DoD Military Burn, Clinical Translational Research Award | HT9425 23 MBRP CTRA

Opportunity Information: Apply for HT9425 23 MBRP CTRA

The DoD Military Burn, Clinical Translational Research Award (CTRA) is a funding opportunity under the Congressionally Directed Medical Research Programs (CDMRP) Military Burn Research Program (MBRP) designed to push burn-care advances into real-world clinical use quickly. The emphasis is on clinical research and clinical trials that can meaningfully improve outcomes for burn-injured patients by translating solid, well-supported findings into practical care, especially where the military has the greatest need: at or near the point of injury and during the early, acute phase of treatment across Roles 1-3 of the military pathway of care (from immediate field care through early definitive care). Projects are expected to demonstrate clear impact, both in the near term and longer term, and to directly address one or more of the FY23 MBRP Focus Areas, with a strong preference for work that improves care in austere or resource-limited environments and supports treatment delivered by combat medics or other first responders.

A central requirement is that the proposed work is highly relevant to military health, meaning it must matter to Service Members, Veterans, military beneficiaries, and/or the broader American public. Applications should clearly connect the project to combat-associated burn injury needs and explain how results will fill a concrete military capability gap within Roles 1-3. The program strongly encourages collaborations that bridge military or VA institutions with civilian partners, since those pairings can combine operational insight, clinical access, infrastructure, and specialized datasets in ways that accelerate progress and strengthen the likelihood of real implementation.

This award mechanism is strictly limited to human subjects clinical research and/or clinical trials; animal studies are not allowed. The announcement distinguishes observational or patient-oriented clinical research (for example, studies of disease mechanisms in humans, diagnostic or biomarker development, imaging, health disparities, epidemiology, behavioral research not evaluating an intervention, outcomes and health services research) from clinical trials, which involve prospective assignment of participants to one or more interventions to assess biomedical or behavioral outcomes. Studies that only use unidentifiable human specimens in vitro, or secondary research that qualifies for certain Common Rule exemptions (notably exemption category 4 where consent is not required), are not considered clinical research under this program’s definitions for funding purposes.

The CTRA is built for speed and readiness. Applicants must include preliminary data that directly supports the proposed clinical effort, and they must show a credible scientific rationale grounded in careful literature analysis. Study startup expectations are tight: enrollment is expected to begin within 9 months of the award date, so applications need to demonstrate real access to an appropriate patient population and a workable recruitment plan. The application must also include a strong statistical foundation, including a clearly described statistical analysis plan, appropriate statistical expertise on the team, and a power analysis with sample size estimates that align with the study objectives.

Because the goal is translation rather than an endpoint publication, applications must include a Transition Plan that explains what happens after the project ends. That plan should lay out how the resulting product, protocol, or evidence base will move into the next clinical phase and/or toward delivery to the market, including anticipated funding sources and resources needed to continue. If the work is a clinical trial, the study must be registered on ClinicalTrials.gov before it begins. Funded clinical trials must also post a copy of the IRB-approved informed consent form on a publicly available federal website, consistent with federal human subjects transparency requirements (referenced as 32 CFR 219).

There are specific regulatory triggers for trials involving drugs or devices. If a clinical trial uses a drug that is not FDA-approved for the proposed investigational use, an Investigational New Drug (IND) application may be required, and it must be submitted to FDA within 60 calendar days of the award date. Similarly, if the investigational product is a device, proof of an Investigational Device Exemption (IDE) submission to FDA within 60 days is required, unless the device is exempt or qualifies for an abbreviated IDE. If an IND or IDE already exists, applicants should provide FDA acceptance documentation. The government can withdraw funding if an IND/IDE is required but not submitted on time, or if documented status is not obtained within the required window.

From an award structure standpoint, the DoD will issue assistance agreements, which can be either grants or cooperative agreements. Which one is used depends on how involved the DoD expects to be during performance: minimal agency involvement typically leads to a grant, while substantial involvement (such as active collaboration or participation) leads to a cooperative agreement. The final instrument type and start date are set during negotiations, and any substantial DoD involvement will be spelled out in the award terms.

On funding and scale, the anticipated maximum total cost per project for the full period of performance is up to $2 million. Program-wide, CDMRP planned about $4 million total to support roughly two awards under this announcement, subject to federal fund availability and the results of scientific and programmatic review. Awards were expected to be made by September 30, 2024, using FY23 funds, which are available for obligation and use within the federal timelines described (with the funding availability window extending through September 30, 2029).

Human subjects oversight is a major operational element. In addition to local Institutional Review Board (IRB) or Ethics Committee review, all DoD-funded work involving human data, human anatomical substances, human subjects, or human cadavers must go through USAMRDC’s Office of Human and Animal Research Oversight, specifically the Office of Human Research Oversight (OHRO), before research can begin. Local IRB approval is not required at the time of application submission, but it is required before OHRO review can occur. The announcement advises applicants to plan for up to three months for OHRO’s regulatory review after complete documentation is submitted. For multi-institutional studies, applicants must provide a plan for a single IRB arrangement (either at submission or during negotiations), identify the lead institution, and clarify who will manage the master protocol, master consent, and regulatory submissions. If the project relies on DoD or VA populations, resources, or databases, the application must describe access up front and include a plan to maintain that access throughout the project.

Finally, the program places value on sharing outputs. CDMRP’s intent is that data, information, and research resources generated through funded awards be made available to the broader research community and the public, consistent with the program’s guidance. Overall, the CTRA is structured to fund clinically ready, human-focused burn research that can start quickly, is statistically and operationally sound, meets strict regulatory expectations, and is clearly positioned to improve frontline and early-phase burn care where military and disaster-response constraints are most acute.

• 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 Military Burn, Clinical 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 26, 2023.
• Applicants must submit their applications by Sep 04, 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 2 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.

Apply for HT9425 23 MBRP CTRA

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