https://redcap.vanderbilt.edu/surveys/?s=LPHC37HW3L
https://www.ctsi.ufl.edu/files/2018/01/eConsenting-using-REDCap-Instructions-updated.pdf
...
| Info |
|---|
REB approval is needed before a project can use electronic consent |
Benefits of Electronic Consent (eConsent)
Better inform participants to empower them to make knowledgeable decisions using interactive multimedia components
Participants well informed while utilizing technology our society has become accustomed to using.
...
Incorporate weblinks within the consent that allow participants to view pictures/videos of procedures, medical equipment, or explanations of key terminology.
Decrease participants' confusion due to variability in literacy levels and cultural diversity.
Improve patient recruitment process and reduce the withdraw rates.
Enhance participant comprehension of the consent process by the addition of a set of simple questions at the end of the consent.
Enabling the improved quality and efficiency of clinical studies through insight into the participant experience, improved data quality, and a fully electronic system
Linked with surveys to assess participant inclusion/exclusion criteria to allow a
...
seamless workflow from recruitment to consent.
Participant compliance increased by gathering metrics on their understanding of study aspects and reducing complex explanations, paperwork and quality risks.
Easily query databases to inspect compliance and provide numbers needed for review and approval processes
Quickly enable process efficiencies such as re-consent or remote consent.
Reduce corrective actions for audits during an inspection of consent findings.
...
SETTING UP e-CONSENT FRAMEWORK
...
Enable surveys on the “Project Setup” page.
Set up a survey instrument with the consent language as well as first, last, signature, and a date validated field. Optional fields may be included, such as ‘date of birth’.
Enable the consent instrument as a survey.
...
If it is already enabled go into survey settings and turn on “auto-archiver + e-Consent Framework”.
A pop up will appear requesting first and last name variables as well as version number. *Versioning of a form is a concept whereby you may give it a number or alpha-numeric designation to represent the current version.
If the form is modified AFTER data collection begins, then it is recommended that a new version be applied. For example, the first version might simply be ‘1’, and after collecting the consent of a few participants, a question is modified or added, which represents a new version of the form, so you might increment the version to ‘2’ (and so forth).
You can select the optional fields like date of birth or the e-consent type.
*The e-Consent ‘type’ is another free-form text field that can be used to signify the type of e-Consent that this survey represents (e.g., pediatric). ‘Type’ is often used to distinguish between multiple e-Consent forms within a project.
...
Resources about eConsent
View Vanderbilt's overview for REDCap eConsent
U.S. FDA: Use of Electronic Informed Consent Q&A