NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional) | PAR 24 094

Opportunity Information: Apply for PAR 24 094

The NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional), PAR-24-094, is an NIH funding opportunity meant to help research teams get complex, multi-center clinical studies ready to launch. It targets investigator-initiated projects that are considered high-risk and involve more than one study site, and it uses a two-part pathway where the U34 supports the planning and start-up work before a later, separate application for full study implementation. The central idea is to strengthen a proposed study early by giving it a structured planning period, close interaction with the funder, and a formal peer review of the scientific rationale and the practical design before major resources are committed.

The U34 mechanism is specifically designed to accomplish four main goals during the planning phase. First, it allows early peer review of whether the clinical question is compelling and whether the study is worth doing, which helps reduce the chance of moving forward with a weak or poorly justified trial concept. Second, it supports a detailed assessment and refinement of the study design and protocol, including the kinds of decisions that determine whether a multi-site study will actually be feasible (for example, eligibility criteria, recruitment strategy, endpoints, follow-up schedule, and analytic approach). Third, it provides funds and structure for developing the core documents needed to run the study, most notably a Manual of Operations, which typically standardizes procedures across sites so that recruitment, intervention delivery, measurements, data handling, and safety reporting are consistent. Fourth, it supports development of other essential elements required to conduct the clinical study, which commonly includes things like finalized case report forms, data and safety monitoring plans, quality assurance procedures, site training plans, governance structures, and other materials that prevent delays once implementation begins.

The opportunity is aimed at hypothesis-driven clinical studies that align with the NIDDK mission, meaning the topic should fall within NIDDK-relevant diseases and conditions (for example, diabetes, digestive diseases, kidney and urologic diseases, and related areas tied to NIDDK programs). Because the funding mechanism is cooperative agreement-based, it implies a more hands-on partnership with the NIH institute than a standard research grant. In practice, that typically means the awardee should expect meaningful scientific and operational involvement from NIDDK staff as the planning work proceeds. Consistent with that approach, consultation with NIDDK scientific staff is strongly encouraged before submitting an application, which can help applicants confirm fit with institute priorities, understand expectations for milestones and deliverables, and reduce the risk of an application that does not match the program purpose.

Eligibility is broad and includes many types of U.S.-based organizations and governments. 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; nonprofit organizations (both with and without 501(c)(3) status, other than higher education institutions); for-profit organizations (other than small businesses) and small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) as well as tribal organizations that are not federally recognized. The announcement also highlights additional eligible applicant categories such as historically black colleges and universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, Asian American Native American Pacific Islander-serving institutions (AANAPISIs), faith-based or community-based organizations, regional organizations, eligible federal agencies, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions.

Foreign eligibility is restricted. Non-domestic (non-U.S.) entities are not eligible to apply as applicant organizations, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as defined under the NIH Grants Policy Statement, are allowed, meaning a U.S. applicant may be able to include certain foreign collaborations in a compliant way as part of the project structure, as long as the applicant organization itself is domestic and the arrangement meets NIH policy requirements.

Administratively, this is an NIH discretionary funding opportunity using the cooperative agreement funding instrument, and it is categorized under Food and Nutrition and Health (CFDA 93.847). The listed award ceiling is $225,000. The opportunity was created on 2024-01-04, and the original closing date is 2027-06-10, indicating a multi-year window during which applications may be accepted according to NIH submission cycles and the specific instructions in the full announcement.

• 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 2024-01-04.
• 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.

Apply for PAR 24 094

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