Posted opportunity — confirm at source
Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
National Institutes of Health · PAR-27-011
See source for award amount
2028-11-02-00-00-00
Confirm exact timezone in the announcement.Special district governments, Small businesses, Others (see text field entitled "Additional Information on Eligibility" for clarification), City or township governments, Public and State controlled institutions of higher education, County governments, Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, State governments, Native American tribal organizations (other than Federally recognized tribal governments), Independent school districts, Public housing authorities/Indian housing authorities, Native American tribal governments (Federally recognized), Private institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, For profit organizations other than small businesses
Geographic eligibility and all attachment-specific conditions require review of the original announcement.
Eligibility details
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.
Matching funds & resources
Source matching-funds field: Not Required.
Matching funds and leveraged resources are different requirements. Read the description and reviewed rules below before determining resource commitments.
About this opportunity
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.
Funding geography: Not specified — review source. A funder’s address does not establish eligibility.
Review original source ↗Funding instrument: Grant. Issuing jurisdiction: Federal. This is not a geographic eligibility determination.
Source fields and evidence
id: 358850
Source ↗ · id
opportunityNumber: PAR-27-011
Source ↗ · opportunityNumber
opportunityTitle: Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
Source ↗ · opportunityTitle
revision: 6
Source ↗ · revision
agencyDetails: {"code":"NIH","seed":"HHS-NIH11","agencyName":"National Institutes of Health","agencyCode":"HHS-NIH11","topAgencyCode":"HHS"}
Source ↗ · agencyDetails
owningAgencyCode: HHS-NIH11
Source ↗ · owningAgencyCode
cfdas: [{"id":428250,"opportunityId":358850,"cfdaNumber":"93.233","programTitle":"National Center on Sleep Disorders Research"},{"id":428249,"opportunityId":358850,"cfdaNumber":"93.837","programTitle":"Cardiovascular Diseases Research"},{"id":428251,"opportunityId":358850,"cfdaNumber":"93.838","programTitle":"Lung Diseases Research"},{"id":428253,"opportunityId":358850,"cfdaNumber":"93.839","programTitle":"Blood Diseases and Resources Research"},{"id":428252,"opportunityId":358850,"cfdaNumber":"93.840","programTitle":"Translation and Implementation Science Research for Heart, Lung, Blood Diseases, and Sleep Disorders"},{"id":432265,"opportunityId":358850}]
Source ↗ · cfdas
applicantTypes: [{"id":"04","description":"Special district governments"},{"id":"23","description":"Small businesses"},{"id":"25","description":"Others (see text field entitled \"Additional Information on Eligibility\" for clarification)"},{"id":"02","description":"City or township governments"},{"id":"06","description":"Public and State controlled institutions of higher education"},{"id":"01","description":"County governments"},{"id":"12","description":"Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"00","description":"State governments"},{"id":"11","description":"Native American tribal organizations (other than Federally recognized tribal governments)"},{"id":"05","description":"Independent school districts"},{"id":"08","description":"Public housing authorities/Indian housing authorities"},{"id":"07","description":"Native American tribal governments (Federally recognized)"},{"id":"20","description":"Private institutions of higher education"},{"id":"13","description":"Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education"},{"id":"22","description":"For profit organizations other than small businesses"}]
Source ↗ · applicantTypes
applicantEligibilityDesc: 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.
Source ↗ · applicantEligibilityDesc
fundingInstruments: [{"id":"G","description":"Grant"}]
Source ↗ · fundingInstruments
fundingActivityCategories: [{"id":"HL","description":"Health"}]
Source ↗ · fundingActivityCategories
awardFloor: none
Source ↗ · awardFloor
awardCeiling: none
Source ↗ · awardCeiling
responseDate: Nov 02, 2028 12:00:00 AM EDT
Source ↗ · responseDate
responseDateStr: 2028-11-02-00-00-00
Source ↗ · responseDateStr
costSharing: false
Source ↗ · costSharing
lastUpdatedDate: Mar 18, 2026 08:31:25 AM EDT
Source ↗ · lastUpdatedDate
status: posted
Source ↗ · oppHits[id=358850].oppStatus
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