Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)
ID: 357659Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Grant

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/357659

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-028.html
Timeline
    Description

    The National Institutes of Health (NIH) is inviting applications for the "Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)" grant, aimed at supporting the development and execution of single-site clinical trials focused on efficacy, comparative effectiveness, and implementation research. Applicants are required to present a comprehensive scientific and operational plan, including project management strategies, subject recruitment and retention plans, and community engagement efforts, all aligned with the mission of the National Heart, Lung, and Blood Institute (NHLBI). This funding opportunity emphasizes the importance of diverse perspectives and strong project management in advancing health research through innovative trial designs. Interested applicants should note that the application deadline is September 11, 2025, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.

    Point(s) of Contact
    grantsinfo@nih.gov
    Files
    Title
    Posted
    PAR-25-028-Full-Announcement.html
    PAR-25-028.html
    The Department of Health and Human Services, through the National Heart, Lung, and Blood Institute (NHLBI), is inviting applications for the funding opportunity titled "Single-Site Investigator-Initiated Clinical Trials (R61/R33 Clinical Trial Required)." This initiative supports the development and execution of single-site clinical trials with a focus on efficacy, comparative effectiveness, and implementation research. Proposed trials must align with NHLBI's mission and utilize a bi-phasic, milestone-driven funding mechanism, with a maximum project period of five years comprising an R61 phase for initial preparation and an R33 phase for full execution. Key expectations include strong project management, community engagement efforts, and the inclusion of diverse perspectives throughout the research process. Applicants must submit specific plans, such as a Trial Management Plan, Community Engagement Plan, and a Plan for Enhancing Diverse Perspectives (PEDP). The notice emphasizes milestones critical for recruitment, diversity, and project completion success. Additional guidance includes registration requirements, compliance with data management policies, and adherence to application instructions. This funding opportunity reinforces NHLBI's commitment to advancing health research through innovative trial designs and ensuring broad participation from diverse groups.
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