DoD, Defense Medical Research and Development Program, Trauma Immunology Research Award

The Trauma Immunology Research Award (TIRA) will support basic and applied research and early-stage development of materiel and knowledge products to address critical gaps in the understanding of immune system, immune response, immune function, and other associated host responses in combat injuries, in particular, severe polytrauma as encountered in the operational environment. Polytrauma is defined as two or more injuries to physical regions or organ systems, one of which may be life-threatening, resulting in physical, cognitive, psychological, or psychosocial impairments and functional disability (https://www.polytrauma.va.gov/ understanding-tbi/definition-and-background.asp). Specifically, the research that supports the understanding of inflammation, immune responses, and other host reactions at and post trauma as well as associated potential treatments represents key priorities for the CCCRP1.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 FY23 DMRDP Trauma Immunology Research Award should not exceed $2.0M. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.Awards will be made no later than September 30, 2024. For additional information refer to Section II.F.1, Federal Award Notices.The CCCRP expects to allot approximately $10.0M to fund approximately five FY23 DMRDP TIRA 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 FY23 funding opportunity will be funded with FY23 funds, which will expire for use on September 30, 2029.Research Involving Human Data, Human Anatomical Substances, or Human Cadavers: All DOD-funded research involving new and ongoing research with human data, human anatomical substances, or human cadavers must be reviewed and approved by the USAMRDC Office of Human and Animal Research Oversight (OHARO), Office of Human Research Oversight (OHRO), 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 application submission is not required; however, local IRB/EC approval is necessary prior to OHRO review. Allow up to 3 months to complete the OHRO regulatory review and approval process following submission of all required and complete documents to the OHRO. Refer to the General Application Instructions, Appendix 1, and the OHARO web page https://mrdc.health.mil/index.cfm/collaborate/research_ protections/hrpo for additional information.Research involving animals, human anatomical substances, and human data is permitted; however, this award may not be used to conduct prospectively enrolled human subject clinical trials or clinical research.Clinical trials are not allowed under this mechanism. 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 a placebo or another control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.Clinical research conducted with prospectively enrolled human subjects is not allowed under this mechanism. Clinical research encompasses research with patient samples, data, and interaction with patients that may or may not be considered a clinical trial. For the purposes of this funding opportunity, research that meets the definition of a clinical trial is distinct from clinical research. Clinical research is observational in nature and includes: (1) Research that does not seek to evaluate the effects of interventions. Research conducted with human subjects (or on material of human origin such as data, tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects, but does not seek to assess the effects of an intervention, qualifies as clinical research. Patient-oriented research may include but is not limited to: (a) mechanisms of human disease, (b) diagnostic or detection studies (e.g., biomarker or imaging), (c) health disparity studies, and (d) development of new technologies. (2) Epidemiologic and behavioral studies that do not seek to study the safety, effectiveness, and/or efficacy outcomes of an intervention. (3) Outcomes research and health services research that do not fit under the definition of clinical trial. Excluded from the definition of clinical research are in vitro studies that utilize human tissues that cannot be linked to a living individual. Note: Studies that meet the requirements for exemption under §46.104(d)(4) of the Common Rule are not considered clinical research as defined by CDMRP. Exemption category 4 refers to secondary research for which consent is not required.Use of DOD or VA Resources: If the proposed research involves access to VA or DOD resources, or databases, the proposal/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. Note, the CDMRP will not serve as the government sponsor or signatory on any access applications or agreements for DOD or VA patient populations, resources, or databases.Access to certain DOD or VA patient samples, resources, or databases may only be obtained by collaboration with a DOD or VA investigator who has a substantial role in the research and may not be available to a non-DOD or non-VA investigator if the resource is restricted to DOD or VA personnel. Investigators should be aware of which resources are available to them if the proposed research involves a non-DOD or non-VA investigator collaborating with the DOD and/or VA. If the application is recommended for funding, the government reserves the right to withdraw or revoke funding until the Principal Investigator (PI) has demonstrated support for and access to the relevant population(s) and/or resource(s).Research Involving Animals: All research funded by the FY23 DMRDP TIRA involving new and ongoing research with animals must be reviewed and approved by the USAMRDC OHARO 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. Allow at least 3 to 4 months for ACURO regulatory review and approval processes for animal studies. Refer to the General Application Instructions, Appendix 1, for additional information.
Categories: Science and Technology and other Research and Development.