DoD Vision Research, Mentored Clinical Research Award
Description
The FY24 VRP MCRA is intended to support patient-oriented vision injury research and develop research expertise of highly motivated military or civilian clinicians in training. Research supported by the MCRA can be a standalone study of high impact to vision injury care or the generation of clinical research data in preparation for a more expansive study.Each MCRA must be led by an established clinician or Ph.D. clinical scientist who will serve as Principal Investigator (PI) of the award. Key personnel must include a clinician in training (e.g., a fellow, resident, junior clinician, clinician in a Ph.D. program). The clinician in training should have sufficient time remaining in their training program to complete the research proposed under the MCRA. The clinician in training will conduct the proposed research under the mentorship of the PI, with support from supporting personnel as appropriate. While additional junior scientists or clinicians may participate in the research, only one clinician in training may be designated as mentee. A Letter of Organizational Support and Mentee Eligibility, signed by the Department Chair or appropriate organization official, and a Letter of Commitment, signed by the mentee, should be submitted as part of Attachment 2: Supporting Documentation.For the purposes of this award mechanism, clinical research is defined as research conducted with human subjects or research on material of human origin, such as tissues or specimens or data obtained from human subjects. Documentation of Institutional Review Board (IRB)/ Ethics Committee (EC) approval or exemption by December 1, 2024, is required for an MCRA application to be considered for funding. See Attachment 2: Supporting Documentation for additional detail.The MCRA may not be used to conduct preclinical research (including animal research) or 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 do not seek to measure safety, effectiveness, and/or efficacy outcome(s) of an intervention are not considered clinical trials.Studies that retrospectively analyze data generated from previously conducted clinical trial(s) are not considered a clinical trial.