REDCap: Utilize e-consent 2.0

This article outlines the steps for utlizing the e-consent 2.0 framework in REDCap@UNC.

 

In This Article:

Option 1: e-Consent Template

Step 1. Submit a New Project Request

  • Request a new REDCap project via UNC Help
  • Ask for the e-Consent template to be applied.

Step 2. Wait for new project creation

The following will be pre-configured for you:

  • Survey instruments for all signature roles (participant, LAR, witness, and study team member)
  • PDF snapshot settings to combine the e-Consent surveys
  • Survey Login for participant identity verification
  • Alert to send a copy of the signed consent PDF (upon request)

Step 3. Add your study specific consent details to the Consent Form on each e-Consent surveys

Option 2: Manual Setup

If you are adding e-Consent to an existing project or prefer to configure everything yourself, you can set up each component manually. This involves creating each survey instrument, configuring survey settings, enabling the e-Consent framework, setting up the PDF snapshot and sending an email with a copy of consent form PDF file.

Step 1. Create an instrument to record the Participant info.

  • Add fields
    • First name – text, Required, Identifier
    • Last name – text, Required, Identifier
    • Date of birth – text (date_mdy), Required, Identifier
    • Email address – text (email), Required, Identifier
    • Phone number – text (phone), Identifier
    • Completed E-Consent PDF File – fileUploaded image

Step 2. Create an instrument for the participant e-consent

  • Add the following fields
    • e-consent detail – descriptive
    • Full name – text, Required, Identifier
    • Signature – file (signature), Required, Identifier
    • Signed Date and Time - text (datetime_seconds_mdy)
      Action Tags: @DEFAULT=@NOW @READONLY
    • Uploaded image
  • Add a field for voluntary consent
    • Create a Checkboxes field
    • Add Choices -  “1, I voluntarily consent to participate in this study and agree to the collection and use of my information as described in this form.”
    • Set as required
    • Change Custom Alignment to “Left / Horizontal (LH)Uploaded image
  • Add a field for email receipt
    • Create a Checkboxes field
    • Add Choices – “1, I consent to receive a copy of this e-consent form to my email address on file.”
    • Change Custom Alignment to “Left / Horizontal (LH)”Uploaded image

Step 3. Create an instrument for the Legally Authorized Representative (LAR) (if applicable)

  • Add field
    • Relationship to participant – radio, Required
      • 1, Parent
      • 2, Guardian
      • 3, Spouse
      • 4, Other { embedded field}
    • Full name - text, Required, Identifier
    • Signature - file (signature), Required, Identifier
    • Signed Date and Time - text (datetime_seconds_mdy)
      Action Tags: @DEFAULT=@NOW @READONLYUploaded image
  • Add a field for voluntary consent
    • Create a Checkboxes field
    • Add Choices – “1, I am the legally authorized representative of the participant and voluntarily consent on their behalf to participate in this study and agree to the collection and use of their information as described in this form.”
    • Set as required
    • Change Custom Alignment to “Left / Horizontal (LH)”Uploaded image
  • Add a field for email receipt
    • Create a Checkboxes field
    • Add Choices – “1, I consent to receive a copy of this e-consent form to my email address.”
    • Change Custom Alignment to “Left / Horizontal (LH)”
    • Add a text (email) field for email addressUploaded image

Step 4. Create an instrument for the witness (if required)

  • Add field
    • Relationship to Participant - text
    • Full name - text, Required, Identifier
    • Signature - file (signature), Required, Identifier
    • Signed Date and Time - text (datetime_seconds_mdy)
      Action Tags: @DEFAULT=@NOW @READONLYUploaded image
  • Add a field for voluntary consent
    • Create a Checkboxes field
    • Add Choices – “1, I confirm that I witnessed the informed consent process, that the information was accurately presented to the participant/LAR, and that consent was given freely and voluntarily.”
    • Set as required
    • Change Custom Alignment to “Left / Horizontal (LH)”Uploaded image

Step 5. Create an instrument for the study team attestation

  • Add field
    • Full name - text, Required, Identifier
    • Role – radio, Required
      • 1, Principal Investigator (PI)
      • 2, Co-Investigator
      • 3, Research Coordinator
      • 4, Research Nurse
      • 5, Other {embedded field}
    • Signed Date and Time - text (datetime_seconds_mdy)
      Action Tags: @DEFAULT=@NOW @READONLY
  • Add a field for attestation
    • Create a Checkboxes field
    • Add Choices – “1, I certify that I have explained the nature of the study to the participant/LAR, answered all questions to the best of my ability, and believe the participant/LAR has voluntarily agreed to participate with full understanding.”
    • Set as required
    • Change Custom Alignment to “Left / Horizontal (LH)”Uploaded image

Step 6. Set up Survey Login

Setting up the Survey Login assures the participant, LAR, and witness are filling out the appropriate e-Consent form

  • Enable Survey LoginUploaded image
  • Set Login field
    • participant’s last name
    • participant’s date of birth
    • or other fields
  • Change Customizations for survey login
    • Minimum number of fields above that are required for login – 2
    • Apply the survey login to all surveys in project? – Only selected surveys (set on Survey Settings page)
    • Custom Error message -
      If you have any trouble logging in to the survey, please contact <a href="mailto:survey_admin@myinstitution.edu">survey_admin@myinstitution.edu</a> for help.
  • Click “Save”Uploaded image

Step 7. Enable instruments as a survey

  • Enable the Participant, LAR, witness, and attestation instruments as surveyUploaded image
  • Make sure “Enforce ‘Survey Login’ are set as “Yes” in the Survey SettingsUploaded image

Step 8. Enable e-Consent framework for surveys

  • Each Participant, LAR, witness, and attestation e-consents need to be enabled.Uploaded image

Step 9. Add consent form in the e-consent framework settings

  • Each Participant, LAR, witness, and attestation e-consents need to be added.
  • Copy and paste the IRB approved text into the  Consent Form via rich text editor or in line PDF into the EMPTY descriptive field. This field will then populate with the consent text that has been reviewed by the IRB.Uploaded image

Step 10. Add PDF Snapshots

  • Add new trigger in the online designerUploaded image
  • Set trigger condition to when “Attestation” is completedUploaded image
  • Click the pencil icon in the Step 2 Scope of the snapshot
    • Select the e-consent surveys onlyUploaded image
  • In the Step 3, click on both File Repository and a field to store PDF snapshot.
    • Select the “Completed E-Consent PDF File” field from the Participant info instrument.Uploaded image
  • Click “Save”

Step 11. Add New Alert

  • Select the second trigger type
    • If conditional logic is TRUE when a record is saved on a specific form/survey
  • Set the trigger; when “attestation” survey is completed only, while the participant wants the email ([participant_consent_email] = "1")
    • If applicable, please add [lar_consent_email] = "1" for LAR
  • To make sure, click the checkbox for “Ensure logic is still true before sending notification?”
  • Set the alert to send 5 mins after to ensure the PDF is created and uploaded to the file upload field
  • Select the recipient as the participant email field
    • If applicable, please add LAR’s email address
  • Add the Subject and Message
  • Click Add attachments
    • Select the participant info instrument’s file upload field
  • Click “Save”
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