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Modify E-Consent: Individual Participant Survey Invitations (version control)

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Modify E-Consent: Individual Participant Survey Invitations (version control)

Owned by Mary Irion
Last updated: Dec 08, 2022 by Alyssa Hill
5 min read

NOTE: This article should only be used to modify your E-Consent survey in Production in order to apply version updates as necessary. If you are looking to create a e-consent survey for the first time, see: E-Consent Initial Setup


Initial Considerations
Design changes after the Production phase are discouraged but sometimes needed. If a new version of the consent is needed, it is critical to modify the project in such a way as to not lose existing data nor compromise the audit trail of the REDCap e-Consent.

There are two ways to implement new versions of e-consent:

  1. Creation of new instruments

  2. Branching Logic - this method must be used if your project utilizes a public survey link.

    1. See: Modify E-Consent: Public Surveys (version control)

If you are emailing participants surveys for e-consent you can use either of the above options. This article will focus on the creation of "new instrument" method.  If you would like to use the "branching logic" method, please review the knowledge article titled

The Process
Modifying the e-consent via new instrument:

  1. Since your project is in Production, you’ll need navigate to your online designer and enter Draft Mode

  2. Copy your existing E-consent form to quickly copy over the bulk of your E-Consent

  3. Move the E-consent (version 2) instrument under the now expired (version 1) instrument

     

  4. Apply needed updates to new version (2) such as…

    1. Upload IRB stamp with new expiration date

    2. Apply any consent field/verbiage updates required

    3. All Consent component should be included in your new version

  5. Submit your drafted changes for review to a REDCap Administrator

  6. STOP HERE UNTIL YOUR CHANGE REQUEST HAS BEEN APPROVED

  7. Once the requested changes have been implemented…

    1. Enable E-Consent Version 2 as a survey

  8. Open E-Consent Version 2 survey settings to preform the below:

    1. Setup the E-consent Framework

    2. Update version number from 1 > 2 (you do not have to use the number 2, but the value listed MUST be different from the first version)

       

    3. CRITICAL STEP: in addition to updating the version number, you also must ensure the framework is pulling data from the new fields in the new consent version (2) for the below inputs:

      1. First name (v2)

      2. Last Name (v2)

      3. DOB (v2)

      4. Signautre (v2)

9. Adjust your operational processes or survey settings to send the new e-consent to the participant & retire the old. How this is done depends on your project operational flow and how surveys are sent to participants.

Suggested steps:

  1. Limit user access to the original e-consent survey through ‘User settings’, however this will not limit ASI’s/Form display logic. If your project uses either of these functionalities, further steps are required to ensure the old consent is no longer used or triggered.

  2. Hide the instrument using Form Display logic or by making the survey ASI ‘Not Active’.

  3. The survey itself can be switch from active > ‘Survey Offline’ in survey settings, which ensure respondents will not be able to take the survey, even if mistakenly triggered!

How to retire E-consent (version 1):

If using Form Display Logic, follow the steps below: (expand to see)

  1. Here is how the original e-consent can be hidden using Form Display logic

  • This example uses Conditional logic with record ID > 2 as I have 2 records already created under Version 1 e-consent. Future participants are to be directed to the E-Consent Form 2

     

  • When a new record is created the Form Display logic has eliminated the option to select the Version 1 e-Consent form 

     

  • From the file repository you can see the version control within the 2 versions

     

  • You will note that the identifier name did not display on the PDF repository screen display above because the survey settings were still set to capture this data from the original e-consent form (this is incorrect!) and not the e-consent form 2.

  • Ensure you update this setting as well as the consent version #


Additional Considerations & Questions

Q. What is the optimal way to handle multiple signatures? For instance, the parent or participant consents and then our PI would need to sign the consent. Usually this is all done in person, however, with e-Consent what is the best workflow? I know the records are locked, so what is the best way to have that signed?

A. Use a two-part system.

  1. Survey 1 – e-Consent, signed, reviewed, and submitted within the e-consent framework.

  2. Survey 2 – is triggered by submission of survey 1 and is emailed to the study coordinator or PI. The survey is an attestation that has the participant's information piped in and can be signed by the PI, reviewed, and also submitted within the e-consent framework.

A guide to setting up the 2 part e-consent with a  second survey capturing the second signature is outlined in the knowledge article titled Remote Contactless e-Consent & Attestation