DoD Traumatic Brain Injury and Psychological Health, Translational Research Award | HT9425 23 TBIPHRP TRA

Opportunity Information: Apply for HT9425 23 TBIPHRP TRA

The DoD Traumatic Brain Injury and Psychological Health, Translational Research Award (FY23 TBIPHRP TRA; Funding Opportunity Number HT9425 23 TBIPHRP TRA) is a Department of Defense research funding mechanism run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) that focuses on moving promising traumatic brain injury (TBI) and psychological health research closer to real-world clinical use. The main purpose is to speed up translation of research findings into tangible clinical applications, such as healthcare products, enabling technologies, and evidence-informed clinical practice guidelines. A key point in this announcement is that "translation" is not treated as a simple one-direction pipeline from basic lab work to the clinic; instead, the DoD is explicitly encouraging a back-and-forth exchange between applied research and clinical research so that clinical realities inform the science and scientific advances rapidly feed back into practical care improvements. Because of that translational emphasis, applicants are expected to bring preliminary and/or published data that support the rationale and feasibility of what they are proposing.

The award can support a broad range of study types as long as they clearly align with TBI and/or psychological health conditions and have a credible path toward clinical impact. Proposed work may be preclinical and/or clinical, and it may include human subjects research and research using human anatomical substances. The mechanism also allows studies that build on existing clinical trial infrastructure, including ancillary studies tied to an ongoing or completed clinical trial, as well as projects aimed at improving or optimizing the design of future clinical trials. In other words, the opportunity is not limited to launching a brand-new standalone clinical study; it also supports targeted work that can strengthen evidence, refine endpoints, improve feasibility, or otherwise de-risk a next-stage clinical evaluation.

Animal research is allowed, but it needs to be clinically anchored. The opportunity encourages applicants to pair clinical populations with animal models when that linkage helps validate the model's relevance and supports the development of prevention, assessment, or treatment solutions that are meaningful for patients. Any animal model has to be carefully justified, supported by the scientific literature, and clearly connected to the human condition being addressed; the intent is to avoid animal work that does not translate well or lacks a direct clinical rationale.

A notable feature is that the program allows a pilot or exploratory clinical trial, but only as a component of a larger translational project rather than the entire project. Limited clinical testing can be included when it is necessary to inform the next step in translation, such as establishing feasibility, testing acceptability, refining an intervention, or iterating a device. These trials are expected to be small and should occupy only a portion of the overall Statement of Work. The DoD makes clear that large-scale clinical trials are outside the intent of this mechanism. Applications that are essentially just a pilot trial, or that bundle multiple pilot trials without additional translational research elements, may be administratively withdrawn. While traditional randomized clinical trials are not required, alternative trial designs are permitted as long as they fit the trial's objectives and are well-justified. If a pilot/exploratory clinical trial is included, the application faces additional submission requirements and additional review criteria.

For any funded clinical trial activity, the announcement highlights federal transparency and compliance requirements. Awardees must post the informed consent form used to enroll subjects on a publicly available federal website in accordance with 32 CFR 219. Trials must also be registered on ClinicalTrials.gov before the study begins. The award cannot be used for studies that require an exception from informed consent (EFIC), which effectively rules out certain emergency research scenarios where consent cannot be obtained under typical procedures.

The FY23 TRA also includes an Early-Career Investigator Partnering Option designed to promote substantive collaboration and mentorship-like partnerships without treating the early-career investigator as a minor participant. Under this option, the application can name two Principal Investigators (PIs): one serves as the Initiating PI and handles most submission-related administrative tasks, and the other serves as the Partnering PI. One of these two must be an Early-Career Investigator (either role is acceptable). The application is expected to explain why the partnership is essential, how each PI contributes distinct and necessary expertise, and why the work is stronger as a joint effort rather than two separate projects. If selected for funding, each PI is named on an individual award within their respective organization, reflecting the program's intent to support true co-leadership.

In terms of basic award logistics, the funding instrument type is listed as a cooperative agreement and/or grant, and the activity category is Science and Technology and other Research and Development (CFDA 12.420). Eligibility is described as unrestricted, meaning a wide range of entity types may apply unless additional eligibility clarifications are provided elsewhere in the full announcement. The anticipated direct costs for the entire period of performance are capped at $1.0 million. The opportunity projected approximately 16 awards, with awards expected to be made no later than September 30, 2024. The original posting date was April 27, 2023, and the original closing date was July 6, 2023.

• 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, Translational Research 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 Jul 06, 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 16 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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