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Faculty Books:
Innovation in Medical Technology

 

 

Innovation in Medical Technology: Ethical Issues and Challenges

Innovation in Medical Technology: Ethical Issues and Challenges
by Margaret L. Eaton and Donald Kennedy. 
Johns Hopkins University Press, 2007

 


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. more...

 

Selected Reviews

 

From Journal of the American Medical Association

Reviewer: Richard M. Stillman, MD. 2007;297:2530-2531

 

"The fundamental question "When can society condone exposing a few people to harm to benefit the many?" was addressed in 1979 through a set of guidelines for ethical human research contained in the Belmont Report and subsequently incorporated into the Code of Federal Regulations (Title 45, Part 46). This so-called Common Rule governs the institutional review board and the consent process in federally funded research.

But medical technology has evolved, and with this evolution have arisen new, formidable ethical dilemmas.

Eighty-seven prominent physicians, researchers, ethicists, journalists, and legal scholars met in May 2003 at the invitation-only Lasker Forum on Ethical Challenges in Biomedical Research and Practice to address some of these issues. Two days of insightful dialogue among those influential scholars inspired Drs Margaret L. Eaton (a forum attendee and Stanford bioethicist) and Donald Kennedy (the forum's co-chair and editor-in-chief of Science) to condense and annotate the forum's explorations. Innovation in Medical Technology is the result of these efforts." more...

 

From The New England Journal of Medicine

Reviewer: Baruch A. Brody, Ph.D. 2007; 357(14):1456-1457

 

"The theme of the book is innovation. The authors recognize that innovations can sometimes be appropriately introduced in clinical practice settings, whereas on other occasions they are best introduced in formal research settings. Examples of each scenario are provided in chapters 3 through 6, in four contexts: the off-label use of drugs, surgery, assisted reproduction, and neuroimaging. These examples are also used to establish the point that "the existing binary choice between research and practice is probably too constraining" and that it is best to think of medical innovation as an in-between category that requires some oversight but not the formal institutional review board system. The authors pose several crucial questions in chapter 7: What are the thresholds and models for oversight? What information should be disclosed to patients? Is there a professional duty to learn and to educate other practitioners? Eaton and Kennedy provide guidelines in response to each question." more...