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Innovation in Medical Technology:

Ethical Issues and Challenges
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This thought-provoking study examines the ethical, legal, and social problems that arise with cutting-edge medical technology. Using as examples four powerful and largely unregulated technologies—off-label use of drugs, innovative surgery, assisted reproduction, and neuroimaging—Margaret L. Eaton and Donald L. Kennedy illustrate the difficult challenges faced by clinicians, researchers, and policy makers who seek to advance the frontiers of medicine safely and responsibly.Supported by medical history and case studies and drawing on reports from dozens of experts, the authors address important practical, ethical, and policy issues. They consider topics such as the responsible introduction of new medical products and services, the importance of patient consent, the extent of the duty to mitigate harm, and the responsibility to facilitate access to new medical therapies.This work's insights into the nature and consequences of medical innovation contribute to the national debate on how best to protect patients while fostering innovation and securing benefits.

PrefaceAcknowledgmentsIntroduction: The Need to Ask Questions about Innovation1. Distinguishing Innovative Medical Practice from Research2. The Modern History of Human Research Ethics3. Innovation in the Off-Label Use of Drugs4. Innovative Surgery5. Innovation in Assisted Reproduction6. Innovation in Neuroimaging7. Questions, Issues, and Recommendations Going ForwardConclusion: Final Thoughts on the Landscape of InnovationAppendix A: Directives for Human Experimentation: Nuremberg CodeAppendix B: World Medical Association Declaration of HelsinkiAppendix C: Description of Department of Health and Human ServicesRegulations for the Protection of Human SubjectsAppendix D: Participants in Lasker Forum on Ethical Challenges in Biomedical Research and PracticeNotesReferencesIndex

""The work provides both medical practitioners and academicians of various levels of experience with a helpful overview of the complicated dilemmas surrounding innovation in medicine.""

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