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Summary

The following documentation document details how to setup set up an approved Institutional Review Board (IRB) electronic consent (e-consent) using the customized REDCap template, "IRB: Web ‘IRB Consent Form Template": Participant Signature Required’. 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

  1. The e-consent is emailed to participants as a survey link
, (2) the
  1. .
  2. The e-consent will capture participant information and their electronic signature (e-signature)
, (3) participant
  1. .
  2. Participants will automatically receive a PDF copy of their signed e-consent via email.

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 set up so that the participant can't cannot 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. Project Title
    2. Select Research from the ‘Purpose Purpose of this project’ 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.
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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 Project.’
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Survey Settings &
  1. section, Project creation option select Use a template to activate the list of project templates. Select the IRB Consent Form: Participant Signature Requiredand click Create Project.
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Send Participant 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 conifiguredThe body of the email may be configured. There are a few optional settings that can be configured.

  1. Navigate to the Online Designer Designerand click the button 'Survey Settings' for the instrument ' Consent to Participate in Research.' 
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    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.
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    Scroll down to the bottom of the page and click the button 'Save Changes' to commit the changes. 
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  2. 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 Option to 'No'.
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  3. Scroll down to the bottom of the page and click the button Save Changes to commit any changes made to the email message. 
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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.
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  2.  Type a user’s NetID or name in the ‘Assign Assign new user’ user box. Select the correct user from the drop-down and click relative role to complete adding the user to the project. Note
     Note: Users need to log in to REDCap at least once before they can be added to a 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

Modify the language in the consent so that it is specific to your project. 

  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.
    Picture of Editing e-Consent Text FieldImage ModifiedThe 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. 
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Move Project Status to Production

When the project is ready to go livebegin collecting real data, and you have tested that the project logic behaves as expected,   you a user must request that the project be moved to move their project to 'Production' status.  Moving Moving the project to production Production status requires the completion of seven steps located in on the ‘Project Setup’ 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 admin administrator to protect the integrity of any collected data. 

Click ‘Project Setup’

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At the bottom of the page, click the button 'Move project to production'
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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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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 set up so that the participant can't cannot 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.

Access Consent Copy

  1. Navigate to the Record Status Dashboard and click select the status Status icon for the instrument 'Participant PDF Consent Form'  of the record that belongs to the desired participantdesired record.
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    Click on the file link to download the PDF copy of their Picture of Record Status DashboardImage Added

  2. Click Download PDF of instrument(s) and then select This survey with saved data to download a PDF copy of the signed e-consent.
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Info

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

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