NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required)
ID: 357989Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes
Timeline
    Description

    The National Institutes of Health (NIH) is offering a funding opportunity for investigator-initiated, high-risk multi-center clinical trials through the Notice of Funding Opportunity (NOFO) PA-25-147. This cooperative agreement (U01) aims to support innovative studies that address critical health issues related to diabetes, digestive diseases, and kidney conditions, requiring proposals to be hypothesis-driven and operationally classified as high-risk. The program emphasizes the importance of diverse perspectives in research and mandates that planning activities be completed prior to application submission. Interested applicants should note that the application period opens on January 3, 2025, with a submission deadline of November 5, 2026. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.

    Point(s) of Contact
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    Title
    Posted
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is offering a funding opportunity for investigator-initiated, high-risk multi-center clinical trials via the Notice of Funding Opportunity (NOFO) PA-25-147. This grants program, specifically under the U01 cooperative agreement mechanism, invites applications aimed at addressing critical health issues within the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), including diabetes, digestive diseases, and kidney conditions. Proposals must present hypothesis-driven studies with an emphasis on innovative therapeutic interventions, operationally classified as high-risk due to either the intervention's complexity or participant vulnerability. Planning activities must be completed prior to the application, and a Plan for Enhancing Diverse Perspectives (PEDP) is required to ensure inclusivity. Key dates include an application opening on January 3, 2025, with corresponding deadlines for submission. The program encourages early applications to address potential submission errors. Ineligible applications encompass low-risk trials and mechanistic studies, ensuring alignment with NIDDK's mission. NIH will assess proposals based on scientific merit, feasibility, and the integration of diverse perspectives throughout the research process.
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