The ethics of biomedical research: an international perspective
Saved in:
| Main Author: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York [u.a.]
Oxford Univ. Press
1998
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| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XIII, 386 S. |
| ISBN: | 0195090071 |
Staff View
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| 245 | 1 | 0 | |a The ethics of biomedical research |b an international perspective |c Baruch A. Brody |
| 264 | 1 | |a New York [u.a.] |b Oxford Univ. Press |c 1998 | |
| 300 | |a XIII, 386 S. | ||
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| 650 | 7 | |a Biomedisch onderzoek |2 gtt | |
| 650 | 7 | |a Ethische aspecten |2 gtt | |
| 650 | 4 | |a Expérimentation humaine en médecine - Aspect moral | |
| 650 | 4 | |a Médecine - Recherche - Aspect moral | |
| 650 | 4 | |a Éthique médicale | |
| 650 | 4 | |a Ethik | |
| 650 | 4 | |a Medizin | |
| 650 | 4 | |a Medicine -- Research -- Moral and ethical aspects | |
| 650 | 4 | |a Human experimentation in medicine -- Moral and ethical aspects | |
| 650 | 4 | |a Medical ethics | |
| 650 | 4 | |a Research | |
| 650 | 4 | |a Ethics, Medical | |
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Record in the Search Index
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CONTENTS
Introduction, 3
The Emergence of Research Ethics Policies, 3
The Book's Coverage, 4
The Sources of the Official Policies, 6
Chapter One The Use of Animals in Research, 11
The Use of Animals: Historical Perspectives, 12
Arguments Concerning Research Using Animals, 15
National Policies on Animal Research: A Cross National
Comparison, 18
Two Special Cases: Transgenic Animals and
Xenotransplantation, 25
Conclusion, 28
Chapter Two Research on Human Subjects, 31
A Historical Introduction, 31
The Major Issues, 37
Conclusion, 53
Chapter Three Epidemiological Research, 55
The Development of Ethical Concerns about Epidemiological
Research, 56
The Ethics of Epidemiological Research, 59
Two Controversial Cases, 67
Interventional Epidemiology, 72
Conclusion, 74
x Contents
Chapter Four Genetic Research, 77
Genetic Engineering, 78
Gene Therapy, 82
The Human Genome Project, 87
Patenting the Results of Genetic Research, 93
Conclusion, 96
Chapter Five Reproductive and Fetal Research, 99
Research on Fetuses in Utero, 100
Research Using Fetal Tissue, 103
Research on Preimplantation Zygotes, 109
Conclusion, 116
Chapter Six Research Involving Vulnerable Subjects, 119
Research Involving Children, 119
Research Involving Mentally Infirm Adults, 129
Research Involving Prisoners, 135
Conclusion, 138
Chapter Seven Clinical Trials, 139
A Brief Introduction to Clinical Trials, 140
The Major Ethical Issues, 144
Conclusion, 159
Chapter Eight Research and the Drug/Device Approval Process, 161
The History of Official Policies on Drug/Device Regulation
and Approval, 162
The Fundamental Policy Issue: Setting Standards for
Approval, 166
Four Issues about the Conduct of Research, 169
Conclusion, 182
Chapter Nine Research Involving Women and Members of
Minority Groups, 185
The Inclusion of Women in Clinical Research, 186
Women of Childbearing Potential and Pregnant Women as
Research Subjects, 189
The Inclusion of Minorities in Clinical Research, 193
Conclusion, 195
Contents xi
Chapter Ten Philosophical Reflections, 197
Origins, Comprehensiveness, and Convergence, 197
Evaluation of Methodology, 202
Evaluation of Content, 208
Conclusion, 212
Appendix 1 International Research Ethics Policies, 213
1.1 The Nuremberg Code (1947), 213
1.2 World Medical Association, Declaration of Helsinki
(1964, 1975, 1983, 1989, 1996), 214
1.3 World Medical Association, Statement on Fetal Tissue
Transplantation, 216
1.4 World Medical Association, Declaration on the Human
Genome Project, 217
1.5 International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for
Human Use, Guidelines for Good Clinical Practice
(1996), 219
1.6 CIOMS, International Guiding Principles for Biomedical
Research Involving Animals (1984), 224
1.7 CIOMS, International Guidelines for Ethical Review of
Epidemiological Studies (1991), 225
1.8 CIOMS, International Ethical Guidelines for Biomedical
Research Involving Human Subjects (1993), 233
Appendix 2 European Transnational Research Ethics Policies, 237
2.1 Council of the European Communities, Directive on the
Protection of Animals Used for Experimental and
Other Scientific Purposes (1986), 237
2.2 Council of Europe, Recommendation Concerning
Medical Research on Human Beings (1990), 241
2.3 Council of Europe, Convention for the Protection of
Human Rights and Dignity of the Human Being with
Regard to the Application of Biology and Medicine:
Convention on Human Rights and Biomedicine
(1996), 251
2.4 Council of Europe, Scientific Research and/or
Experimentation on Human Gametes, Embryos and
Foetuses and Donation of Such Human Material
(1989), 253
xii Contents
2.5 Council of Europe, Recommendation on Genetic Testing
and Screening for Health Care Purposes (1992), 256
2.6 European Medical Research Councils, Gene Therapy in
Man (1988), 258
Appendix 3 U.S. Research Ethics Policies, 262
3.1 Department of Health and Human Services, Regulations
for the Protection of Human Research Subjects
(45 CFR 46), 262
3.2 National Commission, The Belmont Report (1979), 281
3.3 Public Health Service, U.S. Government Principles for
the Utilization and Care of Vertebrate Animals Used
in Testing, Research, and Training (1986), 288
3.4 Food and Drug Administration, (21 CFR 314.126)
Adequate and Well Controlled Studies (1985), 289
3.5 Food and Drug Administration, Subpart H—Accelerated
Approval of New Drugs for Serious or
Life Threatening Illnesses (1992), 293
3.6 Food and Drug Administration, Guideline for the Study
and Evaluation of Gender Differences in the Clinical
Evaluation of Drugs (1993), 293
3.7 Food and Drug Administration, (21 CFR 50.25)
Exception from Informed Consent Requirements for
Emergency Research (1996), 298
3.8 National Institutes of Health, Research Involving
Impaired Human Subjects: Clinical Center Policy for
the Consent Process (1986), 300
3.9 National Institutes of Health, Report of the Human
Embryo Research Panel (1994), 302
3.10 National Center for Human Genome Research, Policy on
Availability and Patenting of Human Genomic DNA
Sequence Produced by NCHGR Pilot Projects
(1996), 310
3.11 NIH Reauthorization Act (1993) Sections on Clinical
Research Equity and on Research on Transplantation
of Fetal Tissue, 312
Appendix 4 Research Ethics Policies from Other Countries, 315
4.1 British Royal College of Physicians, Research Involving
Patients—Summary of Recommendations (1990), 315
Contents xiii
4.2 British Medical Research Council, The Ethical Conduct
of Research on Children (1991), 320
4.3 British Animals (Scientific Procedures) Act (1986), 321
4.4 British Human Fertilisation and Embryology Act
(1990), 325
4.5 British Guidance on the Research Use of Fetuses and
Fetal Material (1989) Conclusion: Summary of
Principles, 330
4.6 British Committee on the Ethics of Gene Therapy,
Summary of Main Conclusions and Recommendations
on the Ethics of Gene Therapy (1989), 330
4.7 German Embryo Protection Law (1990), 333
4.8 French Law on the Protection of Persons to Whom
Medical Experiments are Performed (1988 91), 336
4.9 Canadian Council on Animal Care, Ethics of Animal
Investigation (1989), 338
4.10 Canadian Council on Animal Care, Categories of
Invasiveness in Animal Experiments (1991), 339
4.11 Canadian Federal Center for AIDS, Guidelines on
Ethical and Legal Considerations in Anonymous
Unlinked HIV Seroprevalence Research (1990), 341
4.12 Australian National Health and Medical Research
Council, Statement on Human Experimentation and
Supplementary Notes (1992), 343
4.13 Health Sciences Council of Japan, Guidelines for Gene
Therapy Clinical Research (1993), 354
Notes, 359
Acknowledgment of Sources, 377
Index, 379 |
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| spelling | Brody, Baruch A. Verfasser aut The ethics of biomedical research an international perspective Baruch A. Brody New York [u.a.] Oxford Univ. Press 1998 XIII, 386 S. txt rdacontent n rdamedia nc rdacarrier Biomedisch onderzoek gtt Ethische aspecten gtt Expérimentation humaine en médecine - Aspect moral Médecine - Recherche - Aspect moral Éthique médicale Ethik Medizin Medicine -- Research -- Moral and ethical aspects Human experimentation in medicine -- Moral and ethical aspects Medical ethics Research Ethics, Medical Medizinische Ethik (DE-588)4074672-0 gnd rswk-swf Forschung (DE-588)4017894-8 gnd rswk-swf Medizinische Ethik (DE-588)4074672-0 s Forschung (DE-588)4017894-8 s DE-604 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008327902&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Brody, Baruch A. The ethics of biomedical research an international perspective Biomedisch onderzoek gtt Ethische aspecten gtt Expérimentation humaine en médecine - Aspect moral Médecine - Recherche - Aspect moral Éthique médicale Ethik Medizin Medicine -- Research -- Moral and ethical aspects Human experimentation in medicine -- Moral and ethical aspects Medical ethics Research Ethics, Medical Medizinische Ethik (DE-588)4074672-0 gnd Forschung (DE-588)4017894-8 gnd |
| subject_GND | (DE-588)4074672-0 (DE-588)4017894-8 |
| title | The ethics of biomedical research an international perspective |
| title_auth | The ethics of biomedical research an international perspective |
| title_exact_search | The ethics of biomedical research an international perspective |
| title_full | The ethics of biomedical research an international perspective Baruch A. Brody |
| title_fullStr | The ethics of biomedical research an international perspective Baruch A. Brody |
| title_full_unstemmed | The ethics of biomedical research an international perspective Baruch A. Brody |
| title_short | The ethics of biomedical research |
| title_sort | the ethics of biomedical research an international perspective |
| title_sub | an international perspective |
| topic | Biomedisch onderzoek gtt Ethische aspecten gtt Expérimentation humaine en médecine - Aspect moral Médecine - Recherche - Aspect moral Éthique médicale Ethik Medizin Medicine -- Research -- Moral and ethical aspects Human experimentation in medicine -- Moral and ethical aspects Medical ethics Research Ethics, Medical Medizinische Ethik (DE-588)4074672-0 gnd Forschung (DE-588)4017894-8 gnd |
| topic_facet | Biomedisch onderzoek Ethische aspecten Expérimentation humaine en médecine - Aspect moral Médecine - Recherche - Aspect moral Éthique médicale Ethik Medizin Medicine -- Research -- Moral and ethical aspects Human experimentation in medicine -- Moral and ethical aspects Medical ethics Research Ethics, Medical Medizinische Ethik Forschung |
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