NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)
National Institutes of Health · Allergy and Infectious Diseases Research (93.855)
Posted 16 Jun 2026 · About 34 months left
Summary
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.
Excerpt from the donor's page. The full text, annexes and forms are on the original call.
Eligibility and conditions
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Applicant types: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; State governments; City or township governments; For profit organizations other than small businesses; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Public and State controlled institutions of higher education; Private institutions of higher education; County governments; Native American tribal organizations (other than Federally recognized tribal governments); Native American tribal governments (Federally recognized); Special district governments; Others (see text field entitled "Additional Information on Eligibility" for clarification); Public housing authorities/Indian housing authorities; Small businesses; Independent school districts
Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.Foreign Organizations/International CollaborationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.