Remote Contactless e-Consent & Attestation

REDCap eConsent: Contactless Consent

Initial Considerations
Used where study staff have limited if any direct contact with the study participant. There are many reasons why consent may need to happen entirely virtually and is easily completed using the REDCap e-Consent platform.There are often two steps to most consenting processes:

1. The consent is first completed by the participant
2. Then, in many cases, a witness such as a member of the study staff must also sign to confirm the consent

Both the participant's consent form and the attestation form must be enabled and filled out as surveys for the e-consent framework to function properly and store both PDFs in the project repository. Both Consent and Attestation are linked within a single REDCap record, which represents an individual participant

The Process

• To accomplish this electronically and remotely, add a second instrument for consent attestation after setting up the e-Consent document in REDCap and enabling the e-Consent Framework.
• The second instrument will be used by a member of the study staff or by a witness to confirm or attest to the consent. Here is an example of the Attestation that includes a signature by the study team staff member:
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There are two options to send the e-Consent document to a perspective participant's electronic device:

• A public link: Can be broadly distributed
• Individualized Survey Links: Sent to specific individual

(See Survey Distribution &/or e-Consent Knowledge Articles)

On the Online Designer page, set up the Survey Notifications so that the survey coordinator is notified when the participant's consent document is completed.

Once the Survey Notification is set, the Coordinator will receive an email when the participant has completed the e-Consent.

• The coordinator can then review the consent document and confirm using the second attestation instrument.

It is possible to pipe information into the attestation form, such as the date and time of consent and the participant's name. To do this, include the field name in brackets, then the form will automatically pull this information from the previous instrument

Both Consent and Attestation are linked within a single REDCap record, which represents an individual participant.

Both the participant e-Consent and the Coordinator Attestation can be viewed and printed from the file repository in the e-Consent framework.

• NOTE:  The Attestation instrument MUST be completed as a survey or it will not be filed as a PDF in the file repository
• The coordinator should open the form as a survey. (To Help remind the staff, you can add a reminder at the top of the survey)
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Additional Considerations

• For studies requiring Part 11 Compliance, the Attestation instrument should be enabled as a survey with the e-Consent framework and signature clearing functionality enabled. This is enabled under Survey Settings in the e-consent framework section
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• If amendments are made to the original IRB, should the current e-Consent be updated and a version number used? Or should a new e-consent instrument be created for each IRB amendment?
  • There are several ways to incorporate e-Consent design changes in your project. The best method is dependent upon what is dictated by your PI, IRB, project reporting needs and the project design itself.
    • If your consent is text incorporated in a Section Heading with a simple Yes/No question agreeing to the consent and you plan to use the PDFs in the File Repository to track versions, then adding a version number within the Survey Setting e-Consent parameters would be adequate.
    • If your consent contains a number of qualifying / conditional questions and you plan to make broad changes, you may want to add an additional e-Consent instrument. This will allow you to use REDCap reporting functionality
    • A third option is to use the Hidden Survey action tag functionality in combination with e-consent version numbers. You can leave the original questions, hide them with the Action Tag, and then add new e-consent questions for future participants.

• Should I enable Force Signature in my e-consent settings?
  • "Use of the Force signature fields to be erased" is clinical best practices and is standard for Part 11 compliance.

• Should I use the e-consent type field?

The e-Consent Type field is an optional free form text "label" field that can provide clarification or additional information on the PDF. It (along with the optional Date of Birth) is printed on the bottom of the PDF form. The label can be used to identify gender, patient type, or anything you want it to be to segregate participants. i.e., Adult / Pediatric or Male / Female / Other or Ambulatory / Inpatient. Anything! Merely a label.

• Which is best to use in a study: type in a name or using the 'signature' field?

Clinical best practice would be to include both a printed legible name and a signature field for the participant e-consent and attestation forms.  It is also important to include the date on the consent form

The signature field can also be used to document “wet” initials which may be required for sub-consents within a consent (i.e. can we contact you for future research studies?)