The Oxford Textbook of Clinical Research Ethics (eBook, PDF)

Redaktion: Emanuel, Ezekiel J.; Wendler, David D.; Miller, Franklin G.; Lie, Reidar K.; Crouch, Robert A.; Grady, Christine C.

• Format: PDF

Produktbeschreibung

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 systematic examination 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 from scientific 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 teachers and students.

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Produktdetails

• Verlag: Oxford University Press
• Erscheinungstermin: 18. April 2008
• Englisch
• ISBN-13: 9780199721665
• Artikelnr.: 38134896

Autorenporträt

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

Inhaltsangabe

* 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