Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
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.
Agency: National Institutes of Health
CFDA: 93.840, 93.838, 93.233, 93.837, 93.839
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.
Applicant Types: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; For profit organizations other than small businesses; Native American tribal governments (Federally recognized); Public housing authorities/Indian housing authorities; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Private institutions of higher education; Public and State controlled institutions of higher education; Native American tribal organizations (other than Federally recognized tribal governments); State governments; Small businesses; City or township governments; Independent school districts; County governments; Special district governments; Others (see text field entitled "Additional Information on Eligibility" for clarification)
Cost Sharing: No
Contact: National Institutes of Health
Email: NHLBIDCVSClinical@mail.nih.gov
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About This Opportunity
This is a grants contract in the health and medical services sector. Located in United States, North America, this opportunity is open to firms and consortiums. Proposals must be submitted before November 2, 2028.
Published through Grants.gov, a national government procurement portal. Public procurement tenders follow the country's national bidding regulations and may have specific eligibility and documentation requirements for grants in the health and medical services sector. Grant applications generally require a detailed project proposal, a clear results framework, and evidence of the applicant's capacity to deliver the proposed activities. Interested parties should review the full documentation on the original source before submitting their proposal.