From paper to screen: Regulatory and operational considerations for modernizing the informed consent process

• Authors: Nichelle L Cobb, AAHRPP, Inc.; Dorothy F Edwards, University of Wisconsin School of Medicine and Public Health; Erin M Chin, University of Wisconsin School of Medicine and Public Health; James Lah, Emory University; Felicia Goldstein, Emory University; Cecila M Manzanares, Emory University; Christine M Suver, Sage Bionetworks
• Journal Title: Journal of Clinical and Translational Science
• Volume: Volume 6, Number 1
• Publisher: Cambridge University Press | 2022-03-28, Pages e71-e71
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1017/cts.2022.379
• Subjects: Health Sciences, Medicine and Surgery; Health Sciences, Public Health
• Keywords: Common Rule; IRB; Informed consent; eConsent; ethical oversight; regulation

Abstract

Electronic platforms provide an opportunity to improve the informed consent (IC) process by permitting elements shown to increase research participant understanding and satisfaction, such as graphics, self-pacing, meaningful engagement, and access to additional information on demand. However, including these elements can pose operational and regulatory challenges for study teams and institutional review boards (IRBs) responsible for the ethical conduct and oversight of research. We examined the experience of two study teams at Alzheimer's Disease Research Centers who chose to move from a paper-based IC process to an electronic informed consent (eIC) process to highlight some of these complexities and explore how IRBs and study teams can navigate them. Here, we identify the key regulations that should be considered when developing and using an eIC process as well as some of the operational considerations eIC presents related to IRB review and how they can be addressed.