Ethical Guidelines for Innovative Surgery

Innovative surgery is one of the more controversial political frontiers in modern American medicine: the issues are complex. Every day, U.S. surgeons modify existing operations, attempting to improve their technique and outcomes. Many of these procedures -- perhaps most of them -- are performed under the heading of therapy, not research, and are without prior IRB approval. How should surgeons decide if and when they should seek IRB review and patients consent? What principles should guide surgeons in their efforts to improve surgery? To address these questions, the authors conducted a national survey of surgeons; assembling a multidisciplinary group of leading ethicists, physicians, philosophers, lawyers, and surgeons to discuss these broad issues and the survey. How does surgical innovation happen, and what difference does it make for patients, surgeons, and innovation in medicine? What practice guidelines are necessary for a safer, more ethical, and more efficient means of introducing, understanding, and guiding innovative surgical techniques?