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Alyssa Hill

Alyssa Hill

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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

Warning

Never delete (old) consent instruments, this will result in lost data!

Instead, you can ‘deactivate’ the old survey instrument which will keep you data intact, but ensures said survey is no longer accessible to participants. This is completed using ‘survey settings’, view the below process for details.

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.

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

  1. Creation of new instruments

  2. Branching Logic

If you are using a public survey as your e-consent you must use the branching logic methodology provided below

The Process

The optimal way to add a new version to an existing E-consent Public Survey project is to modify the current instrument Expand the process you wish to review below

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The Process

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 approved…

  1. Enable E-Consent Version 2 as a survey

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

    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.

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

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Updating E-Consent using Branching Logic:

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using branching logic:

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

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  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)

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  2. 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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  2. 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)

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    1. . Best practice would include version number and IRB expiration 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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  2. 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. Anchor_GoBack_GoBack

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

  2. Documentation of Informed Consent /Attestation data form (for staff) can have the participant's information piped in and can be signed by the PI, reviewed, and also submitted within the e-consent framework.

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  1. includes a date & signature field for the PI.