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Innovation in Medical Technology

Ethical Issues and Challenges

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.

About the Authors

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.

Endorsements

Eaton and Kennedy's well-written book is an even-handed examination of the tensions that arise in medical innovation, between treating it as research and considering it an extension of medical practice. They go well beyond the usual framing of the question, 'To IRB or not to IRB?' They address how innovations have emerged historically and cast an eye to the future, using examples from off-label use of drugs, surgical innovation, assisted reproduction, and brain imaging.

- Robert M. Cook-Deegan, Institute for Genome Sciences and Policy, Duke University

Reviews

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 - JAMA

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.

- Choice

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 - Ethics and Medicine
Johns Hopkins University Press
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