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.

Full Product Details

Author:   Emanuel ,  Grady ,  Crouch ,  Lie
Publisher:   Oxford University Press Inc
Imprint:   Oxford University Press Inc
Dimensions:   Width: 22.50cm , Height: 4.50cm , Length: 29.00cm
Weight:   2.620kg
ISBN:  

9780195168655

ISBN 10:   0195168658
Pages:   848
Publication Date:   18 April 2008
Audience:   College/higher education ,  Professional and scholarly ,  Undergraduate ,  Postgraduate, Research & Scholarly
Format:   Hardback
Publisher's Status:   Unknown
Availability:   In Print  
Limited stock is available. It will be ordered for you and shipped pending supplier's limited stock.

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

Reviews

Its excellent articles cover almost all historical, conceptual, and empirical topics of clinical research ethics in a comprehensive and systematic synthesis...not only an excellent resource for training researchers and members of research review committees. Beyond that, it is an essential reading and a very valuable source for anybody working on and interested in research ethics. Medical Health Care and Philosophy ...provides scholarly, well-referenced analyses of different points of view on many of the challenging issues confronting clinical trial ethics. The Lancet This is an excellent and comprehensive compedium 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 it will remain useful for some time to come. Doody's Notes

Its excellent articles cover almost all historical, conceptual, and empirical topics of clinical research ethics in a comprehensive and systematic synthesis...not only an excellent resource for training researchers and members of research review committees. Beyond that, it is an essential reading and a very valuable source for anybody working on and interested in research ethics. Medical Health Care and Philosophy ...provides scholarly, well-referenced analyses of different points of view on many of the challenging issues confronting clinical trial ethics. The Lancet This is an excellent and comprehensive compedium 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 it will remain useful for some time to come. Doody's Notes

...provides scholarly, well-referenced analyses of different points of view on many of the challenging issues confronting clinical trial ethics. The Lancet This is an excellent and comprehensive compedium 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 it will remain useful for some time to come. Doody's Notes

Author Information

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

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