NIDDK High Risk Multi-Center Clinical Study Cooperative Agreement (U01 Clinical Trial Required)

HHS-NIH11 PA-25-147
Posted: Jan 03, 2025 12:00:00 AM EST
Closes: 11/05/2026

Description

This NOFO invites applications for investigator-initiated, high-risk multi-center clinical trials involving more than one clinical center. Proposed trials should be hypothesis-driven, have the potential to change clinical practice and/or public health, and focus on a disease relevant to the mission of NIDDK. Planning activities must be completed prior to submission and are not permitted under this NOFO. Applicants who require a planning phase may first apply for an implementation planning cooperative agreement (U34; see TEMP9971).Consultation with NIDDK Scientific/Research staff is strongly encouraged prior to the submission of either a U34 or U01 application.

Synopsis

This NOFO invites applications for investigator-initiated, high-risk multi-center clinical trials involving more than one clinical center. Proposed trials should be hypothesis-driven, have the potential to change clinical practice and/or public health, and focus on a disease relevant to the mission of NIDDK. Planning activities must be completed prior to submission and are not permitted under this NOFO. Applicants who require a planning phase may first apply for an implementation planning cooperative agreement (U34; see TEMP9971).Consultation with NIDDK Scientific/Research staff is strongly encouraged prior to the submission of either a U34 or U01 application.

Eligibility

Eligible Applicants:
State governments Independent school districts Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Small businesses For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Others (see text field entitled "Additional Information on Eligibility" for clarification) Public and State controlled institutions of higher education County governments
Other Eligible Applicants include the following:
Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Funding Activity Categories

Food and Nutrition Health

CFDA Numbers

  • 93.847 - Diabetes, Digestive, and Kidney Diseases Extramural Research

Contact Information

Agency: National Institutes of Health
Contact: National Institutes of Health
Phone: 301-402-2541
NIH Grants Information
grantsinfo@nih.gov

Additional Information

Document Type: synopsis
Opportunity Category: Discretionary
Version: 1
Last Updated: Jan 03, 2025 10:28:55 AM EST

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