Karpowicz Lila, Bell Emily, Racine Eric
Institut de recherches cliniques de Montréal, Québec, Canada Université de Montréal, Québec, Canada.
Institut de recherches cliniques de Montréal, Québec, Canada McGill University, Montréal, Québec, Canada.
J Empir Res Hum Res Ethics. 2016 Apr;11(2):135-64. doi: 10.1177/1556264616650117.
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.
手术创新通常既不属于传统临床伦理范畴，也不属于研究伦理范畴。由于缺乏对手术创新的监督——再加上存在重大风险的可能性——文献中提出了各种各样的论点来支持或削弱各种监督机制。为了仔细审查围绕监督选项的论证，我们对已发表的论点进行了系统综述。我们发现，这些论点通常基于常识和推测而非证据。目前，无法令人信服地确立任何单一手术创新监督机制的合理性或优越性。我们提出了改进基于论证的文献的方法，并讨论了对论点和理由进行系统综述的价值。
