NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional) | PAR 25 090

Opportunity Information: Apply for PAR 25 090

The NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional) opportunity (PAR-25-090) is an NIH cooperative agreement intended to help investigators get complex, higher-risk multi-center clinical studies ready to launch. It is built around a two-part pathway in which this U34 planning award supports the upfront work needed before moving into full-scale study conduct. The main idea is to de-risk ambitious multi-site clinical research by funding a structured planning phase that strengthens the scientific premise, locks down the protocol, and ensures the operational details are realistic and execution-ready.

This U34 mechanism is specifically designed to accomplish four planning goals. First, it enables early peer review of the scientific rationale for the proposed clinical study, meaning reviewers evaluate whether the hypothesis and justification are strong before a large, expensive trial is underway. Second, it supports rigorous assessment of the study design and protocol, including whether the design can actually answer the clinical question across multiple centers. Third, it funds development of core trial documents needed to run the study, especially a Manual of Operations, which typically standardizes procedures across sites (recruitment and screening workflows, intervention delivery, outcome assessments, data collection schedules, safety reporting, training, and quality control). Fourth, it supports development of other essential elements required for study conduct, which often includes detailed plans for data management and monitoring, site coordination procedures, regulatory and IRB strategies, participant retention approaches, and other start-up materials that allow a future implementation award or launch decision to be based on a well-constructed, feasible package.

The clinical study proposed under this planning award is expected to be hypothesis-driven and to focus on diseases and conditions within the mission area of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The program is aimed at multi-center studies, explicitly meaning more than one clinical site or center is involved. Because the award is labeled "Clinical Trial Optional," applicants should still align their application with NIH definitions and requirements, but the announcement signals that the mechanism can be used in situations where the planning effort may or may not meet NIH’s definition of a clinical trial, depending on the specifics of the project.

A key feature of this opportunity is the cooperative agreement structure, which generally implies substantial scientific or programmatic involvement by NIH staff compared to a standard research grant. In practical terms, that often means NIDDK program staff may play an active role during the planning period to help keep milestones on track, ensure the protocol and operational plans meet institute expectations, and position the project for the next stage. Consistent with that, NIDDK strongly encourages applicants to consult with NIDDK scientific staff before submitting a U34 application, which can help determine fit, clarify expectations for the planning deliverables, and reduce the risk of submitting an application that does not align with program intent.

Eligibility is broad and includes many domestic organization types: state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (outside of higher education institutions); for-profit organizations (other than small businesses); and small businesses. The announcement also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions.

Foreign eligibility is restricted in a way that matters for planning multi-center work. Non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components as defined by the NIH Grants Policy Statement are allowed, meaning a U.S.-based applicant may be able to include certain foreign elements in the project if they meet NIH policy definitions and are justified, even though the primary applicant organization must be domestic.

From the funding details provided, the award ceiling is $225,000. The opportunity is categorized as discretionary funding and sits within the Food and Nutrition, Health activity area under CFDA 93.847. The sponsoring agency is the National Institutes of Health. The original closing date listed is 2027-06-10, and the opportunity record shows a creation date of 2025-01-10.

Overall, this U34 planning opportunity is best understood as a preparatory, milestone-oriented award for investigators proposing ambitious, multi-site clinical studies within NIDDK’s mission, where careful protocol finalization and operational planning are critical. The expected output of the planning phase is a set of peer-reviewed, implementable materials and decisions that make it possible to move into full study execution with fewer preventable design flaws, clearer site-to-site standardization, and stronger readiness for recruitment, data quality, and participant safety oversight.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2025-01-10.
• Applicants must submit their applications by 2027-06-10.
• Each selected applicant is eligible to receive up to $225,000.00 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.

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