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

The National Eye Institute (NEI), part of the U.S. Department of Health and Human Services’ National Institutes of Health, has issued a funding opportunity announcement for the NEI Collaborative Clinical Vision Research Project: Coordinating Center Grant (UG1 Clinical Trial Required). This program represents a reissue of PAR-21-042 and supports large-scale, high-priority vision research clinical trials that require coordinated management. The NEI’s mission is to eliminate vision loss and improve quality of life through vision research, and this program advances that goal by funding coordinating centers to provide scientific and technical leadership in data management, statistical analysis, and oversight of clinical research. The purpose of the Coordinating Center (CC) grant is to ensure the effective management of NEI-supported UG1 cooperative agreements. These agreements are used to fund investigator-initiated clinical trials involving complex interventions such as gene-transfer therapies, stem cell therapies, and other high-risk or resource-intensive studies. Under this program, the Coordinating Center provides infrastructure for statistical support, quality control, and safety monitoring. It plays a critical role in ensuring trial integrity, fidelity to protocol, and adherence to federal regulations. The CC is expected to support the work of a Data and Safety Monitoring Committee, maintain data confidentiality, and coordinate dissemination of findings. The scope of this funding opportunity includes trials evaluating interventions for the screening, diagnosis, prevention, or treatment of vision disorders, as well as comparative effectiveness trials of established interventions. Applications must address study design, trial administration, data collection, and monitoring procedures. Renewal applications are permitted for projects requiring additional time or funds to complete objectives or to extend participant follow-up. Certain activities fall outside of the program’s scope, including non-clinical experiments, low-risk studies, and preclinical development of gene or stem cell therapies. Award budgets are not capped but must reflect the actual needs of the proposed project, and the maximum project period is five years. NIH policies, including cost principles outlined in the NIH Grants Policy Statement, apply. The number of awards depends on the availability of appropriations and the number of meritorious applications. Applications requiring $500,000 or more in direct costs must consult with NEI staff at least six weeks prior to submission. This program is structured as a cooperative agreement, meaning NIH program staff will maintain substantial involvement after award to guide, monitor, and assist grantees. Eligibility is broad and includes higher education institutions, nonprofit organizations with or without 501(c)(3) status, for-profit organizations, small businesses, state and local governments, tribal governments and organizations, school districts, housing authorities, faith-based and community organizations, regional organizations, U.S. territories, and foreign institutions. Both U.S. and non-U.S. entities are eligible, provided they complete required registrations, including SAM.gov, eRA Commons, and Grants.gov. All applicants must follow NIH application policies, including the use of FORMS-H packages and submission through ASSIST, institutional S2S systems, or Grants.gov Workspace. Applications must follow NIH standard due dates, with upcoming deadlines including 2025-09-25, 2026-01-25, and recurring cycles through 2026. Applications are due by 5:00 PM local time of the applicant organization. The program expires on 2026-05-26. Applications must include required attachments such as a Statistical Analysis Plan, Data Handling and Quality Assurance Plan, and Clinical Center Information. Review will be based on NIH peer review criteria, including significance, investigator qualifications, innovation, approach, and environment, with additional considerations for study design, statistical rigor, and protections for human subjects. Scientific and research contacts for this program include Sangeeta Bhargava, PhD (bhargavas@mail.nih.gov, 301-435-8175), Donald Everett, MA (everettd@mail.nih.gov, 301-435-8181), and Jimmy Le, ScD (jimmy.le@nih.gov, 301-435-8160). Peer review questions can be directed to Brian Hoshaw, PhD (brian.hoshaw@nih.gov, 301-402-0566). Grants management contact is Karen Robinson Smith (Karen.Robinson.Smith@nei.nih.gov, 301-435-8178). These officials provide assistance with scientific, submission, and financial aspects of the program. Applicants are strongly encouraged to engage NEI scientific staff at least 12 weeks before submission to ensure responsiveness and alignment with program goals.

Applicants should contact NEI staff at least 12 weeks before submission; strict compliance with NIH policies and required attachments is necessary