Prof. Dr. Nikolaus Forgó, Mgr Magdalena Góralczyk, RA Constankn

Prof. Dr. Nikolaus Forgó, Mgr Magdalena Góralczyk, RA Constan?n Graf von Rex, Ins?tute for Legal Informa?cs, Leibniz Universität Hannover Contents I.  Introduc?on I.  Contract Project II.  Linked2Safety Project III.  Basic introduc?on to consent II.  CONTRACT Project – theore?cal issues of consent III.  Project Linked2Safety – prac?cal examples I. Basic introduc?on to consent •  Act of authorisa?on / agreement legalising infringement of inviolability •  Gives individuals a possibility (and responsibility) to take autonomous choices à AUTONOMY & AUTHORISATION II. CONTRACT Project – theore?cal issues of consent Informed consent for diagnosis and treatment Pa?ent Informed consent for par?cipa?on in a clinical trial Informed consent for processing of data II. CONTRACT Project – theore?cal issues of consent •  Consequence: –  During one encounter between a physician and a pa?ent in fact three completely different authorisa?ons can take place. –  This is also reflected in the legisla?on: concept of consent is sca\ered through different legal acts, that are not coordinated. II. CONTRACT Project – theore?cal issues of consent Informed consent for diagnosis and treatment • Defined under na?onal legisla?on • No common understanding Informed consent for par?cipa?on in a clinical trial
• Defined in Clinical Trials Direc?ve 2001/20/EC • Art. 2 (j) Informed consent for processing of data • Defined in Data Protec?on Direc?ve 95/46/EC • Art. 2 (h) II. CONTRACT Project – theore?cal issues of consent •  Consent for par,cipa,on in a clinical trial (Clinical Trial Direc,ve) •  Art. 2(j) •  decision, which must be wri6en, dated and signed, to take part in a clinical trial, taken freely afer being duly informed of its nature, significance, implica?ons and risks and appropriately documented, by any person capable of giving consent. II. CONTRACT Project – theore?cal issues of consent Consent for data processing (Data Protec,on Direc,ve) •  Art. 2 a): •  'the data subject's consent' shall mean any freely given specific and informed indica?on of his wishes by which the data subject signifies his agreement to personal data rela?ng to him being processed II. CONTRACT Project – theore?cal issues of consent •  Outcome –  Defini?on problems –  Formal problems a painful formalis?c process and uncertainty for both both par?es (doctor / researcher & pa?ent) III. Project Linked2Safety – prac?cal examples •  Data re-­‐use for research – on the example of Linked2Safety Bringing personal data into projects like L2S is useful! III. Project Linked2Safety – prac?cal examples Phases of the project – need for personal data First phase – DEVELOPMENT technical partners of the project need access to develop the technical solu?ons. Second phase -­‐ VALIDATION within the project’s life?me technical and non-­‐
technical partners will need to get access to the plakorm for evalua?on and research purposes. Third phase – EXPLOITATION the data within the plakorm will be made available to a more general audience. It is guaranteed that the data shown to the general public are completely anonymous. (aggregated data) III. Project Linked2Safety – prac?cal examples Data re-­‐use for research – on the example of Linked2Safety –  The data collected in hospitals / for other purposes would be a useful source of informa?on •  However it is difficult to provide such data into research infrastructure In Linked2Safety CONSENT & ANONYMISATION are implemented to protect pa?ents interests III. Project Linked2Safety – prac?cal examples In the case of the project Linked2Safety, the pa?ent data are collected from the pa?ent and anonymised outside of the infrastructure. Only anonymous data enters the infrastructure. However anonymisa,on of data is also processing of data. Therefore a basis for data anonymisa?on is also needed. III. Project Linked2Safety – prac?cal examples Different types of consent Specified Consent consent for the use of pa?ent data for a clearly defined research project. –  difficult for Linked2Safety because the data needed was collected when the project was unknown. the data subject's consent' shall mean any freely given specific and informed indica?on of his wishes by which the data subject signifies his agreement to personal data rela?ng to him being processed III. Project Linked2Safety – prac?cal examples Different types of consent Broad/blanket Consent of the pa?ent as the data subject –  data will be used for future unknown research projects. •  low administra?ve burdens this type of consent (easy for researcher). •  pa?ents do not know what they agree and that this type is vague. the data subject's consent' shall mean any freely given specific and informed indica?on of his wishes by which the data subject signifies his agreement to personal data rela?ng to him being processed III. Project Linked2Safety – prac?cal examples Different types of consent Tiered consent –  pa?ents have a choice between providing consent to specified research, future research related to the current study, any future research – the choice between different alterna?ves is given at different moments in ?me . •  Control over the data remains by the individual •  Requires high administra?ve effort from the researchers the data subject's consent' shall mean any freely given specific and informed indica?on of his wishes by which the data subject signifies his agreement to personal data rela?ng to him being processed III. Project Linked2Safety – prac?cal examples Data within Linked2Safety •  For future data collec?on for the scope of the Linked2Safety project a consent form was developed. CONCLUSIONS •  Especially in case of data re-­‐use it is important to seek for balance between needs of the research community and pa?ent‘s rights •  More effort is needed to define concept of consent clearly and in a consistent manner. •  Legal and technical means should be developed in order to support individuals in control over their data and allow providing and withdrawing data in an easy manner www.snookerbacker.com
Thank you for listening! Magdalena Góralczyk – goralczyk@iri.uni-­‐hannover.de Research leading to these results has received funding from
the European Union FP7 Programme!