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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 |
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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:
Creation of new instruments
Branching Logic
If you are using a public survey as your e-consent you must use the branching logic methodology
Expand the process you wish to review below
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The Process
Background:
Below are images of what a previously set up e-consent looks like and how the files are stored in the file repository
Here is an image of an existing e-consent configuration as view in Survey Settings.
- Note that REDCap automatically inserts "public survey" as the e-consent type
- When e-consent framework has been implemented, PDFs of the signed consents are automatically stored in the project's file repository as shown below
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If you need to modify the consent to Version 2, do NOT copy the project (including the existing records) with the plan to insert a new public instrument as this will break the audit trail of the previously e-consented participants.
- While the record status dashboard and the first screen of the File Repository may appear normal, the PDFs are no longer intact as shown below
- Once you click on PDF survey archive, you will notice that the previous e-consents are not listed
The PDFs of the previous records are gone! This exemplifies the stringent audit trail that the e-consent maintains thus proving the e-consents can't be altered once signed by the participant.
The optimal way to add a new version to an existing E-consent Public Survey project is to modify the current instrument and use branching logic.Updating E-Consent using new instrument creation:
| Expand |
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Modifying the e-consent via new instrument:
Once the requested changes have been approved…
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!  |
Updating E-Consent using Branching Logic:
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using branching logic:
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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
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E-consent Survey: consent is signed, reviewed, and submitted within the e-consent framework.
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Documentation of Informed Consent /Attestation data form (for staff) can have the participant's information piped in and
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includes a date & signature field for the PI.