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

The NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional) is a funding opportunity issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a component of the U.S. Department of Health and Human Services' National Institutes of Health (NIH). This program supports the planning phase of investigator-initiated, high-risk multi-center clinical studies that align with NIDDK’s research priorities. It provides a cooperative agreement mechanism (U34) to support early peer review, detailed protocol assessment, and the development of key administrative and regulatory components required for launching a full-scale clinical study (which would subsequently apply under a U01 mechanism). This notice is a reissue of PAR-24-094 and was active under the funding opportunity number PAR-25-090 until its expiration on February 19, 2026. This funding mechanism is specifically intended for studies that either involve high-risk interventions (e.g., new drug applications, complex invasive procedures) or present high operational risks (e.g., inexperienced investigators or complex coordination requirements). The planning phase (U34) is not meant for pilot studies or preliminary data collection but focuses on readiness for implementation, including finalizing study protocols, establishing monitoring systems, developing manuals of operation, completing regulatory documentation, and ensuring that all study sites and collaborators are identified and prepared. Applicants are expected to develop a comprehensive plan to prepare for full-scale implementation. This includes engagement with community partners, development of recruitment strategies, identification of clinical and laboratory cores, creation of training and certification materials, and navigating the IRB and FDA requirements. A detailed milestone plan must be submitted with specific timelines for achieving critical tasks such as finalizing study protocols, obtaining IRB and DSMB approvals, and preparing clinicaltrials.gov registration. NIH program staff provide substantial involvement during the planning phase, including guidance and potential co-authorship, as well as coordination of review boards and ensuring adherence to NIH policies, including data sharing and participant diversity. The maximum award amount is $225,000 in direct costs per year, with a project period of up to two years. The number of awards is subject to the availability of funds and the merit of applications submitted. While no cost sharing is required, applicants must complete several registrations, including with SAM.gov, eRA Commons, and Grants.gov. The program is open to a wide range of U.S.-based eligible entities including nonprofits, educational institutions, tribal governments, for-profit organizations, and certain government agencies. However, foreign organizations and non-U.S. components of U.S. organizations are not eligible to apply. Applications were due on a triennial cycle with specific deadlines on June 10, February 11, and October 8. The opportunity supported submissions for both new and resubmission applications. Although the NOFO expired on February 19, 2026, NIH policies allow limited late submissions under certain circumstances. Interested applicants are encouraged to contact the NIH eRA Service Desk or relevant program staff listed in the notice for assistance and eligibility confirmation. Successful completion of a U34 award does not guarantee funding of the subsequent U01 application. However, it lays the groundwork for comprehensive planning and rigorous peer review, increasing the likelihood of future support. The cooperative agreement structure reflects NIH's intent to play an active partnership role in complex, high-risk multi-site research efforts that fall within the mission of NIDDK.

Engage NIDDK program staff early; ensure detailed milestone plans and complete application components to avoid rejection; prioritize population diversity and engagement strategies.