DoD Traumatic Brain Injury and Psychological Health, Focused Program Award

Description

The intent of the FY23 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 FY23 TBIPHRP FPA Focus Areas. The award mechanism supports development of a synergistic, multidisciplinary research program with the potential to have a significant impact on psychological health conditions and/or TBI through clinical applications, including health care 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 the FY23 TBIPHRP FPA include:Overarching Challenge: FPA 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 FY23 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 required to submit a minimum of four research projects, of which, a clinical research/trial research project is encouraged. If the intent of the FY23 TBIPHRP FPA is maintained, proposals/applications including more or fewer than four projects 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 collaborative 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.Relevance to Military Health: Relevance to the health care needs of Service Members, their Families, and Veterans 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 psychological health conditions and/or TBI that has direct relevance to the health and/or readiness Service Members, their Families, and Veterans• 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 consultantsCollaborations between researchers at military or Veterans institutions and non-military institutions are 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, their Families, and Veterans. 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.Use of DOD or VA Resources: If the proposed research involves access to VA or DOD patient populations, resources, or databases, the proposal/application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research. Refer to Section II.D.2.b.ii, Full Application Submission Components, for detailed information. Refer to the General Submission Instructions, Appendix 1, Section C, for additional information. Note, the CDMRP will not serve as the government sponsor or signatory on any access applications or agreements for DOD or VA patient populations, resources, or databases.Access to certain DOD or VA patient populations, resources, or databases may only be obtained by collaboration with a DOD or VA investigator who has a substantial role in the research and may not be available to a non-DOD or non-VA investigator if the resource is restricted to DOD or VA personnel. Investigators should be aware of which resources are available to them if the proposed research involves a non-DOD or non-VA investigator collaborating with the DOD and/or VA.Conducting DOD-Funded Human Research with Military Populations: There are unique requirements and prohibitions for compensating DOD-affiliated personnel for study participation and for conducting research with military families/children and U.S. Army Special Operations Command populations. Additional information regarding conducting DOD-funded human research with military populations can be found at https://cdmrp.health.mil/pubs/pdf/Conducting%20Research%20Military%20Pop%20DoD_funded_7NOV2022.pdf.The anticipated direct costs budgeted for the entire period of performance for an FY23 TBIPHRP FPA should not exceed $5.0M. Refer to Section II.D.6, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2024. For additional information refer to Section II.F.1, Federal Award Notices.

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