Introduction

Part I: 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

Part II: 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 Document
Chapter 2-4: Continuing Review of Research
Chapter 2-5: Protocol Revisions
Chapter 2-6: Adverse Event Reports
Chapter 2-7: Primary Reviewer Presentations
Chapter 2-8: Deciding How to Vote

Part III: Specific Topics
Chapter 3-1: Evaluating Study Design and Scientific Inquiry
Chapter 3-2: Researcher Conflict of Interest
Chapter 3-3: Advertisements for Research
Chapter 3-4: Denying Subjects Access to Research Results
Chapter 3-5: Paying Research Subjects
Chapter 3-6: Deception of Research Subjects
Chapter 3-7: Qualitative Social Science Research
Chapter 3-8: Research without Informed Consent or Documentation
Chapter 3-9: Passive Consent (Not Saying No)
Chapter 3-10: Exculpatory Language in the Consent Document
Chapter 3-11: Excluding (Potentially) Pregnant Women from Research
Chapter 3-12: Banking Biologic Tissues for Research
Chapter 3-13: Placebo-Controlled Trials
Chapter 3-14: Treatment Withholding and Washout Periods
Chapter 3-15: Phase I Oncology Trials
Chapter 3-16: Research Involving Prisoners
Chapter 3-17: Research Involving Children

Part IV: References for Additional Information
Chapter 4-1: Ethical Codes
Chapter 4-2: US Government Regulations
Chapter 4-3: US Government Guidance/Resources
Chapter 4-4: International Guidelines
Chapter 4-5: Books
Chapter 4-6: Periodicals/IRB Forum
Chapter 4-7: Video Recordings
Chapter 4-8: Organizations