The Oxford Textbook of Clinical Research Ethics

Paperback | January 24, 2011

EditorEzekiel J. Emanuel, Christine Grady, Robert A. Crouch

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The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematicexamination of all aspects of research with human beings.Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging fromscientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research.The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advances scholarship in the field of human subjects research. Comprehensive in scope and depth, this book will be a crucial resource for researchers in the medical sciences, as well as teachersand students.

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The Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book's 73 chapters offer a wide-ranging and systematicexamination of all aspects of research with human be...

Ezekiel J.Emanuel is Chair in the Department of Bioethics at National Institutes of Health (NIH). Christine Grady is in the Department of Bioethics at NIH. Robert A. Crouch is at Poynter Center for the Study of Ethics at Indiana University. Reidar K. Lie is in the Department of Bioethics at NIH. Franklin G. Miller is in the Departmen...

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Format:PaperbackDimensions:848 pages, 11 × 8.5 × 0.68 inPublished:January 24, 2011Publisher:Oxford University PressLanguage:English

The following ISBNs are associated with this title:

ISBN - 10:0199768633

ISBN - 13:9780199768639

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Table of Contents

Part 1: The History of Research with Humans1. Walter Reed and the Yellow Fever Experiments2. The Nazi Medical Experiments3. The Imperial Japanese Experiments in China4. The Randomized Controlled Trial of Streptomycin5. The Salk Polio Vaccine Field Trial of 19546. The Jewish Chronic Disease Hospital Case7. The Hepatitis Experiments at the Willowbrook State School8. The Tuskegee Syphilis Experiment9. HIV Research10. The Gelsinger Case11. An Ethical Framework for Biomedical ResearchPart 2: Codes, Declarations, and Other Ethical Guidance for Research with Humans12. The Nuremberg Code13. The Declaration of Helsinki14. The Belmont Report15. Regulations for the Protection16. International Ethical Guidance from the Council for International Organizations of Medical Sciences17. The Council of Europe18. The European Community Directives on Data Protection and Clinical Trials19. National Bioethics Commissions and ResearchPart 3: Context, Purpose, and Value of Clinical Research20. Exploitation in Clinical Research21. The Nature, Scope, and Justification of Clinical research: What is Research? Who is a Subject?22. Four Paradigms of Clinical Research and Research Oversight23. The Role of Patient Advocates and Public Representatives in ResearchPart 4: Scientific Design24. Equipoise and Randomization25. The Ethics of Placebo- Controlled Trials26. Challenge Experiments27. Emergency Research28. Consent for Research with Biological Samples29. Genetic Diagnostic, Pedigree, and Screening Research30. Deception in Clinical Research31. Ethics of Epidemiology: Observational Studies on Human Populations32. Ethical Issues in Behavioral and Social Science Research33. Phase 1 Oncology Research34. Surgical Innovation and ResearchPart 5: Participant Selection35. What is Fair in Participant Selection?36. Incentives for Research Participants37. Ethical Issues in Recruiting Research Participants38. Ethical Issues in Research Involving Women39. Ethical Issues in Research with Ethnic and Minority Populations40. Research Involving Economically Disadvantaged Participants41. Research Involving Those at Risk for Impaired Decision-making Capacity42. Research with Children43. Captive Populations: Prisoners, Students, and Soldiers44. Research with Identifiable and Targeted Communities45. Research with Health Volunteers46. Research with Fetuses, Embryos, and Stem CellsPart 6: Risk-Benefit Assessments47. Risk-Benefit Analysis and the Net Risks Test48. Assessing the Comparing Potential Benefits and Risks of Harm49. Risk-Benefit Assessment in Pediatric ResearchPart 7: Independent Review and Oversight50. Institutional Review Boards: Their Origins and the Policies that Govern Them51. Models of Institutional Review Board Function52. Assessing and Comparing Potential Benefits and Risks of Harm53. Data and Safety Monitoring Boards54. The Food and drug Administration and Drug Development: Historic, Scientific, and Ethical ConsiderationsPart 8: Informed Consent55. A History of Informed Consent in Clinical Research56. Philosophical Justifications of Informed Consent in Research57. Legal and Regulatory Standards of Informed Consent in Research58. The Therapeutic Misconception59. Empirical Issues in Informed Consent for Research60. The Assent Requirement in Pediatric ResearchPart 9: Respect for Human Research Participants61. Confidentiality62. Legal Responsibility to Research Subjects: Liability and Compensation for Injury63. The Obligation to Ensure StandardsPart 10 Multi-National Research64. Appropriate Standards65. Benefits to Host Countries66. The Standard of Care in Multi-National Research67. Responsiveness to Host Community Health NeedsPart 11: Clinical Investigator Behavior68. Conflicts of Interest in Medical Research: historical Developments69. Conflicts of Interest70. Empirical Data on Obligations of Publication: Authorship and DisseminationIndex