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Institutional Review Board: Management and Function
Author: Elizabeth A. BankertOVERVIEW
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).
Features and Benefits
- 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
TABLE OF CONTENTS
- Part 1 Ethical and Historical Background
- Part 2 Organizing the IRB Office
- Part 3 Organizing the IRB Committee
- Part 4 Single/Central IRBs
- Part 5 Review of Research
- Part 6 Informed Consent
- Part 7 IRB Review of Approved Protocols
- Part 8 Administration, Education, and Regulatory Issues
- Part 9 Considerations Based on Study Population
- Part 10 Issues Based on Study Design or Category
- Part 11 Research Regulated by FDA and Other Agencies
- Part 12 Special Topics
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