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#### W81XWH-21-MBRP-CTRA

The MBRP CTRA is intended to support human research projects that are likely to have a major impact on patient 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 acute phase of injury.Impact is a key component of this award mechanism. The potential impact of the research, both short-term and long-term, in addressing the FY21 MBRP Focus Area should be clearly described. High-impact research will, if successful, significantly advance the burn research field and the care of burn-injured patients. Burn care interventions or projects scalable to mass casualty events are of particular interest to the MBRP. To be competitive the application must include a sound scientific rationale, logical reasoning, and a well-formulated, testable hypothesis.The proposed research must be relevant to Service Members, Veterans, military beneficiaries, and/or the American public. Collaborations 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.Only Clinical Research and/or Clinical Trials will be considered for funding under this mechanism.Applications to the FY21 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; and (3) outcomes research and health services research. Note: 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 Institutional Review Board (IRB)-approved informed consent form used to enroll subjects on a publicly available federal website in accordance with federal requirements described in Code of federal Regulations, Title 32, Part 219 (32 CFR 219).Funding from this award mechanism must support clinical research involving human subjects; animal research is not allowed under this funding opportunity.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 Department of Defense (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 FY21 MBRP award will not exceed $1.5M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2022. For additional information refer to Section II.F.1, Federal Award Notices.The CDMRP expects to allot approximately$6.0M to fund approximately four MBRP CTRA 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 FY21 funding opportunity will be funded with FY21 funds, which will expire for use on September 30, 2027.The following are important aspects of the 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 12 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 FY21 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.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 U.S. Army Medical Research and Development Command (USAMRDC) Office of Research Protections (ORP), 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 a minimum of 3 months for HRPO regulatory review and approval processes. Refer to the General Application Instructions, Appendix 1, and the Human Subject Resource 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 clinical study is multi-institutional, plans for the multi-institutional structure governing the research protocol(s) should be outlined.In accordance with §.114 of the Federal Policy for the Protection of Human Subjects (the Common Rule), any institution located in the United States engaged in cooperative research (i.e., research involving more than one institution) must rely upon approval by a single IRB for the portion of that research that is conducted in the United States (except as specified in §.114(2)(i)). The awardee/offeror must designate a single IRB and include a plan for the single IRB review process in the proposal submission. Additionally, the proposal must identify the lead institution responsible for developing the master protocol and informed consent document and that will serve as the single point of contact for regulatory submissions and requirements. The master protocol and consent form must be reviewed by the HRPO prior to distribution to the additional sites for IRB/EC review. Communication and data transfer between or among the collaborating institutions, as well as how specimens and/or imaging products obtained during the study will be handled, should be included in the appropriate sections of the application. A separate intellectual and material property plan agreed upon by all participating institutions is also required for multi-institutional clinical studies.Use of DOD or Department of Veterans Affairs (VA) Resources: If the proposed research involves access to active-duty military or Veteran 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 submission requirements. Refer to the General Application Instructions, Appendix 1, Section C for additional detailed information.Encouraged DOD and/or VA Collaboration and Alignment: Military relevance is a key feature of this award. Therefore, 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.
Categories: Science and Technology and other Research and Development.
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