Interventions to improve research participants’ understanding in informed consent for research. A systematic review

Abstract

A medline literature review was conducted to evaluate the efficacy of interventions designed to improve research participants’ understanding of information disclosed in the informed consent process. The understanding achieved by standard informed consent process was compared to that achieved by an additional intervention for patients participating in randomized controlled trials, longitudinal trials, and controlled trials with nonrandom allocation. Thirty studies described 42 trials that met inclusion criteria. In 12 trials of multimedia interventions, only three showed significant improvement in understanding. In 15 trials with enhanced consent forms, only six showed significant improvement in understanding, of which five trials were of limited quality, casting doubt on their practical relevance. In five trials of test/feedback, improvement in understanding was probably related to mistaking memorization for improved understanding. The authors conclude that efforts to improve research participants’ understanding through the use of multimedia and enhanced consent forms only has limited success. Having a study team member or a neutral educator spend more time talking one-on-one to study participants appears to be the most effective available way of improving research participants’ understanding.—Michael D. Wagoner