DoD Traumatic Brain Injury and Psychological Health, Focused Program Award | HT9425 23 S TBIPH2

Opportunity Information: Apply for HT9425 23 S TBIPH2

The DoD Traumatic Brain Injury and Psychological Health (TBIPHRP) Focused Program Award (FPA) is a large, team-based funding opportunity from the Department of Defense (managed through the U.S. Army Medical Research Acquisition Activity, USAMRAA) aimed at speeding up practical solutions for traumatic brain injury (TBI) and psychological health challenges that matter to Service Members, their families, and Veterans. The core idea is to fund an integrated, multidisciplinary program that tackles one clearly defined, high-impact problem (called the "overarching challenge") within at least one sub-area of one of the program's three FY23 focus areas. Rather than supporting disconnected studies, the FPA is designed to push a coordinated set of projects toward real clinical or operational impact, such as new or improved health care products, technologies, and practice guidelines.

A defining feature of this mechanism is that applicants must build a synergistic program made up of multiple distinct research projects led by individual project leaders, all aligned to the same overarching challenge. The program encourages (and effectively expects) a minimum of four projects, with a clinical research or clinical trial component encouraged as part of the overall package, although proposals with more or fewer than four projects can be considered if they still fit the intent of the award. Each project must be scientifically strong on its own, but the projects also need to reinforce each other so that the combined effort can produce outcomes that would not be achievable by any single project operating independently. At the same time, the award is not meant to fund a chain of projects where later projects only work if earlier ones succeed; each project should stand alone and contribute meaningfully even if another project encounters problems. The program also welcomes proposals that examine multiple hypotheses or perspectives around the same central question, as long as the work remains coordinated and clearly tied to solving the overarching challenge.

In terms of what research is allowed, the FPA supports applied, preclinical, and clinical research, including clinical trials. Clinical trials can focus on evaluating promising new products, new uses for existing interventions, pharmacologic agents (drugs or biologics), devices, clinical guidance, and emerging approaches and technologies. The scope also explicitly includes hypothesis-driven health services research, implementation science, and follow-up care research, reflecting an interest not only in discovering what works, but also in how to deliver it effectively in real-world settings. Proposed trials are expected to be positioned as feasibility studies or as work that informs the design of later, more definitive efficacy trials in relevant patient populations. Another important boundary is that basic research is not the target for this mechanism; applicants are expected to provide preliminary data for each project and show a clear intention to move toward translational and clinical application during the performance period.

Because the award is structured as a focused program rather than a single-study grant, the application must include a detailed implementation plan. This plan needs to lay out critical milestones, describe the resources and innovations that will be used to reach them, and explain how progress will be monitored both at the project level and at the overall program level. Where appropriate, a robust statistical plan and statistical expertise are expected, signaling that the DoD is looking for well-powered, well-governed studies with clear decision points. Applicants are encouraged to use an External Advisory Board, but they must avoid conflicts of interest during peer review by not contacting, recruiting, or naming specific advisory board members in the application itself. For multi-institution collaborations, the proposal must also spell out how the team will communicate, how data and specimens will be transferred and managed, and how any resulting data, specimens, or products will be handled. A formal intellectual property and material property plan agreed to by participating organizations is required as part of the supporting documentation, reflecting the program's emphasis on translational outputs and real-world deployment.

Leadership expectations are significant. The overall program is led by a Principal Investigator who has demonstrated success running large, focused collaborative efforts, and the PI must commit at least 20 percent effort to the award. The PI is expected to actively create a collaborative environment that supports innovation and meaningfully engages all team members. Each research project must have an identified project leader, and the combined team should be multidisciplinary, with complementary expertise that adds up to something stronger than the sum of its parts. The DoD also builds in ongoing program involvement: the TBIPHRP Science Officer assigned to the award should be invited to participate in team meetings (for example, annual full-team meetings), and the plan for those meetings should be described in the application.

The program also includes a formal checkpoint: after the conclusion of year 2, the PI must present progress at a Milestone Meeting in the National Capital Area. The PI can bring up to three additional team members. Attendance includes TBIPHRP program leadership (such as the Programmatic Panel), CDMRP staff, the USAMRAA grants or contracts officer, and other DoD stakeholders. This structure emphasizes accountability, milestone-driven execution, and clear movement toward deliverables that the military health system can potentially use.

Relevance to military health is not a side note; it is a central review and programmatic consideration. Applications are expected to show direct relevance to health and readiness needs for Service Members, their families, and Veterans. Examples of strong relevance include addressing a psychological health or TBI issue that affects readiness or long-term functioning, producing knowledge or tools that can be implemented in both military and civilian settings (dual-use), using military or Veteran populations or datasets when appropriate, and collaborating with DoD or VA investigators. The opportunity explicitly encourages partnerships between military or Veteran institutions and non-military institutions, since those collaborations can combine access to unique populations and infrastructure with specialized academic or industry expertise.

If an application relies on access to DoD or VA populations, resources, or databases, it must explain the status of that access at the time of submission and provide a plan to maintain access throughout the study. A key practical point is that CDMRP will not act as the government sponsor or signatory for access agreements, so applicants must arrange permissions and collaborations themselves. In some cases, access to restricted DoD or VA resources may only be possible through collaboration with a DoD or VA investigator who has a substantial role in the work, and non-DoD/non-VA investigators should plan accordingly. The opportunity also flags that human research with military populations can involve unique rules, including limits on participant compensation and additional protections or prohibitions for certain groups (for example, military families or specific operational communities), and applicants are expected to understand and comply with those requirements.

From an administrative standpoint, this is a discretionary funding opportunity under DoD, using grant and cooperative agreement instruments, associated with CFDA 12.420. Eligibility is described as unrestricted (open to any entity type), subject to any clarifications in the full announcement. The anticipated direct cost budget for the full period of performance is capped at $5.0 million, and the program anticipated making around three awards. For the FY23 cycle described, the opportunity was posted April 27, 2023, with an original closing date of September 28, 2023, and the DoD indicated awards would be made no later than September 30, 2024.

• The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD Traumatic Brain Injury and Psychological Health, Focused Program Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on Apr 27, 2023.
• Applicants must submit their applications by Sep 28, 2023. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 3 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

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