The Ethics of Biomedical Research An International Perspective

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ISBN: 9780195090079 | 0195090071
Cover: Hardcover
Copyright: 5/14/1998

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This book analyzes the major issues of research ethics through a careful review of the treatment in official policies on research ethics developed throughout the world (especially North America, Western Europe, and the Pacific Rim). Among the issues covered are animal research, research on human subjects, epidemiological research, genetic research, reproductive research, research on vulnerable subjects, clinical trials, drug approval and the research process, and research on women and minorities. Brody also evaluates the content and the methods of developing these policies in light of his philosophical position of pluralistic casuistry. This is the only book that analyzes all the major issues in research ethics. It is the only book which deals with these issues from an international perspective rather than just a US perspective. Major official policies from important research-intensive countries are reprinted in the appendix (close to 200 plates of otherwise difficult material).

Introduction

(1)

The Emergence of Research Ethics Policies

(1)

The Book's Coverage

(2)

The Sources of the Official Policies

(5)

Chapter One The Use of Animals in Research

(20)

The Use of Animals: Historical Perspectives

(3)

Arguments Concerning Research Using Animals

(3)

National Policies on Animal Research: A Cross-National Comparison

(7)

Two Special Cases: Transgenic Animals and Xenotransplantation

(3)

Conclusion

(3)

Chapter Two Research on Human Subjects

(24)

A Historical Introduction

(6)

The Major Issues

(16)

Conclusion

(2)

Chapter Three Epidemiological Research

(22)

The Development of Ethical Concerns about Epidemiological Research

(3)

The Ethics of Epidemiological Research

(8)

Two Controversial Cases

(5)

Interventional Epidemiology

(2)

Conclusion

(3)

Chapter Four Genetic Research

(22)

Genetic Engineering

(4)

Gene Therapy

(5)

The Human Genome Project

(6)

Patenting the Results of Genetic Research

(3)

Conclusion

(3)

Chapter Five Reproductive and Fetal Research

(20)

Research on Fetuses in Utero

100

(3)

Research Using Fetal Tissue

103

(6)

Research on Preimplantation Zygotes

109

(7)

Conclusion

116

(3)

Chapter Six Research Involving Vulnerable Subjects

119

(20)

Research Involving Children

119

(10)

Research Involving Mentally Infirm Adults

129

(6)

Research Involving Prisoners

135

(3)

Conclusion

138

(1)

Chapter Seven Clinical Trials

139

(22)

A Brief Introduction to Clinical Trials

140

(4)

The Major Ethical Issues

144

(15)

Conclusion

159

(2)

Chapter Eight Research and the Drug/Device Approval Process

161

(24)

The History of Official Policies on Drug/Device Regulation and Approval

162

(4)

The Fundamental Policy Issue: Setting Standards for Approval

166

(3)

Four Issues about the Conduct of Research

169

(13)

Conclusion

182

(3)

Chapter Nine Research Involving Women and Members of Minority Groups

185

(12)

The Inclusion of Women in Clinical Research

186

(3)

Women of Childbearing Potential and Pregnant Women as Research Subjects

189

(4)

The Inclusion of Minorities in Clinical Research

193

(2)

Conclusion

195

(2)

Chapter Ten Philosophical Reflections

197

(16)

Origins, Comprehensiveness, and Convergence

197

(5)

Evaluation of Methodology

202

(6)

Evaluation of Content

208

(4)

Conclusion

212

(1)

Appendix 1 International Research Ethics Policies

213

(24)

1.1 The Nuremberg Code (1947)

213

(1)

1.2 World Medical Association, Declaration of Helsinki (1964, 1975, 1983, 1989, 1996)

214

(2)

1.3 World Medical Association, Statement on Fetal Tissue Transplantation

216

(1)

1.4 World Medical Association, Declaration on the Human Genome Project

217

(2)

1.5 International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Guidelines for Good Clinical Practice (1996)

219

(5)

1.6 CIOMS, International Guiding Principles for Biomedical Research Involving Animals (1984)

224

(1)

1.7 CIOMS, International Guidelines for Ethical Review of Epidemiological Studies (1991)

225

(8)

1.8 CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects (1993)

233

(4)

Appendix 2 European Transnational Research Ethics Policies

237

(25)

2.1 Council of the European Communities, Directive on the Protection of Animals Used for Experimental and Other Scientific Purposes (1986)

237

(4)

2.2 Council of Europe, Recommendation Concerning Medical Research on Human Beings (1990)

241

(10)

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)

2.4 Council of Europe, Scientific Research and/or Experimentation on Human Gametes, Embryos and Foetuses and Donation of Such Human Material (1989)

253

(3)

2.5 Council of Europe, Recommendation on Genetic Testing and Screening for Health Care Purposes (1992)

256

(2)

2.6 European Medical Research Councils, Gene Therapy in Man (1988)

258

(4)

Appendix 3 U.S. Research Ethics Policies

262

(53)

3.1 Department of Health and Human Services, Regulations for the Protection of Human Research Subjects (45 CFR 46)

262

(19)

3.2 National Commission, The Belmont Report (1979)

281

(7)

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

(1)

3.4 Food and Drug Administration, (21 CFR 314.126) Adequate and Well-Controlled Studies (1985)

289

(4)

3.5 Food and Drug Administration, Subpart H-Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses (1992)

293

(1)

3.6 Food and Drug Administration, Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs (1993)

293

(5)

3.7 Food and Drug Administration, (21 CFR 50.25) Exception from Informed Consent Requirements for Emergency Research (1996)

298

(2)

3.8 National Institutes of Health, Research Involving Impaired Human Subjects: Clinical Center Policy for the Consent Process (1986)

300

(2)

3.9 National Institutes of Health, Report of the Human Embryo Research Panel (1994)

302

(8)

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

(2)

3.11 NIH Reauthorization Act (1993) Sections on Clinical Research Equity and on Research on Transplantation of Fetal Tissue

312

(3)

Appendix 4 Research Ethics Policies from Other Countries

315

(44)

4.1 British Royal College of Physicians, Research Involving Patients-Summary of Recommendations (1990)

315

(5)

4.2 British Medical Research Council, The Ethical Conduct of Research on Children (1991)

320

(1)

4.3 British Animals (Scientific Procedures) Act (1986)

321

(4)

4.4 British Human Fertilisation and Embryology Act (1990)

325

(5)

4.5 British Guidance on the Research Use of Fetuses and Fetal Material (1989) Conclusion: Summary of Principles

330

(1)

4.6 British Committee on the Ethics of Gene Therapy, Summary of Main Conclusions and Recommendations on the Ethics of Gene Therapy (1989)

330

(3)

4.7 German Embryo Protection Law (1990)

333

(3)

4.8 French Law on the Protection of Persons to Whom Medical Experiments are Performed (1988-91)

336

(2)

4.9 Canadian Council on Animal Care, Ethics of Animal Investigation (1989)

338

(1)

4.10 Canadian Council on Animal Care, Categories of Invasiveness in Animal Experiments (1991)

339

(2)

4.11 Canadian Federal Center for AIDS, Guidelines on Ethical and Legal Considerations in Anonymous Unlinked HIV Seroprevalence Research (1990)

341

(2)

4.12 Australian National Health and Medical Research Council, Statement on Human Experimentation and Supplementary Notes (1992)

343

(11)

4.13 Health Sciences Council of Japan, Guidelines for Gene Therapy Clinical Research (1993)

354

(5)

Notes

359

(18)

Acknowledgment of Sources

377

(2)

Index

379

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The Ethics of Biomedical Research An International Perspective

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