Human Subjects Mechanistic and Minimal Risk Studies (R21 Clinical Trial Optional)

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The purpose of this FOA is to encourage applications that seek to conduct studies of the visual system. Eligible applications may be either: Those that involve human subjects, but are not NIH-defined clinical trials (see NOT-OD-15-015); or Those that are NIH-defined clinical trials and are designed to address either: 1) mechanisms underlying human vision in health and disease; or 2) interventions that entail procedures with minimal risk to subjects. More information about eligibility can be found in Part 2 Section III.3. A mechanistic trial is defined as "A study designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. "Minimal risk" means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. NIH-defined clinical trial applications that are neither mechanistic nor minimal risk are not eligible for this FOA. Large-scale clinical trials, human gene-transfer and stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials are not appropriate for this FOA. Applicants are strongly advised to consult with NEI program staff prior to submitting an application with human subjects to determine the appropriate funding opportunity.

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