Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
Open Posted
- Opportunity number
- PAR-27-011
- Agency
-
National Institutes of Health
Department of Health and Human Services
- Applications due
- Award size
- Not on record
Opportunity facts
- Assistance listings
- Funding instrument
- Grant
- Category
-
- Health
- Eligible applicants
-
- City/Township Governments
- Tribal Organizations (Not Federally Recognized)
- Independent School Districts
- Higher Education Inst. (Private)
- Special District Governments
- Non-501(c)(3) Nonprofits
- For Profit Organizations
- Public or Indian Housing Auth.
- State Governments
- County Governments
- 501(c)(3) Nonprofits
- Other
- Higher Education Inst. (Public)
- Tribal Governments (Federally Recognized)
- Small Businesses
- Points of contact
Opportunity details come from Grants.gov. Updated .
About this opportunity
The National Heart, Lung, and Blood Institute (NHLBI) is soliciting applications for investigator-initiated single-site clinical trials using the R61/R33 phased award mechanism, with applications due by 5:00 PM local time on November 2, 2028. Trials must meet the NIH definition of a clinical trial and be relevant to NHLBI's research mission; Phase I trials, observational studies, multi-site trials, and safety-only trials are ineligible. Foreign organizations and non-domestic components of U.S. organizations are eligible, but applications involving foreign subawards or subcontracts are noncompliant and will not be reviewed as of May 1, 2025.
The R61 phase supports up to one year of protocol finalization and trial preparation; the R33 phase supports up to four years of full enrollment and trial execution. Combined maximum project period is five years. Award budgets are not limited and must reflect actual project needs; no cost sharing is required. The NOFO supports Phase II and above clinical trials testing efficacy, comparative effectiveness, pragmatic, or dissemination and implementation science approaches in cardiovascular sciences, lung diseases, blood diseases, and sleep disorders. Trials using innovative designs including platform trials, adaptive, and Bayesian designs are encouraged.
Eligible applicant categories include higher education institutions (public and private), nonprofits (501(c)(3) and non-501(c)(3)), for-profit organizations, state and local governments, tribal organizations (federally and non-federally recognized), school districts, and public or Indian housing authorities. The multiple PD/PI model is strongly encouraged but not required. Applicants should include a PD/PI with expertise in biostatistics, clinical trial design, and coordination. Applications must address project management, participant recruitment and retention, performance milestones, scientific conduct of the trial, dissemination of results, approaches to increase community engagement from conceptual design through implementation, and strategies to close health outcome gaps within the U.S. population.
Scientific merit review occurs 2–3 months after submission, with advisory council review approximately one month later. Peer review criteria include significance, innovation, rigor, feasibility, and investigator expertise. Early consultation with NHLBI scientific staff is strongly encouraged at least 12 weeks prior to submission. Funding is available under CFDA 93.837 (Cardiovascular Diseases Research), 93.838 (Lung Diseases Research), 93.233 (National Center on Sleep Disorders Research), 93.840 (Translation and Implementation Science Research), and 93.839 (Blood Diseases and Resources Research).
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.
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.
Files
| File | Type | Posted |
|---|---|---|
| PKG00292135.pdf | ||
| PAR-27-011-Full-Announcement.html | HTML file |
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