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Who should review this material:

  • Personnel building project
  • Personnel managing the project

Personnel building and/or managing projects using consent are required to complete Basics and Survey training, in addition to be well versed regarding with the guidance and requirements, outlined here in the wiki, for using REDCap for consenting participants.

Topics covered: 

Documenting the Consent Implementation

It's expected that the project builder will create documentation for the study team, directing staff how to use their REDCap project for consenting their research participants. To that end, we recommend the builder address:

  • How the e-consent form is distributed.
  • If a subject's signature is required:
    • How the signature is obtained.
    • How the e-consent framework operates.
    • How the consent form is saved to the File Repository.
    • How to complete the the attestation form.

User Permissions

No user should be given the user permission for Data Viewing Rights > Edit survey response on Consent survey that's completed by the subject. Editing a subject's completed Consent survey would invalidate a subject’s consent.

Making Revisions to the E-Consent Form

The study team is responsible for ensuring their e-consent form is up-to-date. Except for correcting typos, edits should include versioning, as described below, so as to retain the fidelity of electronic versions of the consent form that participants already completed and submitted. By fidelity, we mean that when the study team member reviews the REDCap record of participant who has consented, the study team member can open the exact version of the e-consent form the participant submitted.

The following approach for managing versioning of the consent form uses the radio button field you created in STEP 1, for capturing the consent version, in conjunction with the discrete sections you created to transform the content of the paper consent document into a REDCap form.

(lightbulb)Tip: It can be helpful to practice making revisions to the e-consent form in a copy of your project before implementing the changes to the e-consent form in production. Reach out to the REDCap Team to ask about how you can make a copy of project for testing e-consent changes.

Edit Form Field for Versioning

(plus) Edit the versioning field to add a new radio button option for the new version.

  • Change the default value to the raw value of the new version option by editing the @DEFAULT action tag.

V-1: New option added to the versioning field and update @DEFAULT action tag - Online Designer view

Add New Descriptive Text Fields for Revised Content

(plus) For each section that contains a revision to the consent language, create a corresponding new section of the consent form.

  • Add the new approval and expirations dates.

V-2: Added new descriptive text field for new dates - Online Designer view

V-3: Added new descriptive text field for revised content - Online Designer view

Apply Branching Logic Consistent with Corresponding Version

(tick) Apply branching logic to the new and deprecated descriptive text fields.

  • Hide sections that correspond to the old version.

  • Show sections that correspond to the new version.

V-4: Branching logic applied to new and old approval and expiration dates - Online Designer view

V-5: Branching logic applied to new and old content

(warning) Update e-Consent Settings (if consent form requires the subject's signature)

(tick) Edit the e-Consent version in the Survey Settings > e-Consent Framework options.

V-6: Updated version in e-Consent configuration - Survey Settings

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