| The aim of this study was to investigate the comprehension of Phase I healthy subjects after they either read a standard informed consent form (control group) or viewed and listened to a video with the same information (experimental group). The findings of this study were to be applied to the efforts of clinical research personnel that perform the consenting process with these subjects. The approach to this dissertation was quantitative and experimental. The nonprobability, convenience sampling design was the best for obtaining access to a sample that could fit the inclusion criteria needed to answer the survey questions. The Cognitive Theory of Multimedia Learning suggests that receiving information through two channels, visual and auditory in this case, and incorporating it with previous knowledge improves comprehension. In this study, analysis of the data did not support the hypothesis that comprehension would be higher for the group that viewed the multimedia presentation. On average, participants in the control group (standard informed consent form presentation) scored 15.47 on the Deaconess Informed Consent Comprehension Test, while participants in the experimental group (multimedia informed consent form presentation) scored 14.67 out of a possible 28 points. These two group mean scores were not significantly different. Findings do suggest that informed consent form comprehension was very low on average, regardless of education, age, residence, occupation, gender, or predicted verbal IQ. Further research is needed to understand how to improve comprehension. |
