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.

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.