NIH Funding Opportunity: Single-Site Investigator-Initiated Clinical Trials (R61/R33)
Summary
The National Institutes of Health (NIH) has issued a Notice of Funding Opportunity (NOFO) for single-site investigator-initiated clinical trials. This opportunity supports efficacy, comparative effectiveness, pragmatic, and dissemination/implementation science trials relevant to the NHLBI mission.
What changed
The National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI), has released a Notice of Funding Opportunity (NOFO) for investigator-initiated single-site clinical trials. This NOFO supports various types of trials, including efficacy, comparative effectiveness, pragmatic, and dissemination/implementation science trials, encouraging innovative designs. It specifies that trials must be relevant to the NHLBI's research mission and adhere to the NIH definition of a clinical trial. The funding mechanism is bi-phasic and milestone-driven, requiring applicants to present a comprehensive scientific and operational plan, including project management, participant recruitment, performance milestones, and dissemination strategies. The NIH also emphasizes increasing community engagement and addressing health outcome gaps within the US population.
While this is a funding opportunity announcement rather than a regulatory rule, entities seeking research grants must comply with the specific requirements outlined in the NOFO. This includes eligibility criteria for government, nonprofit, educational, and business entities, as well as specific conditions regarding foreign subawards/subcontracts, which are no longer permitted for domestic or foreign entities under this NOFO as of May 1, 2025. Applicants must carefully review the eligibility information and the full description to ensure their applications are compliant and competitive for funding. There are no explicit compliance deadlines mentioned for application submission within this document, but applicants should refer to the Grants.gov listing for specific application due dates.
What to do next
- Review NOFO for eligibility and specific research requirements.
- Ensure applications adhere to NIH definition of a clinical trial and NHLBI mission relevance.
- Verify compliance with new policy on foreign subawards/subcontracts effective May 1, 2025.
Source document (simplified)
Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
Agency: National Institutes of Health
Assistance Listings: 93.837 -- Cardiovascular Diseases Research
93.233 -- National Center on Sleep Disorders Research
93.838 -- Lung Diseases Research
93.840 -- Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
93.839 -- Blood Diseases and Resources Research
Last Updated: March 18, 2026 View version history on Grants.gov
Description
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. Show full description
Eligibility
Eligible applicants
Government
- City or township governments
- Special district governments
- Public and Indian housing authorities
- State governments
- County governments
- Federally recognized Native American tribal governments
Nonprofit
- Other Native American tribal organizations
- Nonprofits non-higher education without 501(c)(3)
- Nonprofits non-higher education with 501(c)(3)
Education
- Independent school districts
- Private institutions of higher education
- Public and state institutions of higher education
Business
- For-profit organizations other than small businesses
- Small businesses
Miscellaneous
- Other
Additional information
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.
Grantor contact information
Description
Division of Cardiovascular Sciences
NHLBIDCVSClinical@mail.nih.gov
NHLBIDCVSClinical@mail.nih.gov
NHLBIDCVSClinical@mail.nih.gov
Documents
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| File name | Description | Last updated |
| --- | --- | --- |
| PAR-27-011-Full-Announcement.html | PAR-27-011-Full-Announcement.html | Mar 18, 2026 12:31 PM UTC |
Link to additional information
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Closing: November 2, 2028
Application process
This site is a work in progress. Go to www.grants.gov to apply, track application status, and subscribe to updates. View on Grants.gov
Award
$--
Program Funding
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Expected awards
$--
Award Minimum
$--
Award Maximum
Funding opportunity number:
PAR-27-011
Cost sharing or matching requirement:
No Funding instrument type:
Grant
Opportunity Category:
Discretionary
Opportunity Category Explanation:
-- Category of Funding Activity:
Health
Category Explanation:
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History
Version:
1
Posted date:
March 18, 2026
Archive date:
January 2, 2029
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