The National Eye Institute (NEI), a component of the National Institutes of Health (NIH), is issuing a funding opportunity under the NEI Collaborative Clinical Vision Research Project: Coordinating Center Grant (UG1 Clinical Trial Required). This grant opportunity supports investigator-initiated large-scale clinical trials, including human gene transfer, stem cell therapy trials, and other complex or high-risk clinical trials related to vision disorders. The Coordinating Center (CC) is expected to provide scientific and technical leadership in trial statistical and data management activities and oversee investigators conducting the study. This funding mechanism, under the UG1 cooperative agreement, is intended for studies evaluating interventions aimed at screening, diagnosing, preventing, or treating vision disorders or comparing the effectiveness of established interventions.

The Coordinating Center’s responsibilities include designing clinical trials, supporting data management and statistical analysis, ensuring quality control, and overseeing safety monitoring, including support for the Data and Safety Monitoring Committee. The UG1-supported studies typically involve a group of companion grant awards, such as the Chair’s Grant, the Coordinating Center, and Resource Centers. The CC is essential in ensuring the successful execution of clinical trials through strong oversight and coordination.

Eligible applicants include a broad range of organizations, including public and private higher education institutions, nonprofits with or without 501(c)(3) IRS status, small businesses, for-profit organizations other than small businesses, local governments, state governments, tribal governments (both federally recognized and non-recognized), public housing authorities, regional organizations, and independent school districts. Foreign institutions and non-U.S. components of U.S. organizations are also eligible to apply. The application process requires multiple registrations, including the System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (for foreign applicants), eRA Commons, and Grants.gov.

Applications for this funding opportunity must comply with NIH’s SF424 (R&R) Application Guide and include detailed sections such as a Statistical Analysis Plan, Data Handling and Quality Assurance Plans, and Clinical Center Information. Submissions must be completed electronically through NIH’s ASSIST system, Grants.gov Workspace, or an institutional system-to-system solution. The review process will assess the significance, approach, innovation, investigator qualifications, and environment of the proposed Coordinating Center, alongside additional criteria such as human subject protections and inclusion of diverse populations.

Funding for the Coordinating Center grant is contingent upon NIH appropriations and the number of meritorious applications received. There is no predefined award ceiling, but budgets should reflect the actual needs of the proposed project. The maximum project period is five years. Application deadlines follow NIH standard due dates, with cycles occurring in July, September, January, and May. The earliest start date for funded projects varies based on the review and advisory council processes, with awards potentially beginning in April, July, December, or later.

Applicants are encouraged to contact NEI Scientific/Research staff at least 12 weeks before submission to discuss their proposals. Additional programmatic and administrative information can be obtained from NIH contacts listed in the funding opportunity. Applications that do not comply with submission guidelines or NIH’s policies may be delayed or not accepted for review. The grant is set to expire on May 26, 2026.