What is the e-Consent Framework?
The e-Consent Framework in REDCap helps you obtain participant consent electronically using a REDCap survey. This module is located in the Online Designer under the "e-Consent" button in the Data Collection Instruments header box. The e-Consent Framework offers standardized tools to create and store electronic consent forms, including a certification screen and automatic generation of a PDF copy of the signed form. The generated PDF is the official consent document and contains necessary regulatory information, including a footer with critical information for regulatory compliance.
Always consult your local IRB or regulatory body to ensure that your e-Consent process meets all necessary legal and ethical standards.
Can e-Consent be used on all projects?
An electronic consent process (e-Consent) is allowable on research studies, even for greater-than-minimal-risk studies. The IRB will review the use of e-Consent on a study by study basis, considering the details of your proposed consent process, the study population, and the appropriateness of the electronic platform for the study overall.
If you are planning to use e-Consent for an upcoming study, please read the useful Use of Electronic Informed Consent.
The FDA Part 11 - Electronic Records; Electronic Signatures - Scope and Application document is available HERE. It provides more details on what information you will need to provide to the IRB and the language you should include in the consent document.
How is e-Consent set-up in REDCap?
- Enable the e-Consent Framework for a survey
- Configure Settings
- Add Consent Versions
Interested in using e-Consent?
Find detailed how-to documentation and more information using the links below.
Links/Videos
Videos on setting up and using the e-Consent Framework in REDCap
- REDZone - eConsent Framework (Pre 14.5.0)
- REDZone - eConsent Framework (14.5.0)
- REDZone - Using Multi-Language Management and DAGs with the eConsent Framework
- REDZone - eConsents for Multiple Sites and Public Survey Link
- REDZone - eConsent Framework Project Template
Documents
- How to Enable e-Consent in REDCap (v.15.3.2): This guide will walk you through setting up the e-Consent Framework in REDCap
- Use of Electronic Informed Consent: This link will open a Question and Answer .pdf document that provides Guidance for Institutional Review Boards, Investigators, and Sponsors. This document is provided by a number of federal agencies.
