NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Not Allowed)
ID: 357995Type: 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 inviting applications for the NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01), aimed at supporting high-risk, multi-center observational studies related to diabetes, digestive, kidney, and associated diseases. This funding opportunity emphasizes hypothesis-driven research that engages diverse populations, particularly underserved communities, and requires a comprehensive study design, community engagement, and a detailed budget. The initiative is crucial for advancing health equity and enhancing participant diversity in clinical research. Interested applicants should note that the submission period opens on January 3, 2025, with a closing date of November 5, 2026, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.

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    Title
    Posted
    The National Institutes of Health (NIH) invites applications for the NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01), focusing on high-risk, multi-center observational studies relevant to diabetes, digestive, kidney, and related diseases. This funding opportunity (PAR-25-089), reissued as a cooperative agreement, supports hypothesis-driven research conducted at multiple clinical centers, emphasizing participation from diverse populations, including underserved communities. Notably, the process involves two phases: a planning phase (U34) to prepare for recruitment and a subsequent clinical study phase (U01). Essential components include a Plan for Enhancing Diverse Perspectives (PEDP) to improve inclusivity within research teams. Key dates include a submission opening on January 3, 2025, and funding restricted to high-risk studies, excluding low-risk clinical trials. Eligible applicants range from higher education institutions to for-profit organizations, though foreign entities are ineligible to apply directly. Applications should detail the study design, community engagement, and a comprehensive budget, with an emphasis on quality control and data management. Successful proposals will demonstrate significant societal impact, innovation, and a robust approach to participant diversity, aligned with NIDDK’s health equity goals.
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