This Funding Opportunity Announcement (FOA) invites Exploratory Grant (P20) applications for the planning and initiation of collaborative efforts to advance Parkinson’s Disease (PD) research. The goal of this program is to formalize new collaborative directions and/or novel interdisciplinary teams to address critical gaps in PD research and to establish a rigorous foundation of research discovery leading directly to an NINDS Morris K. Udall Center of Excellence (P50) application. Through this mechanism, the NINDS seeks to develop synergistic, proof-of-concept research efforts around investigator-defined gaps in PD research and support collaborative teams to develop a research plan, construct an effective administrative organization, create standardized policies/procedures, and gather rigorous preliminary data in support of novel ideas to address urgent needs and emergent issues in PD research. The Exploratory Grant theme and proposed research feasibility projects will inform the etiology, pathogenesis, or treatment of PD; investigations on related synucleinopathies may be included if such directly address the identified PD research gap. Required components of this FOA include an Overall section, an Administrative Core, and three or more research feasibility projects, at least one of which must be led by an early career researcher poised to become an expert in PD research. Synergy among proposed research projects must be evident as well as required for successful completion of the overall aims. To foster the development of innovative research consortia, this solicitation will provide support to formalize new collaborative directions and/or novel interdisciplinary teams only. NINDS funding decisions will focus primarily on scientific merit, i.e., on those applications that are most likely to make innovative contributions to PD research and that demonstrate potential to submit a P50 application at the end of the Exploratory Grant project period.
The Exploratory Grant provides each individual team with flexibility in project design. For example, some existing teams may have preliminary data for novel projects requiring further proof-of-concept, whereas emergent teams may have identified a key area of need and require time to convene, establish collaborative approaches, and obtain preliminary data. The collective expertise required to form effective partnerships and develop a rigorous evidence base may involve multiple sites and institutions.
Programmatic requirements of this FOA include an Overall section, an Administrative Core, and three or more research feasibility Projects, at least one of which must be led by an early career researcher poised to make contributions to PD research. In this context, “early career researcher” includes those who are about to transition, or have recently moved, to fully independent positions as investigators, faculty members or clinician scientists, and who focus on establishing themselves as experts in their chosen research area. For this initiative, “early career” is inclusive of Early Stage Investigators (ESI), as well junior faculty without current NIH R01-equivalent, independent support; New Investigators are eligible only if the criteria for “early career” are met. Leadership of a research feasibility project will allow ESI to retain ESI status according to NIH ESI policy. Inclusion of an early career researcher is intended to provide a timely leadership development opportunity within the supportive and collaborative structure of the Exploratory Grant consortium.
Because a goal of this initiative is to establish productive and innovative collaborations, extensive preliminary data is not required for proposed research feasibility projects. This FOA is not intended for support of clinical trials, but does permit mechanistic clinical research, as described below. Applicants may also request support for establishment of administrative structures to form the foundation for future basic, translational, and clinical research efforts. Applicants are encouraged to link their proposed theme and activities to critical gaps in PD research, including but not limited to research priorities from the NINDS conference, “Parkinson’s Disease 2014: Advancing Research, Improving Lives”. Proposed studies must be feasible within the two-year project period and justified within the budget limits described elsewhere in this announcement.
Due to the project timeframe and focus on research feasibility projects, research Cores are not within scope of the Exploratory Grant; applications proposing research Cores will be considered non-responsive to this FOA.
Clinical research is within scope of this initiative but is not required: completion of proposed clinical studies should be feasible within the timeline of the Exploratory Grant. For this solicitation, NINDS will accept hypothesis-driven mechanistic clinical trials in basic and/or translational discovery research in healthy human subjects and in the pathobiology, pathophysiology, and neuropathology of PD. The goal of such studies is to address basic questions and to interrogate concepts in biology, behavior, and pathophysiology that will provide insight into understanding neurological disorders. Such studies may seek to understand a biological or behavioral process, or the mechanism of action of an intervention. Designs that seek to answer specific questions about safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions must be submitted to an NINDS clinical trial-specific funding announcement (see NINDS Clinical Research). For related information on NINDS policy for submission of clinical trials, see NOT-NS-18-054.
Collection of biospecimens and clinical data will follow policies and procedures of the NINDS Parkinson’s Disease Biomarker Program (PDBP).
Per NOT-OD-16-011, the NIH expects applicants to apply rigor in designing and performing scientific research according to the NIH Principles and Guidelines for Reporting Preclinical Research.
This initiative is intended to provide flexibility for new applicant teams to design, establish, and strengthen collaborative efforts, and for existing applicant teams to explore novel research directions. Full-scale multicomponent research projects from established investigative teams, with requirements for supportive research Cores, are best suited to the NINDS Udall Centers of Excellence (P50) program itself.
NINDS funding decisions will focus primarily on scientific merit, i.e., on those applications that are most likely to make innovative contributions to PD research and that demonstrate potential to submit a P50 application at the end of the Exploratory Grant project period. The NINDS will also consider the full scope of Udall Center programmatic activities when making funding decisions; applications proposing goals identical to or largely overlapping with active Udall Centers will receive lower program priority. In addition, the NINDS may also consider whether proposed research addresses recommendations from the NINDS conference “Parkinson’s Disease 2014: Advancing Research, Improving Lives.”
The NINDS intends to fund up to 4 awards in FY2021, corresponding to a total of $1.2 million in direct costs. Only one Exploratory Grant will be awarded per applicant institution. Please inform Dr. Driscoll of your intention to pursue this grant opportunity.
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Filed Under: Funding Opportunities