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

US Dept. of Health & Human Services: National Institutes of Health (NIH)

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Predicted Deadline
The next cycle for this opportunity is predicted based on past data. If you save this grant, we’ll notify you if there are any changes.

Next predicted deadline: Oct 11, 2023 (Full proposal)

Later predicted deadlines: Jan 13, 2024 (Letter of inquiry), Feb 13, 2024 (Full proposal), May 11, 2024 (Letter of inquiry), Jun 11, 2024 (Full proposal), Sep 11, 2024 (Letter of inquiry), Oct 11, 2024 (Full proposal), Jan 11, 2025 (Letter of inquiry), Feb 11, 2025 (Full proposal), May 11, 2025 (Letter of inquiry), Jun 11, 2025 (Full proposal)

Grant amount: Unspecified amount

Fields of work: Sleep Cardiovascular Diseases & Systems Respiratory Diseases & Systems Hematological Systems

Applicant type: Organizations

Funding uses: Research

Location of project: Anywhere in the world

Location of residency: Anywhere in the world


NOTE: All applications are due by 5:00 PM local time of the applicant organization. 

This Funding Opportunity Announcement (FOA) supports applications to develop and implement investigator-initiated single site clinical trials including efficacy, comparative effectiveness, pragmatic and/or implementation research clinical trials. These trials may include ones that test different therapeutic, behavioral, and/or prevention strategies. Trials for which this FOA 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 FOA 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, subject 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.

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This page was last reviewed September 17, 2023 and last updated May 09, 2023