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

Background
The NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) is a funding opportunity encouraging cooperative agreement applications for implementation of investigator-initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials. The National Institute of Allergy and Infectious Diseases (NIAID) supports infrastructure and networks focusing on high-priority disease research areas, such as the HIV/AIDS Clinical Trial Networks, the Infectious Diseases Clinical Research Consortium, and the Immune Tolerance Network. NIAID has committed over $5.5 billion to clinical research in the past three years, with $2.5 billion devoted to clinical trials and supportive activities.

Grant Details
The NIAID Clinical Trial Implementation Cooperative Agreement supports implementation of high-risk clinical trials that address high-priority research areas well-matched with the mission and goals of NIAID. It will support a single clinical trial that may include more than one intervention, but applications including more than one clinical trial will not be supported.

The proposed trial must be hypothesis-driven, related to the research mission of NIAID, and address a research area considered a high priority by the Institute.

Mechanistic studies will be supported as part of all clinical trials in this NOFO.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, state and local governments, federal agencies, U.S. territories or possessions, Indian/Native American tribal governments (both federally recognized and other than federally recognized), public housing authorities/Indian housing authorities, faith-based or community-based organizations, regional organizations, non-domestic (non-U.S.) entities (foreign organizations), and foreign components of U.S. organizations.

Period of Performance
The maximum project period is 5 years.

The open date for submission is April 12, 2024, with an expiration date of January 14, 2027.

Grant Value
Application budgets are not limited but need to reflect the actual needs of the proposed project.

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.