Summary

The following documentation details how to setup an approved Institutional Review Board (IRB) electronic consent (e-consent) using the customized REDCap template, "IRB: Web Consent Form Template". This template should not be confused with the "IRB: Consent to Participate in Research Template (PI Signature Required)", as this template requires only the participant to sign the e-consent. This template should be used for online studies that do not involve any interaction with the participant. 

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) participant will automatically receive a PDF copy of their signed e-consent via email.

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.’
   
   

Survey Settings & e-Consent Copy

This template is pre-configured to automatically send participants an email with a PDF copy of their signed consent. When the project is first created, the full settings are not conifigured.

1. Navigate to the Online Designer and click the button 'Survey Settings' for the instrument 'Consent to Participate in Research.' 
   
   
   
   
2. Scroll down to the section 'Survey Termination Options' and under 'e-Consent Framework Options' enable the signature field variable so that the signature field is reset if the participant clicks the 'Previous Page' button while on the certification page.
   
   
   
3. Scroll down to the bottom of the page and click the button 'Save Changes' to commit the changes. 
   
   
   
   
4. The 'Send confirmation email?' section settings are pre-configured so that when a participant submits their e-consent, they automatically receive an email with a PDF copy of the signed e-consent. You may modify the body of the email but DO NOT un-check the setting 'Include PDF of completed survey as attachment' or change the 'Send confirmation email?' option to 'No'.
   
   

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.

   
   
   

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.