September 2025 Trans-Divisional Council-Approved Concepts

Due to current HHS and NIH restructuring, some content on niaid.nih.gov is not being updated regularly. Please refer to clinicaltrials.gov and nih.gov for the most up-to-date information on NIH research.

Concepts represent early planning stages for program announcements, requests for applications, or solicitations for Council’s input. If NIAID publishes an initiative from one of these concepts, we link to it below. To find NIAID initiatives, go to Explore NIH Grant Opportunities.

Note: Council approval does not guarantee that a concept will become an initiative.

Table of Contents

Fiscal Year (FY) 2027 Concepts

NIAID Clinical Trial Implementation Cooperative Agreement

For more information, go to View Grant Opportunity for NIAID Clinical Trial Implementation Cooperative Agreement. Note: Information is tentative and subject to change.

Program Announcement with Special Receipt, Referral, and/or Review Considerations—proposed FY 2027 initiative

Contact:
Cynthia de la Fuente
cynthia.delafuente@nih.gov

Objective: Although clinical research infrastructure is crucial to furthering the Institute’s research, NIAID recognizes that additional models of clinical research may be important to advancing its research mission; therefore, NIAID has established the investigator-initiated clinical trial program for clinical trials that cannot or will not be conducted through existing NIAID-supported clinical trial infrastructure.

Description: This notice of funding opportunity (NOFO) will support the NIAID Clinical Trial Implementation (U01) Cooperative Agreement. This NOFO focuses on the implementation of investigator-initiated, milestone driven, high-risk clinical trials, and as applicable, 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.

NIAID Resource-Related Research Projects

For the published program announcement with special receipt, referral, and/or review considerations, check the May 7, 2026 grant opportunity, NIAID Resource-Related Research Projects (R24, Clinical Trial Not Allowed).

NIAID Investigator-Initiated Program Project Applications

For the published program announcement with special receipt, referral, and/or review considerations, check the May 7, 2026 grant opportunity, NIAID Investigator-Initiated Program Project Applications (P01, Clinical Trial Not Allowed).

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