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Department of Health and Human Services, National Institutes of Health

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

Who can apply

  • Private colleges and universities
  • Public and tribal housing authorities
  • Nonprofits with 501(c)(3) status
  • Tribal organizations
  • Small businesses
  • For-profit organizations (not small businesses)
  • City or township governments
  • Nonprofits without 501(c)(3) status
  • State governments
  • Public and state-controlled colleges
  • Independent school districts
  • Federally recognized tribal governments
  • Special district governments
  • County governments
  • Others (see eligibility details)

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.

About this grant

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.

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