The REDCap eConsent framework was informed by nearly 5 years of discussion with researchers, Vanderbilt IRB analysts and legal counsel, developers, and prospective participant users, in addition to conversations with stakeholders across the Clinical and Translational Science Award (CTSA) Network and the Trial Innovation Network (TIN).
REDCap-based eConsent is especially useful in situations where in-person access may be limited or in cases where not all consenting parties are in the same location as the platform allows for consenting to occur entirely remotely.
One of the primary benefits of eConsent is the ability to customize the platform based on the needs of particular communities. For example, the multi-site PREVENTABLE study, which focused on recruiting older adults (> 75 years old), utilized features within eConsent to increase the standard text size as well as text-to-speech functionality to allow potential participants to elect to have the consent read to them. The eConsent also included additional instructions (e.g., how to sign the document) to guide users who may have lower technological literacy through the eConsent interface.
• Web-based consent allows for review and signature of consent documents via tablet, smartphone, or desktop either in-clinic or fully remotely.
• Leveraging standard REDCap survey features including multi-lingual language capacity for information rendering and capture; video, audio and/or image rendering; ‘read it to me’ accessibility options; skip logic to support comprehension questions or trigger ‘help needed’ events; ‘wet’ signatures; document upload; and camera integration for photos and images
• Maintains record of all interactions with eConsents and key information (including documented changes, consent type, status, and version). Copies of consents are also stored in separate secure document system.
• Potential for Part 21 CFR Part validation.
To learn more about eConsent, visit https://victr.vumc.org/econsent/