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

This FOA invites applications for investigator-initiated, high-risk multi-center clinical trials involving m?o?r?e? ?t?h?a?n? ?o?n?e? 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 FOA. 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.

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.