WashU REDCap e-Consent

Owned by Christopher Sorensen
Last updated: Aug 12, 2024
2 min read

Please consult the WUSTL IRB/HRPO Guidance to make sure your study is  appropriate for executing any of the following methods for implementing electronic informed consent (eIC).  

REDCap has the ability for users to obtain informed consent from participants via an electronic survey on a computer, tablet, or smartphone (e-consent). REDCap does have a built-in e-Consent Framework tool in the survey settings; however, it is important for WashU REDCap users to know that this tool by itself does not meet WashU regulatory compliance for obtaining consent from a participant. The two primary issues with the built-in e-Consent Framework are:

  1. The consent survey is delivered to the participant prior to the study team signing the consent attestation

  2. The consent survey is delivered as an email attachment

This means the participant does not receive a fully executed copy of the consent, and the incomplete copy of the consent is delivered in an unsecure delivery method. Both of these are considered non-compliance. To overcome these issues, the WashU e-Consent and Part 11 compliance working group created a REDCap template project and standard operating procedures (SOP) so WashU REDCap users had a guide for creating an e-consent process in REDCap that meets all regulatory requirements for our institution. It is important to recognize that if you create an e-consent in REDCap using only the built-in e-Consent Framework and not the materials below, your consent process is likely not in compliance with WashU regulatory standards. Please use the links below to create a REDCap project with e-Consent or update your current project. Please Submit a REDCap Ticket if you have questions or need help.

 

REDCap e-Consent with multiple signatures

There currently is no SOP for projects that need multiple signatures on the consent. There are new tools coming to REDCap in late 2024 to help reduce the complexity of REDCap e-consent requiring more than one signature or a consent and assent. For now:

Use file SOP WUSTL REDCap Academic eConsent v1.04.1pdf to create a project. Manually add the additional signature fields required to the e-consent survey.  If signatures needed varies across participants, for example due to age or cognitive ability, use branching logic to make the correct signatures appear on the e-consent survey.  For example, if only a participant signature is required for participants 18 and older, but participant and parent or legal guardian signature is required for participants under 18, create an [age] field on a screening form.  The [age] field can then be used to create branching logic for the parent or legal guardian signature fields, e.g. [parent_lg_signature] only appears if [age] < 18. 

 

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