The Oxford textbook of clinical research ethics:
Gespeichert in:
| Weitere Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Oxford [u.a.]
Oxford University Press
2011
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| Ausgabe: | First issued as an Oxford University Paperpack 2011 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis Klappentext |
| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | XX, 827 Seiten Illustrationen, Diagramme |
| ISBN: | 9780195168655 9780199768639 |
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Datensatz im Suchindex
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| adam_text | Contents Contributors xv Introduction 3 I A Selected History of Research With Humans 1 Walter Reed and the Yellow Fever Experiments 9 Susan E. Lederer 2 The Nazi Medical Experiments 18 Paul J. Weindling 3 The Imperial Japanese Experiments in China 31 Takashi Tsuchiya 4 The Randomized Controlled Trial of Streptomycin 46 Alan Yoshioka 5 The Salk Polio Vaccine Field Trial of 1954 61 Marcia L. Meldrum 6 The Jewish Chronic Disease Hospital Case 73 John D. Arras 7 The Hepatitis Experiments at the Willowbrook State School Walter M. Robinson and Brandon T. Unruh 8 The Tuskegee Syphilis Experiment James H. (ones 86 80
Contents 9 HIV Research 97 ļohn Y. Killen |r. 10 The Gelsinger Case 7 70 Robert Steinbrook II Codes, Declarations, and Other Ethical Guidance for Research With Humans 11 An Ethical Framework for Biomedical Research 723 Ezekiel J. Emanuel, David Wendler, and Christine Grady 12 The Nuremberg Code 136 George J. Annas and Michael A. Grodin 13 The Declaration of Helsinki 141 Richard E. Ashcroft 14 The Belmont Report 149 Tom L. Beauchamp 15 Regulations for the Protection of Humans in Research in the United States: The Common Rule 156 Joan P. Porter and Greg Koski 16 International Ethical Guidance From the Council for International Organizations of Medical Sciences 7 68 Juhana E. Idänpään-Heikkilä and Sev S. Fluss 17 The Council of Europe 7 74 Pēteris Zilgalvis 18 The European Community Directives on Data Protection and Clinical Trials Deryck Beyleveld and Sebastian Sethe 19 National Bioethics Commissions and Research Ethics 187 Eric M, Mesiin and Summer Johnson III 20 Context, Purpose, and Value of Clinical Research Exploitation in Clinical Research 201 Alan Wertheimer 21 The Nature, Scope, and Justification of Clinical Research: What Is Research? Who Is a Subject? 211 Robert J, Levine 22 Four Paradigms of Clinical Research and Research Oversight 222 Ezekiel J. Emanuel and Christine Grady 23 The Role of Patient Advocates and Public Representatives in Research Rebecca Dresser IV Scientific Design 24 Equipoise and Randomization 245 Steven Joffe and Robert D. Truog 25 The Ethics of Placebo-Controlled Trials Franklin C. Miller 261 231 180
Contents 26 Challenge Experiments 273 Franklin C. Miller and Donald L. Rosenstein 27 Emergency Research 280 jason H. T. Karlawish 28 Research With Biological Samples 290 David Wendler 29 Genetic Diagnostic, Pedigree, and Screening Research Eric T. juengst and Aaron Coldenberg ЗО Deception in Clinical Research 298 315 David Wendler and Franklin C. Miller 31 Epidemiology: Observational Studies on Human Populations 325 Douglas L. Weed and Robert E. McKeown 32 Behavioral and Social Science Research 336 Felice J. Levine and Paula R. Skedsvold 33 Phase 1 Oncology Research 356 Manish Agrawal and Ezekiel J. Emanuel 34 Surgical Innovation and Research 367 Grant R. Gillett V Participant Selection Section A. Fair Participant Selection 35 What Is Fair Participant Selection? 377 Leslie A. Meitzer and James F. Childress 36 Incentives for Research Participants 386 Neal Dickert and Christine Grady 37 Recruiting Research Participants 397 Franklin G. Miller Section B. Special Populations 38 Research Involving Women 407 Colleen Denny and Christine Grady 39 Research With Ethnic and Minority Populations 423 Bernard Lo and Nesrin Garan 40 Research Involving Economically Disadvantaged Participants Carol Levine 41 Research Involving Those at Risk for Impaired Decision-Making Capacity 431 437 Donald L. Rosenstein and Franklin G. Miller 42 Research With Children 446 Alan R. Fleischman and Lauren K. Collogan 43 Research With Captive Populations: Prisoners, Students, and Soldiers Valerie H. Bonham and jonathan D. Moreno 44 Research With Identifiable and Targeted Communities Morris W. Foster and
Richard R. Sharp 475 461 xi
Contents 45 Research With Healthy Volunteers 481 Albert R. |onsen and Franklin C. Miller 46 Research With Fetuses, Embryos, and Stem Cells 488 Ronald M. Green VI Risk-Benefit Assessments 47 Risk-Benefit Analysis and the Net Risks Test 503 David Wendler and Franklin G. Miller 48 Assessing and Comparing Potential Benefits and Risks of Harm 514 Nancy M. P. King and Larry R. Churchill 49 Risk-Benefit Assessment in Pediatric Research 527 Sumeeta Varma and David Wendler VII 50 Independent Review and Oversight The Origins and Policies That Govern Institutional Review Boards 541 Charles R. McCarthy 51 Models of Institutional Review Board Function 552 Angela ). Bowen 52 Evaluating the Effectiveness of Institutional Review Boards 560 Marjorie A. Speers 53 Data and Safety Monitoring Boards 569 Lawrence M. Friedman and Eleanor B. Schron 54 The Food and Drug Administration and Drug Development: Historic, Scientific, and Ethical Considerations 577 Robert Temple and Sara F. Goldkind VIII 55 Informed Consent A History of Informed Consent in Clinical Research 591 Erika Blacksher and Jonathan D. Moreno 56 Philosophical Justifications of Informed Consent in Research 606 Dan W. Brock 57 Legal and Regulatory Standards of Informed Consent in Research Alexander M. Capron 58 The Therapeutic Misconception 633 Paul S. Appelbaum and Charles W. Lidz 59 Empirical Issues in Informed Consent for Research James H. Flory, David Wendler, and Ezekiel J. Emanuel 60 The Assent Requirement in Pediatric Research David Wendler IX Respect for Human Research Participants 61 Confidentiality 673 James G. Hodge Jr.
and Lawrence O. Göstin 661 645 613
Contents 62 Liability and Compensation for Injury of Research Subjects 682 Wendy K. Mariner 63 The Obligation to Ensure Access to Beneficial Treatments for Research Participants at the Conclusion of Clinical Trials 697 James V. Lavery x 64 Multinational Research Appropriate Ethical Standards 77 7 Ruth Macklin 65 Benefits to Host Countries 77 9 Ezekiel J. Emanuel 66 The Standard of Care in Multinational Research 729 Søren Holm and John Harris 67 Responsiveness to Host Community Health Needs 737 Alex John London XI 68 Clinical Investigator Behavior Conflict of Interest in Medical Research: Historical Developments 747 Trudo Lemmens 69 The Concept of Conflicts of Interest 758 Ezekiel J. Emanuel and Dennis F. Thompson 70 Empirical Data on Conflicts of Interest 767 Lindsay A. Hampson, Justin E. Bekelman, and Cary P. Cross 71 Industrialization of Academic Science and Threats to Scientific Integrity Eric C. Campbell and David Blumenthal 72 Fraud, Fabrication, and Falsification 787 David B. Resnik 73 The Obligation to Publish and Disseminate Results Drummond Rennie Credits and Permissions Index 809 805 795 780 xiii
PART I: A SELECTED HISTORY OF RESEARCH WITH HUMANS PART II: CODES, DECLARATIONS, AND OTHER ETHICAL GUIDANCE FOR RESEARCH WITH HUMANS PART III: CONTEXT, PURPOSE AND VALUE OF CLINICAL RESEARCH PART IV:SCIENTIFIC DESIGN PART V: PARTICIPANT SELECTION PART VI: RISK-BENEFIT ASSESSMENTS PART VII: INDEPENDENT REVIEW AND OVERSIGHT Praise for The Oxford Textbook oj Clinical Research Ethics The Oxford lextbook 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. PART VIII: INFORMED CONSENT PART IX: RESPECT FOR HUMAN RESEARCH PARTICIPANTS PART X: MULTINATIONAL RESEARCH PART XI: CLINICAL INVESTIGATOR BEHAVIOR 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 otter a work that critically assesses and advances scholarship m 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. ABOUT THE EDITORS 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 К. 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 ( fovor і/слд’п: Ілг Siud OiYv мг. Rccvorh Miícnw u НП . .-!/ΠΝ nidy ut Піні! R,ih,U. í į.Mhf.i. Photo coiii toy)’ of Lzokicl J. 1 ¿uuinoot. Department of Bioethics at the National Institutes of Health.
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| spelling | The Oxford textbook of clinical research ethics edited by Ezekiel J. Emanuel, Christine Grady, Robert A. Crouch, Reidar K. Lie, Franklin G. Miller, David Wendler Textbook of clinical research ethics Clinical research ethics First issued as an Oxford University Paperpack 2011 Oxford [u.a.] Oxford University Press 2011 XX, 827 Seiten Illustrationen, Diagramme txt rdacontent n rdamedia nc rdacarrier Includes bibliographical references and index Human Experimentation ethics Ethics, Research Ethics Committees, Research Research Subjects legislation & jurisprudence Human experimentation in medicine Moral and ethical aspects Clinical trials Moral and ethical aspects Menschenversuch (DE-588)4038649-1 gnd rswk-swf Forschung (DE-588)4017894-8 gnd rswk-swf Medizinische Ethik (DE-588)4074672-0 gnd rswk-swf Wissenschaftsethik (DE-588)4066602-5 gnd rswk-swf Klinisches Experiment (DE-588)4164223-5 gnd rswk-swf 1\p (DE-588)4143413-4 Aufsatzsammlung gnd-content Klinisches Experiment (DE-588)4164223-5 s Medizinische Ethik (DE-588)4074672-0 s Forschung (DE-588)4017894-8 s DE-604 Menschenversuch (DE-588)4038649-1 s Wissenschaftsethik (DE-588)4066602-5 s 2\p DE-604 Emanuel, Ezekiel J. 1957- (DE-588)141377305 edt Digitalisierung UB Augsburg - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=030595927&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis Digitalisierung UB Augsburg - ADAM Catalogue Enrichment application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=030595927&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Klappentext 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk 2\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
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| title | The Oxford textbook of clinical research ethics |
| title_alt | Textbook of clinical research ethics Clinical research ethics |
| title_auth | The Oxford textbook of clinical research ethics |
| title_exact_search | The Oxford textbook of clinical research ethics |
| title_full | The Oxford textbook of clinical research ethics edited by Ezekiel J. Emanuel, Christine Grady, Robert A. Crouch, Reidar K. Lie, Franklin G. Miller, David Wendler |
| title_fullStr | The Oxford textbook of clinical research ethics edited by Ezekiel J. Emanuel, Christine Grady, Robert A. Crouch, Reidar K. Lie, Franklin G. Miller, David Wendler |
| title_full_unstemmed | The Oxford textbook of clinical research ethics edited by Ezekiel J. Emanuel, Christine Grady, Robert A. Crouch, Reidar K. Lie, Franklin G. Miller, David Wendler |
| title_short | The Oxford textbook of clinical research ethics |
| title_sort | the oxford textbook of clinical research ethics |
| topic | Human Experimentation ethics Ethics, Research Ethics Committees, Research Research Subjects legislation & jurisprudence Human experimentation in medicine Moral and ethical aspects Clinical trials Moral and ethical aspects Menschenversuch (DE-588)4038649-1 gnd Forschung (DE-588)4017894-8 gnd Medizinische Ethik (DE-588)4074672-0 gnd Wissenschaftsethik (DE-588)4066602-5 gnd Klinisches Experiment (DE-588)4164223-5 gnd |
| topic_facet | Human Experimentation ethics Ethics, Research Ethics Committees, Research Research Subjects legislation & jurisprudence Human experimentation in medicine Moral and ethical aspects Clinical trials Moral and ethical aspects Menschenversuch Forschung Medizinische Ethik Wissenschaftsethik Klinisches Experiment Aufsatzsammlung |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=030595927&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=030595927&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA |
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