May Thomas, Craig J M, Spellecy Ryan
Center for the Study of Bioethics, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.
Acad Med. 2007 Jul;82(7):670-4. doi: 10.1097/ACM.0b013e31806743ef.
In this paper, the authors contrast the model of informed consent oversight employed by most IRBs with that most commonly employed by hospital ethics committees at academic medical centers. The challenge of developing adequate consent forms is complicated by competing aims that are difficult to reconcile. "Completeness" in conveying highly technical information is often at odds with comprehensibility for lay audiences. The authors argue that the problems posed by consent are tied to the fact that in clinical research, consent documents are perceived as the primary mechanism for securing informed consent, as opposed to viewing the consent process and conversation as the primary mechanism. Concerns for informed consent should be refocused to the consent process rather than IRB review of documents, using teams of consent monitors, and this new emphasis should be piloted through the National Institute of Health's recent turn toward clinical and translational science awards.
在本文中，作者将大多数机构审查委员会（IRB）采用的知情同意监督模式与学术医疗中心医院伦理委员会最常用的模式进行了对比。制定适当的同意书面临的挑战因难以协调的相互竞争的目标而变得复杂。在传达高度技术性信息时的“完整性”往往与普通受众的可理解性相矛盾。作者认为，同意问题与以下事实相关：在临床研究中，同意文件被视为获得知情同意的主要机制，而不是将同意过程和对话视为主要机制。对知情同意的关注应重新聚焦于同意过程，而不是IRB对文件的审查，可使用同意监督小组，并且这种新的重点应通过美国国立卫生研究院最近转向临床和转化科学奖来进行试点。
