CTSI Announcement

New REDCap E-Consent Policy: Guidelines for Electronic Consent in Enterprise REDCap

December 17, 2025

Wake Forest CTSI has issued a policy detailing the proper use of the e-consent module in Enterprise REDCap for research studies, ensuring informed consent is obtained electronically in accordance with ethical, regulatory, and institutional standards.

Policy Statement

  • Permitted Use: E-consent is permitted in the Enterprise REDCap system for most research studies. Researchers are encouraged to use REDCap's e-consent module for studies where electronic consent is appropriate and does not involve heightened sensitivity or risk.
  • Food and Drug Administration (FDA) Regulated Studies: For studies regulated by FDA, researchers should use alternative platforms such as DocuSign or Florence for electronic consent to ensure enhanced security and compliance.
  • Institutional Review Board (IRB) Approval: Prior to implementing REDCap's e-consent module in any research study, researchers must consult with the Institutional Review Board (IRB) to confirm that the use of e-consent is appropriate and approved for their specific study.
  • Documentation and Version Control: Researchers should utilize REDCap's versioning feature to document and track all versions of the consent form. This ensures transparency and maintains a record of any changes made to the consent documents over time.

Procedures

  • Review your study protocol to determine whether e-consent is appropriate based on the study's risk level and sensitivity.
  • Consult with the IRB before enabling e-consent in REDCap. Obtain explicit IRB approval for e-consent use.
  • If approved, configure the REDCap e-consent module according to institutional and IRB guidelines.
  • Use the versioning feature within REDCap to document all consent form updates. Retain previous versions for audit and compliance purposes.
  • For FDA regulated studies, use DocuSign, Florence, or other IRB-approved e-consent platforms.

For more information on the e-consent feature in REDCap, please review the REDCap e-Consent Setup course or the shorter REDCap Practical Example: e-Consent with pre-validation course.

For questions regarding this policy or the use of e-consent in REDCap, contact the IRB office.  For questions on how to setup or use the e-consent feature, contact the REDCap support team.