How can we make sure participants understand what they’re consenting to?

Under the FDA’s informed consent requirements and guidance, informed consent is more than obtaining a participant’s signature. Participants should be given information in language they can understand, have an opportunity to ask questions, and be supported in understanding the information before deciding whether to participate.

5thPort helps study teams support this process with teach-back questions and comprehension checks built into eConsent. Participant responses can highlight areas where more explanation may be needed, giving the study team an opportunity to address questions or clarify information before consent is completed.