WashU REDCap e-Consent Standard Operating Procedures

All procedures for the WashU REDCap e-Consent can be found in this WUSTL Box folder:

WashU REDCap e-Consent Standard Operating Procedures

https://wustl.box.com/v/WUSTL-RCA-econsent-template

Creating a new REDCap e-consent project?

  1. Use file WashU REDCap e-Consent 2.0 - Create e-Consent Project.pdf to create, edit, and test the project.

 

Already have a REDCap e-consent project and modifying your Informed Consent Form?

  1. Use file WashU REDCap e-Consent 2.0 - Modify e-Consent Project after ICF Modification Approval.pdf to modify the e-consent survey to match the modified Informed Consent Form.

  2. 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 

 

Creating a REDCap e-consent that needs multiple signatures on the consent?

There is no SOP for projects than need multiple signatures on the consent.

Use file WashU REDCap e-Consent 2.0 - Create e-Consent Project.pdf 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.