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

HHS-NIH11 PAR-25-028

Posted: Dec 11, 2024 12:00:00 AM EST

Closes: 01/11/2026

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.

Synopsis

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:

Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) For profit organizations other than small businesses Others (see text field entitled "Additional Information on Eligibility" for clarification) Private institutions of higher education State governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses City or township governments County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Public housing authorities/Indian housing authorities Special district governments

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.

Funding Activity Categories

Health

CFDA Numbers

93.233 - National Center on Sleep Disorders Research
93.837 - Cardiovascular Diseases Research
93.838 - Lung Diseases Research
93.839 - Blood Diseases and Resources Research
93.840 - Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders

Contact Information

Agency: National Institutes of Health

Contact: National Institutes of Health

Email: grantsinfo@nih.gov

Phone: 301-402-2541

NIH Grants Information
grantsinfo@nih.gov

Additional Information

Document Type: synopsis

Opportunity Category: Discretionary

Version: 2

Last Updated: May 21, 2025 11:10:41 AM EDT

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