DoD VRP, Investigator-Initiated Research Award

The FY24 VRP IIRA is intended to support studies that will yield highly impactful discoveries or major advancements in the research and/or patient care of eye injury and/or visual dysfunction as related to military exposure.

To support research projects at different stages and the exploration/development of ideas of different maturity levels, two different funding levels are available under this program announcement. When submitting the pre-application, it is the responsibility of the applicant organization to select the funding level that is most appropriate for the research proposed. The funding level should be selected based on the stage and maturity level of the research project, rather than the amount of the budget.

• Funding Level 1 supports exploratory, innovative, high-risk/high-reward research that is in the earliest stages of idea development. Research must have the potential to yield new avenues of investigation, such as new approaches, new research tools, or new paradigms.

○ Preliminary data are not required. However, applicants must provide solid rationale for the research idea, supported by literature.

○ Investigators without prior experience with the visual system are welcome to submit research ideas to Funding Level 1, provided that the investigating team have sufficient expertise to test the research idea.

• Funding Level 2 supports the advancement of more mature research toward clinical translation. The research idea or solution should be innovative or novel, or offer significant refinements, improvements, or new applications of existing ideas or solutions, as applicable.

○ Funding Level 2 applications may focus on any phase of research from basic through translational.

○ Preliminary data supporting the readiness and feasibility of the proposed research are required.

○ Partnering PI Option: The FY24 VRP IIRA Funding Level 2 includes an option for two Principal Investigators (PIs). One PI will be identified as the Initiating PI and

DOD FY24 Vision Investigator-Initiated Research Award 5

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 human subjects and human anatomical substances is permitted; however, the IIRA may not be used to conduct clinical trials.

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.