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.
How is LastPass different from myAccount?
myAccount is our official password management service for WCM. It is where you will go to create or change your official WCM password. However, LastPass can be used as an optional support tool to help you manage passwords for both WCM and your personal accounts. It can also help you remember longer and various passwords, if you tend to forget them. It is safer to have LastPass manage your passwords rather than write down what your passwords are somewhere else.