REDCap IRB Consent Form: Participant Signatures Required

Summary

The following document details how to set up an approved Institutional Review Board (IRB) electronic consent (e-consent) using the customized REDCap templates and the Multi Signature Consent External Module. This template should be used for online studies that do not involve any interaction with the participant.

The e-consent process works as follows:

• The e-consent is emailed to participants as a survey link.
• The e-consent will capture participant information and their electronic signature (e-signature).
• If needed, the researcher will sign the e-consent form. 
• Participants will automatically receive a PDF copy of the fully signed e-consent via email.
   

Setting up a New Project

Create Project from Template

• Navigate to https://redcap.utdallas.edu and log-in using your NetID and password.
• Create a new project by clicking +New Project.
  
   
• Enter the following project relevant information:
  • a. Project Title
  • b. Select Research from the Purpose of this project drop-down menu.
  • c. Administrative details of the project such as the name of the P.I., email, IRB number, etc.
  • d. Specify the type of research that best applies.

• Under the section, Project creation option: 
  • Select Use a template to activate the list of project templates
  • If only the participant signature is required, select IRB Consent Form: Participant Signature Required
  • If researcher and participant signature is required, select IRB Consent Form: Participant & Researcher Signatures Required
  • IRB Consent Form: Participant Signature Required
  • Click Create Project

Add Users and Define User Rights

Add users to the project and define their access rights by assigning pre-defined user roles.

• Navigate to User Rights.
                                                                                                                        
•  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.

• See the image below to view the access rights which pertain to each role.
  • a. Lab Manager Role: Have complete control and access to the project. They have access to identifiable information.
  • b. 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. 

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

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

  

• Edit a field by clicking the pencil icon.

• Click the full-screen icon to widen the window to better edit the content. Be sure to click Save to commit any changes.
  

Send Participant e-Consent Copy (Only Participant Signature Needed)

This template is pre-configured to automatically send participants an email with a PDF copy of their signed consent. The body of the email may be configured. There are a few optional settings that can be configured.

• Navigate to the Online Designer and click the button Survey Settings for the instrument Consent to Participate in Research. 
  
   
• 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.
  
• Scroll down to the bottom of the page and click the button Save Changes to commit any changes made to the email message. 

Multi Signature Consent Form (Participant and Researcher Signatures Needed)

The Multi Signature Consent module allows you to merge multiple signatures into one form. 

CONFIGURING THE EXTERNAL MODULE

• Navigate to the 'External Modules' section on the right side and click on Manage.
  
   
• Click on View available modules.
  
• Find 'Multi Signature Consent - v1.1.3' and click on Request Activation.
  • A REDCap admin will have to activate the module for you. If you encounter any problems, please contact redcap-help@utdallas.edu.
    
• Once activated, click on Configure.
  
• In the 'Form' section, select the instrument that has the consent signature fields. If multiple instruments are required, use on the '+' sign to add as many instruments as needed.
  
• In the 'File Field' section, select the field you would like to save Multi Signature Consent PDF to. (Note: This must be a file-upload field).
  
• In the 'Update Logic' section, specify the logic needed to create the Multi Signature Consent PDF.
  • This will specify when the PDF will be created based on fields that have been filled/not filled. For example, the logic below specifies that the PDF should only be generated when the participant and researcher signature is aquired and another file should not be generated after one is made.
  • The syntax for filled fields is: [variable_name]<> ””
  • The syntax for empty fields is: [variable_name]= ””
  • Make sure to carefully check the logic as the external module will NOT present an error message if logic syntax is incorrect!
• The remaining sections are optional and up to personal preferences on how to customize and save the PDF file.
• Click Save.

SETTING UP ALERTS

• Click on 'Alerts and Notifications' on the right side
  
• Click on Add New Alert.
  
• Create a title for the alert
• Under the 'Triggering the Alert' section:
  • Select If conditional logic is TRUE when a record is saved on a specific form/survey
  • Choose the instrument/survey that was used for the External Module from the dropdown list
  • Select 'is saved with Complete status only' in the second dropdown
  • In the logic box, type “[filename]<>"" where 'filename' corresponds to the field variable name which the Multi Signature Consent PDF will save to. This statement that specifies that when this field is not empty (file has been saved), the alert will be sent out.
    
• In the 'Set the Alert Schedule', you can customize when and how many times to send the alert and well as an expiration date.
  
• In the 'Message Settings' section, you can customize the email that will be sent out when the alert is triggered
  
• In the 'Message Attachments' sections, attach your Multi Signature Consent PDF file.
  
• Click Save.
  

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. 

ACCESSING CONSENT COPY

• Navigate to the Record Status Dashboard and select the Status icon for the desired record.
  
• Click Download PDF of instrument(s) and then select This survey with saved data to download a PDF copy of the signed e-consent.