DoD, Defense Medical Research and Development Program, Trauma Immunology Research Award | HT9425 23 DMRDP TIRA

Opportunity Information: Apply for HT9425 23 DMRDP TIRA

The FY23 Department of Defense (DoD) Defense Medical Research and Development Program (DMRDP) Trauma Immunology Research Award (TIRA) is a discretionary research funding opportunity focused on improving what is known about how the immune system behaves during and after combat-related injuries, especially severe polytrauma. In this context, polytrauma generally means two or more injuries affecting different body regions or organ systems, with at least one injury potentially life-threatening, and with possible long-term physical, cognitive, psychological, or psychosocial consequences. The intent of TIRA is to fund basic and applied research, along with early-stage development of both materiel and knowledge products, that can close key gaps in understanding immune responses, inflammation, immune function, and other host-response pathways triggered by traumatic injury in operational settings. Work that advances insight into post-trauma inflammatory processes and immune-driven complications, and that supports development of potential countermeasures or treatment concepts aligned with those mechanisms, is positioned as a core priority area.

Awards under this announcement are made as federal assistance agreements, meaning the government is supporting a public-purpose research effort rather than purchasing a product or service for direct government use. Applicants may receive either a grant or a cooperative agreement depending on how involved DoD expects to be during the project. If the program anticipates no substantial federal involvement, the award is typically a grant; if substantial involvement is expected, the mechanism becomes a cooperative agreement, and the specific nature of that involvement (for example, collaboration or participation in elements of the research) is identified during award negotiation. The award type and project start date are not fully locked in at the application stage and are instead determined through the negotiation process after selection.

From a funding perspective, the anticipated maximum total cost for the entire period of performance is capped at $2.0 million per TIRA project. Program leadership indicated an overall intent to commit about $10.0 million in total to this mechanism in FY23, with an expected portfolio of roughly five awards, assuming adequate federal funding and a sufficient number of high-quality, meritorious applications. Selections are contingent on scientific and programmatic review outcomes as well as government requirements and available appropriations. Awards were planned to be issued no later than September 30, 2024, and the funds supporting FY23 awards are expected to remain available for obligation and use only within the applicable fiscal limits, with FY23 funds described as expiring for use on September 30, 2029.

A major compliance point is that this mechanism does not support prospectively enrolled human subject clinical trials, and it also does not support clinical research involving prospectively enrolled human subjects. In other words, studies where human participants are recruited and followed forward in time, whether interventional (clinical trials) or observational (clinical research), are not allowed here. The announcement uses the standard clinical trial definition: prospective assignment of one or more human subjects to one or more interventions (including placebo or control) to evaluate effects on health-related outcomes. It also clarifies that clinical research can include patient-oriented observational work (for example, studies of disease mechanisms, diagnostic or detection approaches like biomarker or imaging work, technology development involving patient interaction, epidemiology, behavioral studies, outcomes research, or health services research) when it involves interaction with human subjects or use of identifiable human-origin materials and data tied to living individuals. That entire category is excluded if it involves prospective enrollment under this award. One important nuance is that in vitro studies using human tissues that cannot be linked to a living individual are not considered clinical research for these purposes, and secondary research that qualifies for Common Rule exemption category 4 (secondary research use of identifiable private information or identifiable biospecimens under specific conditions where consent is not required) is also called out as not being clinical research as defined by the program.

Even though prospective human clinical work is prohibited, the opportunity does allow research involving human data, human anatomical substances, or human cadavers, as well as animal research, provided it stays within the mechanism limits and passes required oversight. Any DoD-funded work involving human data or human-origin materials must undergo administrative review and approval through the USAMRDC Office of Human and Animal Research Oversight (OHARO), specifically the Office of Human Research Oversight (OHRO), before research activities begin. This OHRO review is in addition to a local Institutional Review Board (IRB) or Ethics Committee review. Local IRB/EC approval is not required at the time of application submission, but it is required before OHRO will conduct its review. The timeline matters: applicants are advised to budget up to about three months for OHRO regulatory review after submitting a complete package.

For projects involving animals, a similar dual-layer oversight applies. Animal studies must be reviewed and approved not only by the local Institutional Animal Care and Use Committee (IACUC), but also by OHARO’s Animal Care and Use Review Office (ACURO). As with human research oversight, IACUC approval is not required at submission, but it is required for later stages, and applicants should plan for a relatively long regulatory runway: at least three to four months is suggested for ACURO review and approval once materials are submitted.

The announcement also highlights practical access and collaboration issues when applicants plan to use Department of Defense or Department of Veterans Affairs (VA) resources, including databases, patient samples, or other controlled assets. If the research depends on access to DoD or VA resources, the application must describe that access at submission and include a plan to maintain it throughout the project. The program notes that it will not act as a government sponsor or signatory to secure access agreements on an applicant’s behalf, so investigators need to have realistic, documentable pathways for access. Some resources may be restricted to DoD or VA personnel, meaning a non-DoD/non-VA principal investigator may need a bona fide collaboration with a DoD or VA investigator who holds a substantial role in the research to obtain access. If an application is recommended for funding, the government can still withdraw or delay the award if the principal investigator cannot demonstrate adequate access to the required populations, samples, or data.

Administrative details from the listing include the funding opportunity number HT9425 23 DMRDP TIRA, the administering organization within DoD being the Department of the Army USAMRAA, the assistance instruments being grants and cooperative agreements, and the activity category being science and technology and other research and development under CFDA 12.420. Eligibility is described as unrestricted (open to any entity type) subject to any clarifications in the full announcement. The original posting date was July 3, 2023, with an original closing date of November 9, 2023, and an expected award count of about five projects under the FY23 allocation assumptions.

• The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD, Defense Medical Research and Development Program, Trauma Immunology Research Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on Jul 03, 2023.
• Applicants must submit their applications by Nov 09, 2023. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 5 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

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