NEI Collaborative Clinical Vision Research Project: Coordinating Center Grant (UG1 Clinical Trial Required)

Background
The National Eye Institute (NEI) uses UG1 cooperative agreement awards to support investigator-initiated large-scale clinical trials, human gene-transfer, stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials. These projects are multifaceted and of high public health significance requiring clear delineation of study organization including roles and responsibilities and require careful performance oversight and monitoring.

The proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders, or to compare the effectiveness of two or more established interventions. The NEI UG1-supported studies are typically funded as a group of single-component companion grant awards including the Chair’s Grant, the Coordinating Center, and Resource Centers, when appropriate.

Grant Details
The Coordinating Center grant provides scientific and technical leadership for trial statistical and data management activities and oversees investigators conducting the study. The application must include details pertaining to the trial's design, clinical center activities, data management and analysis, quality control, statistical considerations, and safety monitoring including support of the Data and Safety Monitoring Committee. The scope of this NOFO encourages grant applications for investigator-initiated clinical trials to establish the efficacy or compare the effectiveness of screening, diagnostic, preventative or therapeutic interventions. Renewal applications that request additional years or funds to complete the original aims of a clinical trial will be accepted under this NOFO.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits with 501(c)(3) IRS status (other than institutions of higher education), for-profit organizations (including small businesses), state governments, county governments, city or township governments, special district governments, independent school districts, public housing authorities/Indian housing authorities, Native American tribal organizations (other than federally recognized tribal governments), faith-based or community-based organizations, regional organizations, non-domestic (non-U.S.) entities (foreign institutions), foreign components of U.S. Organizations.

Period of Performance
The earliest start date is July 13, 2023. The project period can be up to five years.

Grant Value
Application budgets are not limited but need to reflect the actual needs of the proposed project. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.