Contributors
Acknowledgements and Permission
Introduction
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 Syphillis 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 Clincial 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 of 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 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 Healthy Volunteers
46. Research with Fetuses, Embryos, and Stem Cells
Part 6: Risk-Benefit Assessments
47. Risk-Benefit Analysis adn the Net Risks Test
48. Assesseing and 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. Evaluating the Effectiveness of Institutional Review Boards
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 Access to Beneficial Treatments for Research Participants at Conclusion of Clinical Trials
Part 10: Multi-National Research
64. Appropriate Ethical 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. Conflictso f Interest
70. Empirical Data on Conflicts of Interest
71. Industrialization of Academic Science and Threats to Scientific Integrity
72. Altering Data: Fraud, Fabrication, and Falsification
73. Obligations of Publication: Authorship and Dissemination
Index