Kelly M. Willenberg (kelly@kellywillenberg.com) is President and CEO of Kelly Willenberg LLC in Greenville, SC.
Electronic consent to clinical research (eConsent) has been a recurring issue during the pandemic. Seemingly overnight, we went to virtual everything. Since consent involves providing a potential participant with adequate information to allow for an informed decision to be made about participation in a trial, we must assess comprehension. That includes facilitating not only the potential participant’s understanding of the information but also ensuring they have an appropriate amount of time to ask questions, discuss with family whether they should participate, and are participating voluntarily. While some sites had eConsent capabilities prior to the pandemic, they had to consider what eConsent being acquired remotely meant quickly in the spring. How has that advanced compliantly?
