Innovation in Medical Technology: Ethical Issues and Challenges

by Margaret L. Eaton PharmD JD, Donald Kennedy PhD

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.

Product Details

ISBN-13:	9780801891946
Publisher:	Johns Hopkins University Press
Publication date:	02/28/2007
Sold by:	Barnes & Noble
Format:	eBook
Pages:	176
File size:	2 MB
Age Range:	18 Years

About 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.

Table of Contents

Preface
Acknowledgments
Introduction: The Need to Ask Questions about Innovation
1. Distinguishing Innovative Medical Practice from Research
2. The Modern History of Human Research Ethics
3. Innovation in the Off-Label Use of Drugs
4. Innovative Surgery
5. Innovation in Assisted Reproduction
6. Innovation in Neuroimaging
7. Questions, Issues, and Recommendations Going Forward
Conclusion: Final Thoughts on the Landscape of Innovation
Appendix A: Directives for Human Experimentation: Nuremberg Code
Appendix B: World Medical Association Declaration of Helsinki
Appendix C: Description of Department of Health and Human Services
Regulations for the Protection of Human Subjects
Appendix D: Participants in Lasker Forum on Ethical Challenges in Biomedical Research and Practice
Notes
References
Index

What People are Saying About This

Robert M. Cook-Deegan

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

From the Publisher

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

Editorial 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

From the Publisher

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

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.

JAMA - Richard M. Stillman

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.

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.

— Jacob William Shatzer

Ethics and Medicine

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