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.
How can the study team get access to the completed consent forms?
Signed consent documents will be housed electronically in REDCap's File Repository.
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.
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.
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.
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.
