Editing the eConsent Tool Templates

The template(s) you receive for your project depend on your eConsent requirements. The following templates are available:

• Ex1 Participant Information

• Ex2 In-Person eConsent

• Ex3 Remote eConsent, One Signature

• Ex3a Remote eConsent, Participant Form

• Ex3b Remote eConsent, Person Obtaining Consent Form

• Ex4 Send Completed Forms

• Ex5 Study Withdrawal Undertaking

Navigate to the Online Designer using the ‘Designer’ button in the lefthand menu. Click the instrument’s name to edit the template.

Open

Reminder Banner

Each eConsent template has a reminder banner that displays at the top of the REDCap form. This banner does not appear in the survey.

Open

Blank Consent Form for Download

The below field can be used to give the participant access to a PDF of the blank consent form.

To add your consent form, click the pencil icon in the top left of the field to open the editor. Click ‘Remove’ to remove the existing example form and then click ‘Upload File’ to select your copy.

The ‘display format of the attachment on page' should be set to 'Link’ for easy download.

Consent Form Contents

Using images or a PDF (rather than copy/pasting the form into a descriptive field) ensures that the form is exact to the paper copy. Images allow the pagination to be better controlled. PNG image files seem to work best. They are smaller and easier to read.

Ex. Adobe Acrobat allows a PDF to be saved as images in the ‘Save As’ function. This will save each page of the document as a separate image file.

Consent Statements and Agreements

The example templates include statements and questions that the participant must agree to before continuing.

Some questions may need to be added/removed/modified and/or some branching logic changed. There is also a question relating to the storage of specimens. This is an example and can probably be removed.

Consent Question

Each eConsent template has a consent question included that is using a Stop Action. This means that, if the participant selects the configured option, they will be asked if they want to end the survey now.

In the Online Designer, the field has an [End Survey] indicator next to the option that will trigger the survey to stop. To edit or remove the Stop Action, click the ‘stop sign’ icon at the top of the field.

Participant Information and Signature

Each eConsent template hides the fields for the participant’s name, signature, and the date that the signature was obtained until the participant agrees to the consent question.

These fields are hidden using Branching Logic.

Clicking the ‘branching green arrow' icon opens the branching logic editor. From there, the existing branching logic can be cleared by clicking ‘Clear logic’ and then clicking 'Save’

Other Persons Information and Signature

Your eConsent template may include information for the Person Obtaining Consent or Witness. These sections can be modified or deleted.

Section Headers and Footer

Each eConsent template has headers that include the study title.

The last field on the eConsent template contains information about the study and consent form.

Editing REDCap’s Survey Settings

Navigate to the Online Designer using the ‘Designer’ button in the lefthand menu. Next to the instrument’s name, click the ‘Survey settings’ button.

Survey Instructions and Appearance

The Survey settings page controls the survey’s title, instructions, completion text, logo, colour scheme, button labels, and more.

eConsent Settings

Each eConsent template has REDCap’s e-Consent Framework already enabled. Scroll to the bottom of the Survey Settings page to find these settings.

• ‘Allow e-Consent responses to be edited by users?’ should be unchecked
  After submitting the form, a copy will be automatically saved in the PDF Survey Archive. It is not recommended to allow REDCap users to edit a consent form that has been submitted.

• e-Consent version should be filled out with a version number and/or date
  This will allow the version of the form to be easily identified in the PDF Survey Archive in the event that the form is updated.

• The first name, last name, e-Consent type, and date of birth fields are used when identifying the consent form in the PDF Survey Archive. The first and last name fields can also be used to represent the names of the participant and person obtaining consent.

• Selecting specific field(s) as Signature fields will erase their contents in the event that the user navigates back to a previous page, forcing them to sign the field(s) again before continuing.

Design Considerations for In-Person eConsent

If the eConsent forms are completed in-person, the participant and the person obtaining consent (and witness, if applicable) are together and will sign the eConsent form at the same time. But the form must be completed as a survey, not completed in REDCap, to use the eConsent Framework.

Key fields in the eConsent form are marked with the @READONLY-FORM action tag to prevent data entry in REDCap. The form must be opened as a survey to enter data.

Design Considerations for Remote eConsent

If the eConsent forms are completed remotely, they will need to be sent to the participant. This is easiest to do if the participant’s email address exists in their record, allowing the ‘To’ email field to be filled automatically.

To create an email field, use the ‘Text Box’ field type and select the field validation as ‘Email’.

In the Project Setup page, under ‘Enable optional modules and customizations’, click ‘Enable’ for Designate an email field for communications.
(If a field is already designated, click ‘Disable’ to erase it so that a new field can be selected)

Setting Up Automated Survey Invitations (ASIs)

Sending the eConsent form can be done individually using the ‘Compose survey invitation' option or sent in bulk using the 'Survey Distribution Tools’.

You may also want to set the eConsent forms to be sent automatically to the participant.

Navigate to the Online Designer using the ‘Designer’ button in the lefthand menu. Next to the instrument’s name, click the ‘Automated Invitations’ button.

Each remote eConsent template has ASIs already enabled. Scroll to the bottom of the Survey Settings page to find these settings.

1. Set the ‘From’ email address to be the email address for your study.

2. Change the Subject line. (Note: do not put the study title in the email as this is not considered appropriate by the REB. It contains too much information for an insecure medium)

3. Change the body of the email. Leave the [survey-link] and [survey-url] intact as these will be replaced with the URL for the specific participant’s survey.

4. Specify the conditions (the trigger) for the invitation to be sent.
In the image above, the remote eConsent template ASI is set to trigger after a field in ‘Ex1 Participant Information’ with the variable name participant_send_forms has the choice 1 selected.

5. If desired, set the invitation to be sent at a specific time

6. If desired, set the invitation to resend if the participant doesn’t respond.

Once the settings are complete, ensure the Survey Invitation is set to ‘Active’ and ‘Save’

Remote eConsent Forms Requiring Multiple Signatures

An eConsent form that is signed remotely can’t be easily signed by the person obtaining consent. Once the participant submits the form it is not allowed to be edited in REDCap.

If the consent form only requires the participant’s information, no special considerations are needed. Otherwise, the consent form is split into two parts: one for the participant, one for the person obtaining consent. These examples are present in the eConsent Template.

Design Considerations for Study Withdrawal Undertaking

An electronic form for study withdrawal has the same features as an eConsent form. It also uses the REDCap e-Consent Framework to ensure the completed form is archived.

In the eConsent options (near the bottom of the Survey Settings page), the e-Consent type is set to ‘Withdrawal’ to easily set it apart from other eConsent forms.