NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional)
ID: 358129Type: Posted
Overview

Buyer

National Institutes of Health (HHS-NIH11)

Award Range

$0 - $225K

Eligible Applicants

Others

Funding Category

Health

Funding Instrument

Cooperative Agreement

Opportunity Category

Discretionary

Cost Sharing or Matching Requirement

Yes

Original Source

https://grants.gov/search-results-detail/358129

Additional Information

http://grants.nih.gov/grants/guide/pa-files/PAR-25-090.html
Timeline
    Description

    The National Institutes of Health (NIH), through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), is offering a funding opportunity titled "NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional)." This initiative aims to support high-risk, investigator-initiated, multi-center clinical studies by facilitating early peer review and the development of essential operational documents necessary for conducting the proposed studies. The program emphasizes the importance of addressing diseases affecting underrepresented populations and requires applicants to include a Plan for Enhancing Diverse Perspectives (PEDP) in their submissions. The maximum award amount is $225,000 per year for up to two years, with applications opening on May 9, 2025, and a submission deadline of June 10, 2027. Interested applicants 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-25-090-Full-Announcement.html
    PAR-25-090.html
    The National Institutes of Health (NIH), through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), announces the funding opportunity titled "NIDDK High Risk Multi-Center Clinical Study Implementation Planning" (PAR-25-090). This initiative aims to support high-risk, investigator-initiated, multi-center clinical studies via a two-part cooperative agreement mechanism (U34), which facilitates early peer review of proposed studies and development of essential operational documents. NIDDK encourages focus on diseases impacting underrepresented populations and emphasizes the importance of community engagement in research planning. Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) and various administrative tasks are to be completed during the U34 phase, laying groundwork for participant recruitment under a subsequent U01 funding opportunity. Key dates include an application opening on May 9, 2025, with a maximum award budget of $225,000 per year for up to two years. Eligible organizations include higher education institutions, nonprofit organizations, and various governmental agencies. The program's structure aims to ensure scientific rigor, operational feasibility, and diversity in research participation, ultimately contributing to improved public health outcomes among diverse communities.
    Similar Opportunities
    NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), is offering a funding opportunity for high-risk multi-center clinical study implementation planning via Cooperative Agreements (U34). This initiative aims to support the early peer review of proposed clinical studies, assess study designs, and develop essential documentation, including operational manuals, focusing on diseases relevant to NIDDK's mission. The program emphasizes health equity and inclusivity, requiring a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application. Interested applicants can apply for up to $225,000 per year for a maximum of two years, with the application submission period opening on September 9, 2024, and the closing date set for June 10, 2027. For further inquiries, applicants may contact NIH Grants Information at grantsinfo@nih.gov.
    NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is inviting applications for the NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01), aimed at supporting investigator-initiated, high-risk clinical trials that involve multiple clinical centers. Applicants must propose hypothesis-driven studies that focus on diseases relevant to the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), with an emphasis on enhancing diverse perspectives in research. This funding opportunity is crucial for advancing therapeutic studies that can significantly improve clinical practices and public health outcomes. Interested applicants should note that the application period opens on January 5, 2024, with a closing date of November 5, 2026, and are encouraged to consult with NIDDK staff prior to submission. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Not Allowed)
    National Institutes of Health
    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 observational studies related to diabetes, digestive, kidney, and metabolic diseases. Applicants must complete all planning activities prior to submission, as these cannot be included in the U01 application, and a Plan for Enhancing Diverse Perspectives (PEDP) is mandatory for consideration. This funding opportunity is crucial for advancing clinical research and addressing health disparities, particularly by encouraging collaboration with underrepresented communities. Interested applicants should note that the application deadline is February 5, 2024, and can reach out to NIH Grants Information at grantsinfo@nih.gov for further inquiries.
    NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Not Allowed)
    National Institutes of Health
    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.
    NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required)
    National Institutes of Health
    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.
    Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), has announced a funding opportunity for small R01 grants aimed at supporting clinical trials that address diseases within its mission. This initiative encourages pilot and feasibility studies in human subjects to gather preliminary and feasibility data necessary for larger clinical trials focused on the prevention and treatment of diabetes and other related conditions. With an anticipated budget of $1 million for fiscal year 2025, NIDDK plans to fund up to three awards, each with a maximum direct cost of $200,000 annually over a three-year project period. Interested applicants must submit their proposals electronically through Grants.gov by May 7, 2026, and are encouraged to include a "Plan for Enhancing Diverse Perspectives" to promote inclusivity in their research efforts. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov.
    High Impact, Interdisciplinary Science in NIDDK Research Areas (RC2 Clinical Trial Optional)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity titled "High Impact, Interdisciplinary Science in NIDDK Research Areas" (PAR-25-277) aimed at supporting innovative research that addresses critical knowledge gaps in diabetes, digestive, and kidney diseases. This grant program encourages interdisciplinary approaches to foster discovery-based science and develop transformative technologies that can significantly impact the broader scientific community. Eligible applicants include a wide range of organizations, such as higher education institutions and nonprofits, with proposals accepted for projects lasting up to five years. Interested parties should ensure compliance with application guidelines and submit their proposals by the deadline of October 15, 2027. For further inquiries, applicants can contact NIH Grants Information at grantsinfo@nih.gov or visit the additional information link at https://grants.nih.gov/grants/guide/pa-files/PAR-25-277.html.
    NIDDK Education Program Grants (R25 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH), through the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), is offering Research Education Program Grants (R25) to enhance training in biomedical, behavioral, and clinical research. This funding opportunity aims to support educational activities that develop research skills and provide hands-on experiences in areas critical to NIDDK, including diabetes, digestive diseases, and obesity. Eligible applicants include a wide range of organizations such as higher education institutions, non-profits, and local governments, with a funding limit of $100,000 per year for up to five years. The application deadline is January 30, 2024, and interested parties can find more information by contacting NIH Grants Information at grantsinfo@nih.gov or visiting the program's webpage at https://grants.nih.gov/grants/guide/pa-files/PAR-24-074.html.
    Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK (R01 Clinical Trial Required)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering a funding opportunity for small Research Project Grants (R01s) aimed at clinical trials focused on diseases under the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). This initiative encourages the submission of pilot and feasibility clinical trials that will provide foundational data for larger, definitive trials intended to improve the prevention and treatment of various health conditions, without the requirement of preliminary efficacy data. The program supports innovative research ideas and emphasizes equitable recruitment from diverse populations, with a maximum grant duration of three years and funding up to $200,000 per year. Interested applicants can find more information and submit their applications by May 7, 2026, and should direct inquiries to NIH Grants Information at grantsinfo@nih.gov.
    NIDDK Catalyst Award (DP1 Clinical Trial Not Allowed)
    National Institutes of Health
    The National Institutes of Health (NIH) is offering the NIDDK Catalyst Award (DP1 Clinical Trial Not Allowed) to support pioneering biomedical research focused on critical scientific challenges related to diabetes, digestive diseases, and kidney diseases. This grant aims to fund individual scientists proposing innovative and high-impact studies that diverge from their existing research, encouraging bold ideas and unconventional hypotheses within the domains of the Division of Diabetes, Endocrinology and Metabolic Diseases and the Division of Digestive Diseases and Nutrition. The award has a budget ceiling of $500,000 per year for a maximum project period of five years, with a total funding commitment of $4.8 million for FY 2026 to support up to six awards. Interested applicants must adhere to NIH registration requirements and submit their proposals by July 18, 2025, with further inquiries directed to grantsinfo@nih.gov.