The NIDDK High-Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional) program, issued by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), provides funding to support the planning and administrative preparation required for high-risk, multi-center clinical studies. These studies focus on hypothesis-driven research related to diseases within NIDDK’s mission, such as diabetes, kidney diseases, and other conditions. This cooperative agreement allows for early peer review of the study rationale and supports the development of protocols, manuals of operations, safety plans, and other essential documents necessary to initiate participant recruitment. The maximum funding available is $225,000 per year for a project period of up to two years.

Eligible applicants include public and private higher education institutions, nonprofits with or without 501(c)(3) status, for-profit organizations, state and local governments, and tribal organizations. Foreign organizations are not eligible, but foreign components of U.S. organizations may participate. Applicants must complete registrations in SAM.gov, eRA Commons, and Grants.gov before submission. NIDDK encourages proposals that focus on underserved and minoritized populations, including racial and ethnic minorities, rural communities, and sexual and gender minorities. Engaging communities, patients, and other stakeholders in research planning and execution is a key program requirement.

The U34 funding supports administrative tasks such as finalizing study protocols, developing consent forms, establishing data management and safety plans, obtaining necessary regulatory approvals, and organizing clinical sites. The program does not fund data collection or pilot studies. Applicants must submit a detailed Milestone Plan outlining timelines for critical administrative and preparatory activities and an Organization Plan describing the management and coordination of the study.

The application process requires submission through Grants.gov, with deadlines of June 10, 2025; February 11, 2026; and October 8, 2026. Applicants must include a Plan for Enhancing Diverse Perspectives (PEDP), detailing actionable strategies to promote inclusivity in research. Incomplete applications or those lacking required documents, such as a Study Protocol or Milestone Plan, will not be reviewed.

Proposals will be evaluated on factors including the scientific significance of the study, feasibility, investigator expertise, and the potential for meaningful outcomes. Applications must include letters of support from participating clinical centers and collaborators. Budget requests should reflect the complexity of the study, and applicants must demonstrate capacity to meet program requirements and milestones.

Award recipients will participate in steering committees and engage with NIDDK project scientists for oversight and guidance. Data and resources generated during the project must adhere to NIH data sharing policies and may be deposited in the NIDDK Central Repository. While receipt of a U34 does not guarantee subsequent funding for the full clinical study (U01), successful completion of U34 milestones is expected to lead to a U01 application.

Interested applicants are strongly encouraged to consult NIDDK program staff at least 12 weeks before submission to ensure alignment with program priorities and appropriateness of the proposed study. Full details are available in the NOFO and supporting resources provided by NIDDK.