Interventions to Improve Research Participants' Understanding in Informed Consent for Research

CONTEXT: Available data suggest that prospective research participants may frequently not understand information disclosed to them in the informed consent process. Little is known about how understanding can be improved. OBJECTIVE: To review research on interventions to improve research participants' understanding of information disclosed in the informed consent process. DATA SOURCES AND STUDY SELECTION: A search of MEDLINE was performed using the terms informed consent and clinical research and informed consent and (comprehension or understanding) from 1966 to March 2004 , which included randomized controlled trials, longitudinal trials, and controlled trials with nonrandom allocation that compared the…