Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
- Posted
- December 11, 2024
- Closed
- January 11, 2026
- Cost sharing
- No
- Instrument
- Grant
- Assistance listing
- 93.838, 93.233, 93.839, 93.840, 93.837
- Category
- Health
- Archives
- February 10, 2026
Program funding history
Awards made under Assistance Listing 93.838 (one of 5 on this opportunity) across FY2025–FY2027, from public federal spending records.
- FY2025 obligated
- −$250,767
- FY2026 obligated
- $0
- FY2027 (to date) obligated
- $0
- Awards in window
- 702
No net new obligations were recorded under this listing in the window shown: downward adjustments to earlier awards offset or exceeded new awards in every year. Awards in window counts awards with at least one recorded transaction in the window, adjustments included.
Top recipients: The Trustees of Columbia University in the City of New York, Northwestern University, University of Washington, University of Maryland, Baltimore, The General Hospital Corporation
Source: USAspending.gov · refreshed October 2026
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.
Who can apply
- Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
- County governments
- For profit organizations other than small businesses
- Private institutions of higher education
- Special district governments
- State governments
- Public housing authorities/Indian housing authorities
- City or township governments
- Public and State controlled institutions of higher education
- Small businesses
- Native American tribal organizations (other than Federally recognized tribal governments)
- Others (see text field entitled "Additional Information on Eligibility" for clarification)
- Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
- Native American tribal governments (Federally recognized)
- Independent school districts
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.
The official record
Grants.gov published the official terms and dates of this opportunity; this page keeps them as they were listed.
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