Department of Surgery and MacLean Center for Clinical Medical Ethics, University of Chicago Medicine, Chicago, IL, USA.
Ann Surg Oncol. 2013 Oct;20(10):3184-7. doi: 10.1245/s10434-013-3178-0. Epub 2013 Aug 22.
Although the historical background of ethical principles of human subjects research are the same for surgery and nonsurgical fields, surgical clinical trials raise several specific ethical issues. Placebo arms in surgical trials are problematic because the closer the sham surgery is to a real operation, the greater the risks for subjects. In order to ethically enter subjects into a clinical trial, a researcher must have equipoise-that is, uncertainty about which treatment arm is more effective. Surgeons must diligently maintain skepticism about whether new treatments are actually better until objective data are available. The dynamic of informed consent between surgeons and patients may be negatively impacted if patients are convinced that new treatments are better even when there are no objective data. Although clinical trials in surgery often are challenging to develop and complete, there is an ethical and social responsibility for surgeons to participate in clinical trials so that data can be gathered to determine what treatments are safe and effective.
尽管手术和非手术领域的人体研究伦理原则的历史背景相同，但外科临床试验提出了一些具体的伦理问题。手术临床试验中的安慰剂组存在问题，因为假手术越接近真实手术，受试者的风险就越大。为了在伦理上让受试者参与临床试验，研究人员必须有平衡感，即不确定哪种治疗方法更有效。外科医生必须坚持不懈地对新治疗方法是否真的更好持怀疑态度，直到有客观数据可用。如果患者确信新的治疗方法更好，即使没有客观数据，外科医生和患者之间的知情同意动态可能会受到负面影响。尽管外科临床试验的开展和完成往往具有挑战性，但外科医生有参与临床试验的伦理和社会责任，以便收集数据以确定哪些治疗方法是安全有效的。
