Why does informed consent fail? A discourse analytic approach.

Informed consent often fails to meet the intended goals that a prospective subject should understand fully and choose autonomously to participate in research. The current study is an attempt to understand such failures by applying linguistic methods of discourse analysis to the transcripts of informed consent interviews. Elements of conversation and of the frame of discourse were analyzed to understand how the participants shaped their spoken interaction during the interview. We looked at the degree to which the subject appeared to be fully informed, at the problem of therapeutic misconception, and at the degree to which the subject was helped to explore concerns relevant to the choice at hand. We found that lapses or miscommunications could be understood specifically in terms of conversational elements and framing. This kind of detailed, language-based analysis is an alternative to approaches that are more abstract and inferential, such as those that are based upon the attitudes or the cognitive performance of speakers. We discuss possible educational and research implications of this approach.