NEI Clinical Research Study Planning Grant Program (R34 Clinical Trial Not Allowed) | PAR 22 128

Opportunity Information: Apply for PAR 22 128

The NEI Clinical Research Study Planning Grant Program (R34 Clinical Trial Not Allowed), funding opportunity number PAR-22-128, is a National Institutes of Health (NIH) grant run by the National Eye Institute (NEI) to help research teams prepare for major, multi-site, and other large-scale clinical vision studies. NEI funds substantial projects such as randomized clinical trials and epidemiologic studies, but those larger applications are expected to be highly detailed at the time they are submitted. In practice, that level of detail typically requires a carefully developed Manual of Procedures (MOP) that spells out exactly how the study will operate, from protocols to staffing to data handling. This program exists because producing that kind of manual and ironing out the operational details can be expensive and time-consuming, especially before a full-scale study is funded.

The core purpose of the R34 planning grant is to support the work that needs to happen before the definitive study starts. That includes refining the study rationale and design, tightening the analytic approach, clarifying and standardizing protocols and procedures, confirming the adequacy of facilities and research environment, and setting up the organizational structure and collaborative arrangements needed to run the eventual study. A central expected product is a well-documented MOP, which often includes items like eligibility criteria, recruitment and retention workflows, examination and imaging procedures, staff training and certification plans, visit schedules, adverse event reporting processes, quality assurance and quality control methods, data management procedures, and governance/communication plans across sites and partners.

In addition to writing and finalizing the MOP, the grant can support preliminary, non-interventional planning activities that reduce risk for the later full study. Examples described in the opportunity include preliminary studies used to refine study procedures or to document recruitment potential, such as testing screening workflows, evaluating the feasibility of proposed assessments, piloting data collection logistics, assessing site readiness, or confirming that the population of interest can be identified and enrolled at the expected pace. The key limitation is that this planning grant cannot be used to generate data on the effects of a proposed intervention. In other words, it is meant to prepare and de-risk a future clinical trial or epidemiologic study, not to run the intervention itself or produce outcomes that would substitute for a clinical efficacy or effectiveness evaluation.

Although the announcement references both epidemiologic and clinical trial research in terms of the types of large studies NEI supports, this specific R34 is explicitly "Clinical Trial Not Allowed." That means the planning activities must stay on the protocol-development and feasibility side rather than crossing into conducting a clinical trial under this award. Applicants should think of this mechanism as a bridge between a promising study concept and a later, fully powered, well-controlled NEI-funded study application, where the final protocol and operating playbook are already mature and ready for implementation.

Eligibility is broad and includes many types of domestic organizations and several special categories. Standard eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations (other than federally recognized tribal governments); public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; and small businesses. The announcement also highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations), reflecting NEI's openness to a range of institutions that can contribute to vision research planning efforts.

Administratively, this is a discretionary grant in the health area (CFDA 93.867) with an award ceiling listed as $150,000. The opportunity was created on 2022-03-02 and lists an original closing date of 2025-05-07. Overall, the program is best understood as targeted support for the unglamorous but essential work of making a complex vision research study operationally ready: producing a rigorous Manual of Procedures, confirming feasibility, and strengthening the study plan so that a subsequent large-scale NEI application can be submitted with the level of detail and readiness NEI expects.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NEI Clinical Research Study Planning Grant Program (R34 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.867.
• This funding opportunity was created on 2022-03-02.
• Applicants must submit their applications by 2025-05-07. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $150,000.00 in funding.
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 22 128

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