Ethics Oversight Mechanisms for Surgical Innovation

Abstract

Surgical innovation typically falls under the purview of neither conventional clinical ethics nor research ethics. Due to a lack of oversight for surgical innovation—combined with a potential for significant risk—a wide range of arguments has been advanced in the literature to support or undermine various oversight mechanisms. To scrutinize the argumentation surrounding oversight options, we conducted a systematic review of published arguments. We found that the arguments are typically grounded in common sense and speculation instead of evidence. Presently, the justification or superiority for any single oversight mechanism for surgical innovation cannot be established convincingly. We suggest ways to improve the argument-based literature and discuss the value of systematic reviews of arguments and reasons.