Bethany Norton

Background Increasingly long and complex informed consents have yielded studies demonstrating comparatively low participant understanding and satisfaction with 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.Methods 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 understanding 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.Results Overall, participants demonstrated high understanding and retention of key human subjects considerations. Enrollees reported high levels of satisfaction with the iConsent, and we found that participant understanding, iConsent clarity, privacy protections, and study goal explanations were associated with overall satisfaction.Conclusions Although opportunities exist to optimize iConsent, we show that such an approach is feasible, can satisfy multiple stakeholder requirements, and can realize high participant satisfaction and understanding while increasing study reach.