The FY22 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 healthcare products, technologies, and/or clinical practice guidelines.Applicants should

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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 basic and clinical science.

As such, applications must include preliminary and/or published data to support the proposed research project.Applications to the FY22 TBIPHRP TRA may include preclinical and/or clinical research involving human subjects and human anatomical substances.

The FY22 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 FY22 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,3 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entirely of a pilot/exploratory clinical trial or multiple pilot/exploratory clinical trials may be administratively withdrawn.Alternative trial designs to traditional randomized clinical trials are allowed, but should be appropriate to the objective of the trial.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 trials are required to post a copy of the Institutional Review Board (IRB)- approved 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).

This award may not be used to support studies requiring an exception from informed consent (EFIC).Applications that consist entirely of multiple pilot/exploratory clinical trials or solely of a pilot/exploratory clinical trial are not permitted under this funding mechanism and should consider submitting to the following FY22 TBIPHRP funding opportunities:• Clinical Trial Award (Funding Opportunity Number:
W81XWH-22-S-TBIPH1)• Focused Program Award (Funding Opportunity Number:
W81XWH-22-S-TBIPH2)