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

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.