Summary

The goal of this tutorial is to show how to use the Institutional Review Board (IRB) approved electronic consent form template in REDCap. REDCap allows for the ability to send the consent from as a survey link via email and can capture participants’ information and electronic signatures.

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 project relevant information.
   1. Enter an appropriate Project Title.
   2. Select Research from the ‘Purpose of this project’ drop-down menu
   3. Enter important administrative details of the project such as the name of the P.I., email, IRB number, etc.
      
      
      
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 an "alert" to send participants an email with a PDF copy of their signed consent.

1. Navigate to "Alerts & Notifications"
   
   
   
   
   
2. Click the checkbox "Show deactivated alerts". When the box is checked, a pre-made alert will appear. In the "Options" drop-down, select "Re-enable alert" to enable the alert.
   
   
   
   
3. Be sure to un-check the checkbox so see the newly activated alert.
   
   
   
   
4. (Optional) Edit the alert to send a customized email message. For example, you may want to add the Lab or Study name in the Subject field or as a signature. 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

The rights of each user accessing a project are defined depending on their role in the study. It is recommended to check access rights on a regular basis thought the duration of the study.

1. Under ‘Applications’ on the left menu pane, select ‘User Rights’.
   
   
   
2. Add users to the project based on their respective roles.
   1. Type the user’s NetID or name in the ‘Assign new user’ text box. A drop-down menu will provide options to select the correct user. Users need to log in to REDCap at least once before they can be added to the project.
      
      
      
3. Click ‘Assign Role’ to assign permissions for personnel working on the project.
   
   
   
   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

1. To modify the consent form and tailor the language specific to your project, click on ‘Designer’ under the 'Project Home and Design section or click ‘Online Designer’ under 'Design your data collection instruments & enable your surveys' in the project Settings.
   
   
   
2. Click on 'Choose action' to Rename the form. To modify the language on the consent, click on the name of the instrument. 
    
   
   

3. To edit a field, click the pencil icon. Modify the text in red. 
   

   
   

4. Click the Full-Screen icon to better view the content in a field.
   
   
   
5. Once the red text has been replaced by project specific language, don't forget to change the text to black.
   
   
   
6. Click Save and continue and continue modifying the language for each field. 
   
   
   
   
7. The form contains fields for the Researcher's name, signature, date, and send copy of signed consent to participant. These fields are hidden while the participant is filling out the consent form. 
   
   
   

Change Project Status to Production

Once you've fully tested that the project logic behaves as expected, and you are ready for the project to go 'live', you must request that the project be moved to 'Production'. Any changes made to a project Production must be approved by a REDCap admin to protect the integrity of any collected data. 

1. Moving the project to production status requires the completion of seven steps located in the ‘Project Setup’ Section’

   1. Click ‘Project Setup’ tab on the top of the page or the ‘Project Setup’ link located under ‘Project Setup and Design.’
      
      
      

2. After completing each of the seven steps, click ‘I am done!’
   
   
   

3. After clicking on the last step ‘Move project to production’, the ‘Move Project to Production Status?’ dialog will open.

   1. Select ‘Keep ALL data saved so far’ or ‘Delete ALL data, calendar events, documents uploaded for records/responses, survey responses (if applicable), and any logging events pertaining to data collection.’

   2. If ‘Delete ALL data… ‘ is selected, a message box will open to confirm that you want to delete all the data.
   3. Click Yes, ‘Move Project to production’.
      
      
      
      

4. After requesting to move a project to Production, you will receive a questionnaire via email to ensure you've fully tested the project. Once a REDCap Administrator approves the project's move to Production, you will be notified via email.

   
   
   

Signatures & Consent Copy

Add Researcher Signature

After the participant completes the survey, the researcher/PI needs to access the record to input their information, signature, and to trigger an email with the attached consent.

1. After the participant completes the survey, click on Record Status Dashboard.
   
   
   
2. Click the Status icon for the 'Consent to participate in Research' instrument that belongs to the new record. 
   
   
   
3. Click 'Edit response.'
   
   
   
4. Complete the following fields:
   1. Name of Researcher Obtaining Consent
   2. Signature of Researcher Obtaining Consent
   3. Date
   4. Click the 'Send signed consent copy to participant.' This is what triggers the ASI to automatically send an email to the participant with a PDF of the consent signed by both the participant and researcher personnel.
      
      
      
      
5. Click the button 'Save & and Exit Record' to save.
   
   
   
   

Access Consent Copy

1. Click Record Status Dashboard to access record.
   
   
   
2. Click the Status icon for the 'Participant PDF Consent form' instrument that belongs to the new record. 
   
   
   
3. Click on the link located under Record ID named Completed_Consent_PDF_xxx_xxx_xxx.pdf to download the PDF.
   

Participant's Consent Copy via Email

1. After research personnel, sign, date, and click the 'Send signed consent copy to participant' an email with a PDF copy of the signed consent will automatically be emailed to the participant. 
   
   
   
2. See below for a preview of what the PDF looks like.
   
   
   
   
   

Consent Comprehension Questions

If an IRB protocol requires comprehension questions as part of the e-consent, extra steps are required to configure the project. Researchers must configure their project to impede participants from submitting their e-consent until they have answered the comprehensions questions correctly. To enable these features in REDCap please follow the steps below.

Add Comprehension Questions

1. Modify the comprehension question fields by clicking the edit pencil. DO NOT modify the 'shazam_1 field' or the 'correct_answer_total' field. These fields are used for branching logic and the Shazam module.
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2.  Replace the field label text with the comprehension question.
   
   
   
3. In the answer 'Choices' section, replace the answers. Be sure to input the "wrong" and "correct" answer choices as described in the field. DO NOT change the variable name because it will break branching logic and the Shazam module.
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4. Repeat steps 1-3 for the rest of the comprehension questions.
   
   
5. You may modify the text in the 'incorrect_answer' and 'correct_answer' fields but DO NOT change the branching logic or the variable names.
   

   

Enable and Configure the Shazam Module

Enabling the Shazam module will introduce the programming framework necessary to impede participants from submitting their e-consent until they have answered the comprehension questions correctly.

Enable Shazam

1. Click on External Modules located in Applications section of the left menu pane.
   
   
   
2. Click 'Enable a module.'
   
   
   
3. Find the Paper Trail and Shazam modules and enable them by clicking the 'Enable' button.
   
   
   
   
4. You should see the two modules in the "Currently Enabled Modules" list.
   

Configure Shazam

In the case of this template, the module Shazam is used to modify the look of a survey with CSS code and introduces the ability that prohibits participants to submit the consent without answering all of the questions to test their comprehension of the consent correctly. 

1. After enabling the shazam module, on the left menu bar, select "Shazam Setup"
   
   
   
2. Click "Add Shazam Field" and select the variable "shazam_js_1".
   
   
3. Enable the "shazam_js_1" variable and copy and paste the following code:
   1. Under CSS tab paste this code: CSS for Button.txt
      
      
      
   2. Under the JS tab paste this code: JS for Button.txt