DoD Traumatic Brain Injury and Psychological Health, Health Services Research Award | HT9425 23 TBIPHRP HSRA

Opportunity Information: Apply for HT9425 23 TBIPHRP HSRA

The DoD Traumatic Brain Injury and Psychological Health, Health Services Research Award (FY23 TBIPHRP HSRA; Funding Opportunity Number HT9425 23 TBIPHRP HSRA) is a Congressionally Directed Medical Research Programs (CDMRP) grant/cooperative agreement mechanism focused on closing the real-world gap between proven research findings and day-to-day clinical care for traumatic brain injury (TBI) and psychological health conditions. The central goal is to move beyond showing that an intervention, guideline, tool, or policy can work, and instead generate practical, generalizable evidence about how to get those evidence-based approaches adopted, implemented, scaled, sustained, or sometimes discontinued in the settings where service members, Veterans, and other affected populations actually receive care. In other words, this award is aimed at implementation, dissemination, comparative effectiveness, and health services research that leads directly to patient benefit and informs clinical practice and policy decisions.

A key requirement is that funded work must be clinical in nature: proposals must involve clinical research and/or clinical trials and must use human subjects, human data/records, and/or human anatomical substances. Preclinical studies and animal research are not allowed under this mechanism. The program also explicitly excludes studies that would require an Exception From Informed Consent (EFIC), which means applicants need to design studies that can be conducted with standard informed consent processes and protections in place. The opportunity recognizes both prospective and retrospective designs, so projects can range from new studies enrolling participants to analyses of existing clinical data resources, as long as they fit the program intent and human research requirements.

Within scope, the HSRA supports research that accelerates the uptake of evidence-based findings into clinical practice, including studies that test strategies for improving adoption and integration of proven interventions, tools, policies, or clinical practice guidelines. It also supports comparative effectiveness research that looks at the benefits and harms of emerging or established approaches in real-world settings, rather than tightly controlled environments that may not reflect routine clinical care. Another major emphasis is identifying barriers to implementation and evaluating strategies that overcome those barriers so that effective practices can be adapted appropriately to different populations and environments, scaled up across systems, and sustained over time. The announcement also highlights work that modifies established clinical tools so they work better for the intended population or context, as well as studies that analyze existing tools and processes to maximize outcomes that matter to patients. Importantly, it also allows "de-implementation" research, meaning studies that identify when and how to stop, reduce, or phase out practices that are ineffective, unproven, low-value, or harmful. Projects that evaluate TBI and psychological health outcomes tied to guideline implementation, evidence-based practices, and process improvements are explicitly included as aligned priorities.

Several program features shape what a competitive application looks like. The TBIPHRP encourages precision medicine approaches when appropriate, meaning projects can incorporate individual differences (such as clinical characteristics or other patient-level factors) to help deliver the right intervention at the right time, rather than assuming one approach works equally well for everyone. The solicitation requires Community-Based Participatory Research (CBPR) methods as part of both study development and execution, signaling that meaningful partnership with the affected community and relevant stakeholders is not optional but a core element of the mechanism; applicants are expected to document CBPR approaches in designated attachments. Preliminary data are also required, so applicants must show some credible foundation that the proposed approach is feasible and grounded in prior evidence.

Operational readiness and feasibility are emphasized. Applicants are expected to demonstrate access to an appropriate study population and to lay out a clear recruitment and accrual plan that can support meaningful outcomes. They must also address inclusion of women and minorities in a manner appropriate to the study aims, with a specific exemption for certain studies using biospecimens or datasets that cannot be linked to individual demographic characteristics (often exempt from IRB review). If the project includes a clinical trial, the program expects the trial to start within 6 months after the award date, which pushes teams to have regulatory, operational, and site logistics largely prepared. For trials involving drugs, devices, or other materials, the application must show documented availability and access to what is needed for the full study period.

The opportunity draws a clear distinction between a clinical trial and other forms of clinical research. A clinical trial, for this program, is a study where human subjects are prospectively assigned to one or more interventions (including placebo or control) to evaluate effects on biomedical or behavioral outcomes. Observational clinical research is also eligible when it involves interaction with participants or uses identifiable human-origin materials (such as linked data or specimens) but does not evaluate an intervention's effects; examples include studies of disease mechanisms, diagnostics/detection (such as biomarkers or imaging), health disparities, epidemiology, behavioral studies, and outcomes or health services research that does not meet the clinical trial definition. The notice also clarifies that certain secondary research that is exempt under Common Rule category 4 (secondary research where consent is not required) is not considered clinical research for CDMRP purposes, which matters for teams proposing only de-identified secondary data analyses.

For funded clinical trials, federal transparency and compliance obligations are spelled out. Trials must be registered on ClinicalTrials.gov before the study begins, and the informed consent form used for enrollment must be posted on a publicly available federal website as required under 32 CFR 219. These requirements reinforce that the HSRA is designed for mature, practice-facing clinical work that can be scrutinized, replicated, and used to guide care decisions and policy.

Administratively, the award is offered by the Department of Defense (Department of the Army, USAMRAA) under CFDA 12.420. Eligibility is broadly described as unrestricted (open to any type of entity, subject to any additional eligibility language in the full announcement). The posted opportunity information indicates an anticipated 8 awards for the cycle and lists the original closing date as July 6, 2023. The award ceiling is listed as 0 in the excerpted record, which typically means applicants need to refer to the full solicitation documents for the actual budget limits and any cost or period-of-performance constraints.

• 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, Health Services 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 8 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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