DoW Traumatic Brain Injury and Psychological Health, Clinical Trial Award

The Fiscal Year 2026 Traumatic Brain Injury and Psychological Health Research Program Clinical Trial Award supports original clinical trials aimed at advancing care for psychological health conditions and traumatic brain injury through the evaluation of interventions such as new drugs, biologics, medical devices, diagnostics, therapies, and behavioral health strategies. Applicants must demonstrate preliminary data and incorporate Community-Based Participatory Research (CBPR) approaches to ensure engagement with affected communities. The program offers two research levels: Research Level 1 supports proof-of-principle pilot studies and Phase 1–2 trials with a maximum budget of $2.1 million, while Research Level 2 funds larger-scale, effectiveness-focused trials with a maximum budget of $4.1 million. An Early-Career Investigator Partnering Option is available for both levels, allowing two Principal Investigators—each receiving a separate award—if one is an early-career researcher, with a required Partnership Statement detailing roles, contributions, and justification. Applications must be submitted in two stages: a pre-application by July 13, 2026, followed by a full application by October 15, 2026, using either eBRAP or Grants.gov depending on the applicant’s institutional status. All submissions require adherence to strict formatting rules, including mandatory PDF uploads with specific filenames, and a maximum total project duration of four years, with trial activation no later than 18 months post-award. Key attachments include a Regulatory Strategy, Study Population Recruitment and Safety Plan, CBPR Documentation, Relevance to Military Health Statement, Personnel Organization Chart, and Required Representations, all of which are critical for compliance. The award is administered through the Department of the Army’s U.S. Army Medical Research and Acquisition Activity under the Congressionally Directed Medical Research Programs, with payment processed via the Defense Health Agency Contracting Activity, and all recipients must be registered in SAM.gov with an active Unique Entity Identifier. No classified research is permitted, and submissions must align with NIH-endorsed Clinical Data Elements, federal inclusion policies, and rigorous scientific standards. Review evaluates scientific merit, relevance to military health needs, alignment with program priorities, regulatory feasibility, and the strength of CBPR integration, with awards determined through a trade-off process that prioritizes programmatic impact over cost alone.