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.
Keywords
Get full access to this article
View all access options for this article.