This course describes the nuts and bolts of how Institutional Review Boards operate. Topics discussed include IRB membership, IRB authority, criteria for IRB approval of research or exemption from review, and suspension or termination of IRB approval of research. The process of risk/benefit decision making is reviewed. The constituencies served by the IRB are examined. Current issues in IRB practice are discussed. Practical information about the week-to-week management of an IRB is explained.