend to reinterpret the information within a framework which
can be immediately applied to their case, accumulating hopes or coming up against disappointments. In
a context that is redefined starting from the condition of illness, the set of communication processes
undergoes a functional reorientation the social effects of which we shall attempt to trace out below.
However, at a personal level, these processes have all the features of strong emotional and trust
involvement.
“In which channel?”
We have already said that the media should be seen increasingly as environments and less as channels
able to transmit a content. Thinking about the nature of these channels thus implies reasoning about
those structural or language features which make a medium into a symbolic environment more or less
favorable to the survival and circulation of ideas, concepts and representations of reality.
One of these forms of representation is, obviously, the macro-genre scientific popularization. Over the
last few years, various studies [32] have focused on models of the different ways in which science can
be popularized (and on models of science itself) which have succeeded one other, historically and in
other ways, at the helm of the discursive praxis of the mass media. Here, it should be remembered only
that a progressivist and cumulative vision of scientific research, able to produce certain and
incontrovertible knowledge, and necessarily directed towards improving man’s life experience has
more recently been flanked by a probabilistic (and problematic) version of scientific knowledge. At the
same time, forms of popularization inspired by the pedagogist and parascholastic model of the media
(especially of TV) have been surpassed by more spectacular formats, which can cater for the
communicative demands of different genres and apply the necessary operation of simplification within
their specific languages.
From this point of view, obviously, not all media are the same. There are at least two things we should
bear in mind if we are to gain a understanding of the changes that have taken place within the sphere of
the formation of public opinion over the last two decades.
The first regards the progressive transformation of the environment composed of electronic
broadcasting media. The whirlwind development of commercial television in Europe, the huge increase
in the number of channels and services available, the finalization of program scheduling and variety to
the construction of the audience and the crisis of part of the very concept of public service in the
television and radio sphere have in fact weakened both the pedagogical-type attitudes (the media as a
place of cultural emancipation and democratization of knowledge), and those of a participative-type
(the media as a place of public confrontation and for the construction of public opinion seen in the
Habermasian sense). On the other hand, the complexity of reality has continually increased, requiring
citizens to possess conceptual tools that are more and more difficult to master if they are to prove
adequate for their comprehension and control.
The result is that topics such as those which concern us in these pages, with often complex ethical and
anthropological implications, are destined to have two different, and often complementary fates. On the
one hand, if one wants to safeguard what remains of the function (pedagogical and participative) of the
200 public service, the growth in complexity requires that the technical and specialist component of the
debate be stressed, and multiplied to fit the number of different conceptual positions recorded. The
figure of the expert who – as we shall see – is a key figure in media rhetoric, no longer produces an
“monolithic, factual and incontrovertible expertise” [33]; the traditional and undisputed authority of the
scientist is reduced into a discursive dialectic or conflictual model which envisages the possibility of a
number of disagreeing opinions, which are all however equally legitimized by the reference to
scientific knowledge. This latter is, in practice, reduced to a technical-operative brand of knowledge,
which is almost political in nature. On the other hand, the same questions end up being represented by
languages (narrative and visual formats for example) and within contexts of relationship with the
general public (media consumption habits, expectations, pre-comprehension in different forms etc.)
which in fact obliterate the most significant aspects only to stress others, which are more immediately
treatable i.e. the most emotional and spectacular aspects. In other words, radio and television behave
increasingly as emotionmachines, getting to grips with a social and scientific innovation which is
downsized to the measure of common sense, when it is not interpreted in terms of feelings and
affections.
This does not mean that what the media offers is not subject to the rules of public debate; it means that
its rules are more complex, more stratified, and that the different levels at which they are positioned
(the specialist argument and the emotive one) are able to interact with one another. Again, as Bucchi
observes, whereas, some time ago, one could keep the level of common sense separate from the level of
scientific popularization which tended to illuminate it, today, the problematicization of scientific
knowledge has done away with this same distinction. In particular, when faced with situations that
might arouse public alarm (for example the subject of cloning) “we could observe that there is no
longer a sphere of common sense, inasmuch as emergency situations are perceived and dealt with in
accordance with the language of danger which is proper to this sphere and within a scientific sphere, in
which they are translated into the risk code” [34].
It is possible to try and list some linguistic-expressive emergencies in this mix of arguments in which
scientific opinions invade the area of common sense and vice versa.
Participative rhetoric, for example satisfies the demand – which is increasingly common in the
electronic media – for the public to be involved in the definition of the situation and in the social
construction of its awareness. Interviews with the man in the street, opinion polls, first person
narrations by the key figures in a certain medical story (patient and relatives), telephone calls from the
audience at home are only a few examples of forms of expression which obey this strategy, helping to
give a vision of the spectators as competent. The pragmatic involvement of the viewer as an agent
works in the same way, as it is rhetorically loaded with the possibility of intervening materially to
change the situation, for example by donating funds for scientific research or mobilizing themselves at
an associative level.
The personalization of conceptual positions is, on the other hand, a strategy which is complementary to
the previous one, based on the principle of humanizing the issue. In some cases it is the weak subjects
who undergo this process to increase the pathemic level of what is said; in others, it is the experts who
are invited to abandon the aseptic impersonality of their role to be reconstructed – at times with their
consent, at others involuntarily – according to a more markedly individual profile, bordering on the
creation of a true television personality. Here, factors such as the communicative capacity of the expert,
his appeal, the possibility of even physically incarnating a series of conflicting values within the arena
of conceptual dialectics, come into play. The more a television personality “works” within the
expressive limits of the medium, the more likely it is that his presence will be sought in similar
broadcasts, confirming himself in the role until he takes on the function of an immediately recognizable
icon of a topic or a theoretical position.
Moreover it should not be forgotten that the praxis of personalization is particularly consistent with the
need of the information apparata to have a list of experts who are not only competent, but also easily
201 reachable, willing to cooperate within the restrictions of time and space the publishing process requires.
If possible, these experts should have already proved themselves on video or audio recordings, in an
interview or as consultants. The combination of all these features make the expert a precious, and not
easily replaceable, resource, one which ensures authority and, at the same time, a good safety margin
during the production phase. The negotiation between the information apparatus and the expert is often
complex: it is therefore more convenient to maintain already consolidated relationships rather than start
up new ones. All this, evidently, contributes to the crystallization of the figure of the expert in
connection with a specific scientific topic and the cultural position he or she represents.
Narrative polarization, often combined with the preceding elements, helps to define a simpler, thus
more comprehensible picture of the situation. It is easier to say something about a complex
phenomenon if one can reduce it, from the rhetorical and narrative point of view, to a clash between a
protagonist and an antagonist. A whole range of metaphors, from sport to political or military conflict
and the mobilization of novel-writing images, can be arranged around this simplification. From this
point of view, a particularly significant fact which must be consciously taken into account seems to be
the predominantly narrative nature of the media, even of those with an informative aim. The perhaps
overly famous endings of the “great narratives” have left ample space for a widespread narrativization;
a myriad of “little stories”, destined to become “good stories” and thus highly newsworthy, crowd
around some narrative schemata, which end up proposing themselves as paradigmatic. Often, these
models, in turn, originate from the media, borrowed from the cinema or from literature, as in the
exemplary case of science fiction or gothic references which are automatically activated whenever
cloning is mentioned.
Moreover, just as often, these models conceal, as one might say, ‘mythological’ narrations, which have
done anything but disappear together with the great ideological narratives. We also see the workings of
the perhaps less evident - but consequently even more effective - science as salvation myth, the
stereotype story of the irreconcilability of faith and reason, the stock situation presented by integralism
and so on. These and similar narrations are particularly potent because they act as a background, as an
interpretative framework in order to relatively effortlessly endow often highly complex issues with
familiarity, comprensibility and sense. Indeed, the stereotype is a convenient conceptual tool for
reducing complexity.
The second element of change must be sought in the development of the new communication
technologies based on computer science and telecommunications. This development has progressively
imposed a new relationship model on social subjects involved in the information process, altering their
roles and powers. The interactive possibilities of these technologies has eroded the distinction between
those who produce information and those who consume it, helping to redefine the very function of
communication experts as mediators.
The consequences are particularly visible on two fronts. The first involves the change in the journalists’
profession, as they are subjected to a growing number of sources and an exorbitant mass of
information, which is not always controllable. The second regards the professionalization of the
consumer who is, on the one hand, authorized to become a source himself (or counter-informer), on the
other urged to carry out the job of newsgathering in person, in other words, to collect the information
that he needs to orientate himself both practically and culturally in the complexity of everyday
experience.
In short, as far as these pages are concerned, the aforesaid changes mean an ever-increasing availability
of scientific and biomedical information (both from the quantitative viewpoint and from that of its
accessibility) but, at the same time, a decreased possibility of discriminating within it on the basis of
the institutionalized reliability of the sources or the authority of the mediating figures. The process of
social reconstruction of the news thus becomes less controllable (so freer, but also more risky) and, in
some senses more permeable to noise phenomena (entailing information losing its visibility) and to
202 misinformation (this produces, for example, the false news items which circulate on the Internet almost
like a virus).
Incidentally, it should be remembered that this process of disintermediation made possible by the Net
acts simultaneously on the information providers as much as it does on the professional class of
doctors, if it is true that the Internet is one of the first sources of consultation for self-treatment
purposes, and especially if the user intends to resort to alternative medicine. Changing the means of
access to knowledge (scientific, medical, specialized …) tends to change social relationships and the
daily habits that take shape depending on this different distribution of knowledge and skills.
“With what effect ?”
Since the seventies, the sphere that studies the social effects of the media has been subject to a series of
ferments which have helped to better define the extent of the influence that the various means of
communication exercise over the social body [35]. Very briefly, we are dealing with their ability to
interact, by accumulation over the medium and long term, with the cognitive dimension of their
recipients influencing their mind set, their precomprehension, their conceptual categories and the
logical processes via which each subject perceives the reality surrounding him, thinks about it and acts
to change it. So it is not so much a question of a direct persuasive or manipulating force, as of a
collection of world representations, of an informative or narrative kind, which help to orientate the
ways in which the world presents itself as food for thought, experience and evaluation. A number of
theories subscribe to this ecological interpretation of the media influence, and these analyze how the
various means of communication “create the symbolic and cognitive culture and environment in which
individuals live and form a resource which they use in their social interactions to situate and give
meaning to their own actions” [36].
In the context of this process of social construction of reality and of the conditions for its thinkability, a
particularly significant theme for reflection in connection with the subject of these pages is suggested
by the theory that Noelle Neumann has defined as the “spiral of silence”. According to this view, “the
process of formation of public opinion consists principally of interaction between the individual’s
monitoring of the surrounding social environment and the attitudes and behaviors of the individual
himself” [37]. The consensus within one human group would thus be the product of a continuous social
elaboration made up of constant realignment processes via which the subjects seek to avoid being
culturally isolated.
Thus a circular and recursive mechanism is triggered, condemning those cultural positions that are
represented in the socio-symbolic media environment as minority opinions to disappear from the
horizon of public debate. In the words of Noelle Neumann, “public opinion can be described as the
dominating opinion which compels compliance of attitude and behaviour in that it threatens the
dissenting individual
with isolation, the politician with loss of popular support” [38].
If the selectiveness of access to the media system and its strong self-referentiality is added to the
“environmental pressure” exerted by the means of communication “to which people respond with
alacrity, or with acquiescence, or with silence” [39], we can understand that the social themes and the
subjects with the highest media visibility will tend to accumulate more and more visibility, whereas
those that are not so obvious, which have low visibility or are, in any case, in the minority, will see
their possibilities of influencing the construction of public opinion progressively reduced to zero.
Clearly, the whole measure of the involvement of larger or smaller slices of this public opinion shows
itself via a significant fallout on the actual developments in scientific research and medical practice.
The first consequences of what has been said so far is the effective pertinence of the topic indicated by
the title of this paper. Not only is the involvement of the general public in the debate on biomedical
research a given fact, to which the growing number of television programs and newspaper columns
203 devoted – in a general way of course- to health topics, medicine and scientific research bear witness
[40]; but, in particular, this involvement leads to the appearance of an aware social subject able to
affect, in various ways, the very development of research. I believe there are two main principles
guiding this development.
On the one hand, the common agreement as to the research policies to be adopted is constructed mainly
through the media, especially in a society like ours in which the intermediate bodies of social and
political participation seem to be marking time compared with the process of disintermediation
developed by the means of mass communication. The large-scale fund-raising initiatives benefiting
research necessarily pass along the pathways of mass communication, where it sometimes becomes
hard to make the necessary distinguo; the complexity of research becomes of secondary importance
compared with the spectacular emotiveness which governs the public and financial success of these
large scale events.
Opinion polls too are, again from this point of view, a powerful investigation tool which is easily
turned – following the model of the self-fulfilling prophesy – into a control tool. So the general public
is thus both the product and the tool of an aggregate of opinions to be politically intercepted by
legislative e political initiatives which, in turn, will form the subject of communication.
On the other hand, it should not be forgotten that the ways in which the formation of public opinion
translates into a consensus around the research policies are more complex and less linear than we might
think. As Bucchi and Neresini remark “two decades of international research on communication and
public awareness show very clearly that, the higher information levels do not correspond to a greater
willingness to support research. Indeed, the greatest propensity for critical mobilization is encountered
precisely amongst the most well-informed population groups, who are most sensitive to medical and
scientific topics” [41]. On the other side, the data recorded by Censis for Italy show a positive
correlation between available cultural capital, information consumption and favorable attitude towards
biotechnologies: after a phase of absent-minded and superficial optimism and one of increasing
delegation “in the current period, assent and consent to the developments in the biotechnologies seem
increasingly restricted with respect to the past […] in the light of the explicit request for information
and transparency to be actuated by public administration, industry and the research world itself” [42].
We probably need to take into account complex tensions and retroactions: the more the knowledge gap
between specialists and public opinion shrinks, the more demands for evaluations are put forward by
the latter; the more the process is carried out following consensualist methods, the more easily the
assessment translates into an attitude of trust; the more room the conflictualist voices gain, the more
public opinion tends to use their increased knowledge margin with a function of control or social
mobilization. In both cases, what seems to assert itself is, in any case, a wish to participate, a refound
protagonism on the part of the subjects concerned, a need for greater awareness and information.
On the other hand, and perhaps more directly, the growing mass of medical and scientific information
consumed by television viewers and readers ends up changing the market of medical practice itself,
acting as a conditioning element, sometimes positively, sometimes negatively. It redefines the doctorpatient relationship on new bases of competence and trust (or mistrust); it makes for a sort of social
legitimization both of the illness (think of the public discussions about Aids) and of the treatment
(again, this is the case with somatostatin or the so-called alternative medicines); it ingenerates
expectations – and, at times, demands – that are unlikely to be met; it may stimulate a “consumerism
functional only to produce a perverse thirst for diagnosis and therapy” [43].
Rather than going into this subject, I would like now to make two marginal notes. The first concerns
the close connection between the cultural dimension of the media which I mentioned at the beginning:
according to some authors, it is the new, widespread “drug culture” and the “medicalization of any
disorder or existential distress that sees the solution in medicine and guarantees a ‘sleeping partner’
income” which creates “the fertile ground in which all kinds of conflicts of interest develop” [44].
204 A central question concerns the two categories risk and trust, which are very important for our society,
at least according to analyses like that of Anthony Giddens [45]. All the mechanisms of space-time
disembedding typical of modernity, such as technologies, expert systems and mass media (from this
viewpoint too, biomedical and media research and praxis reveal a common feature) imply a growing
dose of trust, together with an equally high dose of risk.
According to Roger Silverstone, the media are connected with our ontological security: “the media are
abstract systems in which we trust, which reinforce our willingness to trust other abstract systems, and
which provide a strucutre for us to trust each other”; but “trust is like information. It is not exhausted
by use; the more there is, the more there is likely to be.indeed, it is depleted by not being used. The
media in the modern world deliver both. But in times of change their capacity to do so effectively is
undermined” [46].
Moreover, the so-called new media deserve a separate comment; the Internet, for example forms a
symbolic environment – what is known as Cyberspace- in which the trust element is fundamental. The
virtual communities live on reciprocal trust; the information which circulates freely on the Net is both
uncontrollable (often the source is unknown and it is therefore impossible to apply criteria of
authoritative legimization) but guaranteed by the fact that it belongs to the same cybernaut community
[47].
Then again, sometimes the two terms risk and trust are directly related, as when the mass media are
delegated or vested with the function of representing or socially handling situations where society is at
risk (catastrophes, terrorist acts, food alarms, epidemics etc). This question is clearly of great
importance when the subject is as delicate as that of health and the developments in medicine. In this
case, the investment in terms of emotion and trust which, via the confidential structure of the media is
poured back into the world of research and medicine, is only exceeded by the disappointment and
disenchantment deriving from the discovery that one has misplaced one’s trust.
According to some observers, the crisis situation our health system is going through deriving from lack
of faith in the same is connected precisely with an excessive amplification of the potential of medical
research and the consequent, unrealistic expectations of the public, which are, necessarily,
disappointed. However, the antidote for distorted information can only be better information: “the
regulating effect of a circuit of information in the health and public health system field will thus depend
[…] on the quality of the information” and the way in which it circulates and is made available; “to
have a positive effect, this will have to take place in a way which is, primarily, mediated - by social
subjects of various kinds, some of which already exist and others which are totally new” [48], such as
associations of sick people and pressure groups. On the other hand, the emergence of sensational cases
of conflicts of interests could undermine the foundations of the very mechanism of placing trust,
conflictually tearing apart the relationship between the various actors within it.
It is also useful to remember that informed consent too, if it is not to be reduced to a formal waiver of
responsibility by the doctor to lower the chances of lawsuits, must be constantly fed by a trust
relationship; if trust is not only the frame of relationship within which doctor-patient relations
(communicative too) are to be set, but actually the first placebo, what is in jeopardy is the success of
the treatment itself.
CONCLUSIONS
In these pages I tried to describe some areas of the communication system which may result
problematic in order to a correct involvement of the general public in biomedical research and the
proposition of a Christian vision of the ethics of biomedical research. In the next few pages I would
like to briefly present some operative considerations about both the professional training or the routine
ofthe newsmaking process and the broader cultural challenge of the mass media system.
205 On the one hand, as we have said, the space where news is socially constructed is also the space in
which various forms of conditioning can breed; these are not only direct, occurring in the wake of
public or private investment in research, but also indirect, because they can artificially create a
consensus around certain drugs or therapies. It is within this space that the possibility of demagogical
and populist instrumentalization can creep in, whether this is financial or ideological.
Returning to the initial consideration of the radical affinities between the ethics of biomedical research
and the ethics of mass communications could suggest an operative perspective. Indeed, again as
Claudio Giuliodori remarks, “a true communication of the problems inherent in bioethics cannot ignore
the purely ethical dimension […] We can thus manage to identify the crux of the problem, that is, the
need for a true “ethics of communication to be developed’” [49]. The involvement of the general public
in a debate orientated, in a Christian and ethical fashion, around the development of biomedical
research passes, first and foremost, by way of an intrinsically ethical communication, which naturally
respects personal and truth values. Within this framework, the individual questions raised during these
reflections can be tackled in terms of professional deontology or pragmatic ethics, but they probably
also require the consideration of levels of intervention which go beyond “first person ethics”.
This will involve, for example, developing a reflection on the quality of information, at least within
some particularly sensitive sectors such as that of medical and health service information; yet again, it
will involve thinking in terms of system guarantees which can effectively exclude the risk of conflicts
of interest.
For this reason, we need to think of corrective measures which act on at least two levels at the same
time. On the one hand, as Ron Collins suggests, we have to develop instruments of control that
constantly provide public opinion with the possibility of knowing the nature of the contractual
relationships between the companies concerned and the scientists or university research centers [50];
on the other, we have to draw up codes of behavior for the various professions involved in the
publication phase of research results. This might, for example, require the researcher who has a
consultancy arrangement with a company to declare this in his publications, in press interviews, to
government agencies, and so on [51].
In this connection, translating the matter into deontological terms, it should be remembered examples
like the “Ethical Code for doctors and journalists regarding health information” [52]. Its
recommendations include: specific and on-going training for journalists dealing with biomedical and
bioethical matters, that the information given should be complete and not “engender false expectations
in the sick” (paragraph 3, art. 9), that writings should be distinct from all forms of advertising, and that
excessive emphasis should not be used; even the omission of information dictated by financial interests
is considered a breach (art. 17). The regulations regarding information in the pharmacological research
field are particularly interesting. Amongst other things, these require that sources should be given and
that information which could have a promotional effect regarding drugs still in the experimental phase,
and articles representing scientific progress in the health field which recommend collaboration between
medical researchers and scientific journalists and between these and sources of a public nature, be
eliminated.
Then, we will need to invest in training for those who work in communication, focusing particularly on
the praxis of popularizing medical and scientific information and its languages. The competence of the
disseminators and thus their training, both ethical and scientific, is central. However, there is also a
problem of language, which suggests the need to identify modes of communication which allow
simplification without betraying the deep sense, also bearing in mind the fact that confusion generates
the alienation and detachment of public opinion.
The challenge becomes, in this perspective, a cultural one. Zooming even further in on the problem that
concerns us, there is a large problem area: the question of the degree of compatibility of the Christian
approach, aiming to ethically orientate biomedical research with the cultural environment represented
206 by the media, especially in view of the large dose of attention the various means of communication
give to this research.
So, it is a case of sounding out more analytically the individual ‘knots’ in the cultural debate in which
opportunities for mistakes, misunderstandings and instrumentalization may be lurking; we have to take
an aware look at the limits and restrictions of the tools so that we do not passively bow to the
predeterminations inherent in their use. Some structural features of the system seem decidedly
contradictory: its commercial nature, the fact that it is subject to the laws regarding audience and the
advertising market, the endemic dramatization of news, pose serious problems. It seems even more
unlikely that we could conciliate the concept of truth, in its anthropological and philosophical sense,
seen as a basis for the ethics proper to the Christian tradition and truth, in the sense legitimized by the
media, seeing that the latter swings between a subjective realism and a majority consensus. Likewise, it
is not to confuse a pluralistic expression ofvoices and cultural positions offered by the media with a
hypothetical neutrality:no discussion on values can disregard the fact that, in the media sphere, the
obstacle does not so much lie in a lack of values, but, paradoxically, in their hierarchy-devoid
abundance, in their fungibility, their equivalence, their alternation, which cannot regularly be translated
in axiology.
Finally, we will need to invest in training for the audience at different levels: media education will
provide tools for a critical and conscious use of the informative and cultural resources offered by the
media system; scientific education will provide the knowledge required for a better comprehension of
the real matters, beyond any reduction operated by the media; moral education will grow up
responsible citizens, involved in choices and social participation on which depend research policies.
Carrying out operations at such a plurality of levels and modes of intervention would mean working
towards a unitary cultural recomposition, setting the person back at the center of the communication, as
the “principle of unity around which all the threads of knowledge should be retied” [53].
[1] Let the computer science concept of neural network, or that of global brain to indicate the
development of the Internet and its cognitive potential serve as an example. Cfr. BETTETINI G. et al. I
nuovi strumenti del comunicare, Milano: Bompiani, 2001.
[2] Spagnolo A., Bioetica in Tanzella-Nitti G., Strumia A. (eds.), Dizionario interdisciplinare di scienza
e fede, Città del Vaticano: Urbaniana University Press; Roma: Città Nuova, 2002: 196-213.
[3] Gatti G., Etica della comunicazione in Lever F., Rivoltella P., Zanacchi A.(eds.) La comunicazione.
Il dizionario di scienze e tecniche, Roma: Eri-Elledici, 2002:452-461.
[4] Pontifical Council for Social Communication, Etica nelle comunicazioni sociali, Città del vaticano:
Libreria Editrice Vaticana, 2000 n. 21.
[5] Bettetini G., Fumagalli A., Quel che resta dei media. Idee per un’etica della comunicazione,
Milano: Angeli, 1998.
[6] Gatti G., Etica …p.455.
[7] Cfr. Bettetini G., L’occhio in vendita, Venezia: Marsilio, 1985.
[8] Botturi F., Tecnologia ed esperienza, in AROLDI P., SCIFO B. (eds.), Internet e l’esperienza
religiosa in rete, Milano: Vita e Pensiero, 2002: 97-104.
[9] Martini C.M., Il lembo del mantello, Milano: Centro Ambrosiano, 1991.
[10] Cfr. Giuliodori C., Bioetica e comunicazione in Sgreccia E., DiPietro M.L. (eds.), Bioetica e
formazione, Milano: Vita e Pensiero, 2000:117-126.
[11] Wolf M., Teorie delle comunicazioni di massa, Milano: Bompiani, 1985:25.
[12] LASSWELL H.D., The structure and function of communication in society, in BRYSON L. (ed.),
The communication of ideas, New York: Harper; ora in SCHRAMM W., ROBERTS D., The process
and effects of mass communication, Chicago; University of Illinois Press, 1972:84-99.
207 [13] For a summary of this tradition of researching the media cfr. Wolf M., Teorie …; Sorrentino C., I
percorsi della notizia, Bologna: Baskerville, 1995.
[14] Sorrentino C., I percorsi…pp.13-14.
[15] ibid., p.150
[16] cfr. Nelkin D., Selling science. How the press covers science and technology, New York, 1987;
ID, Medicine and the media: an uneasy relationship: the tensions between medicine and the media, The
Lancet, 1996, 347:1600-1603.
[17] Cfr. GALDON LOPEZ G., Desinformcion. Metodo, aspectos y soluciones, Ediciones Universidad
de Navarra, 1994.
[18] cfr. Cesareo G., RODI P., Il mercato dei sogni, Milano: Bruno Mondadori, 1996.
[19] Sorrentino C., I percorsi… p.182.
[20] In this connection, Sorrentino quotes the following declaration by a reporter “if you don’t know
them and you don’t flatter them, you can’t construct a mechanism of defence from the sources” (Ibid.,
p.182)
[21] For example, the case of “mad cow” disease, according to BUCCHI M., Vino, alghe e mucche
pazze. La rappresentazione televisiva delle situazioni di rischio, Roma: Rai Vqpt, 1999.
[22] Sorrentino C., I percorsi… p.188.
[23] THOMPSON DF. Understanding financial conflict of interest, New England Journal of Medicine,
1993, 329:573-576; cfr. also Catananti C., Medicina, valori e interessi (dichiarati e nascosti), Milano:
Vita e Pensiero, 2002:74.
[24] Cfr. Krimsky et al., Scientific journals and their authors’ financial interests: a pilot study,
Psychotherapy and Psychosomatics, 1998, 67:194-201.
[25] ANONIMOUS, I medici di fronte al conflitto di interesse, Bollettino di informazione sui farmaci,
7, gennaio-febbraio 2000, 1:2.
[26] RENNIE D., Riviste scientifiche e confitto di interessi, intervento alla V Riunione Annuale
Network Cochrane Italiano “Evidence-based medicine e conflitti di interesse”, Milano, 5-6 ottobre
2000; url:http://www.isi.it/research/2000/lifescience/projects/Conflitto_interessi_e_EBM.pdf.
[27] SHAW E., Agenda-setting and mass communication theory, Gazette International Journal for
Mass Communication Studies, 1979, XXV, 2:96-105.
[28] WOLF M., Le discrete influenze, in JACOBELLI J. (ed.), Quali poteri la Tv ?, Bari: Laterza,
1990:150-154.
[29] Ibid. p.151.
[30] Ibid
[31] cfr. Bettetini G., Fumagalli A., Quel che resta ...; BUCCHI M., NERESINI F., Un Nobel a
Sanremo (ma la scienza rimane sconosciuta), Problemi dell’informazione, 2, 2000:233-250
[32] cfr. BETTETINI G., GRASSO A., Lo specchio sporco della televisione, Torino: Fondazione
Agnelli, 1988.
[33] BUCCHI M., Vino, alghe …, p.101.
[34] Ibid., p.103.
[35] WOLF M., Gli effetti sociali dei media, Milano: Bompiani, 1992.
[36] Ibid., p.73.
[37] Ibid., p.67.
[38] NOELLE NEUMANN E., The spiral of silence. A theory of public opinion, Journal of
Communication, Spring, 1974:43-52.
[39] Ibid., p.51.
[40] Cfr. the data recorded by Censis, Cultura scientifica e informazione, Milano: Angeli, 2001.
[41] BUCCHI M., NERESINI F., Un Nobel…p.245-246
[42] Censis, Cultura scientifica …p.188
[43] Catananti c., Medicina …
208 [44] Ibid.
[45] Cfr. Giddens a., The consequences of Modernity, Cambridge: Polity Press, 1990.
[46] Silverstone R., Why study the media ?, London: Sage, 1999: 120-122.
[47] Examples are chain letters asking for help (not financial aid but information) on serious and
particularly rare illnesses.
[48] Satolli R., Una buona informazione, questo è il rimedio, Telèma, III, 1997:14-18.
[49] Giuliodori C., Bioetica e …
[50] Cfr. Centre for science in the public interest, Integrity in Science project, leaded by Ron Collins.
[51] Cfr. an interview with Ron Collins: url http://www.radio.rai.it/radiotre.html.
[52] Subscribed by the Commissione di bioetica dell’Ordine Provinciale di Roma dei Medici Chirurghi
e degli Odontoiatri in collaboraztion with the Commissione Culturale del Consiglio Nazionale
dell’Ordine dei Giornalisti; urlhttp://www.numedi.it/asmi/intesal/codice.html.
[53] Gargantini M., Divulgazione in Tanzella-Nitti G., StrumiaA. (eds.), Dizionario interdisciplinare …
209 ELIO SGRECCIA
POLICY IN BIOMEDICAL RESEARCH
VALUES AND PRIORITIES
DEFINITION OF TERMS AND SPHERES OF ANALYSIS
Research
The New Shorter Oxford Dictionary gives the following definition of research: ‘a search or
investigation undertaken to discover the facts and reach conclusions by a critical study of a subject or
by a course of scientific inquiry’.[1] I intend to speak in a specific way about biomedical research,
which can involve human subjects and is intended to benefit human subjects: we are dealing here with
research carried out by a scientist for man, at times in a laboratory, at times on man and with man.
Research on animals, which will be discussed later in this paper, can also have important connections
with the biomedical sphere.
Great and continuous advantages, above all in the identification of the causes of illness, are expected of
this kind of research, as the history of science has demonstrated.
As C. Weijer observes[2], the character of biomedical research lies in two elements which involve: the
intention to produce something that can be applied and generally accepted, and in addition has as its
subject the spheres of biomedicine or spheres that are connected with it. These spheres cannot be easily
delineated because they can include a great variety of elements: chemical substances, radioactivity,
surgical devices, materials for prostheses, genes, biological agents (micro-organisms), forms of
behaviour, psycho-diagnostic and psychotherapeutic methods, and the human body itself and its
functions.
It is clear that each of these territories involves different methodological approaches.[3] The principal
typologies of biomedical research can be placed under the following headings:
a) The study of ‘case series’: this involves the retrospective study of cases in which a procedure (for
example a surgical procedure) has been applied to subjects who have a similar pathology and require an
identical surgical technique so that these cases can be examined and their results compared.
b) Observational study: a cohort of cases is chosen on the basis of similar characteristics and an
analysis follows with a view to obtaining results without any randomisation.
c) The case control study: these are retrospective studies in which two groups of cases are taken into
consideration on the basis of the presence/absence of a characteristic that is taken as the subject of
analysis, so as to then compare or check the data obtained with a view to exploring a possible
connection of cause and effect. The use of this method is frequent in epidemiological studies.
d) Clinical trials: these are well known in pharmacological experimentation. In clinical trials the plan,
or experimental programme, can envisage a control group, randomisation, with or without a ‘blind’ or
‘double blind’. This is the form of study that is most well known in the clinical sphere.
e) Genetic research. Beginning with the discoveries of molecular biology, genetic research has
constituted a real revolution in the sphere of biomedical research: the identification of chromosome
illnesses and genetic defects has stimulated increasingly vast projects for the mapping, sequencing and
identification of the entire human genome. This sphere of research, which is still undergoing rapid and
continuous development, has its own methodology which can be directed to gaining knowledge about
genes, but it can also allow experimental intervention with therapeutic or even manipulative goals. In
recent years, the stage of pharmacogenetic research has begun, aimed at establishing the interindividual differences of a genetic nature in the action of pharmacies.
A distinction that is currently taken into consideration divides research into two major spheres: basic
research and clinical research. The first largely takes place in a laboratory (on molecules, genes,
210 tissues, micro-organisms) and the second is mainly concerned with a healthy or sick individual. As
regards the preparation of a pharmacy, there is a stage involving basic research followed by a clinical
stage.[4] It should be remembered that today the human embryo is also the subject of basic research in
laboratories, with consequences that are usually suppressive or which do not correctly recognise the
specific dignity of that embryo.
Another distinction, which is easily understood, is that to do with funding: reference is made to public
research, which is planned and financed by the state through its specific organs (a Ministry or research
institutes acting on behalf of the state or financed by it, such as the NIH in the United States of
America or the Istituto Superiore di Sanità (‘Higher Institutes of Health’) in Italy), and to private
research, which is planned and financed by private initiative and/or private business, as is the case with
pharmaceutical companies or in the biotechnological industries. There are mixed forms in which the
initiative is of a private character but has state funding, as is the case with university institutes or
scientific institutes which are qualified for certain kinds of research and obtain the recognition of the
state. This distinction, in line with a system of freedom of research, also has a marked ethical
importance, as we will see below, because of the greater sensitivity to economic profit characteristic of
private research.
Research policy
It is not easy to grasp the exact meaning of this phrase, in particular because of the different semantic
connotations that the word ‘politica’ (‘policy’, ‘politics’) has in different languages: I think I can affirm
that in Italian the prevailing meaning is associated with the exercise of power, whereas in Anglo-Saxon
parlance the word has a wider meaning and refers to the planning in a broad sense carried out by any
undertaking of a certain importance; it includes the set of rules outside research as well. It does not
refer, that is to say, solely to funding but also refers to deontological and ethical norms.[5]
To be more precise and to refer to the specific literature on the question, the following meanings
connected with research policies can be identified:
a) The first meaning, presented by the Encyclopedia of Bioethics, ‘refers to policy that establishes a
program for a general course or plan of action intended to reach a desired target or goal. In biomedical
research the goal or target is usually specified in terms of a program relevant to the diagnosis,
prevention, treatment, or cure of a specific disease or condition’.[6] In this meaning ‘policy’ means
planning in a broad sense, such that one can also envisage a set of research protocols directed towards
the creation of a therapy such as, for example, the preparation of a vaccine for AIDS, or the
identification of the cause of an infection whose agent is unknown. This planning can easily be
established and financed by a public authority but it can also be a part of the concerns of private
research.
The commitment to establish the priorities of programmes and the ways of establishing such priorities
can also fall within the framework of this meaning.[7] Naturally, to establish these priorities is also a
process that involves ethics. The allocation of resources to biomedical research both as a percentage of
GDP and the establishment of the criteria for their distribution to the various sectors of research is also
a question of ethical reflection. The involvement of the public in determining this priority is a special
ethical and political matter.
b) A second meaning ‘refers to policy that imposes conditions or restraints on biomedical research
investigators or their institutions’ [8] In this meaning ‘policy’ means ‘regulation’ or the set of preconditions laid down for the carrying out of research.
These pre-conditions or restraints must involve a complex harmonisation: the protection of the subjects
of experimentation, the obligations and the interests of the researchers,[9] the exclusion of conflicts of
interests,[10] the use of animals, the inclusion of women and ethnic minorities, and the pursuit of the
common good including the good of subjects who are afflicted by serious but rare illnesses. The
211 contribution of business and universities is included in this harmonisation. And it is during this
application stage that many ethical questions and issues of great relevance arise - questions and issues
that are the subject of the codes that govern experimentation.
Amongst the ‘policy’ tasks of the state as such (similar to those of international authorities), is that of
establishing the processes for the approval of research proposed by researchers, both as regards
pharmacies and surgical devices. Moreover, the political authority has the task of drawing up the
working procedures[11] of the control bodies.
c) A third and more broadly ‘political’ meaning is at the present time increasingly taken into account,
and this refers to an awareness on the part of individual states and the international community of the
decisive relevance of scientific research in the development not only of a nation but also of mankind as
a whole. This is a matter of conceiving the terms ‘research and development’ (R&D) in global terms.
Within this framework emerge the requests directed towards avoiding the state’s monopoly over
research[12] and an excess of politicisation which, in historical terms, gave rise to the aberrations of
certain regimes. For that matter, the question of the globalisation of world research increasingly comes
to the fore in the difficult creation of fair, sustainable and peaceful development.[13]
Here we also encounter the position of criticism of what is called scientific Messianism. This criticism
is based upon the risk of the ungovernable character of technological applications. In this context,
reference is made to the fall of the utopia of progress and the rise of bioethics is held up as an appeal
for a governance of global scientific and technological progress.[14]
Nowadays, we are witnessing this synchronic and balanced approach: on the one hand, this involves
the taking into account of the decisive relevance of scientific progress in the development of society
and mankind in the research and development (R&D) ratio, and on the other, a reflection on the
ambivalence of such progress, especially when it is seen not only as ‘knowledge’ but also as ‘power’.
The dangerous nature of science and technology and the possible negative drift of this progress are
attributed to this conjunction of ‘knowledge and power’.
It is certainly the case that trust in science is no longer today of an ‘Enlightenment’ character, in the
sense of optimistic automatism based upon the premise that reason never makes a mistake. Today,
progress is seen as ambivalence and the populations of the world are increasingly sensitised by
alternations between success and fear.
It is for this reason, as well, that the inclusion of ethics within the political management of research
itself is explained and justified.
It is now necessary to move to an analysis of these three different meanings of policy research.
RESEARCH POLICY UNDERSTOOD AS PLANNING
An examination of the ethical questions and issues in the sphere of the policies of planning and
research involves a large number of such questions and issues, which are connected with both basic and
clinical research.
Taking the programme of this conference into account, some of these subjects will be only briefly
touched upon here because they will be addressed by other papers: for example, the subject of the
international rules and regulations governing experimental research; the subject of conflict of interests
and the researcher; the subject of pharmacological experimentation; and the subject of
experimentations involving animals. But even if limited in this way, the framework of ethical questions
and issues remains very broad and complex.
First of all, the fact of the public funding of research must be considered, as well as the consequent
need to examine the resultant responsibilities of the political power and its relationship with private
funding.
212 The interest of the state in research, after the ‘black’ page of the Nazi experience during the Second
World War, has taken on a dual function in the democratic world: that involving the promotion of
development and quality of life and that involving the government of the rights of patients and the
freedom of private and university research.[15] The model of this (promotional-regulative; publicprivate) management is offered first and foremost by the United States of America, upon which the
industrialised countries of other continents have based themselves.
An observation of the decisive weight that the resources of science played in deciding the outcome and
the end of the Second World War convinced the political authority of the United States of America to
give incentives to scientific research as a factor for development both in the field of technology in
general, and in the biotechonological and biomedical field in particular. However, even before the
experience of world war, the American Congress (in 1867) had already created a body for the study of
cholera and other contagious diseases (the Staten Island Hygenic Laboratory), and in 1930 it renewed
and increased its responsibilities by establishing the NIH, to which the National Cancer Institute was
added in 1937. These institutes were endowed by Congress with the authority to co-ordinate research as
well as the budget that was required. After the Second World War the budget of the NIH expanded
enormously: between 1946 and 1949 it went from $180,000 to $800m; in 1993 the same institute had a
budget of $9.6 billion and in 1994 $11 billion; at the same time, another seventeen institutions formed
around the NIH, including the National Library of Medicine.
A ‘political’ programming of research envisages four stages: a) authorisation: the act of Congress
which establishes the programme and the limits to funding; b) appropriation: the assigning of the sums
of money to be made available every year; allocation: the distribution of funds to the individual
programmes; and d) obligation: the paying over of the sums involved. In 1985 a special programme
envisaged the enrolment of six thousand researchers.
In assigning funds, Congress at times also establishes ethical limitations on their use: for example, in
1993 restraints were applied to the use of funds for research on abortion or on the RU486.
I have wanted to dwell at length on explaining the working of research policies in the USA because this
model has in one way or another been repeated in other states (except as regards the actual amounts of
the sums provided!). It should be added that the authorities of the USA, in their regulative function,
when they impose restraints of an ethical nature on the employment of public funds do not apply such
restraints – at least directly – to private companies.
Another difference lies in the fact that many industrial states such as Canada, the United Kingdom,
Germany and Japan and others allocate a percentage of the budget for research to health care for the
support of biomedical research, and in general a set-aside is allocated to medical research institutes
(MRCs)[16] This can achieve better guarantees for the depoliticisation of biomedical research.
The level of the state’s financial commitment to research has a significance that is not only political but
also ethical in character. This is because compared to private investments, public initiative, in general,
is called upon to pay attention to social needs and the requirements of the common good, whereas
private investments are influenced by hopes for profit on the part of businesses themselves.
To have an idea of what the policy of public investments is at the present time, I will offer a few facts
that I have obtained from different sources, albeit not without certain difficulties. CENSIS[17] has
recently supplied a number of data on research in general which also include data on biomedical and
pharmacological research[18]: these are thus data which can offer us a general overall picture.
According to these data, in the world the average level of public expenditure on research and
development (R&D) reserved to biotechnologies is 3.5%; in Italy this figure is 0.4%; in Belgium
13.8%; and in Canada 10.1%. For such research, regional and international alliances have been formed:
of the total of such alliances in 1998, 48.3% were alliances of an international character, the rest being
made up of inter-regional alliances. Most of the international alliances were USA-European alliances.
The statistical data on scientific publications indicate that the USA takes pride of place, followed by
Japan, the United Kingdom, Canada, Germany, France, Spain, Holland and Italy. In general, as we will
213 see in the final part of this paper, the investment of funds in industrialised countries in research
connected with development is on an upward trend and is one that increasingly involves global
connections.
Countries
USA
Japan
Germany
France
Italy
United Kingdom
OECD
EEC
1975
2.3
2.0
2.2
1.8
0.8
2.2
1.9
1.8
1987
2.8
2.8
2.7
2.4
1.3
2.3
2.4
2.7
The schedule below shows a more recent framework of some European countries funds estimated in
Ecu-1995 and elaborated by Ispri - Istituto Superiore di Sanità (Italy) basing on Eurostat's data.
Paesi
1990 1991 1992
1993
1994
1995
1996
1997
1998
1999
Denmark 26
19
Germany 197
197
279
378
453
461
437
412
430
438
Greece
10
7
7
16
16
17
21
19
20
28
Spain
58
84
92
88
139
126
148
Ireland
10
11
10
14
12
13
15
Italy
25
23
14
13
27
26
21
45
U.K.
58
157
140
174
149
173
196
226
242
As regards applications for patents, the data taken from the OECD report of 2001 for the period 19901997 on the total applications for patents deposited with the EPO (European Patent Office) show an
increase of 5.7% for the European Union, 4.8% for the United States of America, and 1.1% for Japan.
These patents refer both to the field of information technologyand the field of biotechnologies: the
increase for the first category was 8% and for the second over 10%.
In the period 1990-1997, the highest levels of increase in the applications for biotechnological patents
made to the EPO came from Canada (37%) and Korea (32%); in the inter-mediate band were Great
Britain and Denmark (15%), Spain (14%), Belgium (13%), and Italy (8%).
A significant statistic can be deduced from the ‘World Report on Human Development 2002’ on R&D
(research connected with development), which covers biomedical research, the biotechnologies,
information technology and dwarf-technology. The statistics refer to all countries and indicate the
percentage of the GDP of each country allocated through their budgets to R&D. The data can be
analysed in the table in the appendix. It may be observed, however, that many countries did not send in
data.
One trend that can be observed in industrialised countries is that of the increase of the intervention of
the private sector, compared to that of the public sector, in the sphere of biotechnological research,
including medical research. The same CENSIS report indicates that from 1983 to 1985 the level of
business funding doubled (from 2.9% to 5.7%), whereas the proportion of public funding fell from
94% to 85.6%. At the present time in the United States of America, private business is responsible for
60% of the overall participation in biomedical research.[19]
A relevant role for public funding, as has already been observed in this paper, is a predictable guarantee
for greater fairness in the distribution of funds, especially in those sectors of research in which private
214 business expresses no economic interest - sectors that are, however, in need of social support (rare
illnesses and orphan pharmacies).[20] It is the task of the state to establish the priorities in research on
the basis of social needs.
Public intervention also has a great weight in the organisation of research structures, in the financing of
universities and research centres, and in the training of researchers. In countries where a sound
organisation of research does not take place, the so-called ‘brain drain’ takes place - a phenomenon
which marks an impoverishment of such countries in terms of the most relevant human factor.
It would be important, out of considerations of an ethical nature as well, to have meaningful data on
research in developing countries. A special conference in Brussels has been planned for this. I have
also been able to deduce little from direct contacts with our members of the Academy. One example of
this may be given. The state funding of research in the Ivory Coast is directed in the main to
agriculture. For about twenty laboratories the budget for research is desultory, irregular and when it has
existed it has amounted to about seven million (in local currency) each year. Within the framework of
the UN, as is described in the appendix to this paper, some African countries have a high index of
investment, but we do not know the sources of such investment (public or private, foreign or domestic).
The ethically relevant aspects of the promotion of research are many in number. The political authority,
in addition to promoting research, also has the duty to organise connections between the various actors
in the research project: the researchers, universities, qualified research centres and the subjects on
whom the research can be carried out.
Not all these subjects work with the same opportunities as regards knowledge and intervention, and it is
the task of the state to ensure the defence of the weak subject, who is a citizen and is a subject cooperating with research, in order to guarantee him or her against risk and to ensure his or her aware
participation through informed consent.[21]
It is usually believed that the interests of researchers coincide with those of the community and the
state. In reality, this is not always the case and it is the task of the same public authority to watch over
the research not only in order to eliminate fraudulent intentions or abuses in research,[22] but also to
impede the establishment of private conflicts of interest beyond defending the payment of a fair salary
and the recognition of intellectual merit. Situations of conflict of interest have been indicated: for
example, in cases where researchers have blocks of shares in the businesses that commission the
research they are engaged in.[23] There are those who draw attention to this conflict and request its
urgent elimination so as to prevent the few funds that are allocated to research being directed more
towards the profit of the researchers than the good of society.[24]
There is also the immense ethical question, which will be discussed in the last part of this paper, of the
great difference in the possibility of engaging in research (as regards means, structures and people)
between industrialised countries and developing countries. This, indeed, is one of the most serious
political and ethical questions that we have to address.
The tasks of ensuring the correct conduct of the researchers and of harmonising the efforts of the
various actors to achieve the common good are tasks of a high social and ethical significance. Yet they
do not, in turn, make the public power immune from engaging in policies that are not correct. Here one
may refer to the authorisation by state authorities of the financing of experimental research that brings
into play the lives of human beings: for example, programmes connected with artificial procreation,
with experimentations on embryos, with cloning and with the ‘morning after pill’, as happened in the
United Kingdom with the special authority entrusted with such tasks, and as is now taking place in
other states.
From this point of view, one must also condemn the complicity of many states in the funding of
programmes of international agencies (the United Nations Fund for Population, the World Health
Organisation, etc.) which have developed and are still developing research programmes involving
artificial family planning, sterilisation, and chemical abortion. We know that since 1968 world research
has supplied support, funding and legitimacy to a real and authentic international ‘plot’ against life, and
215 has created pharmacological substances and invented techniques suited to such a political purpose. The
work of Prof. Schooyans has been able to document this complicity. The echo produced by the
conferences promoted by the United Nations in Cairo (1994) is sufficient proof of this.[25]
The practice of the political authorities of some states which involves denying public funding to some
forms of research considered to be illicit but which at the same time allows private institutions to take
part freely in such experimentations should also be seen as an ambiguity which is not justifiable on the
grounds of the principle of freedom of research.
This question is now of topical relevance in the United States of America as regards the use of
embryonic stem cells[26] and is now also being raised in relation to the funding of research
programmes within the programmes of the European Union.
RESEARCH POLICY UNDERSTOOD AS CONTROL: ETHICAL CODES AND
GUIDELINES
As was observed at the beginning of this paper when a definition of ‘research policy’ was given, the
specific task of institutions to outline controls for biomedical research from the ethical point of view
also belongs to this sphere and falls under this heading.
The policy of control as regards research on humans (and also on animals) has drawn upon different
sources and convergent inputs. In the USA it took concrete shape in the Belmont Report and in Europe
in the Code of Nuremberg. At an international level it was expressed in the Code of Helsinki issued by
the World Medical Association, and subsequently in conventions based upon human rights such as the
‘European Convention on Human Rights and Biomedicine’ of 1996 and the ‘UNESCO Declaration on
the Human Genome and Human Rights’ of 1997.
Other papers given at this meeting will touch upon the subject of rules and regulations, but it seems to
me useful to refer to the principal stages of this control policy, in order, as well, to bring out the ethical
principles upon which it is based and what still seem to be the inadequacies and contradictions of the
existing codes and legislation in this field.
What imposed control over research in different parts of the world was primarily the news about the
research carried out during the Second World War by the Nazis in concentration camps on Jews,
Russians, political prisoners, homosexuals and others in the form of a vast gamut of experiments
involving the abuse of humans: sterilisation techniques, methods of mass extermination, and the
experiments in freezing carried out in Dachau (25% of the subjects died).[27] But it was not only the
experimental practices of the Nazis that required the need for ethical rules and regulations. The most
known-about illicit experiment, carried out in the United States of America, was the Tuokegee Syphilis
Experiment, part of a project prepared by the Public Health Service. In this project Afro-American
citizens of the USA were experimented on and 20% of them died following on-going invasive forms of
treatment. Such experiments continued to take place even after penicillin had become available.[28]
A special office, the Office for Research Integrity (ORI), in a report of 1993 in Canada, reported that a
surgeon in a project of research on breast cancer had falsified data on ninety-nine out of the one
hundred and fifty one women subjected to experimentation. This falsification was hidden and the
researcher, Dr. Roger Poisson, used up $1m.[29] One could add other examples of experimentation
carried out in the United States of America on elderly people and children without their consent and
with resultant infectious damage.
In 1947 the Code of Nuremberg was published with its ten principles, amongst which the prohibition
on carrying out experiments without the consent of the subject. The same principle of consent in
relation to physical operations and forms of treatment is also to be found in the Universal Declaration
of Human Rights. The most famous and still relevant deontological code is the Declaration of Helsinki
of 1964, which has been revised on more than one occasion in response to the new questions and issues
216 that have presented themselves. In this code, in addition to the requirement of consent, there is the
principle of avoiding causing harm to the patient. The document was issued by the World Medical
Association and is still taken as the basis for clinical trials. Another important international document
on experimentation is the ‘International Ethical Guidelines for Biomedical Research Involving Human
Subjects’, which was published by the Council of the International Organisations of the Medical
Sciences (CIOMS) in 1993. The same organisation published its ‘International Guidelines for the
Ethical Review of Epidemiological Studies’, on experimentations in the epidemiological field, in 1999.
Within a European regional context, we should remember the document ‘Good Clinical Practices’[30]
which was adopted by the member states of the European Union. Rules and regulations concerning
experimentation are also contained, as has already been observed, in the ‘European Convention on
Human Rights and Medicine’.[31] With regard to experimentation in the genetic sphere, the ‘Universal
Declaration on the Human Genome’ of UNESCO[32] must be borne inmind.
At a national level, one can say that many ministerial authorities, medical professions and specialist
associations have produced their own documents that set out rules and regulations (national
deontological codes). The Belmont Report of the USA published in 1974 by the ‘National
Commission’, which was created specifically in response to revelations about uncontrolled
experiments, continues to be of historical importance. In this document, the principle of respect for
people, the principle of doing good and of not doing harm, and the principle of justice are all
emphasised. In 1980 in the USA the ‘President’s commission for the Study of Ethical Problems in
Biomedical and Behavioural Research’ was also created, and this published a series of guideline
documents on the most advanced fields of biomedical research: genetic engineering, artificial
procreation, and organ transplants. This commission may be seen as the foremost national ethical
committee; it followed on from the initiative taken by President Mitterand in France in 1984 with his
establishment of the ‘Comité National Consultatif d’Ethique’.
These examples were later followed in all countries (in Italy in 1990). Such national ethical committees
issue judgements not only in the field of care but first and foremost in all the fields of innovation and
research. Such national committees now have before them a proposal for co-ordination made by
UNESCO.
The creation of national, international (the Council of Europe, UNESCO), institutional and local ethical
committees constitutes, in fact, the high presidium for the defence of the subjects and the ethics of
research. The Church, for her part, through her Magisterium, has actively promoted ethical
requirements which have often come to form a part of medical ethics and of deontological codes
themselves.[33]
The presence of centres of applied ethics has been accompanied by the development of bioethics as a
taught discipline and as a discipline which offers support for ethical principles and rules and
regulations- institutes, centres of bioethics, publications and debates continue to emphasise new
principles and to point to new dimensions to ethical problems. In the United States of America, even
after the ‘Belmont Report’, other principles have been emphasised in order to secure guarantees in
research policy. Amongst these, obviously, is a need that is intrinsic to experimental research, namely
scientific validity, which is identified as a ‘pre-requisite’ and refers above all else to methodology.
Together with validity, the value that the research must represent as regards science, medicine and
society is also emphasised.[34] There can be research that is methodologically correct but of very low
value. Those who today also belong to ethical committees on the experimentation of pharmacies know
that many trials have a low innovative character and are often based upon small variations in
pharmacies that are already on the market. They have the sole result of absorbing the resources that are
made available by the state.
Value and validity are also relevant in justifying the proportionality of the risk that a healthy subject is
asked to run.
217 In the ethical literature on the subject stress is also placed on accuracy and honesty in respecting the
results, the procedures, and the methods used at the moment of publishing the research itself.[35]
A further element which has recently been brought to attention is so-called respect of communities,
which involves taking into consideration the values, the beliefs and the public structures of isolated and
primitive communities when an experimentation with them is proposed.[36] In these cases there is a
requirement to acquire accurate information on the customs, mores and traditions of the community
beforehand. As a result, it is proposed that before drawing near to specific individuals within these
populations to receive their consent to the experimentation, consent should be asked of the legitimate
authority of the community (whose assent must not, however, replace that of the individual subject).
Thirdly, there must be a guarantee that the project meets the needs of the place involved, or anyway
involves appropriate advantages for the community, with the obvious prescription, as is the case for all
subjects, of the obligation to avoid harm and risks. Lastly, it is suggested that the local population,
through its representatives, should be able take part in discussion about the project, the carrying out of
the experimentation, and the analysis and publication of the results.
New needs emerge in an increasingly evident way in research of a genetic character and at the
international level such needs are emphasised by documents connected with human rights.[37] They
concern the secrecy of data, the possible communication to family members that they may have the
same risks, as well as prohibitions on forms of discrimination that can emerge from the screening of
workers, families and citizens. We will then also see the limitations of these ethical rules and
regulations codified for these special areas.
The subjects brought to the attention of research policies also refer to the inclusion in experimentations
of populations or groups of individuals that do not enjoy human rights and sufficient conditions of
freedom: such forms of research often receive the approval of authorities that do not respect human
rights, with the result that such research can be carried out on vulnerable populations: for example,
defenceless refugees. In such cases, it is suggested that before proceeding with the experimentation, an
exact knowledge should be acquired of the political and humanitarian conditions relating to respect for
human rights so as to examine under what conditions possible experimentation can be carried out.
Amongst such conditions, the creation of an ‘independent institutional review board’ is proposed: cases
are to be pointed out where a consideration of the political conditions can have relevance in deciding
the risk or in vitiating research because of criminal activity or as regards the objectivity of the research
or as regards negative consequences for the subjects that are interviewed; cases are cited of research
carried out on the effects of torture and on the psychological consequences for children of being
involved in illegal activity. Such conditions have been detected in North Korea and China.[38]
The exclusion of women from scientific research has also become a relevant subject for discussion. The
policy of the NIH and in other industrialised countries is to include women in research programmes –
exclusion would not seem to be justified on scientific grounds because through such an exclusion
important data for research could not be forthcoming.[39] Obviously, there remains the obligation to
exclude women who are expectant because of the risk to the foetus or women who are still fertile
because a pregnancy could take place during the experimentation. For this last eventuality, the
protocols often ask for ‘effective contraception’ to be used in order to keep the woman within the trial.
On this point, the Catholic position is opposed to this binding clause and asks for it to be replaced in
experimentation programmes by a formula that does not impose contraception, but, keeping the
obligation to avoid conception, leaves open the possibility of access to methods that involve abstinence
or natural methods.[40]
The use of animals is generally allowed by the regulatory practices of experimentation despite the
increasingly strong opposition of extreme animalist groups. In many cases, the progress of medicine
and surgery could not be hoped for without experimentation on animals. One need only think here of
the advances in transplant surgery.[41] This subject involves the position of man in the universe of
living things and the irreconcilability of the anthropocentric position, even in its moderate and
218 Christian version, with biologistic theories that deny the ontological and axiological difference between
man and animals or uphold the equal rights of men and animals.[42] Obviously, the rules and
regulations that govern experimentation on animals envisage the avoidance of unnecessary suffering
(anaesthesia) and other norms that refer to the keeping of the animal of the experiment.
Side by side with the policies of control expressed in the codes and by committees, the literature on the
subject has also registered the efforts made to inculcate an ideal of the researcher and to form a sort of
summa of his or her essential capacities and qualities - what Bompiani calls the ‘ethos of the
researcher’.[43]
It has been Marton above all else who has proposed the ideal paradigm of the researcher.[44] This
author lists some of the qualities specific to the researcher or researchers in order, more than anything
else, to guarantee the validity of their research: communism (sharing the results); disinterestedness (as
regards non-cognitive motivations); universalism (in assessing the results that have been achieved); and
organised scepticism (organised scepticism as a method. These qualities are summed up in the acronym
CUDOS, which for some should have also included originality (the replacement of organised
scepticism by originality); others have also added humility and recognition(of other’s people’s merits),
arriving thereby at the acronym CUDOSUR.
On the other hand, as Bompiani observes, these features of ‘extrinsic’ ethics are increasingly influenced
from close quarters by the needs of basic research and the intervention of private business, as a result of
which CUDOSHR is often replaced with another acronym, PLACE: research also becomes private
(reserved), local (circumscribed), authoritative (supported by the authority of the researcher), and
commissioned and expert (entrusted to groups recognised as such)[45]. To the evident inadequacies
and equally evident generic character of these requirements, other authors have added further
formulations. One of these authors is Cannavò,[46] who has proposed a further acronym, namely
SHIPS, in order to indicate new research requirements connected with the need for research to be
strategic, innovative, public and sceptical.
From what has been discerned from this angle, one can see that this type of reflection on the qualities
of a researcher or of an investigating business firm, although it has useful descriptive connotations,
cannot establish research ethics either. This is because a valid epistemology and a complete
anthropology are absent from its base.
THE ETHICAL LIMITS OF REGULATORY CODES FROM AN ETHICAL PERSPECTIVE
Bearing in mind the requirements made by the philosophy of sciences[47] and of the Magisterium of
the Church, and although recognising the effort and the positive results achieved in the drawing up of
deontological codes, in the definition of the tasks of ethical committees and the drawing up of an ideal
profile for the researcher there is required, in my opinion, a more complete epistemological reflection
on the relations between experimental science and ethics, and at the same time a more explicit
reference is required to an anthropology that gives substantial meaning to the frequent appeal to the
‘dignity of the person’.
As regards the relationship between experimental research in the biomedical field and ethics, we should
bear in mind that the experimental method is by its very structure of a ‘reductionist’ character. This
means that what is experimentally assessable is the biological or biochemical or physical datum
concerning determined processes written into corporeity, and this obviously within the order of the
quantifiable. The experiment cannot tell us anything about the ontological nature of the subject and the
ethical value of a biomedical intervention. The truth of an experimental scientific source must,
therefore, be integrated in a dual sense: first of all it must be integrated with other truths of a physical,
biological character, always staying within the realm of science. This takes place in a process of
circular integration, but above all else it has to be referred to global ontological truth (when one is
219 dealing with man reference must be made to anthropology) so that one can, as a result, assess the
ethical dimension of interventions. This latter is a procedure that may be defined as triangular
integration.[48] From an epistemological point of view, it is not possible to move directly from
empirical observation, or scientific-experimental observation, to ethical conclusions, taking into
account in this sense the well-known ‘Hume’s law’, according to which one cannot infer an analysis of
values from facts.[49] This is also emphasised by modern epistemologists. I would like to cite from
them all, D. Antiseri, who states: ‘science cannot (logically) produce ethics. From descriptive
propositions it is not possible to deduce prescriptive assertions. The great division between facts and
values – the so-called Hume’s law – tells us that ‘ought’ does not derive from ‘is’; that ‘ought to be’
does not derive from being. The whole of the value of science, the whole of scientific knowledge
cannot produce values; nor can it deny them’.[50]
To argue that ethics can come from science would produce at the most a reduction of ethics to the
simple duty ‘to know more always’ or to a ‘function of intrinsic ethics’, which would become concrete
only in obligations to engage in scrupulousness, altruism, and truthful communication, which do not
constitute all of the ethics involved in scientific research because it is always possible to carry out
scrupulous research that is not ethically correct.
If, for example, one wants to investigate the ethical acceptability of in vitro fertilisation applied to man,
one has first of all to make clear what this consists of, in what ways it is different from natural
fertilisation, what its effect are (the corner ‘A’ of the triangle). It will then be necessary to ask what
meaning this procreation technology involves for the dignity of man, that is to say for the life and
dignity of the embryo, for the dignity of the parents, and the very dignity of the procreative act (corner
‘B’ of the triangle, the top) and only then can one have valid data with which to pose the ethical
problem and can one raise the question of compromised or compatible values (corner ‘C’).
For that matter, we know that knowledge of reality cannot be understood as being homologous – it is
analogical. The specific knowledge of the experimental sciences is one thing. The specific knowledge
of the so-called human sciences (such as philosophy and metaphysics which are concerned with the
ontological structure of being and can be achieved only through philosophical reflection) is another.
Yet another is ethical knowledge, which is to do with the correspondence of forms of behaviour with
the good of man. If, then, as is specific to the Christian faith, we want to draw upon the light of
Revelation, from this source there reverberates a whole new dimension of knowledge about reality
investigated by natural reason, whether of a scientific, philosophical or ethical kind, because human
reality (its dignity) is connected with the very dignity of the Creator and with the work of supernatural
salvation. The insufficiency of the scientistic vision and the need for the contribution of reason, as well
as of the vision of faith, are clearly illustrated in the encyclical Fides et Ratio,
Speaking about the threat of ‘scientism’, John Paul II states in his encyclical Fides et Ratio: ‘This is the
philosophical notion which refuses to admit the validity of forms of knowledge other than those of the
positive sciences; and it relegates religious, theological, ethical and aesthetic knowledge to the realm of
mere fantasy’.[51] In discussing the approach to ethical values specific to scientism he adds that it
‘dismisses values as mere products of the emotions and rejects the notion of being in order to clear the
way for pure and simple facticity. Science would thus be poised to dominate all aspects of human life
trough technological progress. The undeniable triumphs of scientific research and contemporary
technology have helped to propagate a scientistic outlook, which now seems boundless, given its
inroads into different cultures and the radical changes it has brought’.[52]
We have followed with care the creation of deontological and ethical codes on research but we cannot
deny that at certain points, which are not of secondary importance for the dignity and the lives of
human beings, scientistic thought has overwhelmed and marginalised a consideration of
anthropological and ethical value. One may think of the fact that the Council of Europe in its
‘Convention on Human Rights and Biomedicine’, at article 18, prohibits (paragraph ‘a’) the production
of embryos with the sole aim of experimentation but in point ‘b’ tolerates the fact that certain states
220 which have already allowed such experimentation can continue it, albeit under an ineffective and
dissimulating ‘protection’ of the embryo by the law itself. The deontological codes have neither
prevented nor outlawed experimentation in the preparation of contragestion techniques (such as the RU
486) or interception techniques (the day after pill), or involved the prohibition of mechanical abortion
techniques or intrauterine methods. We know, in addition, that the UNESCO ‘Declaration on the
Human Genome and Human Rights’ does not clarify whether the prohibitions on the altering of the
genome or of discrimination in relation to individuals on the basis of their genetic characteristics are
also applicable to the embryo or are confined only to the already born subject: at base an anthropology
is absent. Following the prevalent influence of scientism the result is that: ‘since it leaves no space for
the critique offered by ethical judgement, the scientistic mentality has succeeded in leading many to
think that if something is technically possible it is therefore morally admissible’.[53]
It is not unusual to encounter a pragmatic vision in the ethical solutions that are adopted in the sphere
of bioethics which has become the principal guiding criterion. Pragmatism, as Fides et Ratio observes,
is ‘an attitude of mind which, in making its choices, precludes theoretical considerations or judgements
based on ethical principles.’
The result of this scientistic reductionism and of pragmatism is that ‘anthropology itself is severely
compromised by a one-dimensional vision of the human being, a vision which excludes the great
ethical dilemmas and the existential analyses of the meaning of suffering and sacrifice, of life and
death.’[54] Even when one speaks about medical anthropology or the anthropological sciences one
remains within the framework of description and ‘a more general conception which appears today as
the common framework of many philosophies which have rejected the meaningfulness of being’. John
Paul II then goes on to make clear: ‘I am referring to the nihilist interpretation, which is at once the
denial of all foundations and the negation of all objective truth’.[55]
Without repeating observations made in other papers, one cannot but observe that the whole of the
process involving the declassification of the human embryo - as a result of which there is legalisation
underway involving its suppression and destructive experimentation, as well as research on human
embryonic stem cells and so-called ‘therapeutic’ cloning - betrays a lack of an underlying anthropology
and in particular a lack of ontology in the field of how the human person is understood.
For this reason, a real regulatory policy regarding research on man cannot be held in conformity with
respect for ‘human dignity’ unless a valid approach is made to epistemological analysis and the
philosophical anthropology of reference. This is the task of bioethics when this discipline wants to take
man to heart in his truth and wants to follow a pathway which can be reconciled – at the least– with the
theology and the morality of the Catholic Church: to clarify to the utmost the problem of the encounter
between experimental scientific knowledge and philosophical and ethical knowledge and restore
fullness of dignity to man from his conception to his death.
In the address he gave on the occasion of the plenary session of the Pontifical Academy of Sciences (13
Nov. 2000), John Paul explored what he called the ‘triple meaning’ of the ‘humanistic dimension of
science’. He declared: ‘when one speaks about the humanistic dimension of science, thought is directed
for the most part to the ethical responsibility of scientific research because of its consequences for man.
The problem is real and has given rise to constant concern on the part of the Magisterium of the
Church, especially during the second part of the twentieth century. But it is clear that it would be
reductive to limit reflection on the humanistic dimension of sciences to a mere reference to this
concern. This could even lead some people to fear that a kind of ‘humanistic control of science’ is
being envisaged, almost as though, on the assumption that there is a dialectical tension between these
two spheres of knowledge, it was the task of the humanistic disciplines to guide and orientate in an
external way the aspirations and the results of the natural sciences, directed as they are towards the
planning of ever new research and extending its practical application’.[56]
The Supreme Pontiff went on to add that ‘from another point of view, analysis of the anthropological
dimension of science raises above all else a precise set of epistemological questions and issues. That is
221 to say, one wants to emphasise that the observer is always involved in the object that is observed’. The
point of view adopted by the observer and ‘the particular philosophical approach adopted by the
scientist can influence in a significant way the description of the cosmos’.[57]
As regards the third meaning of this phrase, the Pope stated: ‘lastly, reference is made to ‘humanism in
science’ or ‘scientific humanism’ in order to emphasise the importance of an integrated and complete
culture capable of overcoming the separation of the humanistic disciplines and the experimentalscientific disciplines. If this separation is certainly advantageous at the analytical and methodological
stage of any given research, it is rather less justified and not without dangers at the stage of synthesis,
when the subject asks himself about the deepest motivations of his doing research’ and about the
‘human’ consequences of the newly acquired knowledge’.[58]
The freedom and the autonomy of the scientist are not threatened by the anthropological vision because
choice is enlightened by values; values are not extraneous to freedom: the whole man should take
responsibility for his fellow man and he works by choosing the best of what is available with in view
the good of his fellow man.
From this point of view, reference may be made to the autonomy and the responsibility of the scientist.
As I observed in a previous publication, sharing in large measure the thought of Agazzi and
Pellegrino,[59] there exist three levels and modalities where one can speak about the autonomy of
science and the scientist:
a) The first level lies in the fact that every science has its specific sphere or field of reflection; in
addition, it has its methodology of research; and lastly it has its own criteria of validation. A criterion
that is valid from an economic point of view may not be equally valid in political or moral terms.
Interrupting the therapies provided to a cancer patient can be held to be economically advantageous,
but it could not be advantageous from an ethical point of view.
In this sense, the autonomy of the individual sciences should in all cases be seen as legitimate: Vatican
Council II also recognised that in their own specific sphere the sciences and the arts employ their own
principles and their own method – in this sense every science legitimately enjoys its own autonomy,
which is relative because it is always called to enter into dialogue with other branches of
knowledge.[60]
b) There is another meaning in which reference is made to the autonomy of science and of research:
this meaning is proposed in the context of scientism – here the meaning is that research and science are
‘value free’. Reference is made to freedom from values and from controls, and to freedom in making
choices. Some people argue in favour of the need for the autonomy of values and controls but not as
regards actions where the legitimacy of intervention by society is acknowledged;[61] others also
recognise the need for controls, but only with reference to public health.
In the context of biomedical research – and in particular one may think of genetic research – this kind
of autonomy from ethical judgement, and even more from the control of the law and in the carrying out
of projects, is not sustainable. Above all else, research in the biomedical and biotechnological field can
have dimensions and consequences of a planetary nature. In this field the essay by Jones and his appeal
to the principle of responsibility conserve all their force.[62]
c) There is a third way of conceiving the autonomy of science, understood above all as the autonomy of
the scientist, and it is that in which the researcher freely and responsibly assumes responsibility for the
ends, the means, the methods, and the consequences of a given research programme. This model is able
to join together scientific knowledge and moral knowledge, and also to join together freedom and
responsibility. This model assumes that the scientist is aware of the moral values in play, regulates
himself accordingly and with consistency, and knows, if the occasion arises, how to enter into dialogue
with experts and ethical committees. The responsibility of the scientist is valid not only in the sector of
applied research where the consequences are more evident but also in basic research where ends, means
and methods must be made known to the members of the same team of co-workers who can, evidently
enough, advance conscientious objections in the face of procedures that are held be illicit.
222 Placing a researcher or a technician to work, for example, in a laboratory on stem cells, involves an
obligation on the part of the director to make clear their origins and their purpose so that the researcher
can freely and responsibly assume his own responsibilities.
A fact that is brought to people’s attention today is that applied research is often co-ordinated at a
multinational level and in a complex way. Two factors have been pointed out. Jonas speaks about the
‘expropriation of results’ in the sense that the results of the research, once they have been
communicated and acquired by business interests, can be applied in ways that the researcher did not
imagine at the time of the research and the communication of the results.[63] Hence the obligation to
engage in ethical formation on the part of researchers and their increased responsibility to avoid ending
up with a production line where the final product is used in a way contrary to their knowledge and the
good of man. Jonas says that we are like passengers getting onto a train – free to get off but not to stop
the train or change its destination.
Another factor to bear in mind is the relationship between research and political power in situations in
which political power finances great research projects where the set of results becomes anonymous and
modular: data banks and patents come to resemble safes and strongboxes on which the political power
can draw for a plan that is not intended by the researchers.
For this reason, the presence of controls at the level of application by scientists themselves and society,
both at a national and an international level, are justified and incumbent.
The harmonisation of the freedom and the responsibility of the scientist can thus be achieved: a)
respecting the legitimacy of every discipline; b) in a harmonious composition and integration of
branches of knowledge marked by the adoption of a correct epistemology and a complete
anthropology; and the acceptance of full responsibility by scientists both in relation to possible
applications and to the political power; and c) through the need for controls of an ethical nature which
can carried out not only on laboratories and when research protocols are approved but also on the
possible subsequent developments carried out by the public power or the economic power.
Research policy thus has duties in relation to the political authority itself, even when this latter finances
research projects. ‘Truth, freedom and responsibility are connected in the experience of the scientist. In
setting out on his path of research, he understands that he must tread not only with the impartiality
required by the objectivity of his method but also with the intellectual honesty, the responsibility, and I
would say with a kind of ‘reverence’, which befits the human spirit in its drawing near to the truth’.[64]
THE GLOBAL DIMENSION OF RESEARCH POLICY
A document of reference that is obligatory when analysing this part of the subject is the ‘Déclaration
sur la science et l’utilisation du savoir scientifique’, which was published at the end of the world
conference held in Budapest (Hungary) on 26 June-1 July 1999 on ‘la science pour le XXI siècle: un
nouvel engagement’.[65] The conference was organised by UNESCO and the International Council for
Sciences, and was followed by the drawing up of a plan of action.
We know that the proclamations contained in documents such as this run the risk of not being applied
at a concrete level given that that these organisms often do not have the practical support of the
countries that would most be involved in their conclusions. However, they are always a culturally
relevant fact and are able to construct, sooner or later, a point of reference, even where they
demonstrate limitations and a need for improvement.
After making this premise, the document referred to above offers, at the least, an enunciation of many
principles of a positive character for the guiding of scientific research policy at a global level.
First of all at the level of observation, the fact is confirmed that ‘le savoir scientifique a conduit à des
innovations remarquables qui ont étés très bénéfiques pour le gendre humain’. This is a reference to
discovery of cures for a large number of illnesses with a consequent increase in life expectancy; to the
223 increase in agricultural production which has allowed the growing food needs of populations in
different regions of the world to be met; and to technological progress and the use of new energy
sources with great industrial potential that allows a lightening of the heavy burdens of labour and a
facilitation of communication, and the intensification of relations, between men.[66]
From this observation, there emerges in this document the need for all nations to be able to be aware of
these benefits and for these resources to be at the service of the whole of mankind.[67]
On the other hand, in the light of negative facts where the abuse of science has been observed, the
Enlightenment and utopian concept by which every scientific advance should be seen as automatically
liberating and beneficial has been overtaken. It is recognised, in contrary fashion, that scientifictechnological progress has already provoked the degradation of the environment, runs the risk of
provoking catastrophes and further social imbalances, and has made possible the building of atomic,
chemical and biological weapons, as a result of which science today is called upon to convert many
military energies into instruments of peace and authentic progress.[68]
As a further premise, the principle is laid down of the need to establish a dialogue between the human
sciences and the experimental sciences in order to deal with the ethical, social and cultural problems
raised by scientific and technological progress, and at the same time to create a dialogue between
legislators, scientists and the public as a part of a democratic debate on the use of scientific
knowledge.[69]
Once again as a premise, the document condemns the reality of the unequal distribution of the
resources of science, because of the fact, as well, that because scientific discoveries are a factor in
producing wealth many poor countries are at the same time excluded from wealth and from the sources
of the creation of technological resources.
On the basis of these preliminary observations, the document offers a series of ‘consideranda’[70]
which bring out: the possible benefits to be derived from scientific research on society; the role of
scientific knowledge in the drawing up of political programmes; the need for access to scientific
knowledge to be a part of the right to education of every man and every woman for their growth and
development and in order to create an endogenous scientific capacity; the beneficial consequences for
research, the overcoming of poverty, and the progress of mankind; the process of globalisation of such
knowledge; the urgent need to fill the gap between developed countries and developing countries as
regards capacity for research and the infrastructures given to it. On the other hand, there is also an
emphasis on the need for policies of control over research and its applications because of the dangers
that can come from applications that are dangerous for the very survival of mankind. Consequently,
there is an emphasis on the need for reference to ethics and human rights. Lastly there is stress on the
urgent need for a new link between science and society in order to solve such urgent problems as
poverty, hunger, inadequacies as regards health, food and water insecurity, and population growth.[71]
With these premises and requests, the document proposes certain lines for a political programme:
a) The promotion of fundamental and applied research is essential for the ‘endogenous’ progress of
individual countries (the link between science, knowledge and progress). For this reason, governments
must recognise the fundamental role of scientific research in the acquisition of knowledge, the training
of scientists, and the education of the public. Research financed by private forces should be seen as
important but it cannot replace public research: the two sectors must act in co-operation with one
another and with long-term objectives.[72]
b) Scientific research is called to contribute to the building of peace and for this reason the principle of
free access to information and data must be guaranteed. In addition, scientific research must be subject
to ethical indications and the duty to inform the public. Furthermore, moral and intellectual solidarity,
which is the foundation of the culture of peace, must be fostered between scientists. ‘The collaboration
of the scientists of the whole world is a valuable contribution to global security and the development of
peaceful relations between nations, societies and cultures’. Governments must ensure that the sciences
224 and knowledge contribute to the promotion of human rights and to eliminating the causes of
conflicts.[73]
c) Special attention is paid by the document to defining the relationship between scientific research and
development: it reaffirms the duty to pursue lasting and sustainable development, in addition to the
protection of natural resources, biodiversity and the survival systems of the planet. It calls for a
commitment to eliminate discrimination and inequality between rich countries and developing
countries in matters of scientific knowledge and research, laying emphasis on the promotion of basic
scientific culture, the role of universities that respect moral values; it makes an appeal for international
co-operation in the sphere of scientific and technological research and refers to the need to avoid the
so-called ‘brain drain’ brought about by the negative conditions of research in certain countries; and
lastly it stresses the need for a national science policy and collaboration in the management of risks at
an international level as well. It refers to the need for a regulation on patents that does not impede the
access of developing countries to scientific knowledge and avoids new forms of monopoly.[74]
d) The document ends by reaffirming the references to ethical norms, to human rights, to the principle
of the free circulation of information, to the rigorous obligation to control the reliability of results and
obedience to the norms of ethics defined as ‘scientific’, and to equality in access to research for
women.[75]
Beyond these declarations promulgated by UNESCO, which make us understand the directions hoped
for in policies of research directed towards development (directions which tend to achieve a positive
effect in the phenomenon of globalisation), it is, however, advisable to see how some of the most
advanced and richest states perceive and understand the need to link research with global development.
Scientific and technological competitiveness are increasingly seen, within the context of globalisation,
as being a preliminary condition for economic competitiveness.For example, in the ‘Linee Guida del
Governo Italiano per Promuovere la Ricerca Scientifica’ (‘Guidelines of the Italian Government to
Promote Scientific Research’), the premise states that for 2003-2006: ‘the strong strengthening of our
structure of scientific and technological research and of our system of production appears as a vital
need of our economy to deal with the increasingly harsh competition, produced by the process of
globalisation, with the economies of developed countries and developing countries’[76] Bearing in
mind that scientific research includes not only biomedical research but also biotechnological research
in general, information technology and dwarftechnology,[77] there is a constant emphasis on the link
between research, productivity, economic competition and globalisation.
Within the framework of globalisation, industrialised countries are now engaging in profound revisions
of their scientific policies, as indeed emerges from the summary to be found in the above mentioned
document on Italian planning.[78]
It is said that the United States of America has recently redefined federal policy for 2003 in relation to
the research sector by deciding in favour of a substantial increase in resources (+ 8.5%) compared to
2002.
Over 50% of the record sum of $104 milliard is allocated to defence expenditure. About $24 milliard is
allocated to biomedical research – an increase of 15%, space research receives £15 milliard (an
increase of 4.5%), and energy resources are to receive $8 milliard – a rise of 5%.
It is also emphasised that all of the countries of the European Union put together allocate a sum equal
to one half of the USA to all research activities and that private investment in research in the United
States of America is markedly higher that its public counterpart.
In Great Britain, the Department of Trade and Industry, in its budgetary and planning document
‘Science and Innovation 2001’, defined the new strategic directions in the sector of research and
development, which are seen as of basic importance for the competitiveness of the country. In this
document, the areas of primary importance for action are identified: the strengthening of the great
infrastructures of research, basic technologies (dwarftechnology, photon studies, sensors, new
materials, etc.), aeronautics and space, and an increase in the number and quality of researchers.
225 Special emphasis is placed on the need for greater integration between public research and the
industrial use of the know-how that is generated by it through the fostering of processes of osmosis
between the various subjects and the birth of high-tech companies. An increase in expenditure of the
order of 7% a year is envisaged for the next three years.
With its ‘Budget civil de recherché e de developpement 2001’, France defined a programme based
upon four priorities: measures in favour of research staff with a relevant increase in funding; a major
strengthening of investments in research infrastructures (an increase of 18% compared to 2000); in
particular the development of advanced calculation centres (IDRIS) supported by technological
platforms (INRA); the strengthening of equipment and the creation of new ‘teams’ in the field of
epidemiology and research into forms of treatment (INSERY); the beginning of the building of the
third generation synchrotone light machine (SOLEIL); a major increase in investments (about 15%) in
scientific areas of priority importance: the genome, the post-genome, bio-information technology,
information technology, dwarftechnology and materials; and an increase of about 10% in the funding
of industrial research, with particular reference to partnership between the public and private sectors. In
this area, the sector of aeronautics is especially favoured, with an in increase of over 20%.
As can be observed, biomedical research is one of the many sectors of technological research and it is
placed within a context of economic competitiveness: this context has the ability to put the therapeutic
goals of biomedical research in the shade, to relegate it to a secondary position, and to involve an
increasing inequality between industrialised and developing countries.
THE TASKS OF THE CHURCH IN THE FIELD OF RESEARCH
I believe that the multifaceted task that emerges for the Church in the field of scientific research
escapes nobody’ attention.
a) It is first of all a task of ethical guidance. In the constitution Gaudium et Spes of Vatican Council II,
and in the more recent encyclical, Fides et Ratio, the Magisterium of the Church has already clarified,
on the one hand, her recognition of the autonomy of every science, and on the other, her appeal on
behalf of the centrality of man both as a responsible subject and as the end and the beneficiary of
research itself. If the Magisterium of the Church has laid emphasis on the need to overcome
‘scientism’, this has not been in order to deny the possibility of scientific research and the autonomy of
the spheres, the methods and the internal criteria of each science, but to enrich scientific research itself
by favouring an opening up to an overall vision of man and the pursuit of his good for every man and
all men.[79]
b) In order to carry out her mission, the Church herself at times trusts and appeals to the indispensable
contribution of scientists and scientific research. We may recall the appeal ‘to men of thought and
science’ made at the end of Vatican Council II: ‘We cannot not meet you. Your road is our road. Your
paths are never extraneous to ours’[80]
We also recall the explicit request for collaboration made to researchers in Humanae Vitae in order to
overcome the difficulties of marriage partners in relation to the solution of the problem of the
regulation of fertility, a problem that today is also raised for research addressed to overcoming the
causes of infertility.[81]
We also remember the appeal to men of culture that the Holy Father John Paul II placed at the end of
his encyclical Evangelium Vitae, including in this appeal the creation of the PontificalAcademy for
Life,[82] specifically for the defence of human life.
I believe that one of the urgent tasks of the ‘laity’ within the Church is specifically to be located in this
sphere of science and research, pertinent to temporal realities but linked to the overall promotion of
man and thus to the Kingdom of God as well.
226 c) We must ask ourselves today whether the Church, understood above all as a community that
appreciates the specific mission of the laity, should feel herself directly committed to the promotion of
scientific research through her initiatives, above all on those frontiers where the future of man is at
stake, man in a condition of ‘emergency’ because of the ethical consequences of research or because of
the conditions of inferiority of populations without the resources of science and the premises for its
specific development. On this point, one cannot ignore the appeal made by John Paul II in his
encyclical letter Novo Millennio Ineunte, where he refers to those who take advantage of the new
possibilities of science, especially in the terrain of the biotechnologies, calling on them not to disregard
the fundamental requirements of ethics.[83]
It is not difficult to observe that at times amongst believers it is easier to respond to an appeal to solve
the special immediate problems of poverty, of material need, or even for pastoral structures of an
educational character – something that is increasingly necessary in the life of the Church – whereas it is
difficult or very rare to obtain help for a strategy for the promotion of science or scientific research,
even when it has a close connection with questions connected with life.
Here I am easily led to refer to Catholic universities and to the scientific and medical faculties within
them, as well as the great institutes that worthily contribute to the progress of society. But everybody
knows that it is arduous for these universities, especially in some nations, to gain access to public
research funds, unless they are open to making compromises. This difficulty becomes closure in the
case of foundations and institutions that have aims in contrast with the Catholic vision of life. But also
as regards the Catholic world, the equipping of structures and their funding becomes very difficult
because of the economic costs involved.
This is the experience of many Catholic universities and many research institutions. For this reason, the
danger is brought about that Catholic scientific institutions themselves will become excessively
dependent on public funding, There is the risk that there will be, as a result, a dimming of the identities
of these institutions and of Catholic researchers attracted by forms of public dynamism and by the need
to search for funding.
Perhaps we need to create within the Catholic world real and authentic ‘foundations’ directed towards
‘qualified’ scientific research in order to guarantee the presence within the Catholic community of
research that is clearly open to the overall good of man and free from forms of dependency and
compromises that can attenuate or obfuscate commitment.
This commitment would not only work in favour of the creation and efficiency of the scientific
faculties of Catholic universities in the third world, in order to appreciate the resources of such
countries and guarantee the presence of authentic development, but could also be a presidium of
freedom for society itself. This is because where research faithful to the good of man and moral law is
guaranteed, not only the good of the Church is worked for but also that of the whole of mankind, as is
called for by the Apostolic Constitution addressed to Catholic universities, Ex Corde Ecclesiae,
published on 15 August 1990. In this document, the Supreme Pontiff observed that ‘without in any way
neglecting the acquisition of useful knowledge, a Catholic University is distinguished by its free search
for the whole truth about nature, man and God…It does this without fear but rather with enthusiasm,
dedicating itself to every path of knowledge, aware of being preceded by him who is ‘the Way, the
Truth, and the Life’.[84]
Defining the nature and the objectives of Catholic universities, the Supreme Pontiff stated in the same
document: ‘A Catholic University, therefore, is a place of research, where scholars scrutinize reality
with the methods proper to each academic discipline, and so contribute to the treasury of human
knowledge. Each individual discipline is studied in a systematic manner; moreover, the various
disciplines are brought into dialogue for their mutual enhancement…In a Catholic University, research
necessarily includes (a) the search for an integration of knowledge, (b) a dialogue between faith and
reason, (c) an ethical concern, and (d) a theological perspective.’[85]
227 Perhaps the appeal already referred to made by Vatican Council II to ‘men of thought and science’ is
still of contemporary relevance, where the Council Fathers in addressing these men declared: ‘trust
faith, this great friend of intelligence. Turn to its light to achieve truth, the whole of the truth! This is
the wish, the encouragement, the hope that the fathers of the whole world, gathered together in Council
in Rome, express to you before leaving each other’.[86]
With a realistic awareness of how commitment to research is today located by policies in close
connection with productivity and economic competition between states in a context of increasing
globalisation, the voice and the role of the Catholic community should be directed to ensuring that a
dual link remains alive: between scientific research and the health of people and populations (even
whereimmediate economic profits do not exist), and between scientific research and the promotion of
economies and the research organisations themselves which are a part of developing countries, in
harmony with the requests for justice at an international level. In his encyclical Sollecitudo rei socialis,
John Paul II, referring to the encyclical of Paul IV, Populorum Progressio issued twenty years
previously, observed: ‘Therefore political leaders, and citizens of rich countries considered as
individuals, especially if they are Christians, have the moral obligation, according to the degree of each
one's responsibility, to take into consideration, in personal decisions and decisions of government, this
relationship of universality, this interdependence which exists between their conduct and the poverty
and underdevelopment of so many millions of people. Pope Paul's Encyclical translates more
succinctly the moral obligation as the ‘duty of solidarity’; and this affirmation, even though many
situations have changed in the world, has the same force and validity today as when it was written.[87]
It seems to me useful, lastly, to recall a passage from the address of Pope John Paul II to UNESCO
given on 2 June 1980: ‘It is essential to convince ourselves of the prior importance of the ethical over
the technical, of the primacy of man over things, of the superiority of the spirit over matter. The cause
of man will be served only if knowledge is united with conscience: the men of science will really help
mankind only if they conserve a sense of the transcendence of man over the world of God over
man’.[88]
1. From C.H. Weijer, ‘Research Methods and Policies’, in Encyclopedia of Applied Ethics, vol. 3
(Academic Press, San Diego California, 1988), pp. 853-860.
2. Idem, pp. 853-854.
3. This classification is based upon the above study by Weijer, ‘Research Methods and Policies’, p.
855.
4. A. Bompiani, ‘Ricerca, Etica, Diritto e Ricerca biomedica’ in F. Compagnoni (ed.), Etica della vita ,
San Paolo, Alba, 1996: 267-307.
5. On this subject I refer to the following publications: P. M. Neil, The Ethics and Policies of Human
Experimentations (Cambridge University Press, Cambridge, 1993), pp. 1-182; C. R. McCarty, L. M.
Kopelman and C. Levine, ‘Research Policy’, in W. T. Reich (ed.), Encyclopedia of Bioethics (Simon
and Schuster, McMillan, New York, 1995), vol. 4, pp. 2285-2300.
6. C. R. McCarty, ‘Research Policy. General guidelines’, in Encyclopedia of Bioethics, p. 2285.
7. D. Resnik, ‘Setting Biomedical Research Priorities: Justice, Science and Public Participation’,
Kennedy Institute of Ethics Journal, 11 (June 2001), 181-205.
8. MCCARTY, Research policy…., p. 2285.
9. RESNIK, Setting Biomedical Research….
10. See the editorial in The Lancet, 2001, 358: 854-856, republished by Tempo Medico, 14 March
2002.
228 11. B.A. Brody, The Ethics of Biomedical Research. An International Perspective (Oxford University
Press, New York/Oxford, 1998), pp. 161-181.
12. P. Bisogno, ‘Evoluzione della politica scientifica’, in La politica scientifica italiana negli ultimi 40
anni: risorse, problemi, tendenze e rapporti internazionali (CNR, Rome, 1988).
13. UNESCO, Conférence Mondiale sur la science, Projet de Déclaration sur la Science et l’utilisation
du Savoir Scientifique, Budapest 3 juin 1999; A. Blanc-La Pierre, ‘Society in the Face of Scientific and
Technological Development: Risk, Decision, Responsability’, in Pontificiae Academiae Scientiarum,
Science and the Future of Mankind (Vatican City, Scripta Varia n . 99, 2001), pp. 189-200.
14. J. M. Maldamé, ‘The Progress of Science and the Messiame Ideal’, in Pontifical Academy of
Sciences, pp. 318-332.
15. C. H.McCarty, ‘Research Policy. General Guidelines’, in Encyclopedia of Bioethics, p.2286;
Brody, The Ethics of Biomedical Reseach. An International Perspective (Oxford University Press, New
York, 1998), pp. 161-212.
16. MCCARTY, Research policy…., p.2288.
17. CENSIS, Ricerca biotech in Italia: grandi aspettative, poche risorse nelle reti università-industria
(http://www.censis.it).
18. Comitato Nazionale per la Bioetica, Etica Sistema sanitario e risorse, Roma: Presidenza del
Consiglio dei Ministri- Dipartimento per l’Informazione e l’Editoria, 1998: 137-139.
19. Resnik, ‘Setting Biomedical Research Priorities: Justice, Science and Public Participation’,
Kennedy Institute of Ethics Journal, 11 (2001), 2, p.181.
20. SPAGNOLO A., MINACORI R., Farmacogenetica e Farmacogenomica: aspettative e questioni
etiche, Medicina e Morale 2002, 5: 819-866.
21. For an analysis of the significance and importance of informed consent see E. Sgreccia, Manuale di
Bioetica. I. Fondamenti ed etica biomedical, Vita e Pensiero, Milan, 1999, third edition), pp. 210-220.
22. J.D. Moreno and S. Lederer, Revising the History of Cold War Research Ethics, Kennedy Institute
of Ethics Journal, vol.6, n.3 (1996), 223-237.
23. B. Lo, E. Leslie, J. D. Wolf, and A. Berkley, ‘Conflict of Interest Policies for Investigators in
Clinical Trials’, NEJM, 30 November, 2000, 1616-1620.
24. Appeal of the journal Tempo Medico of 14 March 2002, which refers to a similar condemnation
signed by many directors of scientific journals and reproduced from The Lancet, 2001, 358: 854-856.
25. M. Schooyans, L’avortement: Enjeu Politique (Lou guenil, Quebe, 1990), Italian edition: Aborto e
politica (Vatican City, 1992); Bioétique et population(Fayard, Paris, 1994) ; L’évangile face au
desordre mondial (Fayard, Paris 1997). For the conference of Cairo see Medicina e Morale 1994, 5,
979-1027, in which the speeches of John Paul II are also printed.
26. J.A. Robertson, ‘Ethics and policy in embrionic stem cell research’, Kennedy Institute of Ethics
Journal, vol.9, n.2, 109-136; S. Krimsky and R. Hubbard, ‘The Business of research’, Hasting Center
Report, 25, n.1 (1995); 41-43. The authors discuss the controversial subjects of the debate on the
legitimacy of research in the sphere of IVF, pre-implantation genetic examinations, nuclear transplants
(cloning) and the engineering of the cells of the germinal line.
27. R.J. Lifton, I medici nazisti, (Rizzoli, Milan, 1988).
28. C. Weijer, Research methods and Policies, p.856; J.H. Jones, Bad Blood: the Tuskegee Syphilis
Experiment (New York, Free Press, 1993).
29. C. Weijer, ‘Research methods and Policies’, p.856.
30. Consiglio d’Europa, Comitato dei Ministri, Convenzione sui diritti dell’uomo e la biomedicina,
19.11.1996, Medicina e Morale, 1997, 1, 128-149.
31. Ibidem
32. UNESCO, Universal Declaration on the Human Genome and Human Rights. Déclaration
Universellé sur le genome humain et les droits de l’homme, 11.11.1997. See also A.G. Spagnolo and E.
Sgreccia (eds.), Lineamenti di etica della sperimentazione.
229 33. E. Sgreccia, Manuale di Bioetica, I (Vita e Pensiero, Milan, 1999), pp.235-289, which has a
detailed bibiography; A.G. Spagnolo, A.A. Bignamini and A. De Franciscis, ‘I comitati di etica fra
linee guida dell’Unione Europea e decreti ministeriali’, Medicina e Morale, 1997, 6: 1059-1097. The
thought of the Church on the subject of experimentation on man is to be found in many addresses of
Pius XII and John Paul II. The main ones may be remembered: Pio XII, ‘Ai partecipanti al I Congresso
Internazionale di Ispatologia del Sistema Nervoso’ (14.9.52) in Discorsi e Radiomessagi, XIV
(Tipografia Poliglotta Vaticana, Vatican City, 1961), pp.317-330; ‘Discorso alla X-VI Sessione
dell’Ufficio Intenazionale di Documentazione di Medicina Militare’ (19.10.53), in Discorsi e
Radiomessagi, XI, (Tipografia Poliglotta Vaticana, Vatican City, 1969, pp.415-428; ‘Discorso ai
partecipanti all’VIII Assemblea dell’Associazione Medica Mondiale’. (30.9.54), in Discorsi e
Radiomessagi, XVII (Tipografia Poliglotta Vaticana, Vatican City,1969), pp.167-179; Giovanni Paolo
II, ‘Discorso ai partecipanti a due Congressi di Medicina e Chirugia’ (27.10.1980), in Insegnamenti di
Giovanni Paolo II, III, 2 (Libreria Editrice Vaticana, Vatican City, 1980), pp. 1005-1010; ‘Discorso alla
Pontificia Accademia delle Scienze ‘(23.10.1982), in Insegnamenti di Giovanni Paolo II (Libreria
Editrice Vaticana, Vatican City, 1982), pp.889-898; ‘Discorso ai partecipanti ad un convegno sulla
sperimentazione biologica promosso dalla Pontificia Accademia delle Scienze’ (23.10.1982), in
Insegnamenti di Giovanni Paolo II (Libreria Editrice Vaticana, Vatican City, 1982), pp.898-893; ‘
Discorso ai partecipanti al I° Convegno Medico Internazionale promosso dal Movimento per la Vita’
(3.12.1982), Insegnamenti di Giovanni Paolo II, vol. V/3 (Libreria Editrice Vaticana, Vatican City,
1982, pp. 1509-1513;‘Ai partecipanti ad un corso di studio sulle “pre-leucemie umane”’ (15.11.1985),
in Insegnamenti di Giovanni Paolo II, VIII/2 (Libreria Editrice Vaticana, Vatican City,1985,
pp.1265ss;‘Ai partecipanti ad un congresso sul cancro’ (24.6.1986) inInsegnamenti di Giovanni Paolo
II,IX, I (Libreria Editrice Vaticana Vatican City, 1986, pp.1052-1053; ‘Ad una conferenza sui farmaci
svoltasi nell’Aula del Sinodo’ (24.10.1986) in Insegnamenti di Giovanni Paolo II, IX/2 (Libreria
Editrice Vaticana, Vatican City 1986), pp. 1183ss.; ‘A scienziati e operatori sanitari’ (12.11.1987) in
Insegnamenti di Giovanni Paolo II, X/2 (Libreria Editrice Vaticana, Vatican City, 1987), pp. 10861087; John Paul II Encyclical LetterEvangelium Vitae (25.3.1995) (Libreria Editrice Vaticana, Vatican
City, 1995), part III; Congregation for the Doctrine of the Faith, Istruzione Donum Vitae (22.2.1987).
34. C. Weijer, ‘Research Methods and Policies’, p. 858.
35. Ibid., p. 859.
36. AUSTRALIA NATIONAL HEALTH AND MEDICAL RESEARCH COUNCIL, Guidelines on
Ethical matters in Aboriginal and Torres Strait Islander Health Research (1991).
37. I am referring here to the Declaration on the Human Genome of UNESCO and to the Convention
on Human Rights and Biomedicine of the Council of Europe cited above (notes 32 and 33).
38. C. BEYRER and N.E. Kass, ‘Human Rights, Politics and Reviews of Research Ethics’, The Lancet,
360, 20 July 2002.
39. C. Levine, ‘Research Policy’, in Encyclopedia of Bioethics, p. 2289.
40. COMITATO ETICO DELLA UNIVERSITÀ CATTOLICA, Raccomandazioni riguardo alla
inclusione delle donne in età fertile nei protocolli di sperimentazione clinica, Medicina e Morale 1996,
4: 793-796.
41. E. Manni, ‘Sperimentazione sull’animale’, Medicina e Morale, 1989, 6, pp. 1057ff.
42. S. Castignone (ed.), I diritti degli animali’ (Il Mulino, Bologna, 1985); L. Ciccone, ‘L’animale ben
creato e bene per l’uomo. Aspetti bioetici della sperimentazione sull’animale’, Medicina e Morale,
1989, 6, pp. 1095ss. See also E. Sgreccia and B. Fisso Etica dell’ambiente, extract from Medicina e
Morale, 1996, I, II..
43. A. Bompiani, ‘Ricerca etica, diritto e ricerca biomedica’, in F.Compagnoni (ed.), Etica della vita (S.
Paolo, Alba, 1996), pp. 267-307.
44. Cf. BOMPIANI, Ricerca etica…, p.275.
45. Ibid., pp. 275-276.
230 46. L. Cannavò, ‘La scienza fra collettivizzazione e privatizzazione’, in G. Statera and L. Cannavò
(eds.), Sociologia della scienza e politiche della ricerca (1987), cited by A. Bompiani, op. cit., p.276,
note 5.
47. E. Agazzi, Il bene, il male, la scienza (Rusconi, Milan, 1992); D. Antiseri, Filosofia della scienza e
problemi etici (Borla, Rome, 1993); C.S.J. Huber, ‘Limiti della validità delpensiero scientifico’, in
A.G. Spagnolo and E. Sgreccia (eds.), Lineamenti di etica della sperimentazione clinica (Vita e
Pensiero, Milan, 1994), pp. 29-39; J. Ladriere, I rischi della razionalità(SEI Turin, 1978); WillebrodWelten, ‘Sessant’anni difilosofia della scienza’, in A.G. Spagnolo and E. Sgreccia (eds.), op. cit.,pp.
21-29.
48. E. Sgreccia, ‘Pontenzialità e limiti del progresso scientifico e tecnologico’, Dolentium Hominum,
1988, 37(1), 137-144; Manuale di Bioetica, vol. I (Vita e Pensiero, Milan, 1999), pp. 40-47.In relation
to the subject of scientific ‘truth’, epistemologically speaking one has to make a distinction between the
‘objectivity’ of the data and the scientific ‘truth’ which is the outcome of the interpretation of that data.
I do not want to address here the question of ‘evidence’ and ‘evidence based medicine’, in which today
not everyone is prepared to believe, giving increasing space to the researcher and also to the continuous
growth in knowledge. But none of all this removes scientific value, which can always be improved and
falsified by the biomedical sciences.
49. D. Hume, A Treatise upon Human Nature, Italian edition: Lecandano, Trattato sulla natura umana,
libro III, parte 1, in Opere Filosofiche, vol. I (Rome/Bari, 1995), pp. 496-7.
50. Quoted by A. Bompiani, op. cit., p. 291.
51. John Paul II, Encyclical Letter Fides et Ratio, 14.9.1998, (Libreria Editrice Vaticana, Vatican City,
1999), n.88, p. 129.
52. Ibidem, n. 88, pp. 129-30.
53. Ibidem, n. 88, p 130.
54. Ibidem, n. 89, p. 131.
55. Ibidem, n. 90, p.131.
56. John Paul II, ‘Discorso tenuto in occasione della Sessione Plenaria della Pontificia Accademia delle
Scienze’, L’Osservatore Romano, 14 Nov. 2000.
57. Ibidem.
58. Ibidem.
59. E. Sgreccia, ‘Autonomia e responsabilità della scienza’, in A.G. Spagnolo and E. Sgreccia(eds.),
Lineamenti di etica della sperimentazione clinic (Vita e Pensiero, Milan, 1994), pp.39-50; E.
Agazzi,‘Autonomia e responsabilità della scienza’, in P. Cattorini(ed.), Scienza ed etica nella centralità
dell’uomo (F.Angeli Editore, Milan, 1990); E. Pellegrino, ‘Autonomia scientifica e responsabilità
morale’ in P. Cattorini (ed.)., Scienza ed etica,pp. 173-188.
60.Vatican Council II, Costitution Gaudium et Spes, n. 59, A.A.S.........
61. R. Dulbecco, Ingegneri della vita (Mondadori, Milan, 1989).
62. H. Jonas, Il principio responsabilità (Einaudi, Turin, 1999).
63. E. Sgreccia, ‘Autonomia e responsabilità della scienza’, p.45
64. John Paul II, ‘Discorso tenuto in occasione della Sessione Plenaria della Pontificia Accademia delle
Scienze’.
65. Document proposed at the end of the Conference of Budapest (2-3 June 1999) and approved by the
assembly of UNESCO in Paris on 26 October-17 November 1999. The text of this document is
reproduced in the appendix to this paper.
66. Ibidem, n.2 of the preamble.
67. Ibidem n.1 of the preamble.
68. Ibidem n.3 of the preamble.
69. Ibidem, n.4 of the preamble.
70. Ibidem, nn 7-22.
231 71. Ibidem, n.24.
72. Ibidem, nn.26-27.
73. Ibidem, nn 28-29.
74. Ibidem, nn. 30-35.
75. Ibidem, nn. 36-42.
76. G. Possa, Promuovere la ricerca scientifica e tecnologica per accelerare lo sviluppo del Paese:
Linee Guida della Ricerca (“Atenei” Le Mounier, Florence, 2001).
77. Reference is made to biosciences, dwarfsciences and infosciences: Ibidem, p.22.
78. Ibidem, pp.109-110
79. John Paul II, Encyclical Letter Fides et Ratio, nn. 88-90.
80. Vatican Council II, ‘Messaggi L’heure de départ ad alcune categorie di persone’, 8.12.1965, AAS.,
pp. 8-18.
81. Paul VI, Lettera Enciclica Huanae Vitae, 25.7.1968, n.24, AAS. 60 (1968), pp. 401-503.
82. John Paul II, Encyclical Letter Evangelium Vitae, 25.3.1995 (Libreria Editrice Vaticana, Vatican
City, 1995), pp. 137-8: ‘A special task falls to Catholic intellectuals, who are called to be present and
active in the leading centres where culture is formed, in schools and universities, in place of scientific
and technological research, of artistic creativity and of the study of man’. All this is intended ‘to build a
new culture of human life’.
83. John Paul II, Encyclical Letter Novo Millennio Ineunte at the end of the Great Jubilee of the Year
2000, n. 51: ‘A special commitment is needed with regard to certain aspects of the Gospel’s radical
message which are often less well understood, even to the point of making the Church’s presence
unpopular, but which nevertheless must be a part of her mission of charity. I am speaking of the duty to
be committed to respect for the life of every human being, from conception until natural death.
Likewise, the service of humanity leads us to insist, in season and out of season, that those using the
latest advances of sciences, especially in the field of biotechnology, must never disregard fundamental
ethical requirements by invoking a questionable solidarity which eventually leads to discriminating
between one life and another and ignoring the dignity which belongs to every human being. For
Christian witness to be effective, especially in these delicate and controversial areas, it is important that
special efforts be made to explain properly the reasons for the Church’s position, stressing that it is not
a case of imposing on non-believers a vision based on faith, but of interpreting and defending the
values rooted in the very nature of the human person. In this way charity will necessarily become
service to culture, politics, the economy and the family, so that the fundamental principles upon which
depend the destiny of human beings and the future of civilisation will be everywhere respected’.
84. John PaulII, Costituzione Apostolica Ex corde Ecclesiae, 15 agosto 1990 AAS 82 (1990), 14751509, n. 4
85. Ibidem,n. 15.
86. Vatican Council II, Messaggi.
87. John Paul II, Apostolic Letter, Sollecitudo Rei Socialis 30. 12. 1997 (Pauline Books & Media,
Boston MA, 1999), n. 9, p. 17.
88. John Paul II, ‘Allocuzione all’UNESCO’, 2.6.1980, AAS, 72(1980) 750, n. 22;‘Allocuzione alla
Pontificia Accademia delle Scienze’, 10.11.1979, Insegnamenti di Giovanni Paolo II, II, 2 (1979) p.
1109.
232 Final Communiqué
1. The IX General Assembly of the Pontifical Academy for Life took place at the Vatican from 24-26
February. This year it was dedicated to a crucial theme that has a strong social impact, "Ethics of
Biomedical Research. For a Christian Vision".
It is evident that, especially in the recent decades, biomedicine has developed in an extraordinary way,
helped by the enormous progress in technology and computer science that have vastly extended the
possibilities for experimentation on living beings and, especially on the human being. There have been
tremendous breakthroughs, for example, in the fields of genetics, molecular biology, as well as in
transplants and the neurological sciences.
Today more than ever, among the factors that contributed to this development, certainly biomedical
research has been instrumental in the progress of knowledge in this sector of medicine, as the Holy
Father himself recently pointed out: "It is a recognized fact that improvements in the medical treatment
of disease primarily depend on progress in research" (John Paul II, Address to participants at the IX
General Assembly of the Pontifical Academy for Life, 24 February 2003, n. 2; published in
"L'Osservatore Romano", Engl. edit., 5 March 2003, p. 4).
2. In the present setting, every new discovery in biomedicine seems destined to produce a "cascade"
effect, opening up many new prospects and possibilities for the diagnosis and treatment of numerous
pathologies that are still incurable.
Obviously, the acquisition of a growing technical possibility of intervention on human beings, on other
living beings and on the environment, and the attainment of ever more decisive and permanent effects,
obviously demands that scientists and society as a whole assume an ever greater responsibility in
proportion to the power of intervention. It follows that the experimental sciences, and biomedicine
itself, as "instruments" in human hands, are not complete in themselves, but must be directed to defined
ends and put in dialogue with the world of values.
3. The primary agent of this continuous process of "ethical orientation" is, unmistakeably, the human
person. Indivisible unity of body and soul, the human being is characterized by his capacity to choose
in freedom and responsibility the goal of his own actions and the means to achieve it. His burning
desire to seek the truth, that belongs to his nature and his specific vocation, finds an indispensable help
in the Truth itself, God, who comes to meet the needs of the human being and reveals to him his Face
through creation, and more directly, through Revelation. Thus God favours and supports the efforts of
human reason, and enables the human being to recognize so many "seeds of truth" present in reality,
and finally, to enter into communion with the Truth itself which He is.
In principle, therefore, there are no ethical limits to the knowledge of the truth, that is, there are no
"barriers" beyond which the human person is forbidden to apply his cognitive energy: the Holy Father
has wisely defined the human being as "the one who seeks the truth" (Fides et ratio, n. 28); but, on the
other hand, precise ethical limits are set out for the manner the human being in search of the truth
should act, since "what is technically possible is not for that very reason morally admissible"
(Congregation for the Doctrine of the Faith, Donum Vitae, n. 4). It is therefore the ethical dimension of
the human person, which he applies concretely through the judgements of his moral conscience, that
connotes the existential goodness of his life.
4. In the commitment to research and to recognize the objective truth in every creature, a particularly
important role falls to scientists in the area of biomedicine, who are called to work for the well-being
233 and health of human beings; the ultimate aim of every research activity in this field must be the integral
good of man. The means used, must fully respect every person's inalienable dignity as a person, his
right to life and his substantial physical integrity.
Against any false accusation or misunderstanding, let us repeat in communion with the Pope, John Paul
II, that: "The Church respects and supports scientific research when it has a genuinely human
orientation, avoiding any form of instrumentalization or destruction of the human being and keeping
itself free from the slavery of political and economic interests" (John Paul II, Address to participants...,
n. 4).
In this perspective, one must express the greatest possible gratitude to the thousands of doctors and
researchers of the whole world who, generously and with great professionality, dedicate their energies
every day to the service of the suffering and the treatment of pathologies. Further, the Pope recalled
that: "All, believers and non-believers, acknowledge and express sincere support for these efforts in
biomedical science that are not only designed to familiarize us with the marvels of the human body, but
also to encourage worthy standards of health and life for the peoples of our planet" (John Paul II,
Address to participants..., n. 2).
5. For the reasons already mentioned, one can and must speak of an "ethics of biomedical research"
that, in fact, has been increasingly developed and expressed in the last 30 years. Christian thought too
has been able to make its important contribution to this development, bringing to the fore certain new
problems in the light of its original anthropological vision. Historically, at least two themes can be cited
as an example of the ethical attention the Christian community pays to the world of biomedical
research: the call for respect for the person when he/she is the subject of research, especially in the case
of experimentation that is not directly therapeutic; the emphasis on the close bond between science,
society and the individual, which is at stake in the entire process of research.
6. Thus, in elaborating an itinerary for biomedical research that will respect the true good of the human
person, it is necessary for the synergy of the different disciplines concerned to converge through an
integrative methodology, that will take into account the complex constitutive unity of the human being.
To this end, the proposal of the so-called "triangular method" seems to be appropriate. It is divided into
three stages: the exposition of the biomedical data; the examination of the consequences for the human
person and the discernment of the values this factor brings to the fore; the elaboration of the ethical
norms that can guide the work of those who are involved in a given situation, in accord with the
meanings and values that were previously identified.
7. Another theme of great importance in the context of biomedical research is certainly that of
therapeutic and non-therapeutic experimentation, considered from the perspective of its application to
the human being. It involves many problematic aspects, both of a scientific and ethical nature. It is
indispensable, for example, to demand a high professional standard from the researchers involved in
the experimental project, and to adopt a methodology that is rigorous in determining and applying
procedural criteria. Moreover, it is also ethically necessary that the person conducting the experiment,
with his collaborators, maintain total personal and professional independence with regard to possible
interests (financial, ideological, political, etc.) unrelated to the goal of the research, to the good of the
subjects involved and to the genuine progress of humanity.
8. Besides, we want to reaffirm the need to do sufficient experimentation on animals prior to the
clinical experimental phase (the application on human beings) that will enable researchers to acquire
advance knowledge of the possible harm and risks that this experimentation could have in order to
guarantee the safety of the human subjects involved. Naturally, experimentation on animals also has to
234 be carried out with the observance of precise ethical norms to safeguard, as far as possible, the wellbeing of the specimens used.
9. Special attention must also be paid to the treatment of human subjects who undergo research who are
especially "vulnerable" because of their state of life, as the example of human embryos clearly
illustrates. Because of the delicate stage of their development, possible experimentation on them in the
light of current technological possibilities would involve a very high - and therefore ethically
unacceptable - risk of causing them irreversible damage and even death.
The attitude some adopt concerning the legitimacy of sacrificing the (physical and genetic) integrity of
human beings at the embryonic stage, until destroy them if necessary, in order to benefit other human
individuals is likewise totally unacceptable. It is never morally licit to do evil intentionally, even in
order to achieve ends that are good in themselves.
Moreover, it should be borne in mind that, although the human individual at the embryonic stage
deserves the full respect that is due to every human person, human embryos are certainly not subjects
who can give their personal consent to experimentation that exposes them to grave risks without the
benefit of any directly therapeutic effect for themselves. Therefore, any experimentation on the human
embryo that does not have the goal of obtaining direct benefits for his/her own health, cannot be
considered morally licit.
10. The current process of progressive globalization that involves the whole planet and whose
consequences do not always seem to be positive, impels us to reflect on biomedical research under the
heading of its social, political and economic implications.
Given the growing limitation of the resources that are available for the development of biomedical
research, it is in fact necessary to pay great attention to achieving a just distribution between the
different countries, taking into account the living conditions in the various parts of the world and the
emergence of the primary needs of the poorest and most harshly tried peoples. That means that all
should be guaranteed the conditions and minimal means so that they can enjoy the benefits deriving
from research, and develop and support an endogenous capacity for research.
11. At the legislative level, once again, we express the hope and the recommendation that an
international legislation with a unified content can be arrived at, based on the values inscribed in the
nature of the human person. In this way, one could overcome the actual disparities which frequently
make possible the abuse and exploitation of the individual as well as of entire peoples.
12. Finally, recognizing the enormous influence of the mass media in the formation of public opinion
and the important role they play in inspiring in the broader public, expectations and desires that are
more or less well-founded, it appears ever more necessary that those engaged in the sector, who choose
to be concerned with the biomedical sector and with bioethics, should be properly trained, both in the
scientific and the ethical fields, to be able to communicate the facts in simple, and concise language
without confusion or misrepresentation.
13. To conclude, the Pontifical Academy for Life, with great enthusiasm and a deep sense of
responsibility, desires to renew its commitment and dedication to the cause of life, in sincere and
respectful collaboration with all who are involved in the field of biomedical research, as the Pope
himself said in his recent address to the Pontifical Academy for Life: "In the area of biomedical
research, the Academy for Life can therefore be a point of reference and enlightenment, not only for
Catholic researchers, but also for all who desire to work in this sector of biomedicine for the true good
of every human being" (John Paul II, Address to participants..., n. 3). The Academy's principal task
continues to be to make available to the Church, to society at every level, and, especially, to the
235 scientific community, its own "statutory" service of study, formation and information, in the attempt to
identify and to point out to the whole of society the values rooted in the dignity of the human person
that are indispensable if we aspire to the true good of every person and of the whole person, with the
goal of deducing from them the ethical directives that can guide those involved in this field in their
daily endeavour.
(original version in Italian, published in "L'Osservatore Romano", Thursday 13 March, p. 7)
236 Proposal of an Ethical Commitment for Researchers in the Biomedical Field
Introductory Note
The following "manifesto" is published as an appendix to the Final Communiqué of the IX General
Assembly of the Pontifical Academy for life. It is a concrete result of the Assembly's deliberations,
whose theme this year was "Ethics of biomedical research. For a Christian vision", offered as an open
proposal to be freely supported.
The invitation for a personal adherence is addressed to all researchers and those involved in research in
the biomedical field and also to researchers in bioethics. Those who wish to adhere to this "manifesto",
which means that they embrace the principles it contains, should communicate to the Academy by one
of the following ways:
- by email (address to: pav@acdlife.va )
- by fax (send to: +39 06 69882014)
- by ordinary mail (address to: Pontificia Accademia per la Vita, Via della Conciliazione 3, 00193
Roma - ITALY)
Whatever the chosen modality, it is obligatory to include one's personal details (name, surname,
address, telephone, fax, email), profession and place of employment, academic degrees and other
qualifications.
13 March 2003
237 Premise
The scientific developments of recent decades have brought about important cultural and social
transformations, modifying in a qualitative way many aspects of human life. Indeed, the advance of
scientific progress in many sectors has given rise to great hopes of concrete improvements for the life
and future of the human person. However, in certain sectors of scientific research problems and/or
doubts of an ethical and religious nature have arisen; they have demonstrated unequivocally the real
need for constant dialogue/integration between the experimental sciences and the broader human
sciences and philosophy in terms of operating in a more ample perspective so that the acquisition of
greater knowledge may effectively serve the true good of the human person.
Human life and human nature appear to be realities too complex to be exhaustively evaluated from a
single perspective; a multidisciplinary approach therefore appears indispensable for a better
understanding of the human being in his integrity and contribute to a meaningful growth of a science
that would truly be for the human being.
Moreover, such an interdisciplinary dialogue, by re-focusing attention on the centrality of the human
person, would make the scientists more aware of the ethical implications of their work, and,
conversely, would incite those involved in philosophical and theological anthropology to assume
toward the scientists a mission of dialogue, collaboration and practical support , with the mutual
intention of developing cognitive and applied tools for the service of the human community.
In this perspective, the reference to human values, and finally, to an anthropological and ethical vision,
is an indispensable premise for a correct scientific research, that recognises the person's responsibility
to himself and to others.
In fact, without reference to ethics, science and technology can be used either to kill or to save human
lives, to manipulate or to promote, to destroy or to build. It is therefore necessary that, through
responsible management, research be addressed toward the true common good, a good that transcends
any merely private interest, going beyond the geographical and cultural boundaries of nations and
keeping one's vision directed toward the good of future generations..
For science to be really placed at the service of the human being, it is necessary that it goes "beyond
matter", intuiting in the corporeal dimension of the individual the expression of a greater spiritual good.
Scientists should understand the human body as the tangible dimension of a unitary personal reality,
which is at the same time corporeal and spiritual. The spiritual soul of the human being, although not in
itself tangible, it is always the root of his existential and tangible reality, of his relationship with the rest
of the world, and consequently, of his specific and inalienable value.
Only such a vision can make scientific research effectively respectful of the human person, considered
in his complex corporeal-spiritual unity, every time he/she becomes the object of investigation, with
particular reference to those events that constitute the beginning and the end of the individual human
life.
For this reason, emerges a strong need to offer to young researchers formative programmes that put the
accent not only on the scientific preparation, but also on the acquisition of the fundamental notions of
anthropology and ethics. The expression of such programmes could, then, crystallize in the elaboration
of a true and proper Deontological Code for researchers, to which each researcher could safely refer in
his work, and which, at the same time, would represent a sign of hope and commitment for a truly
"humanized" medicine in the new millennium.
A first indication of the way to take, might concern the manner in which the researchers should behave
and the norms they should observe in order to direct their research towards the objective just recalled
above. It is our desire to propose such ethical indications, to which we firmly adhere, to all others who
are involved in the world of biomedical research; somehow, they delineate the principal features of the
researcher's "moral personality".
238 Commitment
1. I commit myself to adhere to a methodology of research characterized by scientific rigour and a high
quality of the information that is furnished.
2. I will not take part in research projects in which I could be subject of a conflict of interests, from the
personal, professional or economic point of view.
3. I recognise that science and technology must be at the service of the human person, fully respecting
his dignity and rights.
4. I recognise and respect all researches and their applications which are based on the principle of
"moral goodness" and referring to the correct vision of the corporeal and spiritual dimensions of the
human being.
5. I recognise that every human being, from the first moment of his existence (process of fertilization)
up to the moment of his natural death, is to be guaranteed the full and unconditional respect due to
every human person by virtue of his peculiar dignity.
6. I recognise, because of my duty to safeguard human life and health, the usefulness and the obligation
of a serious and responsible experimentation on animals, carried out according to determined ethical
guidelines, before applying new diagnostic and therapeutic methodologies to human beings. I also
recognise that the passage from the experiments with animals to the clinical experimental stage (on
man) should take place only when the evidences resulting from the experiments with animals
sufficiently demonstrate the harmlessness or the acceptability of the possible harms and risks that such
experiments might involve.
7. I recognise the legitimacy of clinical experiments on the human being, but only under precise
conditions, including, in the first place, the safeguarding of the life and physical integrity of human
beings who are involved. Then, there is the need that the experiments be always preceded by proper,
correct and complete information regarding the significance and developments of the same
experiments. I will treat each person who submits to an experiment as a free and responsible subject
and never as a mere means to achieve other ends. I will never let a person be involved in an experiment
unless he/she has given his/her free and informed consent.
(original version in Italian, published in "L'Osservatore Romano", Thursday 13 March 2003, p.7)
239