Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
Grant Opportunity Analysis
The National Institutes of Health, through the National Heart, Lung, and Blood Institute, is seeking investigator-initiated funding for single-site clinical trials under the R61/R33 mechanism. The program supports efficacy, comparative effectiveness, pragmatic, and dissemination and implementation science trials, including studies of therapeutic, behavioral, and prevention strategies. It uses a bi-phasic, milestone-driven award structure and expects a comprehensive scientific and operational plan covering project management, participant recruitment and retention, performance milestones, trial conduct, and dissemination, with innovative designs and community engagement encouraged. Applications are evaluated on the importance of the research, rigor and feasibility of the approach, and investigator expertise and resources, and foreign subawards or subcontracts are not allowed. The closing date is November 2, 2028, and applicants may contact NHLBIDCVSClinical@mail.nih.gov for the Division of Cardiovascular Sciences.
Eligible Applicants
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.