Study Guide for Institutional Review Board Management and Function

Part One: Background and Overview Topics Chapter 1:1 An Ethics Primer for IRB's Chapter 1:2 Reflections of an Outsider Chapter 1:3 A Unified Human:Research Protection Program Chapter 1:4 A Shared Responsibility to Protect Human Subjects Chapter 1:5 A Brief History of PRIM&R and IRB Education Chapter 1:6 The IRB: Definition and Federal Oversight Chapter 1:7 The Limits of IRB Authority Part One Answer Key Part Two: Organizing the Office Chapter 2:1 Administrative Reporting Structure for the IRB Chapter 2:2 Policies, Procedures and Documenting Compliance with Federal Regulations Chapter 2:3 Tracking Systems Using Information Technology Chapter 2:4 Support Staff Chapter 2:5 Audit Systems Chapter 2:6 Charging for IRB Review Part Two Answer Key Part Three: Organizing the IRB Committee Chapter 3:1 Reflections on Chairing an IRB Chapter 3:2 The IRB Chair Chapter 3:3 The IRB Administrative Director Chapter 3:4 The Role of an Attorney Chapter 3:5 Committee Size, Alternates and Consultants Chapter 3:6 Length, Frequency and Time of IRB Meetings Chapter 3:7 IRB Subcommittees Chapter 3:8 Social Science vs. Biomedical IRBs Part Three Answer Key Part Four: Review Categories Other Than Full Board Review Chapter 4:1 Exempt from IRB Review Chapter 4:2 Expedited from IRB Review Chapter 4:3 Definition of Research Chapter 4:4 'Compassionate Use' and the Emergency Use Exemption Chapter 4:5 Waiver of Consent in Emergency Medicine Research Part Four Answer Key Part Five: Initial Protocol Review and the Full:Committee Meeting Chapter 5:1 Overview of Initial Protocol Review Chapter 5:2 Evaluating Study Design and Quality Chapter 5:3 The Study Population: Women, Minorities and Children Chapter 5:4 Community Consultation to Assess and Minimize Group Harms Chapter 5:5 Privacy and Confidentiality Chapter 5:6 Recruitment of Research Subjects Chapter 5:7 Advertisments for Research Chapter 5:8 Paying Research Subjects Chapter 5:9 Provisions for Data Monitoring Chapter 5:10 Conflict of Interest: Researchers Chapter 5:11 Conflict of Interest: Recruitment Incentives Chapter 5:12 Conflict of Interest: IRBs Chapter 5:13 Administrative Tasks Before Each IRB Meeting Chapter 5:14 Guidelines for Review, Discussion and Voting Chapter 5:15 Administrative Tasks After Each IRB Meeting Part Five Answer Key Part Six: Informed Consent Chapter 6:1 The IRB's Role in Editing the Consent Document Chapter 6:2 The Consent Document Chapter 6:3 Exculpatory Language in Informed Consent Documents Chapter 6:4 Requiring a Witness Signature on the Consent Form Chapter 6:5 Deception of Research Subjects Chapter 6:6 Waiving Informed Consent or a Signed Consent Form Chapter 6:7 Selecting a Surrogate to Consent to Medical Research Chapter 6:8 Research:Related Injuries Chapter 6:9 Informing Subjects of Research Results Chapter 6:10 Explaining the Costs of Research Participation Chapter 6:11 Improving Informed Consent Chapter 6:12 Informed Consent Evaluation Feedback Tool Part Six Answer Key Part Seven: Continuing Review Chapter 7:1 Revisions to Approved Protocol Chapter 7:2 Protocol Renewal Chapter 7:3 IRB Review of Adverse Events Chapter 7:4 Data and Safety Monitoring Chapter 7:5 Noncompliance, Complaints, Deviations, Eligibility Exceptions Chapter 7:6 Closing Out a Study Part Seven: Answer Key Part Eight: Administrative and Regulatory Issues Chapter 8:1 HIPAA and Research Chapter 8:2 OHRP Federal:Wide Assurance Chapter 8:3 International Conference on Harmonization Chapter 8:4 Gene Therapy Oversight Chapter 8:5 Understanding the FDA's IND Process Chapter 8:6 Differences Between DHHS and FDA Regulations Chapter 8:7 Veteran's Administration Research Guidelines Chapter 8:8 State Law Chapter 8:9 IRB Member Liability Chapter 8:10 Certificate of Confidentiality Chapter 8:11 Training IRB Members Chapter 8:12 Investigator Training Chapter 8:13 Accreditation of an IRB Chapter 8:14 Certification of IRB Professionals Chapter 8:15 Preparing for an FDA Audit Chapter 8:16 Preparing for an OHRP Site Visit Part Eight Answer