NEI Clinical Research Study Planning Grant Program (R34 Clinical Trial Not Allowed) | PAR 19 231

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

What is the NEI Clinical Research Study Planning Grant Program (R34)?

It is a National Eye Institute (NEI) funding opportunity under NIH designed to support planning and pre-study development work for large, complex vision research projects. The purpose is to help research teams get a future full-scale clinical study or epidemiology application to a high level of readiness before submitting it.

What is the main goal of this R34 planning grant?

The goal is to reduce uncertainty and strengthen the eventual full-scale submission by supporting practical planning activities such as refining the protocol, finalizing procedures, establishing governance and collaborations, and producing implementation-ready documentation (especially a Manual of Procedures).

Who is the sponsoring institute and what program numbers identify this opportunity?

The sponsoring institute is the National Eye Institute (NEI) within NIH. The opportunity number is PAR 19 231, and the CFDA number listed is 93.867.

What is the award ceiling for this opportunity?

The listed award ceiling is $150,000.

What kinds of studies is this planning grant meant to support?

It is broadly applicable to the types of studies NEI supports, including large epidemiologic studies and clinical trial-type studies at the planning stage, as long as the activities funded by this R34 remain planning and feasibility work rather than collecting intervention-effect data.

Why does NEI emphasize having a highly developed plan for major clinical vision projects?

NEI expects large projects (such as randomized clinical trials and large epidemiologic studies) to be submitted with a highly developed plan that already covers key operational and scientific components, including study rationale, design, analytic approach, protocols, procedures, facilities, environment, governance, and multi-site collaboration details.

What is a Manual of Procedures (MOP), and why is it central to this program?

A Manual of Procedures (MOP) is a detailed document that standardizes how a study is implemented across staff and sites. NEI describes it as essential for consistent implementation, but also expensive and time-consuming to develop, which is why this R34 is designed to help pay for that planning work.

What types of activities can R34 funds be used for?

Funds can be used for practical pre-study activities such as drafting and finalizing the Manual of Procedures, refining study procedures, testing or standardizing workflows, and conducting preliminary efforts that support feasibility (for example, demonstrating recruitment potential or fine-tuning operational steps needed for a future large-scale study).

Can this R34 be used to run a clinical trial or evaluate whether a treatment works?

No. The key boundary is that the grant cannot be used to generate data on the effects of a proposed intervention. It supports planning and feasibility work, not interventional outcomes testing.

What does "Clinical Trial Not Allowed" mean in the context of this FOA?

It means that, even though the FOA references clinical trials in the broader context of future studies, the R34-supported work itself cannot cross into an interventional outcomes study. Activities must remain focused on preparation, optimization, and documentation, not on measuring intervention effects.

What kinds of planning elements are expected to be developed under this program?

NEI highlights planning elements that typically include the scientific rationale, study design, statistical and analytic approach, detailed protocols and procedures, the facilities and environment where work will occur, the organizational and governance structure, and any multi-site or cross-institution collaborations.

How does this planning grant help with multi-site or cross-institution studies?

The program is intended to support the work needed to make multi-site or cross-institution efforts operationally realistic and consistent, including documenting procedures in a Manual of Procedures and developing collaboration and governance structures so sites and staff can implement the study consistently.

What is meant by "feasibility" activities in this R34?

Feasibility activities are preliminary efforts that help confirm and strengthen the practical ability to conduct the future large-scale study, such as demonstrating recruitment potential or optimizing operational steps and workflows. These activities are meant to support readiness, not to test intervention outcomes.

What is the intended next step after completing an R34 planning grant?

The intent is that investigators use the planning work to submit a stronger, more complete, and more operationally realistic application for a subsequent, larger NEI-supported project (such as a full-scale clinical study or epidemiology application).

What is the funding instrument and activity category for this opportunity?

The opportunity uses the grant funding instrument and is listed under the health activity category.

Who is eligible to apply?

Eligibility is broad and includes many government, academic, nonprofit, and private-sector organizations. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits with or without 501(c)(3) status (excluding institutions of higher education where relevant); for-profit organizations other than small businesses; small businesses; public housing authorities and Indian housing authorities; federally recognized tribal governments; and other tribal organizations.

Are minority-serving institutions and community-based organizations included in eligibility?

Yes. The FOA explicitly highlights eligibility for Historically Black Colleges and Universities, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions. It also notes faith-based or community-based organizations as eligible applicant types.

Can federal agencies or regional organizations apply?

Yes. The FOA includes eligible federal agencies and regional organizations among the eligible applicant types.

Are U.S. territories or possessions eligible?

Yes. The FOA lists U.S. territories or possessions as eligible applicant types.

Are non-U.S. (foreign) entities eligible to apply?

Yes. The FOA indicates that non-U.S. (foreign) entities are eligible.

How should applicants think about the scope of work to keep it compliant with the R34 restrictions?

The scope should stay focused on planning, optimization, and documentation activities that improve readiness for a future large-scale study. The work should not include generating data on the effects of an intervention, since that would move into evaluating whether a treatment works, which is not allowed under this mechanism.

What overall problem does this R34 program solve for research teams?

It helps cover the time and cost of doing the "nuts-and-bolts" pre-study development needed to produce a refined, implementable protocol and a high-quality Manual of Procedures, along with supporting plans for staffing, collaborations, governance, and site readiness that are expected for large NEI vision research submissions.