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Summary

The following document details how to set up an approved Institutional Review Board (IRB) electronic consent (e-consent) using the customized REDCap template, ‘IRB Consent Form: Participant Signature Required’. 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 e-consent is emailed to participants as a survey link.
  2. The e-consent will capture participant information and their electronic signature (e-signature).
  3. 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 set up so that the participant 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.
    Picture of Redcap Landing page

  3. Enter the following project relevant information:
    1. Project Title
    2. Select Research from the Purpose of this 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.
      Picture of Create New Project

  4. Under the 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.
    Picture of Create New Project Template Area



Send Participant e-Consent Copy

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.

  1. Navigate to the Online Designerand click the button Survey Settings for the instrument Consent to Participate in Research
    Picture of Survey Instruments

  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 to No.
    Picture of Send Confirmation Email

  3. Scroll down to the bottom of the page and click the button Save Changes to commit any changes made to the email message. 
    Picture of Save Changes of Send Confirmation Email

Add Users and Define User Rights

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

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.
    Picture of User Rights Link

  2.  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.
    Picture of Assign New User to a Role

  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.
      Picture of User Roles



Modify Consent Language

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

  1. Navigate to the Online Designer.
    Picture of Online Designer

  2. (Optional) Click Choose action and select Rename to rename the form. 
     Picture of Renaming an Instrument

  3. Click on the instrument name to modify the language in the consent. 
    Picture of Survey Instrument

  4. Edit a field by clicking the pencil icon.
    Note: Text in red requires modification.
    Picture of Edit Field buttonImage Modified

  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 Modified


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. 

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 set up so that the participant 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 File Repository and click the PDF download icon to download the Record Status Dashboard and select the Status icon for the desired record.
    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 of the record that belongs to the desired participant.
    Image RemovedPicture of Download PDF of Instruments LinkImage Added


Info

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

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