Institutional Review Board: Member Handbook

3rd Edition
Softcover: 230 pages
ISBN 0763780006
978-0763780005
Jones & Bartlett
May 2010
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Institutional Review Board Member Handbook is designed to give IRB members the information they need to protect the rights and welfare of research subjects in a way that is both effective and efficient.

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.

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 include:

Definition of Human Subject Research,
Exempt & Expedited Review Categories;
IRB Member Conflict of Interest. All chapters are completely updated for 2010 practice!

Chapters are short and to the point with the goal of presenting practical advice on what IRB members should do before and during full-committee meetings.

Contains a brief summary of the events that led to the modern IRB system.
Step-by-step instructions on how to prepare for the IRB meeting.
Contains format for reviewing research proposals and presenting the review at the full-committee meeting.
Enormous information on evaluating specific research issues like paying research subjects, placebo treatment, deception of subjects, and research without informed consent.
Chapters begin with a single page summary of the take-home messages of the chapter.
A useful list of the resources and publications that focus on issues of interest to IRB members.

A large portion of the book is devoted to topic-specific chapters that list the criteria IRB members should use to determine how to vote on specific kinds of studies. This handbook is an excellent accompaniment to Institutional Review Board: Management and Function that IRB members can access and refer to quickly and easily. If you do not already have its companion reference book in your office, we also recommend Institutional Review Board: Management and Function. The book described on this page, Institutional Review Board: Member Handbook, contains the following chapters:

Background Information
- The Purpose of This Handbook
- Your Mission on the IRB
- A Brief History of the IRB System
- Principles of the Belmont Report
- The Full Committee IRB Meeting
- The Work Before An IRB Meeting
- Reviewing A New Research Proposal
- The Consent Document
- Continuing Review of Research
- Protocol Revisions (Amendments)
- Adverse Event Reports
- Primary Reviewer Presentations
Specific Topics
- Evaluating Study Design and Quality
- Researcher Conflict of Interest
- Advertisements for Research
- Denying Subjects Access to Research Results
- Paying Research Subjects
- Deception of Research Subjects
- Qualitative Social Science Research
- Research Without Informed Consent or Documentation
- When are Research Risks Reasonable in Relationship To Anticipated Benefits?
- Exculpatory Language in the Consent Document
- Vulnerability in Research
- Placebo-Controlled Trials
- Treatment Withholding and Washout Periods
- Phase 1 Oncology Trials
- Research Involving Prisoners
- Research Involving Children
- HIPAA
Resources for Additional Information
- Ethical Codes
- U.S. Government Regulations
- U.S. Government Guidance/Resources
- International Guidelines
- Books
- Periodicals and the IRB Form
- Video Recordings
- Organizations

Elizabeth A. Bankert, MA 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.

Robert J. Amdur, MD 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.

(information from the publisher)

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