NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)
Supports investigator-initiated NIAID clinical trials, with enhanced oversight and optional mechanistic studies, for eligible domestic or foreign applicants.
⚑ One clinical trial per application · Enhanced oversight / milestone-driven cooperative agreement · Foreign organizations and foreign components are allowed
Unit fits — one characterization, each unit's own rules
| IPPRA | 40 partial | peripheral portfolio topic: public_health; social/behavioral work is minor; funds service delivery, not research (capped); biomedical core — IPPRA health lane is communication/crisis/policy (capped); clinical-trial/biomedical core — IPPRA angle is policy/community (capped); capped at 40 (non-research funding) |
| Physical Sciences & Engineering (demo) | 25 weak | technical depth: minor; funds service delivery (capped) |
| Tom Love Innovation Hub | 15 none | deep-tech content; no commercialization signal |
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
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.
Apply
View on Grants.gov → CONTACT: National Institutes of Health <NIAID_IICT_U01@mail.nih.gov>
Proposal brief SEE AN EXAMPLE →
A one-page internal memo: fit assessment, submission requirements, document scaffold, and next steps dated back from the deadline — tailored to your project idea if you add one.
Proposal shell · National Institutes of Health conventions SEE AN NIH EXAMPLE →
Funder-faithful document skeletons — National Institutes of Health's document set with section headings, page limits, reviewer guidance, and writing prompts; add a project idea to get [DRAFT] starter bullets. Download as .md for Word or Overleaf.