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Institutional Review Board: Member Handbook, Third Edition

Author(s): Robert J. Amdur, MD, University of Florida College of Medicine, Gainesville, Florida
Elizabeth A. Bankert, MA, Dartmouth IRB
Details:
  • ISBN-13: 9780763780005
  • Paperback    211 pages      © 2011
Price: International Sales $55.95 US List
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Overview

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An Essential Resource for All IRB Members!

Designed to give Institutional Review Board (IRB) members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient, the chapters of the Institutional Review Board Member Handbook are short and to the point. Topic-specific chapters list the criteria IRB members should use to determine how to vote on specific kinds of studies and offer practical advice on what IRB members should do before and during full-committee meetings.

NEW CHAPTERS in this Edition Include:

  • Definition of Human Subject Research, Exempt & Expedited Review Categories
  • IRB Member Conflict of Interest

All chapters are completely updated for 2010 practice!

This handbook is an excellent accompaniment to Institutional Review Board: Management and Function, Second Edition and the Study Guide that IRB members can access and refer to quickly and easily.

ShowTable of Contents

Introduction  
Part 1  Background Information
  Chapter 1.1  The Purpose of This Handbook
  Chapter 1.2  Your Mission on the IRB
  Chapter 1.3  A Brief History of the IRB System
  Chapter 1.4  Principles of the Belmont Report
  Chapter 1.5  Definition of Human Subject Research, Exempt & Expedited Review Categories
Part 2  The Full Committee IRB Meeting
  Chapter 2.1  The Work Before An IRB Meeting
  Chapter 2.2  Reviewing a New Research Proposal
  Chapter 2.3  The Consent Process and Document
  Chapter 2.4  Continuing Review of Research
  Chapter 2.5  Protocol Revisions
  Chapter 2.6  Data and Safety Monitoring and Adverse Event Reporting
  Chapter 2.7  Primary Reviewer Presentations
  Chapter 2.8  Deciding How to Vote
Part 3  Specific Topics
  Chapter 3.1  Evaluating Study Design and Quality
  Chapter 3.2  Researcher Conflict of Interest
  Chapter 3.3  IRB Member Conflict of Interest
  Chapter 3.4  Advertisements for Research
  Chapter 3.5  Paying Research Subjects
  Chapter 3.6  Denying Subjects Access to Research Results
  Chapter 3.7  Deception of Research Subjects
  Chapter 3.8  Qualitative Social Science Research
  Chapter 3.9  Research Without Informed Consent or Documentation
  Chapter 3.10  Exculpatory Language in the Consent Document
  Chapter 3.11  When are Research Risks Reasonable in Relation to Anticipated Benefits?
  Chapter 3.12  Research Involving Children
  Chapter 3.13  Regulatory Issues of Research Involving Prisoners
  Chapter 3.14  Placebo Controlled Trials
  Chapter 3.15  Phase 1 Oncology Trials
  Chapter 3.16  Health Insurance Portability and Accountability Act
Part 4  Resources for Additional Information
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ShowAbout the Author(s)

Robert J. Amdur, MD-University of Florida College of Medicine, Gainesville, Florida

Robert Amdur was a member and Chairman of the IRB at Dartmouth College/Dartmouth Hitchcock Center for several years. Dr. Amdur currently focuses on advancing medicine in the field of radiation oncology.

Additional Titles by this Author

Elizabeth A. Bankert, MA-Dartmouth IRB

Elizabeth Bankert has been the Administrative Director of the IRB at Dartmouth College/Dartmouth Hitchcock Medical Center for ten years. She is a past president of Applied Research Ethics National Association (ARENA), a national membership organization comprised of over 2,000 IRB professionals, members, and researchers. Liz has made numerous presentations at institutions throughout the country as an invited speaker on topics ranging from Adverse Event Report to Research Involving Incompetent Patients.

Liz's most recent endeavor is a collaboration with Robert (Skip) Nelson, MD at Children's Hospital of Philadelphia in the creation of a web-based site referred to as IRBNet. The primary mission of IRBNet is to create an effective and efficient means of education and communication between sponsors, IRBs, and researchers with the goal of enhancing and streamlining the processes involved with research involving human subjects. IRBNet can be found at www.irbnet.org.

Additional Titles by this Author

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ShowReviews

  • The handbook provides a structured approach to the ethics and fundamental principles of protecting human research volunteers. This update absolutely should be required reading for every active member of an IRB as well as for researchers and principal investigators.

    -Vincent F Carr, DO, MSA, FACC, FACP, Uniformed Services University of the Health Sciences

  • As an instructor in course about action research in education, my students are required to be aware of a wide range of considerations and practices for research. A book such as this not only saves time, but also ameliorates many of the concerns associated with research anxiety, and institutional liability associated with sensitive research issues.

    -Randall Westbrook, Fairleigh Dickinson University

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