NIDDK High Risk Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34 Clinical Trial Optional)

NIDDK supports investigator-initiated, high-risk multi-center (more than one center) clinical studies through a two-part process that may include an implementation planning cooperative agreement (U34). The U34 is designed to: 1) Permit early peer review of the rationale for the proposed clinical study; 2) Permit assessment of the design and protocol of the proposed study; 3) Provide support for the development of documents needed for the conduct of the study, including a manual of operations; and 4) Support the development of other essential elements required for the conduct of the clinical study. The proposed clinical study should be hypothesis-driven and focus on a disease in the mission of NIDDK. Consultation with NIDDK scientific staff is strongly encouraged prior to the submission of the U34 application.

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); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Institutions) 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.