Page Tools:
  • print-friendly version

Institutional Review Board: Member Handbook, Second Edition

Author(s): Elizabeth A. Bankert, MA, Dartmouth IRB
Robert J. Amdur, MD, University of Florida College of Medicine, Gainesville, Florida
Details:
  • ISBN-13: 9780763741228
  • ISBN-10:0763741221
  • Paperback    230 pages      © 2007
Price: International Sales $52.95 US List
Add to Cart Request a Review Copy

Overview

An Essential Resource for All IRB Members!

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, 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 to this Edition Include:

  • HIPPA Compliance
  • Vulnerability Among Research Subjects

All chapters are completely updated for 2007 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.

NEED A HANDBOOK FOR EACH OF YOUR MEMBERS?

Contact our Special Sales Department for information on bulk order discounts!

 

ShowTable of Contents

Part 1- Background Information

 

Ch 1-1: The Purpose of This Handbook

Ch 1-2: Your Mission on the IRB

Ch 1-3: A Brief History of the IRB System

Ch 1-4: Principles of the Belmont Report

 

Part 2- The Full Committee IRB Meeting

 

Ch 2-1: The Work Before An IRB Meeting

Ch 2-2: Reviewing A New Research Proposal

Ch 2-3: The Consent Document

Ch 2-4: Continuing Review of Research

Ch 2-5: Protocol Revisions (Amendments)

Ch 2-6: Adverse Event Reports
Ch 2-7: Primary Reviewer Presentations

 

Part 3- Specific Topics

 

Ch 3-1: Evaluating Study Design and Quality

Ch 3-2: Researcher Conflict of Interest

Ch 3-3: Advertisements for Research

Ch 3-4: Denying Subjects Access to Research Results

Ch 3-5: Paying Research Subjects

Ch 3-6: Deception of Research Subjects

Ch 3-7: Qualitative Social Science Research

Ch 3-8: Research Without Informed Consent or Documentation

Ch 3-9: When are Research Risks Reasonable in Relationship To Anticipated Benefits?

Ch 3-10: Exculpatory Language in the Consent Document
Ch 3-11

Ch 3-12: Vulnerability in Research

Ch 3-13: Placebo-Controlled Trials

Ch 3-14: Treatment Withholding and Washout Periods

Ch 3-15: Phase 1 Oncology Trials

Ch 3-16: Research Involving Prisoners
Ch 3-17: Research Involving Children

Ch 3-18: HIPAA

 

Part 4: Resources for Additional Information

 

Ch 4-1: Ethical Codes

Ch 4-2: U.S. Government Regulations

Ch 4-3: U.S. Government Guidance/Resources

Ch 4-4: International Guidelines

Ch 4-5: Books

Ch 4-6: Periodicals and the IRB Form

Ch 4-7: Video Recordings

Ch 4-8: Organizations

 


Back to top

ShowAbout the Author(s)

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

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.

Back to top