This book is designed as an instructional manual that gives Institutional Review Board (IRB) members and administrators the information they need to run an efficient and effective system of protecting human research subjects. This extensively updated reference complies to the new federal research regulations released January 2019, known as the "New Rule" and provides a step-by-step approach to practical details of IRB administration. It includes case studies, sample forms, and sample policy documents, as well as decision-making algorithms and lists of approval criteria for their resolution.