Using decision aids may improve informed consent for research.

This commentary argues that the existing approach towards obtaining informed consent for clinical research may be improved by using decision aids. Problems with the current approach include i) an emphasis on documentation to the detriment of good quality decision-making; ii) ad hoc rather than theory-based research studying how to improve informed consent; and iii) a lack of clarity around what is meant by 'comprehension' and how to measure it. Decision aids, which clearly improve patient treatment decisions but are new to decisions surrounding study participation, have strengths in precisely the areas where the informed consent literature is weak. Decision aids facilitate a process of decision-making, combining clear documentation, exercises to facilitate decision-making, and consultation. They are increasingly informed by theory and clear, empirically-derived standards. Furthermore, decision aid research has clearly defined and operationalized three indicators of good quality decision-making in situations where there is no objectively correct answer: demonstrable knowledge of key aspects of the decision, accurate perceptions of the probabilities of various outcomes, and a match between preferred outcomes and the choice made. We identify outstanding issues and propose a research approach that will determine whether the use of decision aids can improve the informed consent process. Copyright (c) 2010 Elsevier Inc. All rights reserved.