This policy applies to all research involving human participants that is reviewed by the Duke University Health System (DUHS) Institutional Review Board (IRB). The requirements described in this policy also apply to any study conducted by a Duke investigator that has external IRB oversight.  The purpose of this policy is to define the research-related activities that are permissible under DUHS policies and applicable federal regulations prior to IRB approval, and then also during the period between IRB approval and institutional approval.