Innovation in Medical Technology: Ethical Issues and Challenges

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Overview

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 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.

Johns Hopkins University Press

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Editorial Reviews

JAMA - Richard M. Stillman

A captivating read for just about any thoughtful person, Innovation in Medical Technology could serve as an effective springboard for lively teaching sessions in a medical school or residency program, or as a provocative introduction to a course in medical ethics.

Ethics and Medicine - Jacob William Shatzer

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.

JAMA
A captivating read for just about any thoughtful person, Innovation in Medical Technology could serve as an effective springboard for lively teaching sessions in a medical school or residency program, or as a provocative introduction to a course in medical ethics.

— Richard M. Stillman

Choice

This volume serves as an introduction to legal and ethical issues that emerge from medical technological innovation, and to the boundary issues between medical research and clinical practice. It includes policy suggestions for regulation in this gray zone of practice between clinical care and research, as well as a short history of human subjects research.

Ethics and Medicine
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.

— Jacob William Shatzer

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Product Details

  • ISBN-13: 9780801885266
  • Publisher: Johns Hopkins University Press
  • Publication date: 2/28/2007
  • Edition description: New Edition
  • Pages: 176
  • Sales rank: 1,257,563
  • Product dimensions: 6.00 (w) x 9.00 (h) x 0.72 (d)

Meet the Author

Margaret L. Eaton is a lecturer at the Stanford University Graduate School of Business and was formerly a senior research scholar at the Center for Biomedical Ethics, Stanford University School of Medicine. Donald Kennedy is emeritus Bing Professor of Environmental Science and President Emeritus of Stanford University. A former U.S. Food and Drug Administration commissioner, Dr. Kennedy co-chairs the National Academies of Science Project on Science, Technology, and Law and is the editor-in-chief of Science.

Johns Hopkins University Press

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Table of Contents


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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