Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
Agency: National Institutes of Health
Assistance Listings: 93.838 -- Lung Diseases Research
93.233 -- National Center on Sleep Disorders Research
93.840 -- Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders
93.837 -- Cardiovascular Diseases Research
93.839 -- Blood Diseases and Resources Research
Last Updated: May 21, 2025
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
Grantor contact information
Description
See Section VII. Agency Contacts within the full opportunity announcement for all other inquires.
Documents
File name | Description | Last updated |
---|---|---|
PAR-25-028-Full-Announcement.html | PAR-25-028 Full Announcement Text | Dec 11, 2024 05:43 PM UTC |
Link to additional information
https://grants.nih.gov/grants/guide/pa-files/PAR-25-028.html
Closing: January 11, 2026
Award
$--
Program Funding
--
Expected awards
$--
Award Floor
$--
Award Ceiling
Funding opportunity number:
PAR-25-028
Cost sharing or matching requirement:
Funding instrument type:
Grant
Opportunity Category:
Discretionary
Opportunity Category Explanation:
Category of Funding Activity:
Health
Category Explanation:
History
Version:
2
Posted date:
December 11, 2024
Archive date:
February 10, 2026