Gupta Saksham, Muskens Ivo S, Fandino Luis Bradley, Hulsbergen Alexander F C, Broekman Marike L D
Harvard Medical School, Boston, MA, USA.
Department of Neurosurgery, Brain Center Rudolf Magnus, University Medical Center Utrecht, HP G03.124, PO Box 85500, 3508 GA, Utrecht, The Netherlands.
World J Surg. 2018 Sep;42(9):2773-2780. doi: 10.1007/s00268-018-4565-2.
Surgical innovation has advanced outcomes in the field, but carries inherent risk for surgeons and patients alike. Oversight mechanisms exist to support surgeon-innovators through difficulties associated with the innovation process.
A literature review of ethical risks and oversight mechanisms was conducted.
Oversight mechanisms range from the historical concept of surgical exceptionalism to departmental, hospital, and centralized committees. These fragmentary and non-standardized oversight mechanisms leave surgeon-innovators and patients open to significant risk of breaching the ethical principles at the core of surgical practice. A systematized approach that mitigates these risks while maintaining the independence and dignity of the surgical profession is necessary. We propose an oversight framework that incorporates multiple structures tailored toward the ethical risk introduced by different forms of innovation.
We summarize ethical risks and current regulatory structures, and we then use these findings to outline an oversight framework that may be applied to surgical practice.
外科创新提升了该领域的治疗效果，但对外科医生和患者均存在固有风险。存在监督机制以帮助外科创新者应对与创新过程相关的困难。
对伦理风险和监督机制进行了文献综述。
监督机制涵盖从外科例外主义的历史概念到部门、医院及中央委员会等。这些零散且不规范的监督机制使外科创新者和患者面临严重违反外科实践核心伦理原则的风险。需要一种系统化方法来减轻这些风险，同时维护外科职业的独立性和尊严。我们提出一个监督框架，该框架纳入了针对不同形式创新所带来的伦理风险而量身定制的多种结构。
我们总结了伦理风险和当前监管结构，然后利用这些发现概述一个可应用于外科实践的监督框架。
