DoD Traumatic Brain Injury and Psychological Health, Focused Program Award

Description

The intent of the FY21 TBIPHRP FPA is to optimize research and accelerate solutions to a critical question related to at least one sub-area within one of the three FY21 TBIPHRP FPA Focus Areas. The award mechanism supports development of a synergistic, multidisciplinary research program with the potential to have a significant impact on TBI and/or psychological health through clinical applications, including healthcare products, technologies, and/or practice guidelines. Proposals/applications may propose applied/preclinical/clinical research and clinical trials. Clinical trials may be designed to evaluate promising new products, new indications, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Hypothesis-driven health services research, implementation science, and follow-up care research are also within scope for this mechanism. Proposed clinical trials should demonstrate feasibility or inform the design of more advanced trials that determine efficacy in relevant patient populations.Key aspects of this award include:Overarching Challenge: Focused Program Award proposals/applications must describe a unifying, overarching challenge that will be addressed by the set of research projects proposed. The overarching challenge must be relevant to a critical problem or question in the field of research and/or patient care in at least one sub-area within one of the three FY21 TBIPHRP FPA Focus Areas.Research Projects: Proposals/Applications shall include multiple, distinct research projects led by individual project leaders that address complementary aspects of the overarching challenge. Applicants are strongly encouraged to submit a minimum of four research projects; additional studies are allowed. While individual projects must be capable of standing on their own high scientific merits, they must also be interrelated, synergistic, and align with the overarching challenge to advance a solution beyond what would be possible through individual efforts. The exploration of multiple hypotheses or viewpoints of the same line of questioning is encouraged. This award mechanism is not intended to support a series of research projects that are dependent on the success of one of the other projects. Each project should propose a unique approach to addressing the overarching challenge and be capable of producing research findings with potential to impact the field and/or patient care. Individual research projects may include applied research, preclinical research, clinical research and clinical trials. Proposed research projects should not include basic research2. Preliminary data should be included to support each project’s hypothesis/objective(s). There should be a clear intent to progress toward translational/clinical work over the course of the effort.Implementation: The research strategy to address the overarching challenge must be supported by a detailed implementation plan that identifies critical milestones and outlines the knowledge, resources, and technical innovations that will be utilized to achieve the milestones. A robust statistical plan and statistical expertise should be included where applicable. A plan for assessing individual project performance and progress toward addressing the overarching challenge must be included in the implementation plan. Plans to include an External Advisory Board (EAB) are encouraged; however, applicants must be careful to avoid potential conflicts of interest (COIs) during review of the proposal/application by ensuring no contact with, recruiting of, or naming of specific EAB members in the proposal/application. For multi-institutional collaborations, plans for communication and data transfer among the collaborating institutions, as well as how data, specimens, and/or products obtained during the study will be handled, must be included. An appropriate intellectual and material property plan agreed to by participating organizations is required in the proposal/application’s supporting documentation.Research Team: The overall effort will be led by a Principal Investigator (PI) with demonstrated success in leading large, focused projects. The PI is required to devote a minimum of 20% effort to this award. The PI should create an environment that fosters and supports collaboration and innovation in a way that engages all members of the team in all aspects of the research plan. The research team assembled by the PI should be highly qualified and multidisciplinary, with identified project leaders for each of the complementary and synergistic research projects. The resources and expertise brought to the team by each project leader should combine to create a robust, synergistic collaboration. The TBIPHRP Science Officer assigned to a resulting award should be invited to participate in research team meetings (e.g., annual meetings of the entire research team). The plan for such meetings should be noted in the proposal/application.Milestone Meeting: The PI will be required to present an update on progress toward accomplishing the goals of the award at a Milestone Meeting to be held in the National Capital Area after the conclusion of year 2 of the period of performance. The PI may bring up to three additional members of the research team to the meeting. The Milestone Meeting will be attended by members of the TBIPHRP Programmatic Panel, CDMRP staff, the USAMRAA Grants/Contracts Officer, and other DOD stakeholders.Refer to Section II.D.6, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2022. For additional information refer to Section II.F.1, Federal Award Notices.The USAMRDC executes its extramural research program primarily through the awarding of contracts and assistance agreements (grants and cooperative agreements). The type of instrument used to reflect the business relationship between the organization and the government is at the discretion of the government, in accordance with the Federal Grant and Cooperative Agreement Act of 1977, as amended, 31 USC 6301-6308, which provides the legal criteria to select a procurement contract or an assistance agreement. An assistance agreement (grant or cooperative agreement) is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States, instead of acquiring property or service for the direct benefit and use of the U.S. government. An assistance agreement can take the form of a grant or cooperative agreement. If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304).Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305) and the award will identify the specific substantial involvement. Substantial involvement may include collaboration, participation, or intervention in the research to be performed under the award.A contract is required when the principal purpose of the instrument is to acquire property or services for the direct benefit or use of the U.S. government.The award type, along with the start date, will be determined during the negotiation process.Please see Appendix 2, Section E, of the General Submission Instructions for more information.Relevance to Military Health: Relevance to the healthcare needs of Service Members, Veterans, military beneficiaries, and the American public is a key feature of this award. Investigators are encouraged to consider the following characteristics as examples of how a project may demonstrate relevance to military health: Explanation of how the project addresses an aspect of TBI and/or psychological health that has direct relevance to the health and/or readiness of Service Members, Veterans, military beneficiaries, and the American public Description of how the knowledge, information, products, or technologies gained from the proposed research could be implemented in a dual-use capacity to benefit the civilian population and also address a military need Use of military or Veteran populations, samples, or datasets in the proposed research, if appropriate Collaboration with DOD or Department of Veterans Affairs (VA) investigators or consultantsApplicants are encouraged to integrate and/or align their research projects with DOD and/or VA research laboratories and programs. Collaborations between researchers at military or Veterans institutions and non-military institutions are strongly encouraged. These relationships can leverage knowledge, infrastructure, and access to unique data and research resources that the partners bring to the research effort, ultimately advancing TBI and psychological health research of significance to Service Members, Veterans, military beneficiaries, and the American public. A list of websites that may be useful in identifying additional information about ongoing DOD and VA areas of research interest or potential opportunities for collaboration can be found in Appendix II.The CDMRP expects to allot approximately $40.0M to fund approximately five FY21 TBIPHRP FPA proposals/applications. Funding of proposals/applications received is contingent upon the availability of federal funds for this program as well as the number of proposals/applications received, the quality and merit of the proposals/applications as evaluated by scientific and programmatic review, and the requirements of the government. Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds. It is anticipated that awards made from this FY21 funding opportunity will be funded with FY21 funds, which will expir

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