Request for Applications - National Parkinson Foundation

Transcription

Request for Applications - National Parkinson Foundation
Request for Applications
Clinical Research and Intervention Investigator Awards for
Parkinson’s Disease 2015
Issued by:
The National Parkinson Foundation
200 SE 1st Avenue, Suite 800
Miami, Florida 33131
1. Introduction
1.1.Program Goal
The National Parkinson Foundation (“NPF”) is pleased to issue the following Request for Applications
(“RFA”) with the goal of funding investigations in three areas of Parkinson’s disease research. This RFA
will provide support for clinical and pre-clinical studies in the focus areas of 1) Inflammation in
Parkinson’s disease; 2) Depression in Parkinson’s disease; and 3) Sex differences in Parkinson’s disease.
Starting with the FY2010 grant cycle, NPF revised its model of grant funding in order to ensure that
funding goes to the best research addressing the greatest unmet needs. In keeping with this model, this
RFA will fund programs based on both impact and scientific merit, as determined by peer review.
1.2.Eligibility and Funding Considerations
Applications to this RFA will be limited to individuals who are full-time faculty members with the title of
assistant professor or higher rank at nonprofit research institutions (“Applicants”). NPF anticipates
funding $1 million over a two-year period, with funded grants limited to a maximum of US $250,000
total.
1.3.Dates and Deadlines for Applicants
The following are the key dates for this RFA:
Application deadline .................................................. 6:00 pm (EDT) July 1, 2015
Review ........................................................................ September 2015
Anticipated award announcement ............................ October 1, 2015
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2. Program Details
Investigators from eligible institutions are invited to submit applications for funding to conduct novel
research offering the promise of improving care for or understanding of Parkinson’s. Proposals should
focus on well-designed and rigorous hypothesis-driven research. Applications will be evaluated on
impact and scientific merit and should propose to meaningfully test a clearly-articulated hypothesis. A
power analysis and review of potential avenues for the introduction of bias and mechanisms for its
reduction should be included. Applications should include relevant preliminary data; all material
submitted is treated as confidential or proprietary and are restricted to NPF staff and members of the
NPF Clinical and Scientific Advisory Board.
2.1.Proposal Focus Areas
This RFA includes funding opportunities in three focus areas. Clinical studies may link to NPF’s
Parkinson’s Outcomes Project and costs associated with the collection of the Parkinson’s Outcomes
Project need not be included in the budget. For each focus area, both preclinical and clinical proposals
will be considered.
Focus area one: Inflammation.
The intersection between inflammation and Parkinson’s disease offers the potential to provide new
insight into the pathophysiology, etiology, and clinical progression of Parkinson’s. Applications in this
focus area should clearly link the research to both inflammation and Parkinson’s disease.
Focus area two: Depression.
Findings from the Parkinson’s Outcomes Project have highlighted the importance of depressive
symptoms to health-related quality of life in Parkinson’s disease. Applications in this focus area should
clearly link the research to both depression and Parkinson’s disease.
Focus area three: Sex differences.
From biology to social support, males and females experience Parkinson’s disease differently.
Applications in this focus area may consider diverse aspects of sex differences in Parkinson’s disease in
clinical care or preclinical research, with particular attention taken to resolving unambiguously sex
differences and how these arise.
2.2. Funding Considerations
Applications should include detailed budgets, including specific justifications for each clearly-described
budget item. There are no limits on the number of grants that may be submitted by any one institution.
Funds cannot be used to purchase equipment or support conference fees or travel, with the exception
of travel to a co-investigator at another (collaborating) institution.
Indirect costs are not allowed. However a line item for facilities fees may be included under direct costs
for up to 15% of the total grant amount, with the total award capped at $250,000.
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PROGRESS REPORTS.
Applications should include critical milestones for completion over the course of the research. Projects
should include at least two milestones per year of the project. At the time of each milestone applicants
should submit to the NPF a brief (< 1 page) report indicating that the milestone was achieved, or if not
achieved an explanation. A detailed report will be required upon each anniversary of the award date.
2.3.Eligibility to Receive Funds
The principal investigator must be an assistant professor or higher rank at a non-profit or non-for-profit
biomedical research institution, with appropriate budgetary and research (IRB or IACUC) oversight. Each
application must be co-signed by the institutional officer responsible for grants and contracts. Trainees
(residents, fellows, and students) cannot serve as a principal investigator. Applicants must provide
evidence of Institutional Review Board (IRB) or Institutional Animal Care and Use Committee approval
before any funds are dispersed.
3. Application Submission and Review
3.1. Application Submission
Applications will be submitted electronically by e-mail to npf-grants@parkinson.org. The application
should be assembled and uploaded as a single PDF document. The general formatting should follow
that of NIH guidelines (http://grants.nih.gov/grants/writing_application.htm) but with no more than 10
pages of material, including budgets, references, and other material but not including an NIH format
biosketch. All applications should include as the first page(s) a letter indicating institutional approval of
submission, followed by a page indicating the name of the Principle Investigator, their academic rank
and position, departmental and institutional affiliation(s), phone and e-mail contact information. The
third page should be specific aims (limited to one page), with the remaining nine pages of the body of
the grant devoted to background, preliminary data, details of proposed experiments, budget, and
references, concluding with a timeline and list of milestones. Fonts are restricted to the three approved
NIH fonts, with no more than 15 characters/linear inch. NIH format biosketches for all key personnel
should be placed at the end of the pdf document. Appendices or other supplements are not permitted.
Applications that do not conform to these guidelines will not be reviewed.
3.2. Review Criteria
Applications will be reviewed first to ensure compliance with the application guidelines. Applications
that meet these structural requirements will be evaluated for impact and scientific merit by the Clinical
and Scientific Advisory Board. This review of scientific merit will consider the depth of understanding of
the state of the field, an evaluation of the likely impact of the study, and the study design. The direct
relevance of all submitted applications for understanding the pathophysiology, clinical course, and
and/or treatment of Parkinson’s Disease should be clear and explicitly stated.
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3.3.Review Process
Applicants are welcome to submit questions to NPF regarding developing applications that will meet the
RFA’s administrative requirements. While NPF will hold all project details in confidence, general details
of any answered question may be made available to the entire applicant pool. NPF’s goal in this is to
maximize the number of applications that qualify for consideration in the scientific evaluation and
therefore questions are welcome. Applicants are requested to first review the FAQs prior to submitting
a question.
Applications that pass the administrative review will be scored by the CSAB for relevance, impact, and
merit. Awards will be based on the scoring of applications based on this review. Note that scoring will
include consideration for applications that advance NPF’s priorities for research.
All award decisions made by the NPF or its designated agents under this RFA will be final.
4.4. Conflicts of Interest
Committee members with a conflict of interest will be excluded from participation in the review of that
application and any discussions of that application and, at the discretion of NPF and the chairman, other
applications. NPF will have sole discretion in resolving issues of conflict of interest. NPF’s goal is to
eliminate the appearance of a conflict of interest as well as actual conflicts of interest and will endeavor
to take steps to do so; however, it retains its discretion as sole arbiter of any conflicts that arise.
4. Agreements between Applicants and NPF
4.1. Sensitive Information
All applications and all information supplied with applications will be treated by NPF as sensitive
information and NPF will instruct individuals who are given access to the applications (NPF staff and
members of the Clinical and Scientific Advisory Board) that they should not share the applications with
anyone else.
4.2. Special Requirements
All Applicants, their co-investigators and/or their institutions (collectively, “Investigators”), accept full
responsibility for executing research funded by NPF via this RFA. Such responsibility includes execution
of the research in manner consistent with the ethical standards required of clinical research and that all
risks associated with this research shall be disclosed to and evaluated by the institutional review board
at the institution at which this work will be completed. All Investigators recognize that NPF, its CSAB,
and any other individuals involved in reviewing the application (collectively, “Review Panel”) are not
responsible for evaluating the risks to participants and ethical implications of the research.
4.3. Sharing of Research and Findings
NPF is a public charity and research funded by NPF must be conducted in the public interest. Applicants
shall have a right to ownership of the research funded by NPF, but each Applicant shall acknowledge
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NPF’s right to publish a summary of all research findings (“Announcement”) funded under this RFA after
completion. Applicants will report on progress (milestones) and issue a separate, final report to the NPF
upon the successful completion or the termination of the awarded grant. NPF will publish the
Announcement within twelve months of completion of the research. Reasonable justifications for delay
of publication will be considered, based on factors such as the study was part of a larger, on-going
research project that would be affected by the release of the data or that release of the information
must be withheld to allow publication in a major journal. Any conflict or disagreement between
investigators and NPF will be resolved by NPF at its sole discretion.
The NPF encourages submission of papers resulting from any NPF-funded (in part or whole) grants for
peer-reviewed publication. Any public presentation of the research or results by the Applicant or any
co-investigator will acknowledge the funding provided by NPF in such a manner as to make clear that
NPF had provided meaningful support for the research, subject to any requirements for
acknowledgements in the forum in which the presentation is made. No organization providing less
direct funding for the specific research shall be given a more prominent acknowledgement and the
acknowledgement of NPF support shall be done at the same time and/or in the same section, page, or
slide as acknowledgement of other funders unless it is done more prominently.
Commercialization of intellectual property arising from research funded under this RFA, including
perfecting intellectual property rights, will not be funded through this RFA.
4.4. Clinical Trial Registration
Any clinical trial funded under this RFA will be required to be registered with clinicaltrials.gov and other
appropriate public registries. Registration must be done before recruitment of subjects start.
5. Inquiries
Please do not hesitate to make inquiries to NPF should you have any questions regarding this RFA.
Inquiries should be made via e-mail at programs@parkinson.org.
6. Acknowledgement upon submission
Applicants are required to include a statement indicating that they have read and agreed to the terms of
this RFA in their application and that they have secured agreement on behalf of all their coinvestigators. The following text (or a similar statement) will be accepted: “I have read and agree to the
terms of the RFA.”
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