Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
This NIH/NHLBI R61/R33 cooperative agreement funds investigator-initiated single-site clinical trials relevant to the NHLBI mission, using a milestone-driven, two-phase structure. Both U.S. and for…
- Deadline
- Nov 2, 2028
- Posted
- Mar 18, 2026
- Award amount
- Amount not specified
- Focus areas
- Health
Don’t miss this deadline
We’ll email you before Nov 2, 2028 so you have time to apply.
In plain English
This NIH/NHLBI R61/R33 cooperative agreement funds investigator-initiated single-site clinical trials relevant to the NHLBI mission, using a milestone-driven, two-phase structure. Both U.S. and foreign organizations may apply, but applications including funded foreign subawards/subcontracts will be deemed noncompliant. Applicants are encouraged to include expertise in biostatistics and clinical trial design.
AI-generated summary to help you decide quickly — verify the official eligibility rules before applying.
Who can apply
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.
About this grant
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.
Let AI draft your application
Your first draft is free: a narrative and budget outline tailored to this grant, emailed to you. Drafts are written in a nightly batch, so it arrives by email later — not instantly on this page.
Application Kit — $49 one-time
Winner intelligence + a first-draft narrative grounded in applications that actually won. One payment, no subscription.
Get the Application Kit →Related grants
Other open grants funding Health — soonest deadline first.
Advancing Research on the Application of Digital Health Technology to the Management of Type 2 Diabetes (R01- Clinical Trail Required)
National Institutes of Health · Amount varies · Closed
Optimal Treatment Strategies for use of Anti-Obesity Medications (AOMs) in Children and Adolescents Clinical Centers (U01 Clinical Trial Required)
National Institutes of Health · Up to $1M · Due in 3 days
Addressing Methodological Challenges with Clinical Trials of Rapid-Acting Psychotropic Interventional Drugs (RAPIDs) (R01 Clinical Trial Required)
National Institutes of Health · Amount varies · Due in 5 days
Advancing Research on Empirically-Supported Interventions for Older Adults Living with Serious Mental Illness (SMI) (R01 Clinical Trial Optional)
National Institutes of Health · Amount varies · Due in 9 days
CCRP Initiative: NIH Countermeasures Against Chemical Threats (CounterACT) Basic Research on Chemical Threats that Affect the Nervous System (R01 Clinical Trial Not Allowed)
National Institutes of Health · Up to $300K · Due in 10 days
NIH Research Software Engineer (RSE) Award (R50 Clinical Trials Not Allowed)
National Institutes of Health · Amount varies · Due Dec 4, 2026
Also listed under National Institutes of Health and Health Grants.
Source: public records via Grants.gov. UseGrants is an independent aggregator, not affiliated with any funding agency. Always confirm details on the official listing before applying.