Department of Defense is offering the Vision Research Program (VRP) Translational Research Award to advance treatments for military eye injuries.

The FY24 VRP TRA is intended to support translational research that moves promising discoveries into clinical applications that will advance the prevention, diagnosis, mitigation, and/or treatment of eye injury or visual dysfunction associated with military exposure.

Successful applications to the FY24 VRP TRA should establish a clear path to transforming a promising discovery into new drugs, devices, or clinical practice guidelines that are ready for definitive testing in clinical trials. For new drug or device development, the investigative team should include at least one collaborator with expertise in the regulatory approval process.

It is expected that, if applicable, an Investigational New Drug (IND)/Investigational Device Exemption (IDE) application or international equivalent will be submitted to a Regulatory Agency during or by the end of the period of performance. For the purposes of this funding opportunity, Regulatory Agency refers to the U.S. Food and Drug Administration (FDA) or any relevant international regulatory agency.

Partnering PI Option: The FY24 VRP TRA includes an option for two Principal Investigators (PIs). One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as the Partnering PI. Both PIs should contribute significantly to the development and execution of the proposed research project. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission.

Research involving animals, human subjects, and human anatomical substances is permitted. The FY24 VRP TRA allows funding for a pilot clinical trial (PCT) component, but not a full-scale clinical trial. In contrast to full-scale clinical trials that are designed to determine safety or efficacy, the purpose of the PCT is to inform the feasibility, rationale, and design of subsequent clinical trials through limited clinical testing of a novel intervention. Applications that include a PCT component must also have non-PCT translational research component(s)

DOD FY24 Vision Translational Research Award 5

(e.g., preclinical studies, non-PCT clinical studies) and will have additional submission requirements and review criteria.

A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) 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.

Studies that retrospectively analyze data generated from previously conducted clinical trial(s) are not 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 encompasses research with human data, human specimens, and/or interaction with human subjects. Clinical research is observational in nature and includes:

(1) Research conducted with human subjects and/or material of human origin such as data, specimens, and cognitive phenomena for which an investigator (or co-investigator) does not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention. Research meeting this definition 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 assess 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 data or specimens that cannot be linked to a living individual and meet the requirements for exemption under §46.104(d)(4) of the Common Rule.

The FY24 VRP TRA is intended to support translational research that moves promising discoveries into clinical applications that will advance the prevention, diagnosis, mitigation, and/or treatment of eye injury or visual dysfunction associated with military exposure.

Successful applications to the FY24 VRP TRA should establish a clear path to transforming a promising discovery into new drugs, devices, or clinical practice guidelines that are ready for definitive testing in clinical trials. For new drug or device development, the investigative team should include at least one collaborator with expertise in the regulatory approval process.

It is expected that, if applicable, an Investigational New Drug (IND)/Investigational Device Exemption (IDE) application or international equivalent will be submitted to a Regulatory Agency during or by the end of the period of performance. For the purposes of this funding opportunity, Regulatory Agency refers to the U.S. Food and Drug Administration (FDA) or any relevant international regulatory agency.

Partnering PI Option: The FY24 VRP TRA includes an option for two Principal Investigators (PIs). One PI will be identified as the Initiating PI and will be responsible for the majority of the administrative tasks associated with application submission. The other PI will be identified as the Partnering PI. Both PIs should contribute significantly to the development and execution of the proposed research project. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). Each award will be subject to separate reporting, regulatory, and administrative requirements. For individual submission requirements for the Initiating and Partnering PI, refer to Section II.D.2, Content and Form of the Application Submission.

Research involving animals, human subjects, and human anatomical substances is permitted. The FY24 VRP TRA allows funding for a pilot clinical trial (PCT) component, but not a full-scale clinical trial. In contrast to full-scale clinical trials that are designed to determine safety or efficacy, the purpose of the PCT is to inform the feasibility, rationale, and design of subsequent clinical trials through limited clinical testing of a novel intervention. Applications that include a PCT component must also have non-PCT translational research component(s)

DOD FY24 Vision Translational Research Award 5

(e.g., preclinical studies, non-PCT clinical studies) and will have additional submission requirements and review criteria.

A clinical trial is defined in the Code of Federal Regulations, Title 45, Part 46.102 (45 CFR 46.102) 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.

Studies that retrospectively analyze data generated from previously conducted clinical trial(s) are not 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 encompasses research with human data, human specimens, and/or interaction with human subjects. Clinical research is observational in nature and includes:

(1) Research conducted with human subjects and/or material of human origin such as data, specimens, and cognitive phenomena for which an investigator (or co-investigator) does not seek to assess the safety, effectiveness, and/or efficacy outcomes of an intervention. Research meeting this definition 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 assess 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 data or specimens that cannot be linked to a living individual and meet the requirements for exemption under §46.104(d)(4) of the Common Rule.