The Oxford textbook of clinical research ethics:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Oxford [u.a.]
Oxford Univ. Press
2008
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | XX, 827 S. Ill., graph. Darst. |
| ISBN: | 9780195168655 |
Internformat
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| 245 | 1 | 0 | |a The Oxford textbook of clinical research ethics |c ed. by Ezekiel J. Emanuel ... |
| 264 | 1 | |a Oxford [u.a.] |b Oxford Univ. Press |c 2008 | |
| 300 | |a XX, 827 S. |b Ill., graph. Darst. | ||
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| 500 | |a Includes bibliographical references and index | ||
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| 650 | 4 | |a Clinical trials / Moral and ethical aspects | |
| 650 | 4 | |a Medical ethics | |
| 650 | 4 | |a Human Experimentation / ethics | |
| 650 | 4 | |a Ethics Committees, Research | |
| 650 | 4 | |a Ethics, Research | |
| 650 | 4 | |a Research Subjects / legislation & jurisprudence | |
| 650 | 4 | |a Expérimentation humaine en médecine | |
| 650 | 4 | |a Éthique médicale | |
| 650 | 4 | |a Études cliniques | |
| 650 | 4 | |a Ethik | |
| 650 | 4 | |a Clinical trials |x Moral and ethical aspects | |
| 650 | 4 | |a Ethics Committees, Research | |
| 650 | 4 | |a Ethics, Research | |
| 650 | 4 | |a Human Experimentation |x ethics | |
| 650 | 4 | |a Human experimentation in medicine |x Moral and ethical aspects | |
| 650 | 4 | |a Medical ethics | |
| 650 | 4 | |a Research Subjects |x legislation & jurisprudence | |
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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 3 J
Takashi Tsuchiya
4 The Randomized Controlled Trial of Streptomycin 46
Alan Yoshioka
5 The Salk Polio Vaccine Field Trial of 1954 67
Marcia L. Meldrum
6 The Jewish Chronic Disease Hospital Case 73
John D. Arras
7 The Hepatitis Experiments at the Willowbrook State School 80
Walter M. Robinson and Brandon T. Unruh
8 The Tuskegee Syphilis Experiment 86
James H. Jones
x Contents
9 HIV Research 97
John 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 123
Ezekiel ]. Emanuel, David Wendler, and Christine Grady
12 The Nuremberg Code 736
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 756
loan P. Porter and Greg Koski
16 International Ethical Guidance From the Council for International Organizations
of Medical Sciences 768
Juhana E. Idanpaan-Heikkila and Sev S. Fluss
17 The Council of Europe 174
Peteris Zilgalvis
18 The European Community Directives on Data Protection and Clinical Trials 780
Deryck Beyleveld and Sebastian Sethe
19 National Bioethics Commissions and Research Ethics 187
Eric M. Meslin and Summer Johnson
III Context, Purpose, and Value of Clinical Research
20 Exploitation in Clinical Research 207
Alan Wertheimer
21 The Nature, Scope, and Justification of Clinical Research: What Is Research?
Who Is a Subject? 27 7
Robert |. Levine
22 Four Paradigms of Clinical Research and Research Oversight 222
Ezekiel |. Emanuel and Christine Grady
23 The Role of Patient Advocates and Public Representatives in Research 237
Rebecca Dresser
IV Scientific Design
24 Equipoise and Randomization 245
Steven Joffe and Robert D. Truog
25 The Ethics of Placebo-Controlled Trials 267
Franklin G. Miller
Contents xi
26 Challenge Experiments 273
Franklin C. Miller and Donald L. Rosenstein
27 Emergency Research 280
)ason H. T. Karlawish
28 Research With Biological Samples 290
David Wendler
29 Genetic Diagnostic, Pedigree, and Screening Research 298
Eric T. Juengst and Aaron Coldenberg
30 Deception in Clinical Research 315
David Wendler and Franklin G. 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 I 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. Meltzer and )ames 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
Christine Grady and Colleen Denny
39 Research With Ethnic and Minority Populations 423
Bernard Lo and Nesrin Garan
40 Research Involving Economically Disadvantaged Participants 431
Carol Levine
41 Research Involving Those at Risk for Impaired Decision-Making Capacity 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 467
Valerie H. Bonham and Jonathan D. Moreno
44 Research With Identifiable and Targeted Communities 475
Morris W. Foster and Richard R. Sharp
xii Contents
45 Research With Healthy Volunteers 487
Albert R. |onsen and Franklin G. 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 Independent Review and Oversight
50 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 Informed Consent
55 A History of Informed Consent in Clinical Research 597
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 673
Alexander M. Capron
58 The Therapeutic Misconception 633
Paul S. Appelbaum and Charles W. Lidz
59 Empirical Issues in Informed Consent for Research 645
James H. Flory, David Wendler, and Ezekiel J. Emanuel
60 The Assent Requirement in Pediatric Research 661
David Wendler
IX Respect for Human Research Participants
61 Confidentiality 673
James C. Hodge Jr. and Lawrence O. Gostin
Contents xi
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 Multinational Research
64 Appropriate Ethical Standards 711
Ruth Macklin
65 Benefits to Host Countries 719
Ezekiel J. Emanuel
66 The Standard of Care in Multinational Research 729
S0ren Holm and |ohn Harris
67 Responsiveness to Host Community Health Needs 737
Alex |ohn London
XI Clinical Investigator Behavior
68 Conflict of Interest in Medical Research: Historical Developments 747
Trudo Lemmens
69 The Concept of Conflicts of Interest 758
Ezekiel |. Emanuel and Dennis F. Thompson
70 Empirical Data on Conflicts of Interest 767
Lindsay A. Hampson, |ustin E. Bekelman, and Cary P. Cross
71 Industrialization of Academic Science and Threats to Scientific Integrity 780
Eric C. Campbell and David Blumenthal
72 Fraud, Fabrication, and Falsification 787
David B. Resnik
73 The Obligation to Publish and Disseminate Results 795
Drummond Rennie
Credits and Permissions 805
Index 809 |
| adam_txt |
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 3 J
Takashi Tsuchiya
4 The Randomized Controlled Trial of Streptomycin 46
Alan Yoshioka
5 The Salk Polio Vaccine Field Trial of 1954 67
Marcia L. Meldrum
6 The Jewish Chronic Disease Hospital Case 73
John D. Arras
7 The Hepatitis Experiments at the Willowbrook State School 80
Walter M. Robinson and Brandon T. Unruh
8 The Tuskegee Syphilis Experiment 86
James H. Jones
x Contents
9 HIV Research 97
John 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 123
Ezekiel ]. Emanuel, David Wendler, and Christine Grady
12 The Nuremberg Code 736
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 756
loan P. Porter and Greg Koski
16 International Ethical Guidance From the Council for International Organizations
of Medical Sciences 768
Juhana E. Idanpaan-Heikkila and Sev S. Fluss
17 The Council of Europe 174
Peteris Zilgalvis
18 The European Community Directives on Data Protection and Clinical Trials 780
Deryck Beyleveld and Sebastian Sethe
19 National Bioethics Commissions and Research Ethics 187
Eric M. Meslin and Summer Johnson
III Context, Purpose, and Value of Clinical Research
20 Exploitation in Clinical Research 207
Alan Wertheimer
21 The Nature, Scope, and Justification of Clinical Research: What Is Research?
Who Is a Subject? 27 7
Robert |. Levine
22 Four Paradigms of Clinical Research and Research Oversight 222
Ezekiel |. Emanuel and Christine Grady
23 The Role of Patient Advocates and Public Representatives in Research 237
Rebecca Dresser
IV Scientific Design
24 Equipoise and Randomization 245
Steven Joffe and Robert D. Truog
25 The Ethics of Placebo-Controlled Trials 267
Franklin G. Miller
Contents xi
26 Challenge Experiments 273
Franklin C. Miller and Donald L. Rosenstein
27 Emergency Research 280
)ason H. T. Karlawish
28 Research With Biological Samples 290
David Wendler
29 Genetic Diagnostic, Pedigree, and Screening Research 298
Eric T. Juengst and Aaron Coldenberg
30 Deception in Clinical Research 315
David Wendler and Franklin G. 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 I 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. Meltzer and )ames 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
Christine Grady and Colleen Denny
39 Research With Ethnic and Minority Populations 423
Bernard Lo and Nesrin Garan
40 Research Involving Economically Disadvantaged Participants 431
Carol Levine
41 Research Involving Those at Risk for Impaired Decision-Making Capacity 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 467
Valerie H. Bonham and Jonathan D. Moreno
44 Research With Identifiable and Targeted Communities 475
Morris W. Foster and Richard R. Sharp
xii Contents
45 Research With Healthy Volunteers 487
Albert R. |onsen and Franklin G. 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 Independent Review and Oversight
50 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 Informed Consent
55 A History of Informed Consent in Clinical Research 597
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 673
Alexander M. Capron
58 The Therapeutic Misconception 633
Paul S. Appelbaum and Charles W. Lidz
59 Empirical Issues in Informed Consent for Research 645
James H. Flory, David Wendler, and Ezekiel J. Emanuel
60 The Assent Requirement in Pediatric Research 661
David Wendler
IX Respect for Human Research Participants
61 Confidentiality 673
James C. Hodge Jr. and Lawrence O. Gostin
Contents xi
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 Multinational Research
64 Appropriate Ethical Standards 711
Ruth Macklin
65 Benefits to Host Countries 719
Ezekiel J. Emanuel
66 The Standard of Care in Multinational Research 729
S0ren Holm and |ohn Harris
67 Responsiveness to Host Community Health Needs 737
Alex |ohn London
XI Clinical Investigator Behavior
68 Conflict of Interest in Medical Research: Historical Developments 747
Trudo Lemmens
69 The Concept of Conflicts of Interest 758
Ezekiel |. Emanuel and Dennis F. Thompson
70 Empirical Data on Conflicts of Interest 767
Lindsay A. Hampson, |ustin E. Bekelman, and Cary P. Cross
71 Industrialization of Academic Science and Threats to Scientific Integrity 780
Eric C. Campbell and David Blumenthal
72 Fraud, Fabrication, and Falsification 787
David B. Resnik
73 The Obligation to Publish and Disseminate Results 795
Drummond Rennie
Credits and Permissions 805
Index 809 |
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| callnumber-raw | R853.H8 |
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| dewey-full | 174.2 |
| dewey-hundreds | 100 - Philosophy & psychology |
| dewey-ones | 174 - Occupational ethics |
| dewey-raw | 174.2 |
| dewey-search | 174.2 |
| dewey-sort | 3174.2 |
| dewey-tens | 170 - Ethics (Moral philosophy) |
| discipline | Rechtswissenschaft Philosophie |
| discipline_str_mv | Rechtswissenschaft Philosophie |
| format | Book |
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| genre | (DE-588)4143413-4 Aufsatzsammlung gnd-content |
| genre_facet | Aufsatzsammlung |
| id | DE-604.BV023302348 |
| illustrated | Illustrated |
| index_date | 2024-07-02T20:47:08Z |
| indexdate | 2024-10-14T10:01:11Z |
| institution | BVB |
| isbn | 9780195168655 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-016486783 |
| oclc_num | 123332166 |
| open_access_boolean | |
| owner | DE-12 DE-384 DE-19 DE-BY-UBM |
| owner_facet | DE-12 DE-384 DE-19 DE-BY-UBM |
| physical | XX, 827 S. Ill., graph. Darst. |
| publishDate | 2008 |
| publishDateSearch | 2008 |
| publishDateSort | 2008 |
| publisher | Oxford Univ. Press |
| record_format | marc |
| spelling | The Oxford textbook of clinical research ethics ed. by Ezekiel J. Emanuel ... Oxford [u.a.] Oxford Univ. Press 2008 XX, 827 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Includes bibliographical references and index Human experimentation in medicine / Moral and ethical aspects Clinical trials / Moral and ethical aspects Medical ethics Human Experimentation / ethics Ethics Committees, Research Ethics, Research Research Subjects / legislation & jurisprudence Expérimentation humaine en médecine Éthique médicale Études cliniques Ethik Clinical trials Moral and ethical aspects Human Experimentation ethics Human experimentation in medicine Moral and ethical aspects Research Subjects legislation & jurisprudence Medizinische Ethik (DE-588)4074672-0 gnd rswk-swf Menschenversuch (DE-588)4038649-1 gnd rswk-swf Klinisches Experiment (DE-588)4164223-5 gnd rswk-swf Forschung (DE-588)4017894-8 gnd rswk-swf Wissenschaftsethik (DE-588)4066602-5 gnd rswk-swf (DE-588)4143413-4 Aufsatzsammlung gnd-content Menschenversuch (DE-588)4038649-1 s Wissenschaftsethik (DE-588)4066602-5 s DE-604 Klinisches Experiment (DE-588)4164223-5 s Medizinische Ethik (DE-588)4074672-0 s Forschung (DE-588)4017894-8 s 1\p DE-604 Emanuel, Ezekiel J. 1957- Sonstige (DE-588)141377305 oth HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016486783&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | The Oxford textbook of clinical research ethics Human experimentation in medicine / Moral and ethical aspects Clinical trials / Moral and ethical aspects Medical ethics Human Experimentation / ethics Ethics Committees, Research Ethics, Research Research Subjects / legislation & jurisprudence Expérimentation humaine en médecine Éthique médicale Études cliniques Ethik Clinical trials Moral and ethical aspects Human Experimentation ethics Human experimentation in medicine Moral and ethical aspects Research Subjects legislation & jurisprudence Medizinische Ethik (DE-588)4074672-0 gnd Menschenversuch (DE-588)4038649-1 gnd Klinisches Experiment (DE-588)4164223-5 gnd Forschung (DE-588)4017894-8 gnd Wissenschaftsethik (DE-588)4066602-5 gnd |
| subject_GND | (DE-588)4074672-0 (DE-588)4038649-1 (DE-588)4164223-5 (DE-588)4017894-8 (DE-588)4066602-5 (DE-588)4143413-4 |
| title | The Oxford textbook of clinical research ethics |
| title_auth | The Oxford textbook of clinical research ethics |
| title_exact_search | The Oxford textbook of clinical research ethics |
| title_exact_search_txtP | The Oxford textbook of clinical research ethics |
| title_full | The Oxford textbook of clinical research ethics ed. by Ezekiel J. Emanuel ... |
| title_fullStr | The Oxford textbook of clinical research ethics ed. by Ezekiel J. Emanuel ... |
| title_full_unstemmed | The Oxford textbook of clinical research ethics ed. by Ezekiel J. Emanuel ... |
| title_short | The Oxford textbook of clinical research ethics |
| title_sort | the oxford textbook of clinical research ethics |
| topic | Human experimentation in medicine / Moral and ethical aspects Clinical trials / Moral and ethical aspects Medical ethics Human Experimentation / ethics Ethics Committees, Research Ethics, Research Research Subjects / legislation & jurisprudence Expérimentation humaine en médecine Éthique médicale Études cliniques Ethik Clinical trials Moral and ethical aspects Human Experimentation ethics Human experimentation in medicine Moral and ethical aspects Research Subjects legislation & jurisprudence Medizinische Ethik (DE-588)4074672-0 gnd Menschenversuch (DE-588)4038649-1 gnd Klinisches Experiment (DE-588)4164223-5 gnd Forschung (DE-588)4017894-8 gnd Wissenschaftsethik (DE-588)4066602-5 gnd |
| topic_facet | Human experimentation in medicine / Moral and ethical aspects Clinical trials / Moral and ethical aspects Medical ethics Human Experimentation / ethics Ethics Committees, Research Ethics, Research Research Subjects / legislation & jurisprudence Expérimentation humaine en médecine Éthique médicale Études cliniques Ethik Clinical trials Moral and ethical aspects Human Experimentation ethics Human experimentation in medicine Moral and ethical aspects Research Subjects legislation & jurisprudence Medizinische Ethik Menschenversuch Klinisches Experiment Forschung Wissenschaftsethik Aufsatzsammlung |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=016486783&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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