IRB-approved COVID-19 studies can now get study participants’ consent using electronic signature, thanks to a recent effort to validate REDCap’s electronic consent (eConsent) capabilities for FDA compliance purposes.
Rather than collect signatures through paper forms, eligible study teams can collect participant signatures electronically via an online survey created in REDCap. This provides an efficient, safe, and compliant way to obtain informed consent.
Validating REDCap for eConsent
The University of Minnesota Human Research Protection Program asked CTSI to lead the compliance validation process, which became a collaborative effort of individuals across the University.
A 25-person team worked rapidly to validate REDCap in just 10 business days, so the tool could be used to support critical COVID-19 research. The effort aimed to ensure REDCap adhered to FDA Title 21 CFR Part 11, which refers to when electronic signatures and records can be considered secure and trustworthy.
Though initially undertaken to address COVID-19 research, this tool will soon be available for use on any FDA regulated research. HRPP will announce when the tool is available for use on these studies and will share job aids and other resources.
Who can use eConsent
REDCap eConsent is currently only available to studies that require the consent of remote participants, such as some therapeutic COVID-19 studies, and have IRB approval to receive consent electronically. Any study not requiring FDA compliance may also use eConsent, if approved to do so by the IRB. All other studies must continue to obtain consent via traditional paper documentation.