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

National Institutes of Health

Funding

Varies

About

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.

Eligibility

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 types

Grants.gov eligibility code 00 Grants.gov eligibility code 01 Grants.gov eligibility code 02 Grants.gov eligibility code 04 Grants.gov eligibility code 05 Grants.gov eligibility code 06 Grants.gov eligibility code 07 Grants.gov eligibility code 08 Grants.gov eligibility code 11 Grants.gov eligibility code 12 Grants.gov eligibility code 13 Grants.gov eligibility code 20 Grants.gov eligibility code 22 Grants.gov eligibility code 23 Grants.gov eligibility code 25

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Notice-specific evidence check

What an applicant must verify for Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)

Applicant evidence

Applicant type: State governments
Applicant type: County governments
Applicant type: City or township governments
Applicant type: Special district governments
Applicant type: Independent school districts
Applicant type: Public and state-controlled institutions of higher education
Applicant type: Federally recognized tribal governments
Applicant type: Public housing authorities and Indian housing authorities

Opportunity boundaries

Recorded deadline: November 3, 2028; confirm time zone and submission system.
Recorded focus: Health

Do not infer missing fields: award amount. Absence from this directory record is not evidence that a restriction does not exist.

Before investing in an application, connect every eligibility claim, required registration, submission component and deadline to the current official notice. Open the recorded official source →

Application checklist

How to apply for Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)

The steps below turn the recorded grant fields into a pre-submission check. They do not replace the current Notice of Funding Opportunity or its amendments.

Recorded eligibility

• Applicant types: Grants.gov eligibility code 00, Grants.gov eligibility code 01, Grants.gov eligibility code 02, Grants.gov eligibility code 04, Grants.gov eligibility code 05, Grants.gov eligibility code 06.
• Geographic scope is not structured in this record.
• Notice summary: 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.

Focus areas: HL

Recorded deadline

November 2, 2028 — confirm the time zone and submission system

A missing or rolling date is not permission to assume an open application window.

1. Confirm fitMatch your applicant type, location, project scope and any cost-share or registration rule to the official notice.
2. Read the noticeCollect the current guidelines, amendments, budget rules, required attachments and submission instructions.
3. Check timingRecord the deadline time zone, internal review date and any earlier registration or portal cut-off.
4. Submit thereUse the official application route and save the confirmation or submission reference.

Official sources

Recorded source: https://www.grants.gov/xml-extract

Open official notice →

Last directory verification: Sep 13, 2026.