eConsent: A Modern Approach to Informed Consent
eConsent is a digital alternative to traditional paper-based consent forms, designed to enhance the process of informing potential research participants. This electronic format not only provides critical information but also facilitates the documentation of informed consent. Importantly, the core consent process and the responsibilities of the investigator remain unchanged, regardless of whether the consent is obtained electronically or on paper.
The Clinical and Translational Science Institute (CTSI), in collaboration with the University of Utah Institutional Review Board and the Utah Data Coordinating Center (DCC), has established the development of this streamlined electronic consent process.
Access this process and eConsent guidance on the CTSI website here.
For steps a study team should take in preparing to obtain consent using REDCap eConsent that requires FDA 21 CFR Part 11 compliance, see IRB guidance here.
