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Table of Contents Title PageDedicationPrefaceAcknowledgements  Chapter 1. Introduction1.1        Overview1.2        Ethics and the IRB1.3        IRB Process1.4        Evaluating Biomedical Research1.5        Consent in Biomedical Research 1.6        The Social Sciences1.7        Biomedical Research Topics1.8        FDA and OHRP1.9        The Future Chapter 2. Ethics and the IRB2.1    Your Influential Position2.2    Evidence2.3    Scandal2.4    Research Ethics2.4.1      Two Ethical Principles2.4.2      Two Ethical Goals2.4.3      Goals into Practice2.4.4      Today’s Loss of Balance2.4.5      It’s Always about People2.5    Ethical Goals and Regulatory Means2.5.1      Principles of Regulation2.5.2      Organization and Legal Framework2.6    Your IRB Service2.6.1      Compensation2.6.2      Protection from Lawsuits2.6.3      The Community Member2.7    The Triumph of Ethics Review Chapter 3. IRB Process3.1    Principles3.1.1      Respectfulness3.1.2      Transparency3.1.3      Efficiency3.1.4      Clarity3.1.5      Accountability3.1.6      Judiciousness3.1.7      Rationality3.1.8      Restraint3.2    The Curse of Power3.2.1      Scope of IRB Authority3.2.2      Litigation Prevention3.2.3      Beyond the Regulations Chapter 4. Evaluating Biomedical Research4.1    The Objective IRB4.1.1      Ramsey and the Scientist’s Bias4.1.2      Your Reasonable Understanding4.2    Literature Reviews4.2.1      Death at Johns Hopkins4.2.2      Reviews by Investigators4.2.3      Reviews by IRBs4.3    Ethics and Science4.3.1      Scientific Modifications4.3.2      The Value of Research4.3.3      Risk4.4    Weighing Risks, Benefits, and Knowledge4.4.1      Why You Should Protect Subjects4.4.2      Why You Should Let Subjects Choose4.4.3      The Conundrum4.5    Approval Based on Risk and Benefit4.5.1      Established Theories4.5.2      Rajczi and Meyer: Let the Subjects Decide  4.6    Consent before Approval Chapter 5. Consent in Biomedical Research5.1    Consent’s Goals5.2    Multisite Consent Forms5.3    Presenting Risk and Benefit5.4    Subject Understanding5.4.1      Less is More5.4.2      Ethical Considerations5.5    Supervising Consent Form Writing5.5.1      Helping the Investigator5.5.2      Readability5.5.3      Format5.6    Editing the Consent Form Chapter 6. The Social Sciences6.1    The Value of Dissent6.2    The Social Impact of Research 6.3    Freedom of Speech6.4    Psychology6.4.1      Deception6.4.2      Threats to Self-Esteem6.5    Surveys and Interviews6.5.1      Risk and Benefit6.5.2      Modifications6.6    Field Research6.6.1      Risk6.6.2      The Sociologists’ Dispute6.7    Racial Discrimination Chapter 7. Biomedical Research Topics7.1    Archival Research7.1.1      Cancer of the Vagina7.1.2      Regulatory Oversight7.1.3      Ethical Considerations7.1.4      The Common Rule7.1.5      HIPAA7.2    The Learning Health Care System7.2.1      Integrating Research and Clinical Care7.2.2      Ethical Considerations7.2.3      Your IRB’s Role7.3    Randomized Controlled Trials7.3.1      Risks Inside and Outside of a Trial7.3.2      Nonphysical Risks7.4    Comparative Effectiveness Trials7.4.1      Identifying the Better Treatment7.4.2      Faden’s Bold Ethical Proposal7.4.3      Waiver of Consent in Special Circumstances7.5    Justice7.5.1      Unjust Burdens7.5.2      The Governmental Pursuit of Justice7.5.3      The Private Pursuit of Justice7.6    The Vulnerable7.6.1      Regulatory Overprotection7.6.2      Fighting Health Disparities7.7    Paying Subjects7.7.1      Respecting Subject Choice7.7.2      Coercion7.7.3      Setting a Cap on Wages  7.8    Emergency Research7.8.1      Criteria for Approval  7.8.2      Ethical Considerations7.9    Phase 1 Cancer Trials Chapter 8. FDA and OHRP8.1    Agencies under Pressure8.2    Your IRB and the Agencies8.2.1      Balancing Three Goals8.2.2      When Regulations Trump Ethics8.2.3      The Successful IRB8.2.4      Things Can Go Wrong8.3    Pushing Back against Federal Pressure8.3.1      The Agency8.3.2      The Funder8.3.3      The Media8.3.4      The Courts8.4    Risk and your IRB Chapter 9. The Future9.1    Evidence9.2    Reform9.3    The Challenge  ReferencesIndex