The purpose of this policy is to establish the criteria and procedures under which Duke University Health System (DUHS) may rely on an external Institutional Review Board (IRB), for the ethical review and approval of human subjects research. This policy ensures that reliance on an external IRB is conducted in a manner that protects research participants and complies with applicable federal regulations and guidance, and clearly defines roles, responsibilities, selection criteria for external IRBs, as well as the documentation and administrative processes required for reliance arrangements.