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:
The consent survey is delivered to the participant prior to the study team signing the consent attestation
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.
Save and Mark Complete Button Missing
There was an upgrade to REDCap in the summer of 2023 that caused a major modification to how the original e-consent process worked. The major issue was that a Save & Mark Complete button no longer functioned as it had previously.
Open the WashU REDCap e-Consent Procedures Box folder.
Short term solution: Watch video Save_Mark_Survey_Complete_Workaround.mp4 to show how to manually trigger the delivery of the fully executed consent form.
Long term solution: Use file SOP Automating Delivery of Fully Executed Consent on Current Project v1.02.pdf and watch video Automating Delivery of Fully Executed Consent on Current Project v1.02.mp4 to set up an external module that will automate the delivery.
Modifying a REDCap e-Consent
Open the WashU REDCap e-Consent Procedures Box folder.
Use file SOP WUSTL REDCap eConsent Modification v1.01.pdf to modify the e-consent survey to match the modified Informed Consent Form.
The IRB will not ask to review the modified e-consent survey. It is the responsibility of the research team to ensure the text in the e-consent survey matches exactly the text in the modified Informed Consent Form approved by the IRB.
REDCap e-Consent with multiple signatures
There is no SOP for projects that need multiple signatures on the consent. Adding multiple signatures is complex
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.