DoD Military Burn, Clinical Translational Research Award | W81XWH 21 MBRP CTRA

Opportunity Information: Apply for W81XWH 21 MBRP CTRA

The DoD Military Burn, Clinical Translational Research Award (CTRA) under the Military Burn Research Program (MBRP) is a funding opportunity aimed squarely at improving real-world care for people with burn injuries, with a clear emphasis on near-term and practical clinical impact. The core idea is to move promising, well-supported findings into clinical practice for burn patients, especially in the earliest stages of care, such as at the point-of-injury or during the acute phase immediately afterward. The program places heavy weight on impact: applications are expected to spell out how the work could change patient care in the short term and how it could move the field forward over the long term, specifically in alignment with the FY21 MBRP Focus Area. Projects that can be scaled for mass casualty situations are particularly attractive, reflecting the military reality of austere environments and surge events where burn care must be delivered quickly, consistently, and at scale.

This award mechanism is limited to clinical research and clinical trials only. That means proposals must involve human subjects research and can include early proof-of-concept clinical trials, prospective studies that involve human anatomical substances, observational studies, and projects that also use some retrospective analysis of clinical data repositories, as long as the overall effort qualifies as clinical research under the program definitions. Importantly, studies that only use existing publicly available, de-identified specimens or data in a way that falls under IRB Exemption 4 do not count as CDMRP-defined clinical research for this mechanism. If the project is a clinical trial, it must fit the standard definition of prospectively assigning human participants to one or more interventions to measure effects on health-related outcomes. Animal work is not allowed; the budget must support clinical research involving human subjects rather than preclinical experimentation.

Competitive applications are expected to look like mature, ready-to-launch clinical studies rather than exploratory concepts. The announcement calls for a sound scientific rationale grounded in critical literature review, logical reasoning, and a clear, testable hypothesis. Preliminary data relevant to the proposed clinical research is required, which signals that the DoD wants applicants to demonstrate feasibility and reduce scientific risk. Proposals also need to show practical readiness: investigators should demonstrate access to an appropriate patient population sufficient to produce meaningful results, and the study is expected to begin within 12 months of the award date. Statistical rigor is a required centerpiece, including a clearly described statistical analysis plan, appropriate statistical expertise on the team, and a power analysis that supports the proposed sample size and endpoints.

Military relevance is a non-negotiable feature. The proposed work must be relevant to Service Members, Veterans, military beneficiaries, and/or the broader American public, and applicants are strongly encouraged to build collaborations that connect military or Veteran institutions with non-military partners. The intent is to combine strengths such as military/VA patient access, specialized clinical infrastructure, unique datasets, and operational experience with academic or industry expertise in trial design, technology development, or analytics. If the work relies on Department of Defense or Department of Veterans Affairs patient populations, databases, or other resources, the application must explain how access is secured at submission and how it will be maintained throughout the study.

From an award structure standpoint, funding is issued as an assistance agreement, which can be either a grant or a cooperative agreement depending on how much involvement the DoD anticipates having during the project. If there is no substantial federal involvement, a grant is used; if the DoD expects to collaborate or participate in a substantial way, a cooperative agreement is used, and the specific areas of involvement are spelled out during award negotiations. The anticipated total cost cap is up to $1.5 million per award for the full period of performance. For FY21, the program anticipated about $6.0 million total to support roughly four awards, with final funding dependent on federal availability and the results of scientific and programmatic review. Awards were expected to be made by September 30, 2022, and FY21 funds tied to awards were expected to remain available for obligation within a limited window, with an expiration for use noted as September 30, 2027.

The opportunity also builds in substantial regulatory and transparency expectations that are typical of DoD human subjects research. All DoD-funded research involving human subjects, human anatomical substances, or human cadavers must undergo review by the USAMRDC Office of Research Protections, Human Research Protection Office (HRPO), in addition to local IRB or Ethics Committee review. Local IRB approval is not required at the time of submission, but applicants should plan for HRPO review timelines and are advised to allow at least three months for HRPO regulatory review and approval before research begins. For projects involving clinical trials, registration on ClinicalTrials.gov is required prior to study initiation. In addition, funded trials must publicly post the IRB-approved informed consent form used to enroll participants, consistent with federal requirements under 32 CFR 219.

For multi-institutional studies, the announcement requires applicants to describe how the collaboration will be governed and how the protocol will be managed across sites. Consistent with the Common Rule requirements for cooperative research, U.S.-based multi-site studies must rely on a single IRB, so the proposal must name the single IRB and provide a plan for the single IRB review process. The application must also identify a lead institution responsible for the master protocol and informed consent document and serving as the central point of contact for regulatory submissions. Practical operational details are expected, including plans for communication and data transfer among institutions, specimen or imaging handling, and a separate intellectual and material property plan agreed to by all participating institutions.

Finally, the DoD signals a strong expectation that data and research resources generated through funded projects will be shared in ways that benefit the wider research community and the public. Alongside the required Transition Plan, this reflects the program goal of not just completing a study, but moving successful interventions, tools, or practices into the next clinical phase and ultimately toward broader implementation, whether that means follow-on trials, integration into burn care workflows, or movement toward a deployable or market-ready product.

• 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 29, 2021.
• Applicants must submit their applications by Sep 30, 2021. (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 4 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 W81XWH 21 MBRP CTRA

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