The Oxford Textbook of Clinical Research Ethics

Emanuel: Chair, Department of Bioethics, NIH. Grady: Department of Bioethics, NIH. Crouch: Poynter Center for the Study of Ethics, Indiana University. Lie: Department of Bioethics, NIH. Miller: Department of Bioethics, NIH. Wendler: Department of Bioethics, NIH

Part. 1: The History of Research with Humans; 1. Walter Reed and the Yellow Fever Experiments 2. The Nazi Medical Experiments 3. The Imperial Japanese Experiments in China 4. The Randomized Controlled Trial of Streptomycin 5. The Salk Polio Vaccine Field Trial of 1954 6. The Jewish Chronic Disease Hospital Case 7. The Hepatitis Experiments at the Willowbrook State School 8. The Tuskegee Syphilis Experiment 9. HIV Research 10. The Gelsinger Case 11. An Ethical Framework for Biomedical Research ; Part 2: Codes, Declarations, and Other Ethical Guidance for Research with Humans; 12. The Nuremberg Code 13. The Declaration of Helsinki 14. The Belmont Report 15. Regulations for the Protection 16. International Ethical Guidance from the Council for International Organizations of Medical Sciences 17. The Council of Europe 18. The European Community Directives on Data Protection and Clinical Trials 19. National Bioethics Commissions and Research ; Part 3: Context, Purpose, and Value of Clinical Research ; 20. Exploitation in Clinical Research 21. The Nature, Scope, and Justification of Clinical research: What is Research? Who is a Subject? 22. Four Paradigms of Clinical Research and Research Oversight 23. The Role of Patient Advocates and Public Representatives in Research ; Part 4: ; Scientific Design ; 24. Equipoise and Randomization 25. The Ethics of Placebo- Controlled Trials 26. Challenge Experiments 27. Emergency Research 28. Consent for Research with Biological Samples 29. Genetic Diagnostic, Pedigree, and Screening Research 30. Deception in Clinical Research 31. Ethics of Epidemiology: Observational Studies on Human Populations 32. Ethical Issues in Behavioral and Social Science Research 33. Phase 1 Oncology Research 34. Surgical Innovation and Research ; Part 5: Participant Selection ; 35. What is Fair in Participant Selection? 36. Incentives for Research Participants 37. Ethical Issues in Recruiting Research Participants 38. Ethical Issues in Research Involving Women 39. Ethical Issues in Research with Ethnic and Minority Populations 40. Research Involving Economically Disadvantaged Participants 41. Research Involving Those at Risk for Impaired Decision-making Capacity 42. Research with Children 43. Captive Populations: Prisoners, Students, and Soldiers 44. Research with Identifiable and Targeted Communities 45. Research with Health Volunteers 46. Research with Fetuses, Embryos, and Stem Cells ; Part 6: Risk-Benefit Assessments ; 47. Risk-Benefit Analysis and the Net Risks Test 48. Assessing the Comparing Potential Benefits and Risks of Harm 49. Risk-Benefit Assessment in Pediatric Research ; Part 7: Independent Review and Oversight ; 50. Institutional Review Boards: Their Origins and the Policies that Govern Them 51. Models of Institutional Review Board Function 52. Assessing and Comparing Potential Benefits and Risks of Harm 53. Data and Safety Monitoring Boards 54. The Food and drug Administration and Drug Development: Historic, Scientific, and Ethical Considerations ; Part 8: Informed Consent ; 55. A History of Informed Consent in Clinical Research 56. Philosophical Justifications of Informed Consent in Research 57. Legal and Regulatory Standards of Informed Consent in Research 58. The Therapeutic Misconception 59. Empirical Issues in Informed Consent for Research 60. The Assent Requirement in Pediatric Research ; Part 9: Respect for Human Research Participants ; 61. Confidentiality 62. Legal Responsibility to Research Subjects: Liability and Compensation for Injury 63. The Obligation to Ensure Standards ; Part 10 Multi-National Research ; 64. Appropriate Standards 65. Benefits to Host Countries 66. The Standard of Care in Multi-National Research 67. Responsiveness to Host Community Health Needs ; Part 11: Clinical Investigator Behavior ; 68. Conflicts of Interest in Medical Research: historical Developments 69. Conflicts of Interest 70. Empirical Data on Obligations of Publication: Authorship and Dissemination ; Index