NEI Collaborative Clinical Vision Research: Chair's Grant (UG1-Clinical Trial Required)

The National Eye Institute (NEI), a component of the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services, has announced the reissue of PAR-21-041 under Notice of Funding Opportunity (NOFO) PAR-23-209. This initiative supports the Chair’s Grant under the NEI Collaborative Clinical Vision Research program. The purpose of this cooperative agreement is to fund complex, high-risk clinical trials that address screening, diagnostic, preventative, or therapeutic interventions for vision disorders, or that compare the effectiveness of multiple established interventions. The Chair’s Grant provides leadership in scientific rationale, study design, and organizational oversight of these projects. The NEI emphasizes that such studies must demonstrate public health significance and involve comprehensive performance monitoring. The NOFO requires that applications include detailed clinical protocols, milestone plans, organizational structures, manuals of procedures, and where applicable, documentation on intervention availability. Studies supported through this mechanism are often accompanied by companion Coordinating Center and Resource Center grants, which together ensure statistical, logistical, and infrastructure support. Proposals must include clinical trial designs that address patient safety, regulatory compliance, and data integrity, with special attention given to high-resource and high-safety risk contexts such as human gene-transfer or stem cell therapies. Applications that are not sufficiently complex, high risk, or directly related to clinical interventions will be deemed non-responsive. Applicants are expected to submit full clinical protocols, milestone plans with clear recruitment and reporting benchmarks, and organizational details such as roles of the Chair, Coordinating Center, and participating clinics. Budget requests are not capped, but they must reflect actual project needs. The maximum project period is five years. Applications must also address data sharing policies, dissemination of findings, and compliance with NIH policies on human subjects protections, diversity in participant recruitment, and safety monitoring. Funding decisions will be based on scientific merit, relevance to NEI priorities, and availability of funds. All funded trials must be registered and results submitted to ClinicalTrials.gov. Eligible applicants include U.S. and non-U.S. institutions, both public and private, across higher education, nonprofit, for-profit, tribal, and governmental organizations at all levels. Foreign institutions and non-domestic components of U.S. organizations are eligible to apply. Individual investigators with sufficient expertise, knowledge, and resources may serve as principal investigators. No cost sharing is required. Applicant organizations must maintain active registrations in SAM.gov, eRA Commons, and Grants.gov, which may take several weeks to complete. All principal investigators must also maintain valid eRA Commons IDs. Applications requesting $500,000 or more in direct costs per year must contact program staff at least six weeks before submission. Applications must be submitted electronically through NIH ASSIST, institutional system-to-system solutions, or Grants.gov Workspace. NIH standard application due dates apply, with the next due date being 2025-09-25. Applications will be peer-reviewed based on significance, investigator qualifications, innovation, approach, study design, data management, and feasibility of timelines. Following peer review, applications will undergo second-level review by the National Advisory Eye Council. Awards are anticipated to start as early as four to six months following submission deadlines, depending on review cycles. Scientific and programmatic inquiries should be directed to NEI program staff. Key contacts include Dr. Sangeeta Bhargava (bhargavas@mail.nih.gov, 301-435-8175), Donald Everett (everettd@mail.nih.gov, 301-435-8181), and Dr. Jimmy Le (jimmy.le@nih.gov, 301-435-8160). Peer review inquiries should be addressed to Dr. Brian Hoshaw (brian.hoshaw@nih.gov, 301-402-0566). Grants management questions may be directed to Karen Robinson Smith (Karen.Robinson.Smith@nei.nih.gov, 301-435-8178). The opportunity remains active until its expiration date of 2026-05-26.

Applicants should contact NEI program staff at least 12 weeks before submission. Applications requesting more than $500,000 in direct costs must obtain prior approval. Applicants should apply early to allow time for error correction.