Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)

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Description

This opportunity supports investigator-initiated, single-site clinical trials addressing questions relevant to the National Heart, Lung, and Blood Institute (NHLBI) mission. Eligible trials include those focused on efficacy, comparative effectiveness, pragmatic, and/or implementation research, and may test therapeutic, behavioral, or prevention strategies. Innovative trial designs (e.g., adaptive, Bayesian) are encouraged. The award uses a two-phase, milestone-driven structure: an initial start-up phase (R61) and a full trial execution phase (R33), with progression dependent on achievement of predefined milestones.

The program is intended to accelerate the development and implementation of clinical trials that can inform clinical practice, health policy, or advance scientific knowledge in heart, lung, blood, and sleep disorders. Community engagement and strategies to reduce health disparities are strongly encouraged.

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Due Dates

• Upcoming application deadlines:

  • June 11, 2025
  • October 10, 2025
  • January 12, 2026 (last available cycle for this FOA)

• Letter of Intent: 30 days prior to the application due date.

• Earliest project start dates: Typically 6–9 months after submission, following review and council meetings.

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Funding Amount

• Budget: No specific budget limit. Budgets must be well-justified and reflect actual project needs.
• Project period: Up to 5 years (maximum 1 year for R61/start-up, up to 4 years for R33/full trial).
• Direct costs ≥$500,000 in any year: Prior consultation with NHLBI staff is required at least 6 weeks before submission.
• Number of awards: Contingent on NIH appropriations and the number of meritorious applications.

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Eligibility

• Eligible organizations:

  • Public and private institutions of higher education
  • Nonprofits (with or without 501(c)(3) status)
  • For-profit organizations, including small businesses
  • State, county, city, township, and special district governments
  • Independent school districts, public housing authorities, tribal governments and organizations
  • Faith-based and community-based organizations
  • Regional organizations
  • U.S. territories and possessions
  • Non-domestic (foreign) organizations

• Individuals: Any qualified investigator(s) with the skills, knowledge, and resources to carry out the project. Early Stage Investigators with clinical trial experience are encouraged to apply (with appropriate mentorship).

• Multiple applications: Permitted if scientifically distinct.

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Application Process

• Submission platforms: NIH ASSIST, institutional system-to-system, or Grants.gov Workspace.
• Required registrations: SAM, eRA Commons, Grants.gov, and (for foreign applicants) NCAGE code.
• Application components: In addition to standard NIH components, required attachments include:
  • Single-site Justification Plan (≤2 pages)
  • Trial Management Plan (≤5 pages)
  • Clinical Trials Research Experience (≤3 pages)
  • Community-Engagement Plan (≤1 page)
• Letters of support: Required from clinical leadership and any co-funding sources.
• Budget: Detailed annual budgets required; justification for all costs, including community engagement and data management.
• Data Management and Sharing Plan: Required for all applications.

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Additional Information

• Scope:
  • Only single-site (not multi-site) clinical trials are supported.
  • Not intended for Phase I, observational, drug/device safety, or mechanistic/basic experimental studies in humans.
• Milestones: Core milestones must be proposed for both R61 and R33 phases; transition to R33 depends on successful completion of R61 milestones.
• Progress monitoring: Regular reporting and milestone tracking required; NHLBI may discontinue funding if progress is insufficient.
• Community engagement: Strongly encouraged; plans for reducing health disparities should be included.
• Consultation: Early contact with NHLBI staff is highly recommended, especially for high-budget applications.

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External Links

• Full Funding Opportunity Announcement (PAR-25-028)
• NHLBI Mission and Strategic Vision
• How to Apply - NIH Application Guide
• Grants.gov Opportunity Listing

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Contact Information

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