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The following documentation details how to setup an approved Institutional Review Board (IRB) electronic consent (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.
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. |
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.
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.
Modify the language in the consent so that it is specific to your project.
Click on the instrument name to modify the language in the consent.
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.
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. |
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.
Need help? Contact: redcap-help@utdallas.edu Have IRB specific questions? Contact: irb@utdallas.edu |