Breese Peter E, Burman William J, Goldberg Stefan, Weis Stephen E
Denver Public Health (USA).
J Empir Res Hum Res Ethics. 2007 Dec;2(4):69-79. doi: 10.1525/jer.2007.2.4.69.
TO OBTAIN INFORMATION ON HOW PERSONS from diverse backgrounds experience the informed consent process, we surveyed adults with a wide variety of educational levels and different primary languages (English, Spanish, or Vietnamese) who had recently enrolled in a study requiring written informed consent. Of the 100 participants, 62 were non-White, 43 had less than a high school education, and 60 had a primary language other than English. The median score for comprehension was 62% (IQR 50-76%); the median satisfaction score was 86% (IQR 71-100%). In multivariate analysis, only educational level was significantly associated with comprehension and satisfaction with the informed consent process (p < 0.001). Comprehension and satisfaction with the informed consent process were markedly lower among persons with lower educational levels.
为获取不同背景的人如何体验知情同意过程的信息，我们对近期参加一项需要书面知情同意的研究、具有广泛教育水平和不同主要语言（英语、西班牙语或越南语）的成年人进行了调查。在100名参与者中，62名是非白人，43名接受的教育低于高中水平，60名的主要语言不是英语。理解能力的中位数得分是62%（四分位间距50 - 76%）；满意度的中位数得分是86%（四分位间距71 - 100%）。在多变量分析中，只有教育水平与对知情同意过程的理解和满意度显著相关（p < 0.001）。教育水平较低的人对知情同意过程的理解和满意度明显较低。
