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