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NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required)
National Institutes of Health
Currently Open
As of Jan 8, 2026
Eligible Applicants
County governmentsNative American tribal organizations (other than Federally recognized tribal governments)Native American tribal governments (Federally recognized)Small businessesState governmentsOthers (see text field entitled "Additional Information on Eligibility" for clarification)Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher educationIndependent school districtsPublic and State controlled institutions of higher educationFor profit organizations other than small businessesNonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher educationPublic housing authorities/Indian housing authoritiesCity or township governmentsSpecial district governmentsPrivate institutions of higher education
Overview
This NOFO invites applications for investigator-initiated, high-risk multi-center clinical trials involving more than one clinical center. Proposed trials should be hypothesis-driven, have the potential to change clinical practice and/or public health, and focus on a disease relevant to the mission of NIDDK. Planning activities must be completed prior to submission and are not permitted under this NOFO. Applicants who require a planning phase may first apply for an implementation planning cooperative agreement (U34; see TEMP9971).Consultation with NIDDK Scientific/Research staff is strongly encouraged prior to the submission of either a U34 or U01 application.
Eligibility Requirements
- 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.
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Source: www.grants.gov
Last Verified: Jan 8, 2026, 5:28 PM
Important: Always verify current details directly on the official grant website before applying.