The Effect of Feedback With Photo-Novella Information Sheets on Subjects’ Understanding in Informed Consent for Research

Abstract

This study aimed to investigate the effect of combined interventions composed of both quiz/feedback and information sheet format change performed after the standard informed consent process on the understanding of clinical study participants. The participants were 117 healthy volunteers: group A (n = 50) receiving a standard information sheet, group B (n = 50) receiving the photo-novella, and the control group (n = 17). The subjective understanding level increased from 82.5 to 90.0 out of 100 points ( P < 0.001) and objective understanding level from 13.9 to 16.1 out of 20 points ( P < 0.001) for the choice type and 14.0 to 15.7 points out of 20 points ( P < 0.001) for the short-answer type after providing quiz/feedback with any type of information sheets. However, photo-novella information sheet did not increase understanding levels more than the standard one. In conclusion, quiz/feedback with any type of information sheet can enhance the understanding in the informed consent of research.