DoD VRP, Translational Research Award | HT942524VRPTRA

Opportunity Information: Apply for HT942524VRPTRA

The FY24 Department of Defense Vision Research Program (VRP) Translational Research Award (TRA) is a grant opportunity run through the U.S. Army Medical Research Acquisition Activity (USAMRAA) that focuses on pushing eye- and vision-related discoveries toward real-world clinical use, specifically for eye injury or visual dysfunction linked to military exposures. The central aim is translational work that bridges the gap between promising early findings and clinical-ready solutions that can be definitively tested in later-stage clinical trials. In practical terms, the program is looking for projects that can credibly show how a discovery will become a drug, a medical device, or a clinical practice guideline that is mature enough to justify subsequent full clinical trial testing.

A strong application is expected to lay out a clear, realistic pathway from the current state of the science to a clinically actionable product or practice. That includes concrete development steps, defined milestones, and an explanation of what evidence will be generated during the award period to de-risk the approach for future clinical trials. For teams pursuing drug or device development, the DoD emphasizes the importance of regulatory readiness. Applications should include at least one collaborator with demonstrated expertise in the regulatory approval process, reflecting the program expectation that regulatory strategy is not an afterthought but a core part of translational execution.

If a project involves a product that would require regulatory clearance, the opportunity anticipates that an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE), or an international equivalent, will be submitted to an appropriate Regulatory Agency during the award period or by the end of the period of performance. For this opportunity, "Regulatory Agency" includes the U.S. Food and Drug Administration (FDA) and relevant international counterparts. This expectation signals that the award is meant to move beyond exploratory studies and toward the kind of evidence package and documentation that supports regulated clinical testing.

The funding mechanism also offers a Partnering PI option designed to support genuinely collaborative leadership across institutions or disciplines. Under this structure, the project can name two Principal Investigators: an Initiating PI, who handles most administrative responsibilities for submitting the application, and a Partnering PI, who shares substantive responsibility for developing and carrying out the research. If selected for funding, each PI is listed on a separate award made to their organization (if different), and each award carries its own reporting, regulatory, and administrative requirements. This structure is intended to enable balanced partnerships while keeping accountability clear for each participating organization.

In terms of research scope, the program permits studies involving animals, human subjects, and human anatomical substances. It also allows inclusion of a pilot clinical trial (PCT) component, but it does not support a full-scale clinical trial under this award. The purpose of a PCT in this context is limited clinical testing to inform feasibility, rationale, and the design of future trials, rather than to deliver definitive conclusions about safety or efficacy. Importantly, if an application includes a PCT component, it must also include other non-PCT translational research components, such as preclinical studies or other clinical research activities that are not categorized as a pilot clinical trial. Proposals with a PCT element face additional submission requirements and review criteria, reflecting the higher oversight and planning needs when prospective interventions are tested in humans.

The notice draws a clear line between what counts as a clinical trial versus other types of clinical research. It relies on the federal definition in 45 CFR 46.102: a clinical trial is a study where one or more human subjects are prospectively assigned to one or more interventions (including placebo or control) to evaluate the intervention's effects on biomedical or behavioral health-related outcomes. By contrast, retrospective analyses of data from previously conducted clinical trials are not considered clinical trials for the purposes of this opportunity. The program also distinguishes clinical trials from broader clinical research, which is generally observational and may involve human data, specimens, or interaction with human subjects without prospectively assigning interventions to test safety, effectiveness, or efficacy. Examples of clinical research in this framing include studies on mechanisms of human disease, biomarker or imaging diagnostics, health disparity research, technology development that is not an intervention trial, epidemiologic and behavioral studies that do not test interventions, and outcomes or health services research that does not meet the clinical trial definition. It further notes that certain in vitro studies using human data or specimens that cannot be linked to a living individual, and that meet Common Rule exemption criteria, are excluded from the definition of clinical research.

From the source details provided, this is a discretionary grant opportunity (Funding Opportunity Number HT942524VRPTRA) in the Science and Technology and other Research and Development category, under CFDA 12.420. Eligibility is listed as unrestricted. The original closing date was November 8, 2024. The listing indicates an expected number of awards of one, and an award ceiling is not stated in the provided source fields.

• The Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DoD VRP, Translational 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 2024-05-16.
• Applicants must submit their applications by 2024-11-08. (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 1 candidate(s).
• Eligible applicants include: Unrestricted.

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