We have released new versions of the eConsent Frequently Asked Questions (FAQs) materials. These FAQs provided step-by-step instructions on how to build and use eConsent.
The following FAQ’s have been updated and posted to the Resource Library under the “eConsent” heading:
- eConsent Framework (v4)
- eConsent Build (v2)
- eConsent Checklist (v3)
- eConsent Administration (v5)
- eConsent Translation (v2)
- eConsent Revisions (v3)
Recent changes have been made in coordination with Yale’s Human Research Protection Program (HRPP). HRPP also released eConsent and Part 11 Guidance on March 31st that you may also wish to review.
How does this impact me?
The changes in the FAQ eConsent instructions are recommended as best practices for most study designs.
- If you are building a new eConsent, please download and follow the new instructions.
- If you have an existing eConsent, you are not required to make any changes.
Remember to update any bookmarked or downloaded eConsent FAQs to the new version.
Notable changes include:
- Incorporating ‘read-only’ action tags in all editable fields in the consent surveys to ensure the proper administration of eConsent.
- We are no longer including a time field on the signature forms since a timestamp is part of the eConsent framework.
- To support cross-referencing between the participant and person obtaining consent form, we added instructions to add a descriptive field that is piped across instruments.
- We also recommend including the IRB consent approval date in the REDCap (RC) versioning field.