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

Open

National Institutes of Health

Deadline: Jan 11, 2026federal

Updated: Oct 30, 2025

Summary

The grant supports the development and implementation of investigator-initiated single-site clinical trials focused on efficacy, comparative effectiveness, and implementation research relevant to the NHLBI's mission. Eligible applicants include independent school districts, higher education institutions, nonprofits, government entities, small businesses, and various other organizations, including tribal and community-based organizations. To apply, applicants must present a scientific rationale and operational plan for the trial, addressing project management and recruitment strategies, among other requirements.

Full Description

Description

This Notice of Funding Opportunity (NOFO) 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 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, 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.

Eligibility

Eligible applicants

Education

  • Independent school districts
  • Private institutions of higher education
  • Public and state institutions of higher education

Nonprofit

  • Other Native American tribal organizations
  • Nonprofits non-higher education with 501(c)(3)
  • Nonprofits non-higher education without 501(c)(3)

Government

  • Special district governments
  • State governments
  • Public and Indian housing authorities
  • County governments
  • City or township governments
  • Federally recognized Native American tribal governments

Business

  • Small businesses
  • For-profit organizations other than small businesses

Miscellaneous

  • Other

Additional information

Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.

Grantor contact information

Description

NIH Grants Information grantsinfo@nih.gov

Email

See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.

grantsinfo@nih.gov

Apply on official siteUpdated Oct 30, 2025

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