Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
National Institutes of Health · National Center on Sleep Disorders Research (93.233)
Posted 18 Mar 2026 · About 25 months left
Summary
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…
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Eligibility and conditions
Show the eligibility text from the source
Applicant types: City or township governments; County governments; Special district governments; Public and State controlled institutions of higher education; For profit organizations other than small businesses; Independent school districts; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Small businesses; Private institutions of higher education; Public housing authorities/Indian housing authorities; Others (see text field entitled "Additional Information on Eligibility" for clarification); State governments; Native American tribal organizations (other than Federally recognized tribal governments); Native American tribal governments (Federally recognized); Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
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.