Summary

The following documentation details how to setup an approved Institutional Review Board (IRB) electronic consent (e-consent) using the customized REDCap template, "IRB: Consent to Participate in Research Template (PI Signature Required)". This template should not be confused with the "IRB: Web Consent Form Template", as this template requires a researcher to sign a participant's e-consent, which requires additional project setup.

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

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"
   
   
   
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
      
      
      
4. Under the section Start project from scratch or begin with template, select the IRB: Consent to Participate in Research (PI Signature Required) and click ‘Create Project.’
   
   

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
   
   
   
   
2. Click the checkbox '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.
   
   
   
3. Be sure to un-check the checkbox to see the newly activated alert.
   
   
   
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.
   
   
   

Add Users and Define User Rights

Add users to the project and define their access rights by assigning them 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.
   
   
   
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.
   
   
   
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.
      
      

Modify Consent Language

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

1. Navigate to the Online Designer
   
   
   
2. (Optional) Click 'Choose action' and select 'Rename' to rename the form. 
    
   
   

3. Click on the instrument name to modify the language in the consent. 
   
   
   

   
   

4. Edit a field by clicking the pencil icon. Note: Text in red requires modification.
   
   
   
   
5. Click the full-screen icon to widen the window to better edit the content. Be sure to click 'Save' to commit any changes.
   
   
   
6. The form contains fields for the Research personnel's name, signature, and date; these fields are hidden from the participant when they are filling out the e-consent form. 
   
   
   

Move Project Status to Production

When the project is ready to go live, and you have tested that the project logic behaves as expected,  you must request that the project be moved to 'Production'.  Moving the project to production status requires the completion of seven steps located in the ‘Project Setup’ page. Note: Any changes made to a project in Production must be approved by a REDCap admin to protect the integrity of any collected data. 

1. Click ‘Project Setup’
   
   
   

2. At the bottom of the page, click the button 'Move project to production'
   
   
   

3. A window will pop-up asking if all existing data should be kept or deleted. It is highly recommended to delete all test data when moving a project to Production. Click the 'YES, Move to Production Status' to complete the request.
   
   
   

4. A window will pop-up with a questionnaire survey that is intended to capture information about the project and to serve as a check-list to ensure the project has been sufficiently tested. A REDCap administrator will receive the request and approve the move to Production. When the request is approved, the researcher will be notified via e-mail.

   
   
   

Signatures & Consent Copy

Add Researcher Signature

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.
   
   
   
2. Click the green status icon for the instrument 'Consent to participate in Research' of the record that needs a researcher signature.
   
   
   
3. Click 'Edit response.'
   
   
   
4. Enter information in the following fields:
   1.  Researcher First Name
   2. Researcher Last Name
   3. Signature of Researcher Obtaining Consent
   4. Researcher Signature Date
      
      
      
5. Save the record by choosing the option in the drop-down 'Save & Mark Survey as Complete.' Note: The record MUST be saved this way in order to update the PDF so that it includes the added researcher signature.
   
   

Send Fully Signed Consent

1. Navigate to the Record Status Dashboard and click the status icon for the instrument 'Participant PDF Consent Form'  of the record which has a fully signed e-consent that needs to be sent to the participant. Note: When the status icon is red, this indicates that the e-consent copy may not have yet been sent to the participant. 
   
   
   
   
2. Click the radio-box 'Send PDF to Participant'  and save by clicking the button 'Save & Mark Survey as Complete'. Note: This is what triggers the 'alert' to automatically send an email with a PDF copy of the fully signed e-consent to the participant.
   
   

Access Consent Copy

1. Navigate to the Record Status Dashboard and click the status icon for the instrument 'Participant PDF Consent Form'  of the record that belongs to the desired participant.
   
   
   
2. Click on the file link to download the PDF copy of their e-consent.