Subject Perception of the Effectiveness of an Audio Slide Presentation as a Means of a Consent Review

Abstract

Prior to its initiation, the investigation was reviewed and approved by the IUPUI Institutional Review Board. In clinical research involving humans, it is extremely important that those that participate have a clear understanding of the purpose and procedures of the study as well as any risks or benefits associated with their participation. While required to be written in 8th grade language, informed consent statements may fail at fully informing the participant due to their length and legal and medical terminology required. Also, many adults have poor reading skills. This pilot study assessed subject perception as to the effectiveness of a short audiovisual slide presentation as a means of reviewing key components of the informed consent they had been asked to read. The presentation was provided in English or Spanish (approx. 10 minutes in length) based on the subject’s preference. At the end of the presentation, an anonymous questionnaire containing seven questions regarding their view of the effectiveness of the audiovisual slide presentation was given to the participant. After recording and analyzing the information obtained from the questionnaire it was demonstrated that the majority of subjects believed the presentation improved their overall ability to understand the information provided in the informed consent statement and that it did not appreciably lengthen the consenting process. The results seem to confirm the hypothesis that a presentation such as this has a positive effect in the understanding of the consenting process. This method proved successful in determining the effectiveness of an audio slide presentation as a means of a consent review. Future research may be performed to determine if preferences may vary based on demographic factors such as race or gender.