Uninformed Consent? The Impact of Reading Level, Format, and Interactivity of Consent Forms on Participant Comprehension

The present study examined participants’ comprehension of consent form information based on the consent forms’ reading level, format, and level of interactivity. Our sample consisted of 228 adult English speakers who were randomly assigned to one of eight groups. Each group saw consent forms with a different combination of reading level, format, and interactivity of questions. All participants were asked to answer 12 multiple-choice questions about two consent forms (framed as two studies). Participants read and self-reported whether they read the form or not. Asking participants questions immediately after exposure to the information in the consent form improved comprehension compared to asking all comprehension questions after reading the entire form. Reading level and bulleted format did not improve comprehension significantly. Furthermore, participants were more likely to report that they read the consent form if they were given interactive questions about the form. Results suggest that interactive questions can be an effective method for improving participant comprehension of the purpose, risks, and benefits of the study or procedure in which they plan to participate.