Opportunity Information: Apply for W81XWH 22 VRP CTA
Apply for W81XWH 22 VRP CTA
- 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 Vision, Clinical Trial 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 May 10, 2022.
- Applicants must submit their applications by Nov 09, 2022. (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 (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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Opportunity Summary:
The DoD Vision, Clinical Trial Award (FY22 VRP CTA) is a Department of Defense funding opportunity aimed at quickly launching early-phase clinical trials that could meaningfully improve the treatment or management of service-connected eye injuries and vision-related dysfunction. The focus is specifically on phase 0 through phase 2a studies, which generally means first-in-human work, early safety and feasibility testing, dose finding, and preliminary signals of effectiveness rather than large confirmatory trials. The program is positioned to move promising ideas into real-world testing in people as efficiently as possible, with the underlying goal of producing clinically relevant evidence that could benefit service members and veterans affected by vision problems tied to military service.
Projects funded under this mechanism must be true clinical trials, not preclinical studies or observational research. In practical terms, the DoD is using the standard federal definition: a research study where one or more human participants are prospectively assigned to one or more interventions, which can include a placebo or other control condition, to measure the intervention's effect on biomedical or behavioral health outcomes. That requirement matters because it sets expectations for study design, human-subject protections, regulatory planning, recruitment, data collection, and outcome evaluation. If a proposal does not include prospective assignment to an intervention and the evaluation of health-related outcomes, it would not align with the purpose of this award.
The kinds of interventions the program is willing to support are broad, as long as they are geared toward eye injury and visual dysfunction relevant to military service. Trials may test new products, pharmacologic agents such as drugs or biologics, medical devices, clinical guidance that changes how care is delivered, and emerging technologies or approaches that could shift clinical practice. This breadth gives applicants flexibility to propose a range of translational concepts, from novel therapeutics to device-based solutions or structured care pathways, provided the study is designed as an early-stage interventional clinical trial with outcomes that speak to vision health and function.
The opportunity is administered by the Department of Defense, specifically the Department of the Army through the U.S. Army Medical Research Acquisition Activity (USAMRAA). It is listed as a discretionary funding opportunity under the Science and Technology and other Research and Development activity category, with CFDA number 12.420. The funding instrument types include both grants and cooperative agreements, meaning that depending on the specific award, there may be varying degrees of DoD involvement or programmatic collaboration during project execution.
Eligibility is described as unrestricted, meaning it is broadly open to applicants of any entity type, subject to any additional eligibility language that may have been provided in the full announcement. The original posting indicates a creation date of May 10, 2022, and an original closing date of November 9, 2022. The listing also notes an expected number of awards of 1, and it shows an award ceiling of 0, which typically signals that a specific maximum dollar amount was not provided in that summary field and would need to be confirmed in the full solicitation details.
A notable compliance requirement is tied to transparency and human-subject protections. Funded clinical trials must post a copy of the IRB-approved informed consent form used to enroll participants on a publicly available federal website, consistent with federal requirements in 32 CFR 219. This is an important operational detail for applicants because it affects regulatory planning and documentation workflows, and it underscores that the award expects full adherence to federal rules for ethical conduct of human subjects research.
Overall, the DoD Vision, Clinical Trial Award is designed for teams that are ready to run an early-phase interventional study in humans and can justify why their intervention could substantially improve outcomes for individuals experiencing service-connected ocular injury or vision dysfunction. The program emphasizes speed to implementation, clinically meaningful impact, and full compliance with clinical trial and human research oversight requirements.
FAQs: DoD Vision, Clinical Trial Award (FY22 VRP CTA)
What is the DoD Vision, Clinical Trial Award (FY22 VRP CTA)?
The DoD Vision, Clinical Trial Award (FY22 VRP CTA) is a Department of Defense funding opportunity intended to rapidly launch early-phase clinical trials that could meaningfully improve the treatment or management of service-connected eye injuries and vision-related dysfunction.
What is the main goal of this funding opportunity?
The program is designed to move promising, clinically relevant ideas into real-world testing in people as efficiently as possible, with the goal of generating evidence that could benefit service members and veterans with vision problems tied to military service.
What clinical trial phases does this award support?
This opportunity focuses on early-phase studies, specifically phase 0 through phase 2a. These phases generally include first-in-human work, early safety and feasibility testing, dose-finding activities, and early signals of effectiveness rather than large confirmatory trials.
Are preclinical studies allowed under this mechanism?
No. Projects funded under this mechanism must be true clinical trials in humans. Preclinical work is not aligned with the stated purpose of this award.
Are observational studies eligible for funding through this award?
No. The award is intended for interventional clinical trials, not observational research.
How does the opportunity define a clinical trial?
It uses the standard federal definition: a research study in which one or more human participants are prospectively assigned to one or more interventions (which may include placebo or other control conditions) to evaluate the effects of those interventions on biomedical or behavioral health outcomes.
What does "prospectively assigned to an intervention" mean in this context?
It means participants are assigned in advance to receive a specific intervention (or a control such as placebo), and the study is designed to measure how that assignment affects health-related outcomes.
What kinds of interventions can be tested with this funding?
The opportunity allows a broad range of interventions, as long as they are geared toward eye injury and vision dysfunction relevant to military service. Examples described include new products, pharmacologic agents (such as drugs or biologics), medical devices, clinical guidance that changes how care is delivered, and emerging technologies or approaches that could shift clinical practice.
Does the program require that the study be clinically relevant?
Yes. The emphasis is on producing clinically meaningful evidence that could improve treatment or management of service-connected ocular injuries or vision-related dysfunction.
What type of research design is expected?
An early-stage interventional clinical trial design is expected, with prospective assignment to an intervention and evaluation of biomedical or behavioral health outcomes related to vision health and function.
Who administers this grant opportunity?
The opportunity is administered by the Department of Defense, specifically the Department of the Army through the U.S. Army Medical Research Acquisition Activity (USAMRAA).
What is the activity category for this opportunity?
It is listed as a discretionary funding opportunity under the Science and Technology and other Research and Development activity category.
What is the CFDA number associated with this opportunity?
The CFDA number listed for this opportunity is 12.420.
What funding instruments are used for awards under this program?
The listing indicates that awards may be made as either grants or cooperative agreements.
What is the difference between a grant and a cooperative agreement in this context?
Based on the listing, both instrument types may be used, and the level of DoD involvement or programmatic collaboration may vary depending on whether the award is a grant or a cooperative agreement.
Who is eligible to apply?
Eligibility is described as unrestricted, meaning it is broadly open to applicants of any entity type, subject to any additional eligibility language that may appear in the full announcement.
When was this opportunity originally posted?
The original posting indicates a creation date of May 10, 2022.
What was the original application closing date?
The original closing date listed is November 9, 2022.
How many awards were expected to be made?
The listing notes an expected number of awards of 1.
Is there an award ceiling (maximum funding amount) listed?
The summary field shows an award ceiling of 0, which typically indicates that a specific maximum dollar amount is not provided in that summary and would need to be confirmed in the full solicitation details.
What are the key compliance requirements for human subjects protections?
A specific transparency requirement is highlighted: funded clinical trials must post a copy of the IRB-approved informed consent form used to enroll participants on a publicly available federal website, consistent with federal requirements in 32 CFR 219.
What does the informed consent posting requirement mean for applicants?
It means applicants should plan for the operational and documentation workflows needed to ensure the IRB-approved informed consent form used for enrollment is posted on a publicly available federal website, as required.
What federal regulation is referenced for the informed consent posting requirement?
The requirement is described as consistent with 32 CFR 219.
What types of outcomes does the clinical trial need to measure?
The trial must measure the intervention's effect on biomedical or behavioral health outcomes. The opportunity emphasizes outcomes that speak to vision health and function and are relevant to service-connected eye injuries or vision-related dysfunction.
What kinds of teams are a good fit for this opportunity?
This mechanism is intended for teams that are ready to run an early-phase interventional study in humans and can justify why their intervention could substantially improve outcomes for individuals experiencing service-connected ocular injury or vision dysfunction.
What is the program's overarching emphasis during execution?
The program emphasizes speed to implementation, clinically meaningful impact, and full compliance with clinical trial expectations and human research oversight requirements.
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