The MBRP CTRA is intended to support the rapid implementation of clinical research (including clinical trials) with the potential to significantly impact burn care by applying promising and well-founded research findings to the care of the burn-injured patient, particularly at the point-of-injury, or
during the early, acute phase of burn injury.
The overall impact of the proposed research is a key component of this award mechanism.
The potential impact of the research, both short-term and long-term, in addressing one or more of the FY22 MBRP Focus Areas should be clearly described.
High-impact clinical research will, if successful, significantly advance the burn research field and the care of burn-injured patients.
To be competitive, the application must include a sound scientific rationale, logical reasoning, and a well-formulated, testable hypothesis.Relevance to Military Health:
The proposed research must be relevant to Service Members, Veterans, military beneficiaries, and/or the American public.
Investigators are encouraged to consider the following characteristics as examples of how a project may demonstrate relevance to military health:• Explanation of how the project addresses an aspect of burn injuries relevant to the military• Description of how the results of the proposed research will address a military needCollaborations between researchers at military or Veteran institutions and non-military institutions are strongly encouraged.
These relationships can leverage knowledge, infrastructure, and access to unique data and research resources that the partners bring to the research effort, ultimately advancing burn research which is of significance to the Service Member, military families, and the American public.Inclusion of preliminary data relevant to the proposed clinical research is required.The following are important aspects of the FY22 MBRP CTRA:• The proposed clinical research study must be based on sound scientific rationale that is established through logical reasoning and critical review and analysis of the literature.• The proposed clinical research study is expected to begin no later than 9 months after the award date.• The application should demonstrate availability of, and access to, a suitable patient population that will support a meaningful outcome for the study.• The application should include a clearly articulated statistical analysis plan, appropriate statistical expertise on the research team, and a power analysis reflecting sample size projections that will answer the objectives of the study.• The application should include a Transition Plan (including potential funding and resources) showing how the product will progress to the next clinical phase and/or delivery to the market after the successful completion of the FY22 MBRP CTRA.• Funded studies that contain clinical trials are required to register the study in the National Institutes of Health (NIH) clinical trials registry, www.clinicaltrials.gov, prior to initiation of the study.
Refer to the General Application Instructions, Appendix 1, Section C, for further details.
• If proposing a clinical trial that involves the use of a drug that has not been approved by the Food and Drug Administration (FDA) for the proposed investigational use, an Investigational New Drug (IND) application to the FDA that meets all requirements under the Code of Federal Regulations, Title 21, Part 312 (21 CFR 312) may be required and must be submitted to the FDA within 2 months (60 calendar days) of the award date.
The IND should be specific for the product (i.e., the product should not represent a derivative or alternate version of the investigational agent described in the IND) and indication to be tested in the proposed clinical trial.• If the investigational product is a device, evidence that an Investigational Device Exemption (IDE) application that meets all requirements under 21 CFR 812 has been submitted to the FDA within 2 months (60 calendar days) of the award date, or that the device is exempt or qualifies for an abbreviated IDE, is required.
The IDE should be specific for the device (i.e., should not represent a derivative or modified version of the device described in the IDE application) and indication to be tested in the proposed clinical trial.• If an IND or IDE has already been obtained for the investigational product, provide a copy of the acceptance from the FDA.
The government reserves the right to withdraw funding if an IND or IDE is necessary but has not been submitted to the FDA within 2 months (60 calendar days) of the award date, or if documented status of the IND or IDE has not been obtained within 2 months (60 calendar days) of the award date.Only clinical research and/or clinical trials will be considered for funding under this mechanism.Funding from this award mechanism must support clinical research involving human subjects; animal research is not allowed under this funding opportunity.Applications to the FY22 MBRP CTRA must include clinical research, and may include initial proof of concept clinical trials, prospective studies involving use of human anatomical substances, observational studies, and/or involve some retrospective analysis of clinical data repositories.A clinical research study is defined as:
(1) Patient-oriented research.
Research conducted with human subjects (or on material of human origin such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects.
Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual.
Patient-oriented research includes:
(a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, and (d) development of new technologies.
(2) Epidemiologic and behavioral studies.
(3) Outcomes research and health services research.
Studies that meet the requirements for Institutional Review Board (IRB) Exemption 4 are not considered CDMRP-defined clinical research.
IRB Exemption 4 refers to research involving the collection or study of existing de-identified specimens or data, if these sources are publicly available.A clinical trial is defined as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm.Funded trials are required to post a copy of the IRB-approved informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in 32 CFR 21 9. The types of awards made under the program announcement will be assistance agreements.
An assistance agreement is appropriate when the federal government transfers a “thing of value” to a “state, local government,” or “other recipient” to carry out a public purpose of support or stimulation authorized by a law of the United States instead of acquiring property or service for the direct benefit and use of the U. S. government.
An assistance agreement can take the form of a grant or cooperative agreement.
The level of involvement on the part of the DOD during project performance is the key factor in determining whether to award a grant or cooperative agreement.
If “no substantial involvement” on the part of the funding agency is anticipated, a grant award will be made (31 USC 6304).
Conversely, if substantial involvement on the part of the funding agency is anticipated, a cooperative agreement will be made (31 USC 6305), and the award will identify the specific substantial involvement.
Substantial involvement may include, but is not limited to, collaboration, participation, or intervention in the research to be performed under the award.
The award type, along with the start date, will be determined during the negotiation process.The anticipated total costs budgeted for the entire period of performance for an FY22 MBRP CTRA Award will not exceed $ 2. 21M.
Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 202 3. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately $ 4. 42M to fund approximately two Clinical Translational Research Award applications.
Funding of applications received is contingent upon the availability of federal funds for this program as well as the number of applications received, the quality and merit of the applications as evaluated by scientific and programmatic review, and the requirements of the government.
Funds to be obligated on any award resulting from this funding opportunity will be available for use for a limited time period based on the fiscal year of the funds.
It is anticipated that awards made from this FY22 funding opportunity will be funded with FY22 funds, which will expire for use on September 30, 202 8. Research Involving Human Anatomical Substances, Human Subjects, or Human Cadavers:
All DOD-funded research involving new and ongoing research with human anatomical substances, human subjects, or human cadavers must be reviewed and approved by the USAMRDC Office of Research Protections, Human Research Protection Office (HRPO), prior to research implementation.
This administrative review requirement is in addition to the local IRB or Ethics Committee (EC) review.
Local IRB/EC approval at the time of submission is not required.
Allow up to 3 months to complete the HRPO regulatory review and approval process following submission of all required and complete documents to the HRPO.
Refer to the General Application Instructions, Appendix 1, and the Human Research Protections Office Resources and Overview document available on the electronic Biomedical Research Application Portal (eBRAP) “Funding Opportunities & Forms” web page (https://ebrap.org/eBRAP/public/Program.htm) for additional information.Multi-Institutional Clinical Studies:
If the proposed research involves more than one institution, a written plan for single IRB review arrangements must be provided at the time of application submission or award negotiation.
The lead institution responsible for developing the master protocol and master consent form should be identified and should be the single point of contact for regulatory submissions and requirements.Use of DOD or Department of Veterans Affairs (VA) Resources:
If the proposed research involves access to active-duty military or VA patient populations and/or DOD or VA resources or databases, the application must describe the access at the time of submission and include a plan for maintaining access as needed throughout the proposed research.
Refer to Section II.D.
2. b.ii, Full Application Submission Components, for detailed information.
Refer to the General Application Instructions, Appendix 1, for additional information.Encouraged DOD and/or VA Collaboration and Alignment:
Military relevance is a key feature of this award.
Therefore, Principal Investigators (PIs) are encouraged to collaborate, integrate, and/or align their projects with military and/or VA research laboratories and programs.
Although not a comprehensive list, Appendix 2 lists websites that may be useful in identifying information about DOD and VA areas of research interest, ongoing research, or potential opportunities for collaboration.The CDMRP intends that information, data, and research resources generated under awards funded by this program announcement be made available to the research community (which includes both scientific and consumer advocacy communities) and to the public at large.
For additional guidance, refer to the General Application Instructions, Appendix 2, Section K.