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

Open

National Institutes of Health

Deadline: Jun 10, 2027federal

Updated: Oct 30, 2025

Summary

The grant supports high-risk, multi-center clinical studies initiated by investigators, focusing on diseases within the NIDDK mission, and includes a U34 cooperative agreement for early peer review and study design assessment. Eligible applicants include independent school districts, higher education institutions, state and local governments, nonprofits, and small businesses, among others. Interested parties are encouraged to consult with NIDDK scientific staff before applying, and applications can be submitted through the specified process outlined in the full opportunity announcement.

Full Description

NIDDK supports investigator-initiated, high-risk multi-center (more than one center) clinical studies through a two-part process that may include an implementation planning cooperative agreement (U34). The U34 is designed to: 1) Permit early peer review of the rationale for the proposed clinical study; 2) Permit assessment of the design and protocol of the proposed study; 3) Provide support for the development of documents needed for the conduct of the study, including a manual of operations; and 4) Support the development of other essential elements required for the conduct of the clinical study....

Eligibility

Eligible applicants

Education

  • Independent school districts
  • Private institutions of higher education
  • Public and state institutions of higher education

Miscellaneous

  • Other

Government

  • State governments
  • County governments
  • Federally recognized Native American tribal governments
  • Special district governments
  • City or township governments
  • Public and Indian housing authorities

Nonprofit

  • Other Native American tribal organizations
  • Nonprofits non-higher education with 501(c)(3)
  • Nonprofits non-higher education without 501(c)(3)

Business

  • Small businesses
  • For-profit organizations other than small businesses

Additional information

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Grantor contact information

Description

NIH Grants Information grantsinfo@nih.gov

Email

See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

grantsinfo@nih.gov

Apply on official siteUpdated Oct 30, 2025

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