Grants.govNational Institutes of Health

NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

Posted Jun 16, 2026·open

AGENCY

HHS-NIH11

PROGRAM

Discretionary

AMOUNT

—

CLOSES

Jul 5, 2029

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Description

This notice of funding opportunity (NOFO) encourages applications for implementation of investigator-initiated, milestone driven clinical trials that need enhanced oversight, and as applicable, include mechanistic studies. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities. Support is available for clinical trials up to 5 years, as well as for extended clinical trials of 6- or 7-years.Investigators are encouraged to visit this NIH website for additional information about the overall mission and research areas of NIAID.Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered.

Eligibility

For profit organizations other than small businesses; State governments; Small businesses; Public and State controlled institutions of higher education; Others (see text field entitled "Additional Information on Eligibility" for clarification); Special district governments; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; City or township governments; Independent school districts; County governments; Native American tribal organizations (other than Federally recognized tribal governments); Native American tribal governments (Federally recognized); Public housing authorities/Indian housing authorities; Private institutions of higher education; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education

Contact

National Institutes of Health

NIAID_IICT_U01@mail.nih.gov

301-402-2541

Additional details

Funding instrument: Cooperative Agreement
Cost sharing required: No
Archived: Sep 5, 2029

Opportunity number: PAR-27-064

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