DOD Vision, Clinical Trial Award | W81XWH 21 VRP CTA

FAQs: DOD Vision, Clinical Trial Award (FY21 VRP CTA)

What is the DOD Vision, Clinical Trial Award (FY21 VRP CTA)?

The DOD Vision, Clinical Trial Award (FY21 VRP CTA) is a Department of Defense funding opportunity intended to move promising vision-related treatments into early clinical testing as quickly as possible. It is designed to support clinical trials that are translational and impact-driven, with the goal of improving outcomes for people affected by service-connected eye injuries and visual dysfunction.

What is the main focus area for projects under this award?

The focus is on service-connected eye injuries and visual dysfunction. In other words, the program is specifically interested in conditions affecting military Service Members and Veterans as a result of their military service.

Is this funding opportunity meant for basic research or lab studies?

No. The intent is to fund clinical trials, not basic laboratory work that does not include prospective assignment of human subjects to an intervention. The summary emphasizes translational, impact-driven work that directly supports early clinical testing.

Are only drug trials eligible, or can other intervention types be studied?

The opportunity supports a range of intervention types, not only pharmaceuticals. Examples listed include new products, drugs or biologics, medical devices, clinical guidance (such as protocols or structured care pathways), and emerging approaches or technologies, as long as the project is organized as a clinical trial evaluating biomedical or behavioral health-related outcomes.

What phases of clinical trials does this award support?

This mechanism emphasizes early-phase clinical trials and covers phase 0 through phase 2a. That generally includes first-in-human studies, early safety and dosing evaluations, and preliminary signals of efficacy that could support later, larger confirmatory trials.

Does the award require the proposed work to be a clinical trial?

Yes. This award mechanism is strictly for clinical trials, and the funding is expected to directly support the conduct of the trial, including operational and regulatory elements needed to enroll participants and evaluate outcomes.

How does the announcement define a clinical trial?

It uses the standard federal definition: a research study in which one or more human subjects are prospectively assigned to one or more interventions (which can include a placebo or other control) to evaluate the effects of those interventions on health-related outcomes.

Are observational or retrospective studies allowed under this mechanism?

Based on the provided description, the award is not meant for purely observational studies or retrospective analyses because those designs do not involve prospectively assigning human subjects to interventions.

What types of outcomes should the trial measure?

The description indicates that the clinical trial should be intended to measure biomedical or behavioral health-related outcomes.

What human-subjects transparency requirement applies to funded trials?

Any trial funded through this mechanism must publicly post a copy of the IRB-approved informed consent form used to enroll subjects on a publicly available federal website. This requirement is tied to federal human research protections rules referenced in 32 CFR 219.

When does the informed consent form need to be posted publicly?

The summary states that funded trials must publicly post a copy of the IRB-approved informed consent form used to enroll subjects. It does not specify timing details beyond indicating it is a requirement for trials funded through this mechanism.

What does the informed consent posting requirement imply for applicants?

Applicants should plan for regulatory planning, IRB coordination, and documentation management as core expectations of the award rather than optional add-ons, since the program explicitly requires public posting of the IRB-approved informed consent form.

What type of federal assistance instrument will be used (grant or cooperative agreement)?

The opportunity can be issued as either a cooperative agreement or a grant, depending on the government’s anticipated level of involvement.

What does it mean that this is discretionary funding?

The listing describes the opportunity as discretionary funding, meaning it is awarded through a competitive or discretionary decision process rather than a formula-based entitlement.

What activity category does this opportunity fall under?

It falls under the Science and Technology / Research and Development activity category.

What is the CFDA number associated with this opportunity?

The opportunity is associated with CFDA number 12.420.

Who is the sponsoring and administering agency for this award?

The sponsoring agency is the Department of Defense, Department of the Army, and it is administered through USAMRAA.

Who is eligible to apply?

Eligibility is described as unrestricted, meaning it is open to a broad set of applicant organizations, subject to any additional eligibility details that may appear in the full announcement.

How many awards were anticipated?

The record indicates a very limited number of awards, listed as one.

What is the award ceiling (maximum budget) for this opportunity?

The award ceiling is shown as 0 in the listing. This commonly indicates that applicants should consult the full solicitation for budget limits or that the ceiling is not specified in the summary entry.

When was the opportunity created, and what was the original closing date?

The record shows the opportunity was created on May 14, 2021, and the original closing date was November 16, 2021.

What is the overall goal or expected impact of funded projects?

The program is looking for interventions that could realistically make a meaningful difference in outcomes for people dealing with vision loss or visual impairment tied to military service, and it aims to move those interventions into early clinical testing quickly.