eConsent for research is available using REDCap. You can use eConsent to conduct and record consent for remote participants, or for participants in clinic on tablets or other touchscreen devices. Participants will be able to sign the consent form electronically with a stylus, mouse, or finger and submit it to the study team. Once the consent form is submitted, the participant will receive an email that includes a PDF attachment with a copy of their signed consent form.
Can eConsent be used on all projects?
An electronic consent process (eConsent) is allowable on research studies, even for greater-than-minimal-risk studies. The IRB will review the use of eConsent on a study by study basis, considering the details of your proposed consent process, the study population, and the appropriateness of the electronic platform for the study overall.
If you are planning to use eConsent for an upcoming study, please read the useful joint OHRP/FDA federal guidance on this topic (link also available below).
You can find more details on what information you will need to provide to the IRB and language you should include in the consent document here.
How is eConsent set-up in REDCap?
eConsent in REDCap needs to be set up for each project individually. There are two options for eConsent, one uses built-in functionality, in the Online Designer under the Survey settings, the other option can now be setup with a combination of two External Modules (EM).
The built-in option can be put in place by anyone with builder access in REDCap, but requires some additional work to ensure to properly store a copy of the documents. With this option an email will be sent to the field that has been enabled as the designated email, this can be the participant, or to another email address specified in the survey.
The two EM are Email Alerts and Save Survey PDF to a Field . The EM allows you to also include additional email addresses, such as copying the study coordinator or the Health Information Management (HIM) group.
Interested in using eConsent?
Find detailed how-to documentation and more information usinsg the links below.
From the NYU Health Sciences Library a brief but excellent 3 part series on creating an eConsent in REDCap (YouTube):
Use of Electronic Informed Consent: This link will open a Question and Answer .pdf document that provides Guidance for Institutional Review Boards, Investigators, and Sponsors. This document is provided by a number of federal agencies.
How to setup eConsent with Auto-Archiving
Format/Example for an eConsent survey shared by the Institute of Translational Health
Format/Example for an eConsent survey shared by the University of Florida