Table Of ContentPart1 Background and Overview Topics Part2 Organizing the Office Part3 Organizing the IRB Committee Part4 Review Categories Part5 Initial Protocol Review and The Full-Committee Meeting Part6 Informed Consent Part7 Continuing Review Part8 Administrative and Regulatory Issues Part9 Issues Based on Study Population Part10 IRB Issues Based on Study Design or Category
SynopsisThis 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., The field of human subject protections oversight has grown and evolved considerably. Institutional Review Board (IRB) members and oversight personnel face challenges with research involving new technology, management of big data, globalization of research, and more complex federal regulations. Institutional Review Board: Management and Function, Third Edition provides everything IRBs and administrators need to know about efficiently managing and effectively operating a modern and compliant system of protecting human research subjects.This trusted reference manual has been extensively updated to reflect the 2018 revisions to the Federal Policy for the Protection of Human Subjects (Common Rule). An essential resource for both seasoned and novice IRB administrators and members, Institutional Review Board: Management and Function provides comprehensive and understandable interpretations of the regulations, clear descriptions of the ethical principles on which the regulations are based, and practical step-by-step guidance for effectively implementing regulatory oversight., Preview content now! Find Chapters 1-1 and 3-4 under the Sample Materials tab. The field of human subject protections oversight has grown and evolved considerably. Institutional Review Board (IRB) members and oversight personnel face challenges with research involving new technology, management of big data, globalization of research, and more complex federal regulations. Institutional Review Board: Management and Function, Third Edition provides everything IRBs and administrators need to know about efficiently managing and effectively operating a modern and compliant system of protecting human research subjects. This trusted reference manual has been extensively updated to reflect the 2018 revisions to the Federal Policy for the Protection of Human Subjects (Common Rule). An essential resource for both seasoned and novice IRB administrators and members, Institutional Review Board: Management and Function provides comprehensive and understandable interpretations of the regulations, clear descriptions of the ethical principles on which the regulations are based, and practical step-by-step guidance for effectively implementing regulatory oversight. You may also be interested in Institutional Review Board: Member Handbook, Fourth Edition (ISBN: 978-1-284-19714-3). Provides clear and practical interpretations of complex regulations by experts in the field Extensively revised and updated to incorporate current best practices and modern methodologies Thoroughly covers a wide array of tasks, issues, and challenges commonly encountered in human subject oversight Accessible format of short chapters with practical resources and a clear table of contents allows for quick reference of key information © 2022 1112 pages