Truog Robert D
Harvard Medical School, Department of Social Medicine, Division of Medical Ethics, Boston, MA 02115, USA.
Crit Care. 2007;11(1):111; discussion 111. doi: 10.1186/cc5684.
In the previous issue of Critical Care Chenaud and colleagues found that most intensive care unit patients who had given informed consent for their participation in a clinical trial could not recall either the purpose of the trial or its related risks several days later. These findings should remind us that informed consent is a process, not an event, but they should not be interpreted to mean that recall is, of itself, a useful criterion for evaluating either the validity or the quality of the informed consent process. On an entirely separate note, the decision of the authors not to obtain informed consent for this study itself raises interesting questions about the ethics of doing research on the ethics of doing research.
在上一期的《重症监护》杂志中,肖诺及其同事发现,大多数已为参与临床试验签署知情同意书的重症监护病房患者,在数天后既无法回忆起试验目的,也记不起试验相关风险。这些发现应提醒我们,知情同意是一个过程,而非一个事件,但不应将其解读为回忆本身就是评估知情同意过程有效性或质量的有用标准。完全独立来看,作者决定不为这项关于研究伦理的研究本身获取知情同意,这引发了有关开展此类研究伦理问题的有趣疑问。