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Summary

The goal of this tutorial is to show how to use the following documentation details how to setup an approved 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(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.


Note

If an IRB protocol requires comprehension questions to be included in the e-consent, please contact redcap-help@utdallas.edu for assistance. REDCap e-consent projects with required comprehension questions must be setup so that the participant can't submit and complete the e-consent without answering the comprehension questions correctly. This requires the use of external modules, custom CSS, and custom JS to function as expected.

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".
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  3. Enter the following 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 Administrative details of the project such as the name of the P.I., email, IRB number, etc.Image Removed
    4. Specify the type of research that best applies
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  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 click ‘Create Project.’
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Enable Alerts & Notifications

This template uses an 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-made 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 so to see the newly activated alert.


  4. (Optional) Edit the alert to send a customized customize the email message. For example, you may want to add the a Lab or Study name in the Subject field or as a signaturethe 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

The rights of each user accessing a project are defined depending on their role in the study. 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 check access rights on a regular basis thought review and update who has access to the project throughout the duration of the study.

  1. Under ‘Applications’ on the left menu pane, select ‘User Rights’Navigate to User Rights.
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    Add users to the project based on their respective roles.Type the Image Added

  2.  Type a user’s NetID or name in the ‘Assign new user’ text box. A Select the correct user from the drop-down menu will provide options to select the correct user. 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 the a project.
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    Click ‘Assign Role’ to assign permissions for personnel working on the project.
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  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.
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Modify Consent Language

To modify the consent form and tailor the language

Modify the language in the consent so that it is 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.
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Click on 'Choose action' to Rename the form. To modify the language on the consent, click on the name of the instrument. 
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To edit a field, click the pencil icon. Modify the text in red. 
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Click the Full-Screen icon to better view the content in a field.
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Once the red text has been replaced by project specific language, don't forget to change the text to black.
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Click Save and continue and continue modifying the language for each field. 
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  1. Navigate to the Online Designer
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  2. (Optional) Click 'Choose action' and select 'Rename' to rename the form. 
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  3. Click on the instrument name to modify the language in the consent. 
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  4. Edit a field by clicking the pencil icon. Note: Text in red requires modification.
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  5. Click the full-screen icon to widen the window to better edit the content. Be sure to click 'Save' to commit any changes.
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  6. The form contains fields for the ResearcherResearch personnel's name, signature, date, and send copy of signed consent to participant. These and date; these fields are hidden while from the participant is when they are filling out the e-consent form. 
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Change


Move Project Status to Production

Once you've fully When the project is ready to go live, and you have tested that the project logic behaves as expected, and you are ready for the project to go 'live', you   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. Moving the project to production status requires the completion of seven steps located in the Click ‘Project Setup’ Section’

    Click ‘Project Setup’ tab on the top of the page or the ‘Project Setup’ link located under ‘Project Setup and Design.’
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    After completing each of the seven steps, click ‘I am done!’
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    After clicking on the last step ‘Move project to production’, the ‘Move Project to Production Status?’ dialog will open.

  2. 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.’

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

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  5. At the bottom of the page, click the button 'Move project to production'
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  6. 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.
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  7. 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.

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Note

If an IRB protocol requires comprehension questions to be included in the e-consent, please contact redcap-help@utdallas.edu for assistance. REDCap e-consent projects with required comprehension questions must be setup so that the participant can't submit and complete the e-consent without answering the comprehension questions correctly. This requires the use of external modules, custom CSS, and custom JS to function as expected.

Signatures & Consent Copy

Add Researcher Signature

After the When a 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.

After the participant completes the survey, click on

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.
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  2. Click the Status green status icon for the instrument 'Consent to participate in Research' instrument that belongs to of the new record that needs a researcher signature. 
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  3. Click 'Edit response.'
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  4. Complete Enter information in the following fields:
    1.  Researcher First Name of
    2. Researcher Obtaining ConsentLast Name
    3. Signature of Researcher Obtaining Consent
    4. Researcher Signature DateClick 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.
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    Click the button 'Save & and Exit Record' to save.
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Access Consent Copy

Click Record Status Dashboard to access record.
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Click the Status icon for the 'Participant PDF Consent form' instrument that belongs to the new record. 
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  • Click on the link located under Record ID named Completed_Consent_PDF_xxx_xxx_xxx.pdf to download the PDF.
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  • Participant's Consent Copy via Email

    After research personnel, sign, date, and click the '
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    See below for a preview of what the PDF looks like.
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    Consent Comprehension Questions

    Note

    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.Image Removed
     Replace the field label text with the comprehension question.
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    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.Image Removed
    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.

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  • 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

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

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

    For more information, please visit our website REDCap or send us an Email.

    For IRB specific questions, please email: 

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    1. 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.
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    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. 
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    2. Click the radio-box '

    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.
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    2. Click on the file link to download the PDF copy of their e-consent.
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    Info

    Need help? Contact: redcap-help@utdallas.edu

    Have IRB specific questions? Contact: irb@utdallas.edu