eConsent
Electronic informed consent (eConsent) is the transformation of the traditional paper consent process to a digital one, including the capture of electronic signatures from participants and study team members. eConsent provides the same information as a paper consent, but in an electronic format that may include multimedia components such as images, audio, video, diagrams, reports, call out boxes and a digital signature which may aid the consenting process. eConsent is not using virtual platforms to supplement a paper consent process, or to capture verbal consent when written consent is waived. However, you may combine an eConsent and a phone call or virtual meeting when it makes sense.
eConsent for research at Duke 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.
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.
Interested in using eConsent?
Below are some resources to help you use REDCap for electronic consenting.
- Find detailed how-to documentation and more information here.
- Want to incorporate advanced functionality, like videos, knowledge checks, or multiple languages? This tipsheet will help you with that.
- Here is a video with information on setting up a basic eConsent in REDCap:
Need help or want to contract for a build? REDCap Office Hours
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While we are working remote please email redcap-docr@duke.edu to indicate which of the following times you would like a DOCR team member to schedule a WebEx with you.
We offer office hours on the followign dates and times:
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You can also email us at redcap-docr@duke.edu.
If you would like to have one of the DOCR data team members build your project for you please submit a request for services here. Someone will follow-up with you about your project and provide you a quote for the work.