Product Details

	Institutional Review Board: Member Handbook, Second Edition Elizabeth A. Bankert, MA, Dartmouth IRB, Robert J. Amdur, MD, University of Florida College of Medicine, Gainesville, Florida ISBN-13: 9780763741228 ISBN-10: 0763741221 $42.95 (Sugg. US List) Paperback 230 Pages © 2007

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

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

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

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