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REDCap: eConsent - Overview

This feature, which works together with the PDF Auto-Archiver, provides functionality for users to implement electronic consent (eConsent) using a survey as the consent form, such as for capturing the consent of a research study participant.

The eConsent Framework option adds two things to the typical survey-taking process.

    1) Before a participant completes the survey, an extra certification page is added to end of the survey that displays an in-line PDF copy of their survey responses in which they will be asked to confirm that all information in the document is correct. Once they confirm all is correct, the survey will then be marked as complete. The survey will not be considered complete until they fulfill the certification step.
    2) Upon completion of the survey, a static copy of their responses in the form of a consent-specific PDF will be stored in the project's File Repository. The consent-specific PDF will have the values of the eConsent Framework Options inserted at the bottom of each page in the PDF. These values (i.e., IRB number, PI name, participant name, etc.) are added to the PDF as extra documentation of the identity of the person who is consenting.

NOTE: For guidance on documenting consent electronically with the UW-Madison HS-IRB visit their help page on the UW Knowledgebase

Overview:

The eConsent Framework is set up within the Survey Settings page in the Online Designer, thus it can be enabled for any given survey in a project.

Image shows online designer menu.
Navigate to Survey Settings to set-up the e-Consent Framework
Image shows eConsent framework settings
Under "PDF Auto-Archiver" select "Auto-Archiver + e-Consent Framework" and set fields as appropriate



After completing the eConsent Survey, participants will be prompted to certify the information entered and acknowledge signing the form electronically is the equivalent of signing a physical document.

Image shows an eConsent form example.
Example of Signature and e-Consent Acknowledgment

To view and download the auto-archived PDF, access the File Repository on the left side of your project under Applications.

NOTE: Users must be given access to the File Repository via User Rights.

eConsent form in the PDF Survey Archive
Copies of the completed e-Consents are saved in the File Repository

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Keywordseconsent consent PDF pdf   Doc ID88654
OwnerAmy S.GroupSMPH Research Informatics
Created2018-12-21 11:48:36Updated2024-03-20 09:59:05
SitesInstitute for Clinical and Translational Research, SMPH Research Informatics
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