Not all eConsent implementations are the same. Some eConsents simply render the informed consent form in electronic format. Although this approach has its benefits, it does not fundamentally change the participant experience. Some eConsents integrate participant-centered design, multimedia components, interactive elements, and decision aids to improve understanding of study objectives and facilitate participant engagement. Informed consent of participants with memory or cognitive deficits poses unique ethical and operational challenges. This session will present an eConsent developed to replace a traditional IRB-approved paper consent for two longitudinal Alzheimer's Disease (AD) studies at Emory University and the University of Wisconsin Alzheimer's Disease Research Centers. The presenters will discuss the steps to design a participants-centered eConsent, the regulatory issues this eConsent approach raised (and how they were resolved), and how study coordinators and participants viewed the eConsent approach compared to the paper consent document.
Review a participant-centered approach to presenting study information for AD research
Share the relative advantages and disadvantages of eConsent from the perspective of study participants and study coordinators
Identify regulatory challenges and solutions that an interactive eConsent approach can present