Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)

Federal funding opportunity PAR-27-011 from National Institutes of Health (Department of Health and Human Services).

Apply on Grants.gov →Application closes November 2, 2028

Posted: March 18, 2026
Closes: November 2, 2028
Cost sharing: No
Instrument: Grant
Assistance listing: 93.840, 93.838, 93.233, 93.837, 93.839
Category: Health
Archives: January 2, 2029

Program funding history

Awards made under Assistance Listing 93.840 across FY2024–FY2026, from public federal spending records.

FY2024 obligated: $1.2M
FY2025 obligated: $2.1M
FY2026 (to date) obligated: $0
Awards in window: 88

Top recipients: The Regents of the University of Colorado, Indiana Department of Health, Minnesota Department of Health, Michigan Public Health Institute, City of Philadelphia

Source: USAspending.gov · refreshed July 2026

Synopsis

This Notice of Funding Opportunity (NOFO) supports applications to develop and conduct investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or dissemination and implementation science clinical trials. Trials using innovative designs such as platform trials, adaptive, and Bayesian designs are encouraged. These trials may include ones that test different therapeutic, behavioral, dissemination and implementation science clinical trials 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, participant 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. The application should also describe its approaches to increase community engagement from conceptual design of the intervention through implementation and sustainability, close gaps in health outcomes within the US population, and increase health for all.

Who can apply

Native American tribal governments (Federally recognized)
Private institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Small businesses
City or township governments
Independent school districts
Special district governments
Native American tribal organizations (other than Federally recognized tribal governments)
State governments
Others (see text field entitled "Additional Information on Eligibility" for clarification)
County governments
For profit organizations other than small businesses
Public housing authorities/Indian housing authorities
Public and State controlled institutions of higher education

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.NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

How to apply

Applications go through the official government listing. Grants Radar links you straight to the source.

View on Grants.gov

Agency contact: National Institutes of Health · NHLBIDCVSClinical@mail.nih.gov · 301-402-2541

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