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.
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.
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.
Does eConsent support ICFs in multiple languages?
Please email econsent-support@med.cornell.edu for additional information.
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.
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.
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.
I have created the REDCap project. Can I begin consenting?
Once you have created the REDCap eConsent project in development status, the next step is to promote the project to production status within REDCap and email econsent-support@med.cornell.edu.
Once it has been submitted, the project will undergo review by the JCTO. The study team will be notified within one week if the eConsent project has been approved or additional changes need to be made. Consenting within REDCap cannot begin until the REDCap eConsent project has been approved.
Does REDCap eConsent support ICF amendments or changes?
REDCap eConsent supports version control of the ICF documents.
Once the IRB has approved a protocol amendment or continuing review that include changes to the ICF, these changes can be made in REDCap by the study team. Any change to the ICF requires re-review by the JCTO by emailing econsent-support@med.cornell.edu. It is the study teams’ responsibility to keep the eConsent up-to-date, including amending the project every year after the IRB issues a newly stamped ICF at the time of continuing review (even if there are no other changes). For instructions on how to amend a REDCap eConsent project, please read this knowledge article HowTo: Amend REDCap for eConsent.
Will participants get a copy of their consent?
The REDCap eConsent form can be designed to send the participant an email that includes a PDF of their signed consent form. Please email econsent-support@med.cornell.edu for guidance.
How can the study team get access to the completed consent forms?
Signed consent documents will be housed electronically in REDCap's File Repository.
Do I need to upload the eConsent into Epic and OnCore since it’s stored in REDCap?
Yes, REDCap eConsent will create a PDF of the document which you will need to download and upload into OnCore and Epic.
Can my external site collaborators use my eConsent project?
It’s strongly recommended that non-WCM sites use their own institution’s eConsent system. The regulations required for eConsent may vary per local and/or state laws, as well as institution-specific policy which WCM-supported systems may or may not be able to adhere to.
How do I request a DocuSign eConsent?
Please contact econsent-support@med.cornell.edu to request an account.
How do I login to DocuSign?
Once your account has been activated by the JCTO, login via app.docusign.com and enter your WCM/NYP email address and follow the single-sign-on process.
I have created my eConsent in DocuSign, can I begin consenting?
Yes, you can begin a soon as you have created your template. You do not need validation from the JCTO.
Does DocuSign eConsent support ICF amendments or changes?
DocuSign eConsent supports version control of the ICF documents.
Once the IRB has approved a protocol amendment or continuing review that includes changes to the ICF, the updated ICF can be uploaded into DocuSign by the study team. It is the study teams’ responsibility to keep the eConsent up-to-date, including amending the project every year after the IRB issues a newly stamped ICF (even if there are no other changes). The JCTO does not need to review any updates to the eConsent in DocuSign.
Will participants get a copy of their consent from DocuSign?
Yes. Once the ICF is completed by all parties, the participant will receive an email with a link to download the fully executed ICF. The study team should explain to participants that they should download the PDF as soon as possible, because it will only be stored in the DocuSign repository for 12 months.
How can the study team get access to the completed forms in DocuSign?
The consenting investigator will automatically have access to the completed ICF and should ensure they download it for their research records as soon as possible as it will only be stored in DocuSign for 12 months. DocuSign can be designed to send a link to other study team members as well. Please refer to the DocuSign knowledge base article for guidance.