DOD Military Burn - Idea Development Award

Description

The MBRP Idea Development Award (IDA) mechanism is being offered for the first time in FY19. The intent of the FY19/20 MBRP IDA is to support highly impactful and military relevant research in the field of burn wound care. Applications proposing applied research DoD FY19/20 Military Burn Idea Development Award 4 and/or preclinical research will be considered for funding. Fundamental basic research and clinical studies will not be considered for funding. Burns have comprised some 5%-20% of the casualties sustained in post-World War II conflicts.1 Potential future conflicts may cause a rise in the number of burn injuries sustained by Service members and the general public should those conflicts occur in rural areas, austere combat zones, and in mass casualty events, whereby medical resources are limited and/or access to medical care is delayed for hours, days, or weeks. In order to prepare the military and the Nation for such potential future conflicts, the FY19/20 MBRP is soliciting research to provide burn care solutions closer to the point of injury for the pre-hospital setting and for a prolonged field care scenario. The North Atlantic Treaty Organization (NATO) defines prolonged field care (PFC) as field trauma care extended beyond doctrinal timelines until the patient can be transported from the point of injury to an appropriate level of care. PFC has been identified as a high priority capability gap across the Army and other Services. Additional information regarding PFC can be found in the following articles, Prolonged Field Care: Beyond the ‘Golden Hour’2 and Prolonged Field Care the New Normal says Army, MRMC Brass.3 Although encouraged, applications submitted to the FY19/20 MBRP IDA are not required to address PFC. However, the proposed research must be relevant to active duty Service members and/or Veterans. Outcomes of funded projects are expected to also benefit military beneficiaries and the American public. Inclusion of preliminary and/or published data relevant to the proposed research is required. To be competitive, the application must include a sound scientific rationale, logical reasoning, and a well-formulated, testable hypothesis. The anticipated total costs budgeted for the entire period of performance for an FY19/20 MBRP IDA will not exceed $500,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information. The CDMRP expects to allot approximately $2M of the FY19 MBRP appropriation to fund approximately four (4) FY19/20 MBRP IDA applications. In addition, up to $2M of the FY20 MBRP appropriation may be available to fund an additional four (4) FY19/20 MBRP IDA applications, if appropriated. 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 funding opportunity will be funded with FY19 and FY20 MBRP funds, which must be obligated by September 30, 2020, and September 30, 2021, respectively. Awards will be made no later than September 30, 2021. For additional information, refer to Section II.F.1, Federal Award Notices. The types of awards made under the Program Announcement will be assistance agreements (grants or cooperative agreements). 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. An assistance agreement (grant or cooperative 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. 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 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. Awards 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 fact without specific applications toward process or products in mind. Clinical trials are not allowed and will not be considered. New FY19 definition: A clinical trial is 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. These outcomes represent a direct effect on the subject of that intervention or interaction. Investigators seeking support to conduct clinical research or early phase clinical trials should consider the FY19/20 MBRP Clinical Translational Research Award Program Announcement. Research Involving Animals: All DoD-funded research involving new and ongoing research with animals must be reviewed and approved by the U.S. Army Medical Research and Materiel Command (USAMRMC) Office of Research Protections (ORP) Animal Care and Use Review Office (ACURO), in addition to the local Institutional Animal Care and Use Committee (IACUC) of record. IACUC approval at the time of submission is not required. Specific documents relating to the use of animals in the proposed research will be requested if the application is selected for funding. The ACURO must review and approve all animal use prior to the start of working with animals, including amendments to ongoing projects. PIs must submit the institutional animal use protocol, IACUC approval of that protocol, and a version of the animal use appendix titled, “Research Involving Animals.” Allow at least 2 to 3 months for ACURO regulatory review and approval processes for animal studies. Refer to the General Application Instructions, Appendix 1, for additional information. 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 USAMRMC ORP, Human Research Protection Office (HRPO), prior to research implementation. This administrative review requirement is in addition to the local Institutional Review Board (IRB) or Ethics Committee (EC) review. Local IRB/EC approval at the time of submission is not required. The HRPO is mandated to comply with specific laws and requirements governing all research involving human anatomical substances, human subjects, or human cadavers that is supported by the DoD. These laws and requirements will necessitate information in addition to that supplied to the IRB/EC. Allow a minimum of 2 to 3 months for HRPO regulatory review and approval processes. Additional time for regulatory reviews may be needed for clinical studies taking place in international settings. When possible, protocols should be written for research with human subjects and/or human anatomical substances that are specific to the DoD-supported effort outlined in the submitted application as a stand-alone study. Submission to HRPO of protocols involving more than the scope of work in the DoD-funded award will require HRPO review of the entire protocol (DoD and non-DoD funded). DoD human subjects protection requirements may be applied to non-DoD funded work and necessitate extensive revisions to the protocol. 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. Use of DoD or Department of Veterans Affairs (VA) Resources: If the proposed research involves access to active duty military patient populations and/or DoD 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. Access to target active duty military patient population(s) and/or DoD resource(s) or database(s) should be confirmed by including a letter of support, signed by the lowest-ranking person with approval authority. If the proposed research involves access to VA patient populations, VA study resources and databases, and/or VA research space and equipment, VA Principal Investigators (PIs)/Co-PIs must have a plan for obtaining and maintaining access throughout the proposed research. Access to VA patients, resources, and/or VA research space should be confirmed by including a letter of support from the VA Facility Director(s) or individual designated by the VA Facility Director(s), such as the Associate Chief of Staff for Research and Development (ACOS/R&D) or Clinical Service Chief. If appropriate, the application should identify the VA-affiliated non-profit corporation (NPC) as the applicant institution for VA PIs. If the VA NPC is not identified as the applicant institution for administering the f

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