Using REDCap for more personalized consent forms
Using the REDCap software platform, a team of researchers led from Vanderbilt University Medical Center have developed a new framework for electronic consent in clinical trials that’s designed to address both issues of transparency, efficiency and compliance while also improving participant recruitment and retention of under-represented minority groups.
According to a preproof article for the Journal of Clinical and Translational Science, the researchers developed their framework so that it uses the features unique to electronic media such as videos and interactive questions to provided a customized experience for participants.
Key features of the framework include a video library, branching logic filters to create comprehension questions, in-line descriptive popups, and a virtual assistant avatar that can provide voiceover instruction and clarification.
By providing a customizable experience, the framework is meant to “meet the participant where they are” in terms of health literacy, interest and knowledge, according to the article.
In addition to helping overcome limitations of paper consent documents like length and complexity that at times pose a barrier to the participation of under-represented minority groups in trials, the framework could help address health disparities and research participation among rural communities when paired with telemedicine.
A webinar presentation on the framework is available here.