Neff Margaret J
Division of Pulmonary and Critical Care Medicine, Harborview Medical Center, 325 9th Avenue, Box 359762, Seattle, WA 98104, USA.
Respir Care. 2008 Oct;53(10):1337-41.
The freedom to choose is integral to our daily lives, directs our interactions with patients, and is a key component of our conduct of human-subjects research. Most of the historical errors and atrocities in human experimentation had at their core a failure of consent. In response to those events, national and international law developed to direct researchers to a process of informed consent to participate in research. The application of this process, though, can be challenging. What does this process look like? Does it require written documentation, and if so what type? Who can give informed consent? Though researchers worldwide would agree on the concept of informed consent, the nuts and bolts of applying this ideal can create obstacles to researchers, confusion to subjects, and increasing regulations that may or may not help achieve the goal. I will review the current regulatory guidelines, summarize the types of consent, and consider options for improving the informed-consent process.
选择的自由是我们日常生活中不可或缺的一部分，指导着我们与患者的互动，也是我们进行人体研究的关键组成部分。人类实验中的大多数历史错误和暴行，其核心都是同意的缺失。针对这些事件，国家和国际法得以发展，引导研究人员遵循知情同意程序参与研究。然而，这一程序的应用可能具有挑战性。这个程序是怎样的？它需要书面文件记录吗？如果需要，是哪种类型的？谁能够给予知情同意？尽管全球的研究人员都认同知情同意的概念，但将这一理想付诸实践的具体细节可能会给研究人员带来障碍，给受试者造成困惑，还会导致监管规定不断增加，而这些规定可能有助于也可能无助于实现目标。我将回顾当前的监管指南，总结同意的类型，并思考改进知情同意程序的选项。
