DoW Traumatic Brain Injury and Psychological Health, Clinical Trial Award | HT942526TBIPHRPCTA

FY26 TBIPHRP Clinical Trial Award (HT942526TBIPHRPCTA) - Frequently Asked Questions

1) What is the FY26 TBIPHRP Clinical Trial Award?

The FY26 Traumatic Brain Injury and Psychological Health Research Program (TBIPHRP) Clinical Trial Award is a Department of Defense/Defense Health Agency funding opportunity focused on supporting clinical trials that can meaningfully improve outcomes for traumatic brain injury (TBI) and/or psychological health conditions. The emphasis is on research positioned to translate into real-world clinical application and influence healthcare practice.

2) What types of projects does this award aim to fund?

This award is designed to fund clinical trials that can produce tangible deliverables and evidence with practical clinical impact. Examples of the kinds of outputs described include health care products, enabling technologies, diagnostic approaches, therapeutic approaches, and evidence that could inform practice guidelines.

3) Is a clinical trial required, or are non-clinical studies allowed?

A clinical trial is a defining requirement of this award. The proposed work must be a clinical trial, meaning proposals that are not clinical trials would not align with the core requirement described in the opportunity information provided.

4) What intervention types can be tested in the clinical trial?

The opportunity is open to a broad range of intervention types. Examples explicitly described include pharmaceuticals or biologics, medical devices, diagnostics, clinical therapies, and behavioral health strategies. The listing also indicates that other intervention types may be appropriate, as the program is not limited to only one category.

5) Are exploratory or early concepts without evidence a fit for this award?

The opportunity is not aimed at purely exploratory concepts without support. Preliminary data are required, indicating applicants should have credible early evidence that supports key aspects of the proposed trial (for example, feasibility, safety, rationale, recruitment approach, or likely effect), depending on the trial design and stage.

6) What does the program mean by requiring preliminary data?

Based on the description provided, preliminary data should help demonstrate that the proposed clinical trial is grounded in credible early evidence. The opportunity notes examples of what preliminary data might support, such as feasibility, safety, rationale, recruitment approach, or likely effect, depending on the trial design and stage.

7) What is the required Community-Based Participatory Research (CBPR) approach?

The award requires the use of community-based participatory research (CBPR) approaches. This means the trial is expected to be developed with meaningful involvement from the affected community and relevant stakeholders, in ways that shape the study design, recruitment and retention strategies, outcomes of interest, and dissemination of results.

8) Who counts as the "community" or relevant stakeholders for CBPR in this program?

The opportunity describes examples such as patients, caregivers, clinicians, or military-connected communities. The intent is to ensure the trial is grounded in the realities of the populations it is meant to serve, emphasizing trust, relevance, and practical uptake of results.

9) How should CBPR show up in the clinical trial plan?

The information provided indicates that stakeholder involvement should be meaningful and should influence multiple parts of the trial, including design decisions, strategies to recruit and retain participants, which outcomes matter most, and how results are shared and disseminated.

10) What are the two research levels offered under this award?

The program offers two research levels so applicants can match the maturity and scope of their clinical trial to an appropriate category: Research Level 1 and Research Level 2.

11) What is Research Level 1 intended to support?

Research Level 1 supports proof-of-principle pilot studies and earlier-stage clinical trials. The opportunity explicitly includes Phase 1 and Phase 2 clinical trials in this level, which typically focus on feasibility, safety, dosing, and early signals of efficacy.

12) What is Research Level 2 intended to support?

Research Level 2 is intended for larger, more advanced trials designed to evaluate effectiveness in relevant patient populations. This implies more definitive testing in settings and populations that mirror real clinical use.

13) How do applicants choose between Research Level 1 and Research Level 2?

The applicant is responsible for selecting the research level that aligns with the proposed clinical trial. The opportunity describes Level 1 as earlier-stage/pilot and Level 2 as larger and more advanced/effectiveness-oriented.

14) Does the award include an option for early-career investigators?

Yes. The program includes an Early-Career Investigator Partnering Option that is available under both Research Level 1 and Research Level 2.

15) What is the Early-Career Investigator Partnering Option?

This option allows two Principal Investigators (PIs) to lead the project, with one PI qualifying as an Early-Career Investigator. If funded, each PI receives a separate award, which can help support a genuine collaboration while building leadership capacity for the early-career partner.

16) If using the partnering option, how are awards handled?

As described, if funded under the Early-Career Investigator Partnering Option, each PI receives a separate award.

17) Who is the sponsoring/issuing organization for this opportunity?

This is a Department of Defense/Defense Health Agency grant opportunity. It is managed by the Defense Health Agency Contracting Activity (DHACA).

18) What kind of grant mechanism is this?

The listing describes this as a discretionary grant opportunity.

19) What is the Funding Opportunity Number (FON)?

The Funding Opportunity Number provided is HT942526TBIPHRPCTA.

20) What is the CFDA number associated with this opportunity?

The listing associates this opportunity with CFDA 12.420.

21) Who is eligible to apply?

Eligibility is listed as unrestricted in the information provided.

22) When was this opportunity created and when is it due?

The opportunity was created on May 21, 2026. The original closing date listed is October 15, 2026.

23) How many awards does the agency expect to make?

The agency anticipates making about six awards.

24) Is there a maximum award amount (ceiling)?

An award ceiling is referenced in the listing, but no specific maximum amount is provided in the supplied information.

25) What is the overall emphasis of the program in terms of impact?

The core intent is to move research toward real-world clinical application. The program emphasizes projects positioned to influence healthcare practice through tangible deliverables (such as products, technologies, diagnostics, or therapies) and evidence that could inform practice guidelines.