DoD Military Burn Injuries Research Award

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The MBRP Burn Injuries Research Award is being offered for the first time in FY15. The FY15 MBRP Burn Injuries Research Award is focused on specific research topics related to the treatment of traumatic burn injuries that are relevant to military personnel. Awards funded by the Burn Injuries Research Award may not be used to support fundamental basic research. Basic research is defined as research directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards process or products in mind. The FY15 Burn Injuries Research Award is focused on applied research, defined as research that refines concepts and ideas into potential solutions to health and performance problems with a view toward evaluating technical feasibility; it includes studies and investigations leading to candidate solutions in preparation for initial human testing. Presentation of preliminary data is required. Inclusion of preliminary and/or published data relevant to the research question is required. In addition, investigators must demonstrate logical reasoning. To be competitive, the application must include a sound scientific rationale and a well-formulated, testable hypothesis established through a critical review and analysis of the literature. Clinical trials are allowed. Applications for promising pharmaceutical or biologic candidates and medical devices and technologies may be selected for initial safety and efficacy testing in small scale human clinical trials. A clinical trial is defined as a prospective accrual of human subjects where an intervention (e.g., device, drug, biologic, surgical procedure, rehabilitative modality, behavioral intervention or other) is tested on a human subject for a measurable outcome with respect to exploratory information, safety, effectiveness, and/or efficacy. This outcome represents a direct effect on the human subject of that intervention or interaction. The term “human subjects” is used in this Program Announcement/Funding Opportunity to refer to individuals who will be recruited for or who will participate in the proposed clinical trial. For more information, a Human Subject Resource Document is provided at https://ebrap.org/eBRAP/public/Program.htm. Research Scope: Research proposed under the FY15 MBRP Burn Injuries Research Award may include small- to large-scale projects such as efficacy studies, effective comparison studies, human use, observational studies, clinical trial development, and clinical trials. These awards are expected to yield potential health products, approaches, or technologies positioned for human testing. Applications may include Phase I or early Phase II clinical trials, but not late Phase II or Phase III, large-scale effectiveness clinical trials or advanced development of products and capabilities. Activities allowed under the FY15 Burn Injuries Research Award may include, but are not limited to: • Refinement of concepts and ideas into potential solutions with a view toward evaluating technical feasibility of emerging approaches, technologies, and promising new products • Evaluation, maturation, and/or down-selection of potential product candidates (drugs, biologic/vaccine constructs, or devices/systems) in vitro and/or in vivo • Conducting preclinical safety and/or toxicity studies • Preparation activities needed to support a future clinical trial or regulatory submission • Clinical trials (Phase I or Phase IIa)

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