Table of Contents
Part 1: 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 1 Answer Key
Part 2: 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 2 Answer Key
Part 3: 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 3 Answer Key
Part 4: 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 4 Answer Key
Part 5: 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 5 Answer Key
Part 6: 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 6 Answer Key
Part 7: 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 7 Answer Key
Part 8: 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 8 Answer Key
Part 9: Issues Based on Study Population
Chapter 9-1 Vulnerability in Research
Chapter 9-2 Research in Public Schools
Chapter 9-3 Phase I Clinical Trials in Health Adults
Chapter 9-4 Requiring Birth Control to Participate in Research
Chapter 9-5 Research Involving Fetuses and In Vitro Fertilization
Chapter 9-6 Research Involving Pregnant Women
Chapter 9-7 Research Involving Children
Chapter 9-8 Research Involving Adults with Decisional Impairment
Chapter 9-9 Regulatory Issues of Research Involving Prisoners
Chapter 9-10 Research Involving College Students
Part 9 Answer Key
Part 10: IRB Issues Based on Study Design or Category
Chapter 10-1 When are Research Risks Reasonable in Relation to Anticipated Benefits
Chapter 10-2 Internet Research: A Brief Guide for IRBs
Chapter 10-3 Qualitative Social Science Research
Chapter 10-4 Ethnographic Research
Chapter 10-5 Health Services Research
Chapter 10-6 Epidemiology/Public Health Research
Chapter 10-7 Survey Research
Chapter 10-8 Research Involving A Medical Device
Chapter 10-9 Humanitarian Use Devices
Chapter 10-10 Banking of Biological Materials Research
Chapter 10-11 The Placebo-Controlled Clinical Trial
Chapter 10-12 Treatment-Withholding Studies in Psychiatry
Chapter 10-13 Phase I Oncology Trials
Chapter 10-14 Research Involving Genetic Testing
Chapter 10-15 International Research
Chapter 10-16 Alternative Medicine Research
Part 10 Answer Key
Part 11: Reference Material and Contact Information
Ch 11-1B The Belmont Report
Ch 11-1C World Medical Association Declaration of Helsinki
Part 11 Answer Key
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