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Note

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

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

  1. Creation of new instruments

  2. Branching Logic

Expand the process you wish to review below

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The Process

using branching logic:

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Keep the existing public survey instrument as the first instrument in the project

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Updating E-Consent using Branching Logic:

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new

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  1. Updated fields should sit directly under the original field

Create a field in the public survey to denote Consent Version.

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Use Action tags to ensure that only the current version of the e-consent is selected.

Use the @Default to ensure only the most current version is presented and @HIDDEN SURVEY)

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Use of branching logic makes the new fields visible only when the appropriate current version of the e-consent is selected.

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Open survey settings to preform the below updates:

  1. 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). Best practice would include version number and IRB approval date.

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  2. Below is an example of the issue that occurs if you do NOT update your version number:

    1. participant #3 actually filled out Version 2 but because the survey settings were not updated, the accurate version is not shown in the PDF file display. (However if you open the PDF it will be second version signed by the participant)
       

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After saving your survey settings, the next participant consented will accurately reflect consent version

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Updating E-Consent using new instrument creation:

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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

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

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

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  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

Once the requested changes have been

implemented…

approved…

  1. Enable E-Consent Version 2 as a survey

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

  3. 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.

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

    1. Update the copied Survey Title:

      1. This is what will appear at the top of the participants survey page, edit as needed.

      2. Note, the survey title (red) and the instrument name (blue) can be different.

    2. Setup the E-consent Framework

      1. 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). Best practice would include version number and IRB approval expiration date.

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    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. Signature (v2)

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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:

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  2. Next you need to ensure all appopriate user(s) in the project now have access to view the new form. By default when a new form is added, it defaults to ‘NO ACCESS’ to all users as a safeguard, to ensure you are able to update the framework settings as shown above BEFORE collecting new data.

    1. Update user rights to access the new form

    2. Adjust any operational settings you project may use such as survey queues, ASI’s or form display logic to use the new form.

    3. Deactivate the OLD consent:

The survey itself can be switched from active > ‘Survey Offline’ in survey settings, which

ensure

ensures respondents will not be able to take the survey, even if mistakenly triggered!

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Updating E-Consent using Branching Logic:

Expand

using branching logic:

  1. Keep the existing public survey instrument as the first instrument in the project

    Image Added

  2. Create new fields for each updated section of the consent.

    1. Updated fields should sit directly under the original field

  3. Create a field in the public survey to denote Consent Version.

    1. Use Action tags to ensure that only the current version of the e-consent is selected.

    2. Use the @Default to ensure only the most current version is presented and @HIDDEN SURVEY)

      Image Added

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  4. Use of branching logic makes the new fields visible only when the appropriate current version of the e-consent is selected.

    Image Added

  5. Open survey settings to preform the below updates:

    1. 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). Best practice would include version number and IRB expiration date.

      Image Added

       

    2. Below is an example of the issue that occurs if you do NOT update your version number:

      1. participant #3 actually filled out Version 2 but because the survey settings were not updated, the accurate version is not shown in the PDF file display. (However if you open the PDF it will be second version signed by the participant)
         

        Image Added

  6. After saving your survey settings, the next participant consented will accurately reflect consent version

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Additional Considerations

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. E-consent Survey: consent is signed, reviewed, and submitted within the e-consent framework.

  2. Data entry Attestation Documentation of Informed Consent /Attestation data form (for staff) :form which can have the participant's information piped in and includes a date & signature field for the PI.