Consenting participants to a prospective interventional/observational study can be an involved process. Keeping track of paper consent leads to extensive organizational and administrative overhead, and the use of electronic consent mechanisms can simplify this process, allowing study teams to streamline workflows and enhance regulatory compliance.
To learn more about how to use eConsent for your research, contact email@example.com.
Frequently Asked Questions
How does eConsent work?
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.
What eConsent options are available?
WCM currently supports two eConsent tools: REDCap and DocuSign.
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.