NEI Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U01 Clinical Trial Required)

The NEI uses U01 cooperative agreement awards to support investigator-initiated early-stage clinical trials that are greater than minimal risk and typically are Phase I or II trials. The risk level of the U01 trial requires appropriate performance oversight and safety monitoring. For purposes of this FOA, the proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders.Purpose: The purpose of this Funding Opportunity Announcement (FOA) is to invite cooperative agreement (U01) applications to the National Eye Institute (NEI) for early-stage clinical trials that are greater than minimal risk but are not administratively complex. Projects that are administratively complex often involve several recruiting clinical centers, an independent data coordinating center and often include resource centers. The proposed trials using this U01 mechanism typically are Phase I or II trials with strong scientific rationale and must evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders. Applications supported by this FOA must meet the NIH definition of a clinical trial (see NOT-OD-15-015) and must be greater than minimal risk trials. As defined in 45 CFR 46.102, a minimal risk trial is one in which 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.