How do I request and build a REDCap eConsent project?
For instructions on how to create a REDCap eConsent project, please read this knowledge article HowTo: Create eConsent Form on REDCap.
Please contact econsent-support@med.cornell.edu for more information.
Are there fees associated with eConsent?
REDCap eConsent is a free service provided by the CTSC. Any enhanced services (e.g., project build-out by CTSC member) may require a fee. DocuSign eConsent is fee for service. Current fees can be found on the JCTO website. Questions regarding the cost of service or billing should be directed to: JCTOOperations@med.cornell.edu.
What special considerations should be given to the use of eConsent for pediatric studies?
Please email econsent-support@med.cornell.edu for questions regarding use of eConsent for pediatric studies.
Does eConsent support ICFs in multiple languages?
Please email econsent-support@med.cornell.edu for additional information.
What approvals are needed to use eConsent?
All use of eConsent must be IRB approved before it can be implemented. Downloadable template language that can be used in the IRB application is available within the JCTO Researcher's Toolbox, titled "Remote Consent IRB Submission Language" under the Regulatory Tools and Templates section. Study teams must also have an IRB stamped ICF.
How can I use eConsent?
Both REDCap and DocuSign are available to WCM/NYP researchers. Currently for FDA-regulated studies, which require 21 CFR Part 11 compliance, only DocuSign can be used. For studies that are not FDA-regulated, REDCap can be used.
What eConsent options are available?
WCM currently supports two eConsent tools: REDCap and DocuSign.
How does eConsent work?
A computer or touchscreen device can be used to complete eConsent. The participant’s signature will be captured digitally via the signature field.
eConsent can be used in-person, or remotely. If eConsent is used as a method of remote consent, the subject will need to provide an email address to access the eConsent tools. However, please be aware, if you do not use WCM approved tools for remote consenting, it does not qualify as eConsent and you will not be able to collect valid electronic signatures. For further information on remote consenting methods, please refer to the FDA guidance.
