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
- 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:
- Project Title
- Select Research from the ‘Purpose of this project’ drop-down menu
- Administrative details of the project such as the name of the P.I., email, IRB number, etc.
- Specify the type of research that best applies
- 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.
- Navigate to Alerts & Notifications
- 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.
- Be sure to un-check the checkbox to see the newly activated alert.
- (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.
- 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. Note: Users need to log in to REDCap at least once before they can be added to a project.
- See the image below to view the access rights which pertain to each role.
- Lab Manager Role: Have complete control and access to the project. They have access to identifiable information.
- 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. Note: Text in red requires modification.
- Click the full-screen icon to widen the window to better edit the content. Be sure to click 'Save' to commit any changes.
- 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.
Click ‘Project Setup’
At the bottom of the page, click the button 'Move project to production'
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.
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.
- Navigate to the Record Status Dashboard.
- Click the green status icon for the instrument 'Consent to participate in Research' of the record that needs a researcher signature.
- Click 'Edit response.'
- Enter information in the following fields:
- Researcher First Name
- Researcher Last Name
- Signature of Researcher Obtaining Consent
- Researcher Signature Date
- 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
- 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.
- Click the radio-box '
Access Consent Copy
- 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.
- Click on the file link to download the PDF copy of their e-consent.
Consent Comprehension Questions
The following information only applies to IRB protocols that require comprehension questions to be included as part of the e-consent.
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
- 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.
- Replace the field label text with the comprehension question.
- 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.
- Repeat steps 1-3 for the rest of the comprehension questions.
- 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.
- Click on External Modules located in Applications section of the left menu pane.
- Click 'Enable a module.'
- Find the Paper Trail and Shazam modules and enable them by clicking the 'Enable' button.
- You should see the two modules in the "Currently Enabled Modules" list.
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.
- After enabling the shazam module, on the left menu bar, select "Shazam Setup"
- Click "Add Shazam Field" and select the variable "shazam_js_1".
- Enable the "shazam_js_1" variable and copy and paste the following code: