DoD Traumatic Brain Injury and Psychological Health Translational Research Grant

The FY23 TBIPHRP TRA is intended to support translational research that will accelerate the movement of promising ideas in psychological health conditions and/or TBI research into clinical applications, including health care products, technologies, and/or clinical practice guidelines.

Applicants should not view translational research as a one-way continuum from bench to bedside.  The research plan is encouraged to involve a reciprocal flow of ideas and information between applied and clinical research. As such, applications must include preliminary and/or published data to support the proposed research project.

Applications to the FY23 TBIPHRP TRA may include preclinical and/or clinical research involving human subjects and human anatomical substances. The FY23 TBIPHRP TRA may also support ancillary studies that are associated with an ongoing or completed clinical trial and projects that optimize the design of future clinical trials.

If animal models are proposed, consider the following:

•   Pairing clinical populations to animal models in order to validate the clinical relevance and development of prevention, assessment, and treatment solutions is encouraged.

•   Proposed animal models should be well justified, supported within the literature, and clearly align with clinical relevance to the human condition.

The FY23 TBIPHRP TRA also allows funding for a pilot/exploratory clinical trial as PART of the funded research project where limited clinical testing of a novel knowledge product,2 intervention, or device is necessary to inform the next step in the continuum of translational research. Such pilot/exploratory clinical trial studies should be small, make up only a portion of the research proposed in the Statement of Work (SOW), and be utilized to establish the feasibility of a 

potential approach or to aid in device or intervention refinement. Applications that include large-scale clinical trials do not meet the intent of the mechanism. Applications that consist entirely of a pilot/exploratory clinical trial or multiple pilot/exploratory clinical trials may be administratively withdrawn.

Alternative trial designs to traditional randomized clinical trials are allowed but should be appropriate to the objective of the trial. Applications that include a pilot/exploratory clinical trial as part of the proposed research will have additional submission requirements and review criteria. Funded clinical trials are required to post a copy of the informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements 

described in the Code of Federal Regulations, Title 32, Part 219 (32 CFR 219). Funded trials are required to register the study in the National Institutes of Health (NIH) clinical trials registry, www.clinicaltrials.gov, prior to initiation of the study. Refer to the General Application Instructions, Appendix 1, Section B, for further details. This award may not be used to support studies requiring an exception from informed consent (EFIC).

Early-Career Investigator Partnering Option: The FY23 TBIPHRP encourages applications that include meaningful and productive collaborations between investigators. The FY23 TBIPHRP TRA includes an Early-Career Investigator Partnering Option that is structured to accommodate two PIs, one of whom is an Early-Career Investigator. The PIs may have experience in similar or disparate scientific disciplines, but each PI is expected to bring distinct contributions to the application. One PI will be identified as the Initiating PI and will be responsible for most of the administrative tasks associated with application submission. The

other investigator will be the Partnering PI. One of the named PIs on an application submitted under the Early-Career Investigator Partnering Option must be an Early-Career Investigator; the Early-Career Investigator may be either the Initiating or Partnering PI. Both PIs should contribute significantly to the development of the proposed research project, including the Project Narrative, SOW, and other required components. The application is expected to describe how the PIs’ unique experience/expertise combined as a partnership will better address the research question, how the unique experience/expertise that each individual brings to the application is critical for the research strategy and completion of the SOW, and why the work should be done together rather than through separate efforts. If recommended for funding, each PI will be named to an individual award within the recipient organizations. For individual FY23 TBIPHRP TRA submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission.

The anticipated direct costs budgeted for the entire period of performance for an FY23 TBIPHRP TRA should not exceed $1.0M. Refer to Section II.D.5, 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.