Summary

The following document details how to set up an approved Institutional Review Board (IRB) electronic consent (e-consent) using the customized REDCap template, ‘IRB Consent Form: Participant & Researcher Signatures Required’. This template requires both a participant's and researcher's signature to complete the consent process.

The e-consent process works as follows:

  1. The e-consent is emailed to participants as a survey link.
  2. The e-consent will capture participant information and their electronic signature (e-signature).
  3. A researcher will sign the e-consent.
  4. A researcher will send the participant an email with a PDF copy of the fully signed e-consent.


If an IRB protocol requires comprehension questions to be included in the e-consent, please contact redcap-help@utdallas.edu for assistance. REDCap e-consent projects with required comprehension questions must be set up so that the participant cannot submit and complete the e-consent without answering the comprehension questions correctly. This requires the use of external modules, custom CSS, and custom JS to function as expected.

Setting up a New Project

Create Project from Template

  1. Navigate to https://redcap.utdallas.edu and log-in using your NetID and password.

  2. Create a new project by clicking +New Project.
    Picture of Redcap Landing page

  3. Enter the following project relevant information:
    1. Project Title
    2. Select Research from the Purpose of this project drop-down menu.
    3. Administrative details of the project such as the name of the P.I., email, IRB number, etc.
    4. Specify the type of research that best applies
      Picture of Create New Project

  4. Under the section Project creation option section, select Use a template to activate the list of project templates. Select the IRB Consent Form: Participant & Researcher Signatures Required and click Create Project.
    Picture of Create New Project Template Area


Enable Alerts & Notifications

This template uses a pre-configured alert to send participants an email with a PDF copy of their signed consent. When the project is first created, the alert is deactivated and must be re-enabled.

  1. Navigate to Alerts & Notifications.
    Picture of Alerts and Notifications


  2. Click the checkbox to Show deactivated alerts. When the box is checked, a pre-configured alert will appear. In the Options drop-down, select Re-enable alert to enable the alert.
    Picture of Show Deactivated Alerts

  3. Be sure to un-check the checkbox to see the newly activated alert.
    Picture of Un-check Show Deactivated Alerts

  4. (Optional) Edit the alert to customize the email message. For example, you may want to add a Lab or Study name in the body of the email.
    Note: DO NOT edit the ‘trigger alert’ logic, the ‘Email To’ field, or the ‘File Upload Field’. If these settings are altered, the email may not send as expected.
    Picture of Edit Button


Add Users and Define User Rights

Add users to the project and define their access rights by assigning pre-defined user roles. Each role has pre-defined project access rights.
Note: It is recommended to review and update who has access to the project throughout the duration of the study.

  1. Navigate to User Rights.
    Picture of User Rights Link

  2.  Type a user’s NetID or name in the Assign new user box. Select the correct user from the drop-down and click relative role to complete adding the user to the project.
    Note:
    Users need to log in to REDCap at least once before they can be added to a project.
    Picture of Assign User to a Role

  3. See the image below to view the access rights which pertain to each role.
    1. Lab Manager Role: Have complete control and access to the project. They have access to identifiable information.
    2. Data Collector Role: Have the ability to create, view, and edit records. Data is de-identified when performing data exports.
      Picture of Access Rights for Each Role


Modify Consent Language

Modify the language in the consent so that it is specific to your project. 

  1. Navigate to the Online Designer.
    Picture of Online Designer Link

  2. (Optional) Click Choose action and select Rename to rename the form. 
     Picture of Option to Rename Instrument

  3. Click on the instrument name to modify the language in the consent. 
    Picture of Instrument Name


  4. Edit a field by clicking the Pencil icon.
    Note:
    Text in red requires modification.
    Picture of Instrument Fields


  5. Click the full-screen icon to widen the window to better edit the content. Be sure to click Save to commit any changes.
    Picture of Edit Field

  6. The form includes fields that are only visible to the Researcher and remains hidden from the Participant when they are filling out the e-consent form. 
    Picture of Fields Visible to Researchers


Move Project Status to Production

When the project is ready to begin collecting real data, and you have tested that the project logic behaves as expected, a user must request to move their project to 'Production' status. Moving the project to Production status requires the completion of seven steps located on the Project Setup page. Visit our Project Status guide to move a project to production.(WIP) Note: Any changes made to a project in Production must be approved by a REDCap administrator to protect the integrity of any collected data. 

If an IRB protocol requires comprehension questions to be included in the e-consent, please contact redcap-help@utdallas.edu for assistance. REDCap e-consent projects with required comprehension questions must be set up so that the participant cannot submit and complete the e-consent without answering the comprehension questions correctly. This requires the use of external modules, custom CSS, and custom JS to function as expected.

Signatures & Consent Copy

When a participant completes signing and submitting their e-consent, a researcher must also sign the e-consent, and then send a copy to the participant. 

  1. Navigate to the Record Status Dashboard.
    Picture of Record Status Dashboard

  2. Click the green status icon for the record that needs a researcher's signature.
    Picture of Green Status Icon

  3. Click 'Edit response.'


  4. Enter information in the following fields:
    • Researcher First Name
    • Researcher Last Name
    • Signature of Researcher Obtaining Consent
    • Researcher Signature Date
      Picture of Researcher Form Fields

  5. Click the radio box Send PDF to Participant.
    Note:
    This triggers the 'alert' to automatically send an email with a PDF copy of the fully signed e-consent to the participant.
    Picture of Send PDF to Participant

  6. Save the record by choosing Save & Mark Survey as Complete in the upper right corner.
    Note: The record MUST be saved this way to update the PDF so that it includes the added researcher signature.
    Picture of Save and Mark Survey As Complete Button


Access e-Consent

  1. Navigate to the Record Status Dashboard and click the status icon for the record that belongs to the desired participant.
    Picture of Record Status Dashboard

  2. Scroll to the bottom of the page and click on the file link to download the PDF copy of the signed e-consent.
    Picture of PDF copy of the Signed e-Consent


Need help? Contact: redcap-help@utdallas.edu

Have IRB specific questions? Contact: irb@utdallas.edu

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