Reitsma Angelique M, Moreno Jonathan D
Center for Biomedical Ethics, University of Virginia, Charlottesville 22908-0758, USA.
J Am Coll Surg. 2002 Jun;194(6):792-801. doi: 10.1016/s1072-7515(02)01153-5.
There are no clear federal regulations governing innovative surgery, even though general guidelines regulating research with human subjects do exist. We hypothesized that US surgeons are unaware of Department of Health and Human Services regulations, rarely seek IRB review, generally oppose outside regulation of innovative surgery, and are uncertain what constitutes innovation and research. These circumstances, if true, would pose a significant ethical problem and present potential harm to patients as unwitting subjects of research.
In a pilot study we reviewed 527 issues of US surgical and medical journals, selecting 59 articles published between 1992 and 2000, that described innovative surgery. Corresponding authors from university hospitals (71%) and other facilities (29%) were sent an anonymous questionnaire.
The survey was conducted between November 2000 and May 2001. Twenty-one questionnaires were returned, completed with responses, constituting a 35% overall response rate. Fourteen authors confirmed their work was research, yet only six had sought prior IRB review. The majority of authors (15 of 21) did not submit their protocol to IRB. Only seven authors had mentioned the innovative nature of the procedure in the informed consent form. Seven authors claimed familiarity with Office for Human Research Protections definitions of research and human subject. Two-thirds of the respondents stated that government regulations for the protection of human subjects of innovative surgery would not be appropriate.
The current system of definitions, ethical theories, and voluntary professional guidelines may be inadequate to meet the challenge of surgical innovation. Further research is proposed to examine the adequacy of the existing guidelines.
尽管存在关于人体研究的一般指导原则，但目前尚无明确的联邦法规来管理创新手术。我们推测，美国外科医生不了解美国卫生与公众服务部的法规，很少寻求机构审查委员会（IRB）的审查，普遍反对对创新手术进行外部监管，并且不确定什么构成创新和研究。如果这些情况属实，将构成重大的伦理问题，并可能对作为不知情研究对象的患者造成潜在伤害。
在一项试点研究中，我们查阅了527期美国外科和医学期刊，挑选出1992年至2000年间发表的59篇描述创新手术的文章。向大学医院（71%）和其他机构（29%）的通讯作者发送了一份匿名问卷。
调查于2000年11月至2001年5月进行。共收回21份问卷并得到完整回复，总体回复率为35%。14位作者确认他们的工作是研究，但只有6人曾寻求过IRB的事先审查。大多数作者（21人中的15人）未将其方案提交给IRB。只有7位作者在知情同意书中提及了该手术的创新性质。7位作者声称熟悉人类研究保护办公室对研究和人类受试者的定义。三分之二的受访者表示，政府对创新手术人体受试者的保护法规不合适。
当前的定义体系、伦理理论和自愿性专业指南可能不足以应对手术创新的挑战。建议进一步开展研究，以检验现有指南的充分性。
