Innovation in Medical Technology: Ethical Issues and Challenges

Contents

Preface vii Acknowledgments xiii Introduction: The Need to Ask Questions about Innovation 1 1 Distinguishing Innovative Medical Practice from Research 23 2 The Modern History of Human Research Ethics 37 3 Innovation in the Off-Label Use of Drugs 47 4 Innovative Surgery 57 5 Innovation in Assisted Reproduction 72 6 Innovation in Neuroimaging 84 7 Questions, Issues, and Recommendations Going Forward 94 Conclusion: Final Thoughts on the Landscape of Innovation 114 Appendix A. Directives for Human Experimentation: Nuremberg Code 119 Appendix B. World Medical Association Declaration of Helsinki 121 Appendix C. Description of Department of Health and Human Services Regulations for the Protection of Human Subjects 127 Appendix D. Participants in Lasker Forum on Ethical Challenges in Biomedical Research and Practice 130 Notes 135 References 143 Index 151 Contents This page intentionally left blank ...