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To describe policies and procedures for determining the types of activities that qualify as human research or clinical investigations and therefore require prior Institutional Review Board (IRB) review and approval GENERAL DESCRIPTION In accordance with federal and institutional regulations and prior to project implementation, the IRB must approve any undertaking in which a University of Kentucky (UK) faculty, staff, or student conducts human research. The UK policy document entitled “When Do Activities Involving Human Subjects Need Institutional Review Board (IRB) Review and Approval? ” outlines what types of activities are human subjects research or clinical investigations and therefore require IRB review and approval. Definition