National Heart, Lung, and Blood Institute (NHLBI) Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)

National Heart, Lung, and Blood Institute (NHLBI) Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) is sponsored by National Institutes of Health (NIH). National Heart, Lung, and Blood Institute (NHLBI) Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) is a grant from the National Institutes of Health that funds single-site investigator-initiated clinical trials in cardiovascular, lung, blood, and sleep di…

Opportunity Listing - Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required) 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: May 13, 2026 View version history on Grants.

gov 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.

City or township governments Special district governments Public and Indian housing authorities Federally recognized Native American tribal governments Other Native American tribal organizations Nonprofits non-higher education without 501(c)(3) Nonprofits non-higher education with 501(c)(3) Independent school districts Private institutions of higher education Public and state institutions of higher education For-profit organizations other than small businesses 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 Division of Cardiovascular Sciences NHLBIDCVSClinical@mail. nih.

gov NHLBIDCVSClinical@mail. nih. gov NHLBIDCVSClinical@mail.

nih. gov 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 Closing: November 2, 2028 Funding opportunity number : Cost sharing or matching requirement : Funding instrument type : Opportunity Category Explanation : Category of Funding Activity : Your account requires additional identity verification.