NEI Clinical Research Study Planning Grant Program (R34 Clinical Trial Not Allowed) | PAR 25 358

Opportunity Information: Apply for PAR 25 358

The NEI Clinical Research Study Planning Grant Program (R34 Clinical Trial Not Allowed), opportunity number PAR-25-358, is a National Institutes of Health discretionary grant designed to help research teams plan large-scale clinical vision research before they submit a full-scale application. NEI funds major clinical vision studies such as randomized clinical trials and epidemiologic studies across eye and vision conditions, but those larger applications are expected to arrive with very detailed, operationally ready documentation. This planning grant exists because building that level of detail, especially across multiple sites and collaborators, takes substantial time and resources that are often hard to support upfront.

The central purpose of the R34 is to support the practical planning work needed to make a future collaborative clinical study feasible, rigorous, and well organized. The key deliverables are typically a complete study protocol and a Manual of Procedures (MOP). In practice, that means the award is meant to pay for the nuts-and-bolts development work: sharpening the study rationale and objectives, locking down the design, defining endpoints and analytic approaches, specifying eligibility criteria, standardizing clinical and data collection procedures, establishing quality control processes, and mapping out how the study will be run day-to-day across all participating sites. It can also cover planning elements like governance structures, roles and responsibilities, data management and coordinating center functions, and the logistics of multi-site collaboration, including agreements and communication plans.

In addition to protocol and MOP development, the grant can support limited preliminary activities that improve readiness for the later, larger study. Examples include pilot testing and refinement of study procedures, assessing and documenting recruitment potential, or conducting feasibility checks that reduce operational risk. A major limitation is built into the program: the planning award must not be used to generate data on the effects of a proposed intervention. In other words, applicants can use R34 funds to confirm that study procedures work and that recruitment is plausible, but not to run analyses intended to show whether a treatment or intervention works. Even though the NOFO notes relevance to both epidemiologic studies and clinical trial research, this specific mechanism is explicitly "Clinical Trial Not Allowed," so the funded activities must remain in the planning and feasibility space rather than conducting an actual clinical trial.

The opportunity sits in the health funding activity category under CFDA number 93.867 and is offered by the National Institutes of Health, specifically aligned with NEI priorities in vision research. The stated award ceiling is $150,000, indicating it is intended as targeted support for planning rather than full study execution. The original closing date listed is January 7, 2028, which signals a multi-year window during which applications may be accepted according to the NOFO's submission schedule.

Eligibility is broad and includes many types of U.S. organizations and some non-U.S. entities. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; non-federally recognized tribal organizations; nonprofits with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The NOFO also highlights additional eligible groups such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), 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 non-domestic (non-U.S.) entities/foreign organizations. Overall, the program is structured to support a wide range of institutions that can credibly lead or participate in collaborative planning for major vision research studies.

Put simply, this R34 planning grant is best viewed as a bridge between an early concept and a full-scale NEI clinical research application. It pays for the intensive upfront work of turning a study idea into a fully specified, multi-site-ready protocol and operations manual, along with targeted feasibility and recruitment documentation, while drawing a clear line that the award is not for testing intervention effects or conducting a clinical trial itself.

• 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 2025-01-10.
• Applicants must submit their applications by 2028-01-07.
• 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 25 358

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