Enhancing Research Conduct Using eConsent

By Wendy Tate, PhD, GStat, Director, Advanced Analytics and Research Optimization

Perhaps one of the most important aspects of a clinical trial is the informed consent process. Stemming from the ethical principle of Respects for Persons in 1976, the Belmont Report established informed consent parameters, a process designed to provide information to allow potential participants to make the best decision for themselves. This must occur prior to participating in the research.

Since then, there have been U.S. federal regulations established for informed consent, primarily through OHRP, and codified in 45 CFR 46.116 and 46.117. FDA-regulated products are codified in 21 CFR 50.25 and 50.27.

Currently, there are no federal regulations specifically covering electronic consent. This blog defines eConsent, offers considerations for conducting eConsent, and navigates communicating with your institutional review board (IRB) as you figure out how to include this process at your organization.