Grants / Department of Health and Human Services / National Institutes of Health

PAR-25-028: Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)

Closed Closed January 11, 2026 Opportunity PAR-25-028 ☆ Save

This grant is closed. A newer notice from the same program is open now: Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) (PAR-27-011). Status: Due dates in the notice, expires November 2, 2028. It is in our archive of National Institutes of Health notices from 2024.

• Award amountsNot given on Grants.gov
• Cost sharingNot required
• Funding typeGrant

Key dates

Who can apply

This opportunity was open to nonprofits, colleges and universities, state and local governments, tribes, small businesses and businesses.

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

More grants for nonprofits, colleges and universities, state and local governments, tribes, small businesses, businesses.

Is this a realistic fit?

• Most of the money in the 3 programs behind this notice (69% over five years) went to colleges and universities.
• No cost sharing or match is required.

What the grant funds

This Notice of Funding Opportunity (NOFO) supports applications to develop and implement investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this NOFO applies must be relevant to the research mission of the NHLBI and meet the NIH definition of a clinical trial (see NOT-OD-15-015). For additional information about the mission, strategic vision, and research priorities of the NHLBI, applicants are encouraged to consult the NHLBI website. This NOFO will utilize a bi-phasic, milestone-driven mechanism of award. The objective of the application is to present the scientific rationale for the clinical trial and a comprehensive scientific and operational plan that describes it. The application should address project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, and dissemination of results. The multiple PD/PI model is strongly encouraged but not required. Applicants are encouraged to include a PD/PI with expertise in biostatistics, clinical trial design, and coordination.

Category: Health.

Applying now

This notice no longer takes applications. Apply under the newer notice, PAR-27-011, which is open now.

The notice on Grants.gov keeps its full text and attachments, which is useful for planning a resubmission.