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 Clinical research and intervention investigator awards for Parkinson’s Disease 2015 | 1 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. Clinical research and intervention investigator awards for Parkinson’s Disease 2015 | 2 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 [email protected]. 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. Clinical research and intervention investigator awards for Parkinson’s Disease 2015 | 3 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 Clinical research and intervention investigator awards for Parkinson’s Disease 2015 | 4 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 [email protected]. 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.” Clinical research and intervention investigator awards for Parkinson’s Disease 2015 | 5
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