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

National Institutes of Health

PAR-27-011

HHS-NIH11

General Information

Est. Program Funding:

November 2, 2028

Closing Date:

Expected No. of Awards

Award Ceiling

Opportunity Number:
PAR-27-011

Owning Agency:
HHS-NIH11

Opportunity Category:
Discretionary (D)

Synopsis

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.

Response Date	Nov 02, 2028 12:00:00 AM EDT
Posting Date	Mar 18, 2026 12:00:00 AM EDT
Archive Date	Jan 02, 2029 12:00:00 AM EST
Award Ceiling
Award Floor
Cost Sharing	No

Eligibility

Eligible Applicants

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

Additional Info on Eligibility:

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.

Additional Information

Agency Name	National Institutes of Health
Link to Additional Information:
Grantor Contact Information:	If you have difficulty accessing the full announcement electronically, please contact: GrantSolutions Help Desk Phone: 301-402-2541

CFDA Program(s)

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
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