NEI Clinical Research Study Planning Grant Program (R34 Clinical Trial Not Allowed)

The National Eye Institute (NEI) invites applications for the Clinical Research Study Planning Grant Program (R34). This funding opportunity supports the planning and development of protocols and essential materials for large-scale clinical trials or epidemiologic studies related to eye and vision health. This program funds activities like preparing a Manual of Procedures (MOP), developing study protocols, conducting preliminary studies to assess recruitment potential, and establishing collaborative frameworks. However, the grant cannot be used for implementing clinical trials or conducting preclinical studies. The goal is to ensure projects are well-prepared to transition into full-scale clinical research that aligns with NEI priorities, such as addressing the leading causes of blindness, improving vision rehabilitation, and enhancing understanding of the visual system. Applicants can request up to $150,000 in direct costs annually, with a maximum project period of two years. The funding supports a range of activities, including finalizing protocols and study designs, establishing collaborative agreements, developing data collection and management tools, and preparing regulatory submissions. This grant is designed for projects requiring detailed study preparation, such as refining inclusion and exclusion criteria, defining study interventions and outcomes, and ensuring compliance with federal guidelines on gender and minority inclusion. Milestones must be outlined to demonstrate progress throughout the planning process. Eligible applicants include higher education institutions, nonprofits, for-profits, government agencies, and international organizations. The program welcomes applications from diverse institutions, including historically underrepresented groups such as HBCUs, Hispanic-serving institutions, and Native-serving institutions. Foreign organizations and non-U.S. components of U.S. organizations are also eligible. Principal investigators should have the necessary expertise and resources to successfully complete the planning activities. Applicants are encouraged to consult with NEI staff at least 10 weeks before submission to ensure alignment with program priorities. Applications are accepted on NIH standard due dates through January 2028, with review cycles scheduled throughout the year. Submissions must comply with NIH guidelines, including page limitations and the inclusion of required plans, such as the Data Management and Sharing Plan. The application must clearly outline milestones and describe how the planning activities will support decisions regarding subsequent clinical trials. NEI also encourages the adoption of standardized formats and metadata standards, such as DICOM for imaging data, to advance interoperability and data-sharing across studies. Applications will be reviewed based on significance, innovation, approach, and investigator expertise. Reviewers will evaluate whether the proposed planning activities are necessary and sufficient to inform a subsequent trial and whether the study’s design and analysis plans are appropriate for the intended objectives. Engagement with community partners and the use of common data elements (CDEs) are encouraged to enhance research utility and standardization. Award decisions will consider scientific merit, program priorities, and the availability of funds. Key contacts include NEI scientific, peer review, and grants management staff, who can provide guidance on application preparation and submission. Successful applicants will need to comply with NIH reporting requirements, including progress reports and data-sharing policies. The R34 Planning Grant is a strategic opportunity for investigators to prepare for impactful clinical vision research projects that align with NEI's mission to improve eye health and prevent blindness.