Surgical Innovation
Introduction
- Surgical Innovation is both part of clinical practice and a form of investigation in surgical research. It is more broadly defined than traditional human subjects' experimentation. This ambiguity complicates regulation of surgical innovation and raises unique ethical issues.
- The term "surgical innovation" applies to a spectrum of activities, ranging minor modifications in clinical care and surgical technique to complex and sometimes risky experimental surgery with or without controlled clinical trials comparing two operative techniques.
- Routine and minor intra-operative innovation represents conventional clinical care and therefore should be evaluated using professional surgical ethics. Formal trials clearly constitute research, making them the subject of ethical and regulatory standards for human subject research. Between the two ends of this spectrum, investigations fall into an undefined category, a "gray area", of surgical innovation. This "gray-zone" is currently unaddressed or disputed by practice norms and policy guidelines.