Abstract
ABSTRACTIncreasingly long and complex informed consents have yielded studies demonstrating comparatively low participantcomprehensionandsatisfactionwith traditional face-to-face approaches. In parallel, interest in electronic consents for clinical and research genomics has steadily increased, yet limited data are available for trio-based genomic discovery studies. We describe the design, development, implementation, and validation of an electronic iConsent application for trio-based genomic research deployed to support genomic studies of cerebral palsy. iConsent development incorporated stakeholder perspectives including researchers, patient advocates, institutional review board members, and genomic data-sharing considerations. The iConsent platform integrated principles derived from prior electronic consenting research and elements of multimedia learning theory. Participant comprehension was assessed in an interactive teachback format. The iConsent application achieved nine of ten proposed desiderata for effective patient-focused electronic consenting for genomic research.Overall, participants demonstrated highcomprehensionandretentionof key human subjects’ considerations. Enrollees reported high levels ofsatisfactionwith the iConsent, and we found that participantcomprehension, iConsentclarity,privacy protections, andstudy goal explanationswere associated with overallsatisfaction. Although opportunities exist to optimize iConsent, we show that such an approach is feasible, can satisfy multiple stakeholder requirements, and can realize high participantsatisfactionandcomprehensionwhile increasing study reach.
Publisher
Cold Spring Harbor Laboratory