Innovation in medical technology : ethical issues and challenges /

Eaton (Stanford Univ.) and Kennedy (emer., Stanford; former editor in chief, Science) address the question of whether innovative medical technologies should be regarded as a variation in medical practice or as biomedical research. They believe the answer exists somewhere in between. The ethical-legal stakes of this question are huge: biomedical research is formally regulated, with regulations for human subjects research, whereas medical practice is lightly regulated by professional and malpractice standards. This book addresses the question through four cases of innovative medical technologies that are largely unregulated in the US: off-label use of drugs, innovative surgery, assisted reproduction, and neuroimaging. It emerged from author conversations with an invited delegation of 87 prominent physicians, researchers, ethicists, journalists, and legal scholars at a May 2003 forum in Washington, DC, sponsored by the Lasker Foundation. 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. Summing Up: Recommended. Lower-level undergraduates and above. M.M. Gillis