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More About This Textbook
Overview
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.
Editorial Reviews
From The Critics
Reviewer: Daniel Bustillos, JD, PhD(Saint Louis University)Description: A comprehensive book outlining the major areas of controversy in the ethics of clinical research, this is a compendium of research ethics analysis and cases for the classroom, clinic, and ethics committee room.
Purpose: It is intended as a textbook for students of clinical research ethics as well as a reference for researchers and institutional review board (IRB) members. By systematically dissecting hard cases and focusing on empirical evidence, it offers an analytic framework for resolving ethical issues in clinical research ethics.
Audience: This book is of special interest to students of clinical research ethics, teachers, researchers, and IRB members. Those with an interest in international research ethics will be pleased with the attention given that subject. The broad and deep scope of the book makes it a useful reference.
Features: Throughout 73 chapters that deal with nearly every conceivable issue in clinical research ethics, the authors take pains to adhere to a systematic and analytical framework with which to educate readers and equip them to resolve the practical issues likely to arise in clinical research.
Assessment: This is an excellent and comprehensive compendium of scholarship, novel research, practical advice, and dependable reference. The chapters dedicated to international research ethics and disparities in research are prescient of the foci that the field will have to embrace in the near future. The book's inclusive and broad focus makes it a worthwhile investment as the it will remain useful for some time to come.
Product Details
Related Subjects
Meet the Author
Ezekiel J. Emanuel is Chair of the Department of Bioethics at the National Institutes of Health.
Christine Grady is Head of the Section on Human Subjects Research at the Department of Bioethics at the National Institutes of Health.
Robert A. Crouch is at The Poynter Center for the Study of Ethics and American Institutions at Indiana University.
Reidar K. Lie is Head of International Programs in the Department of Bioethics at the National Institutes of Health.
Franklin G. Miller is on the faculty of the Department of Bioethics at the National Institutes of Health.
David Wendler is Head of the Unit on Vulnerable Populations in the Department of Bioethics at the National Institutes of Health.
Table of Contents
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