Opportunity Information: Apply for W81XWH 22 MBRP CTRA
The DoD Military Burn, Clinical Translational Research Award (CTRA) under the Congressionally Directed Medical Research Programs (CDMRP) Military Burn Research Program is designed to move strong, well-supported burn research findings into real-world clinical use as quickly as possible. The emphasis is on clinical research that can meaningfully improve burn care for injured patients, especially in the earliest parts of the care pathway such as point-of-injury treatment and the early acute phase after a burn. In practice, this mechanism is meant for studies that are ready to be implemented in clinical settings rather than exploratory lab work, and it prioritizes projects that could change clinical decision-making, improve outcomes, or accelerate adoption of better interventions and technologies.
A central feature of the award is demonstrated impact. Applications are expected to clearly explain the short- and long-term benefit of the proposed work and how it addresses one or more of the FY22 Military Burn Research Program Focus Areas. Competitive proposals are expected to rest on a solid scientific foundation, including a credible rationale backed by a critical assessment of existing evidence, logical reasoning, and a clear, testable hypothesis. Importantly, preliminary data that directly support the proposed clinical research are required, reflecting the program's preference for projects that are already mature enough to move into clinical evaluation.
Military relevance is not optional. Proposed studies must be tied to the needs of Service Members, Veterans, military beneficiaries, and/or the broader American public, with a clear explanation of why the burn problem being addressed matters in military contexts and how the results could meet a specific military need. The program strongly encourages collaborations that connect military or Veteran institutions with non-military partners, since those relationships can combine unique patient access, specialized infrastructure, operational knowledge, and data resources to strengthen the research and improve the odds of real-world adoption.
Only clinical research involving human subjects (or qualifying human-origin materials in the context of patient-oriented work) is eligible for funding under this mechanism, and animal research is explicitly not allowed. The opportunity supports a range of clinical study types, including clinical trials (including early proof-of-concept trials), prospective clinical studies, observational studies, studies using human anatomical substances, and certain retrospective analyses of clinical data repositories. At the same time, the program draws boundaries around what counts as clinical research for CDMRP purposes; for example, work that would fall under IRB Exemption 4 (research using existing, de-identified specimens or data that are publicly available) is not considered CDMRP-defined clinical research for this mechanism.
Because the program is oriented toward rapid execution and meaningful outcomes, there are several practical expectations built into the solicitation. Studies are expected to begin within 9 months of the award date, so applicants need to show they have a realistic operational path to launch. Applications must demonstrate access to an appropriate patient population to support valid, meaningful endpoints. They must also include a rigorous statistical analysis plan, appropriate statistical expertise on the team, and a power analysis that justifies the proposed sample size and demonstrates that the study can answer its primary objectives. In addition, applicants must provide a Transition Plan describing how the resulting product, intervention, or clinical approach will move forward after the award period, including likely next clinical steps and potential funding/resources to support progression toward broader clinical use and/or commercialization when relevant.
If the project includes a clinical trial, the award carries additional compliance requirements. Funded trials must be registered on ClinicalTrials.gov prior to initiation. Trials must also comply with federal requirements related to human subjects protections, including posting the IRB-approved informed consent form on a publicly available federal website as required under 32 CFR 219. Where investigational drugs or devices are involved, the program sets specific timelines and documentation expectations: if an Investigational New Drug (IND) or Investigational Device Exemption (IDE) is required, the recipient may need to submit the IND or provide evidence of IDE submission to the FDA within 60 calendar days of the award date (or provide documentation that the product is exempt or qualifies for an abbreviated IDE). If an IND or IDE is necessary and the awardee does not meet these requirements within the stated timeframe, the government reserves the right to withdraw funding.
From an oversight and regulatory standpoint, all DoD-funded research involving human subjects, human anatomical substances, or human cadavers must undergo review by the US Army Medical Research and Development Command (USAMRDC) Human Research Protection Office (HRPO) before research can begin. This HRPO review is in addition to local IRB or Ethics Committee review. Local IRB approval is not required at the time of application submission, but applicants should plan for the HRPO process, which can take up to about three months once a complete regulatory package is submitted. For multi-institutional studies, applicants must provide a plan for single IRB arrangements, identify the lead institution responsible for the master protocol and consent, and clarify the regulatory coordination approach.
Applicants proposing to use DoD or VA resources, databases, or patient populations must describe their access plans in the application and explain how access will be maintained throughout the study. The program also encourages alignment with DoD and/or VA laboratories and research programs to strengthen military relevance and feasibility. Finally, the DoD signals an expectation that information, data, and research resources generated through funded projects should be made available to the broader research community and the public, consistent with CDMRP data sharing expectations.
On the funding and award structure side, this opportunity uses assistance agreements, meaning awards will be made as either grants or cooperative agreements depending on the anticipated level of DoD involvement during performance. If no substantial federal involvement is expected, a grant is used; if substantial involvement is anticipated (for example, ongoing collaboration or participation by the agency), a cooperative agreement is used. The anticipated total cost ceiling per award for the full period of performance is up to $2.21 million, and the program expected to allocate roughly $4.42 million total to make about two awards. The original FY22 opportunity was posted by the Department of Defense (USAMRAA) with an original closing date of October 11, 2022, and awards were expected to be made by September 30, 2023, with FY22 funds available for use for a limited period (anticipated to expire for use on September 30, 2028).Apply for W81XWH 22 MBRP CTRA
- 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 May 20, 2022.
- Applicants must submit their applications by Oct 11, 2022. (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.
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FAQs: DoD Military Burn, Clinical Translational Research Award (CTRA) - CDMRP Military Burn Research Program (FY22)
What is the purpose of the Military Burn Clinical Translational Research Award (CTRA)?
The CTRA is designed to move strong, well-supported burn research findings into real-world clinical use as quickly as possible. It emphasizes clinical research that can meaningfully improve burn care for injured patients, with a particular focus on early care such as point-of-injury treatment and the early acute phase after a burn.
What kinds of projects are a good fit for this award?
Projects that are ready to be implemented in clinical settings rather than exploratory laboratory work are the intended fit. The mechanism prioritizes research that could change clinical decision-making, improve patient outcomes, and/or accelerate adoption of better interventions and technologies in burn care.
Is exploratory or basic laboratory research eligible under this mechanism?
No. The CTRA is intended for clinically ready work and is not aimed at exploratory lab studies. The solicitation requires clinical research and explicitly disallows animal research.
Does the program require the project to address specific focus areas?
Yes. Applications are expected to describe impact and explain how the work addresses one or more FY22 Military Burn Research Program Focus Areas.
What does the program mean by "demonstrated impact"?
The application is expected to clearly explain both short- and long-term benefits of the proposed work and why the results would matter in practice. Competitive proposals should show the potential to improve care, influence clinical decisions, or speed adoption of improved approaches.
Are preliminary data required?
Yes. Preliminary data that directly support the proposed clinical research are required. This reflects the program preference for projects that are mature enough to move into clinical evaluation.
What level of scientific rationale is expected in the application?
The solicitation expects a solid scientific foundation, including a credible rationale supported by a critical assessment of existing evidence, logical reasoning, and a clear, testable hypothesis.
Is military relevance required?
Yes. Military relevance is not optional. Proposed studies must be tied to the needs of Service Members, Veterans, military beneficiaries, and/or the broader American public, and must explain why the burn problem matters in military contexts and how the results could meet a specific military need.
Are collaborations encouraged, and if so, what kind?
Yes. The program strongly encourages collaborations that connect military or Veteran institutions with non-military partners. The stated goal is to combine complementary strengths such as patient access, specialized infrastructure, operational knowledge, and data resources to strengthen the research and improve adoption potential.
What types of research are eligible (human subjects, data studies, etc.)?
Only clinical research involving human subjects (or qualifying human-origin materials in patient-oriented work) is eligible. The program supports several clinical study types, including clinical trials (including early proof-of-concept trials), prospective clinical studies, observational studies, studies using human anatomical substances, and certain retrospective analyses of clinical data repositories.
Is animal research allowed?
No. Animal research is explicitly not allowed under this mechanism.
Are studies using only existing, de-identified, publicly available data considered eligible clinical research?
Not under this mechanism. The solicitation notes that work falling under IRB Exemption 4 (research using existing, de-identified specimens or data that are publicly available) is not considered CDMRP-defined clinical research for this award.
How quickly must the study begin after award?
Studies are expected to begin within 9 months of the award date. Applicants need to show a realistic operational path to launch within that timeline.
Do applicants need to demonstrate access to patients?
Yes. Applications must demonstrate access to an appropriate patient population sufficient to support valid, meaningful endpoints.
What statistical planning is required?
Applications must include a rigorous statistical analysis plan, appropriate statistical expertise on the team, and a power analysis that justifies the proposed sample size and shows the study can answer its primary objectives.
What is the Transition Plan, and what should it cover?
The application must include a Transition Plan describing how the resulting product, intervention, or clinical approach will move forward after the award period. This includes likely next clinical steps and potential funding or resources to support progression toward broader clinical use and/or commercialization when relevant.
What extra requirements apply if the project includes a clinical trial?
Clinical trials funded under this award must be registered on ClinicalTrials.gov prior to initiation. Trials must also comply with federal human subjects requirements, including posting the IRB-approved informed consent form on a publicly available federal website as required under 32 CFR 219.
What are the IND/IDE expectations if an investigational drug or device is involved?
If an IND or IDE is required, the recipient may need to submit the IND or provide evidence of IDE submission to the FDA within 60 calendar days of the award date, or provide documentation that the product is exempt or qualifies for an abbreviated IDE. If these requirements are not met within the stated timeframe when an IND/IDE is necessary, the government reserves the right to withdraw funding.
What oversight applies to DoD-funded human subjects research under this program?
All DoD-funded research involving human subjects, human anatomical substances, or human cadavers must undergo review by the USAMRDC Human Research Protection Office (HRPO) before research can begin. This HRPO review is in addition to local IRB or Ethics Committee review.
Is local IRB approval required at the time of application submission?
No. Local IRB approval is not required at the time of application submission. However, applicants are expected to plan for the HRPO process prior to starting the research.
How long can the HRPO review process take?
The HRPO review can take up to about three months once a complete regulatory package is submitted, based on the solicitation description.
What is required for multi-institutional studies in terms of IRB arrangements?
For multi-institutional studies, applicants must provide a plan for single IRB arrangements, identify the lead institution responsible for the master protocol and consent, and clarify the regulatory coordination approach.
What if a project plans to use DoD or VA resources, databases, or patient populations?
Applicants must describe their access plans in the application and explain how access will be maintained throughout the study when proposing to use DoD or VA resources, databases, or patient populations.
Does the program encourage alignment with DoD and/or VA laboratories or research programs?
Yes. The solicitation encourages alignment with DoD and/or VA laboratories and research programs to strengthen military relevance and feasibility.
Are there expectations for data and resource sharing?
Yes. The DoD signals an expectation that information, data, and research resources generated through funded projects should be made available to the broader research community and the public, consistent with CDMRP data sharing expectations.
What type of funding instrument will be used (grant vs cooperative agreement)?
Awards are made as assistance agreements, meaning they will be either grants or cooperative agreements depending on anticipated DoD involvement during performance. If no substantial federal involvement is expected, a grant is used; if substantial involvement is anticipated, a cooperative agreement is used.
What is the maximum funding amount per award?
The anticipated total cost ceiling per award for the full period of performance is up to $2.21 million.
How many awards and how much total funding were anticipated?
The program expected to allocate roughly $4.42 million total to make about two awards.
Who posted the opportunity and under what program?
The opportunity was posted by the Department of Defense (USAMRAA) under the Congressionally Directed Medical Research Programs (CDMRP) Military Burn Research Program.
What were the original closing date and expected award timing for the FY22 opportunity?
The original closing date was October 11, 2022, and awards were expected to be made by September 30, 2023.
How long were FY22 funds expected to remain available for use?
FY22 funds were described as available for use for a limited period, anticipated to expire for use on September 30, 2028.
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