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Education level, primary language, and comprehension of the informed consent process

J Empir Res Hum Res Ethics. 2007 Dec;2(4):69-79. doi: 10.1525/jer.2007.2.4.69.

Abstract

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.