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National Institutes of Health · United States

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

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Applications close on 2 Nov 2028. Eligible applicant types include special district governments, nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, private institutions of higher education and 12 more.

About this call

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

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

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.

Applicant categories are a starting point. The official call decides eligibility.

Topics

Health

How to apply

1. Read the full notice of funding opportunity (NOFO) linked from the official page: eligibility, cost sharing and evaluation criteria.
2. Make sure your organisation has an active SAM.gov registration and Unique Entity ID (UEI); registration can take several weeks.
3. For NIH: the organisation and the principal investigator also need eRA Commons accounts; applications are usually submitted through Grants.gov (for example with ASSIST).
4. Prepare the required forms, narrative, budget and attachments exactly as the NOFO specifies.
5. Submit before the deadline and keep the tracking number. Check for amendments before you submit.

From the call text

Who can apply

Not stated in the call text we hold — check the official page

Company stage

Not stated in the call text we hold — check the official page

Single applicant or consortium

Not stated in the call text we hold — check the official page

Where applicants must be based

Not stated in the call text we hold — check the official page

Where to apply

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations.

Contact

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

Where these facts come from

Official sources

Official call page

Facts on this page come from the funder’s official data, taken on 13 Nov 2026. The funder's own documents, including later amendments, always take precedence.

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