NEI Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U01 Clinical Trial Required)
ID: 339409Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The National Institutes of Health (NIH), through the National Eye Institute (NEI), has announced a funding opportunity for U01 Cooperative Agreements aimed at supporting early-stage clinical trials that involve greater than minimal risk, specifically Phase I or II trials focused on vision disorders. The objective is to evaluate interventions related to screening, diagnosing, preventing, or treating these disorders, with a strong emphasis on safety monitoring and oversight throughout the trial process. Eligible applicants include a diverse range of organizations such as higher education institutions, nonprofit organizations, and tribal governments, among others, and they must register with relevant systems prior to application submission. Applications are due by May 7, 2025, and interested parties are encouraged to consult with NEI program staff for guidance; for further details, inquiries can be directed to the NIH OER Webmaster at OERWebmaster03@od.nih.gov.

    Point(s) of Contact
    Files
    Title
    Posted
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH) through the National Eye Institute (NEI), has announced a funding opportunity for U01 Cooperative Agreements intended for early-stage clinical trials that involve greater than minimal risk. The funding aims to support Phase I or II trials focused on interventions related to the screening, diagnosis, prevention, or treatment of vision disorders. Key dates indicate that applications opened on April 24, 2022, with the first application due on the same date. Eligible applicants include higher education institutions, nonprofit organizations, and government entities among others, and applicants must register with relevant systems beforehand. Applications require a full clinical protocol submission, a detailed plan for data management and monitoring, and an acknowledgment of NEI staff involvement post-award. The NEI will closely monitor the projects for compliance with milestones and safety protocols, ensuring participant interests are safeguarded. This funding opportunity encourages consultation with NEI program staff prior to application submission and provides clear guidelines regarding eligibility, requirements, and submission processes, asserting NEI's commitment to advancing research in vision science while maintaining rigorous oversight.
    Similar Opportunities
    NEI Small Business Innovation Research (SBIR) Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U44-Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity through the NEI Small Business Innovation Research (SBIR) Cooperative Agreement for Early-Stage Clinical Trials with Greater than Minimal Risk (U44), aimed at supporting small business concerns (SBCs) conducting early-stage clinical trials related to vision disorders. Applicants are required to propose studies that evaluate interventions for screening, diagnosing, preventing, or treating eye diseases, with a focus on trials that typically fall under Phase I or II and involve greater than minimal risk, necessitating appropriate oversight and safety monitoring. This initiative underscores the government's commitment to advancing clinical research and innovation in vision health, with applications due by January 7, 2027. Interested applicants can find more information and guidance by contacting NIH Grants Information at grantsinfo@nih.gov or visiting the official announcement at https://grants.nih.gov/grants/guide/pa-files/PAR-24-066.html.
    NEI Collaborative Clinical Vision Research Project: Coordinating Center Grant (UG1 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for the NEI Collaborative Clinical Vision Research Project, specifically seeking applications for a Coordinating Center grant under the UG1 activity code. This initiative aims to support large-scale, investigator-initiated clinical trials focused on vision disorders, including interventions for screening, diagnosing, preventing, or treating these conditions, with an emphasis on projects that require significant oversight and management. The NEI's mission is to advance vision research and enhance public health through rigorous clinical trials, ensuring compliance with NIH policies and ethical standards in research involving human subjects. Interested applicants, including a diverse range of organizations such as higher education institutions and nonprofits, must submit their applications by May 25, 2026, and can find further details at the provided NIH grants information email: grantsinfo@nih.gov.
    NEI Collaborative Clinical Vision Research Project: Resource Center Grant (UG1 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity through the NEI Collaborative Clinical Vision Research Project, specifically for Resource Center Grants (UG1 Clinical Trial Required). This initiative aims to support large-scale clinical trials focused on screening, diagnosing, preventing, or treating vision disorders, with a particular emphasis on evaluating complex interventions and providing essential services for multi-center trials. The NEI seeks to advance vision health through rigorous research, and applications are encouraged from a diverse range of eligible applicants, including various educational institutions and organizations. Interested parties must submit their applications by May 25, 2026, and can find additional information and guidelines at NIH Grants. For inquiries, contact NIH Grants Information at grantsinfo@nih.gov.
    NEI Collaborative Clinical Vision Research: Chair's Grant (UG1-Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH), through its National Eye Institute (NEI), has announced a Notice of Funding Opportunity (NOFO) for the NEI Collaborative Clinical Vision Research: Chair's Grant (UG1), aimed at supporting large-scale clinical trials focused on vision disorders. This funding opportunity is intended for projects that evaluate interventions for screening, diagnosing, preventing, or treating vision disorders, specifically requiring a clinical trial with a clear scientific rationale and detailed study design. The NEI emphasizes the importance of these trials in advancing vision science and public health, with awards structured as cooperative agreements to ensure substantial NIH involvement in the research process. Interested applicants must submit their proposals by May 25, 2026, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    NEI Translational Research Program for Therapeutics (R33 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the NEI Translational Research Program for Therapeutics (Funding Opportunity Number: PAR-25-363), aimed at advancing innovative therapeutic solutions for visual system diseases. This program seeks to support multidisciplinary teams in generating preclinical data that will facilitate the development of treatments leading to FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications, particularly targeting significant ocular disorders such as retinal diseases and glaucoma. With a funding cap of $1 million annually for a maximum of three years, applicants must demonstrate milestone-driven progress in IND/IDE-enabling studies, with applications due by February 16, 2025. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov.
    NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled the NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed) aimed at accelerating the translation of innovative laboratory research into therapeutic interventions for visual system diseases. This program employs a bi-phasic, milestone-driven mechanism consisting of an Exploratory (R61) phase lasting up to two years and a Developmental (R33) phase lasting up to three years, focusing on generating preclinical data that supports applications for Investigational New Drug (IND) or Investigational Device Exemption (IDE) submissions to the FDA. The initiative is designed to engage diverse organizations, including historically black colleges, tribal governments, and community-based organizations, to foster collaborative efforts in ocular research, ultimately improving health outcomes through vision research. Interested applicants can find more information and guidelines at the provided link, with a funding ceiling of $500,000 and a submission deadline of March 16, 2025.
    NEI Clinical Research Study Planning Grant Program (R34 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the NEI Clinical Research Study Planning Grant Program (R34), aimed at supporting the development of clinical trial protocols and procedures specifically for eye and vision-related studies. This grant facilitates the preparation of a comprehensive Manual of Procedures (MOP) and allows for preliminary studies to assess recruitment potential, without generating data on intervention effects. Grants may provide up to $150,000 per year for a maximum of two years, with applications due by May 7, 2025. Eligible applicants include a wide range of institutions, including educational, nonprofit, and government entities, and inquiries can be directed to the NIH OER Webmaster at OERWebmaster03@od.nih.gov.
    NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity through the NEI Translational Research Program for Therapeutics, aimed at advancing innovative therapies for visual system diseases. This program utilizes a bi-phasic R61/R33 grant mechanism, where the R61 phase supports the refinement of preliminary data, and the R33 phase focuses on advancing promising candidates through FDA regulatory processes leading to Investigational New Drug (IND) applications. The initiative encourages multidisciplinary collaboration among scientists, clinicians, and regulatory experts, with a budget cap of $500,000 for R61 applications and $1,000,000 for R33 applications. Interested applicants must submit their proposals by March 17, 2025, with the program opening for applications on January 16, 2025. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    NEI Clinical Research Study Planning Grant Program (R34 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the NEI Clinical Research Study Planning Grant Program (R34 Clinical Trial Not Allowed) to support the planning and development of clinical vision research studies. This grant program aims to advance knowledge in eye and vision conditions by funding the development of study protocols and manuals, as well as fostering collaborative research efforts, while explicitly prohibiting the generation of data from clinical trials or preclinical studies. Eligible organizations, including educational institutions and nonprofits, can apply for grants of up to $150,000 per year for a maximum of two years, with applications due by January 7, 2028. For further inquiries, interested parties can contact NIH Grants Information at grantsinfo@nih.gov or visit the program's webpage at https://grants.nih.gov/grants/guide/pa-files/PAR-25-358.html.
    NEI Regenerative Medicine Clinical Trial Planning Grant (R34 - Clinical Trials Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the NEI Regenerative Medicine Clinical Trial Planning Grant (R34) to support the development of clinical trial protocols aimed at restoring vision through cell regeneration. This grant is designed to fund essential activities such as creating a Manual of Procedures (MOP), obtaining regulatory approvals, and assessing the feasibility of clinical trials that involve regenerative strategies, particularly those utilizing stem cells. The initiative underscores the federal commitment to advancing vision restoration research, with a funding ceiling of $150,000 per year for projects lasting up to two years. Interested applicants, including various educational institutions and organizations, must adhere to strict submission guidelines via Grants.gov, with applications due by May 7, 2025. For further inquiries, applicants can contact the NIH OER Webmaster at OERWebmaster03@od.nih.gov.