Why use REDCap for eConsent

Approval from your applicable Research Ethics Board (REB/IRB) may be required before using electronic consent framework.

Benefits of Electronic Consent (eConsent)

  1. Better inform participants to empower them to make knowledgeable decisions using interactive multimedia components

    • Participants well informed while utilizing technology our society has become accustomed to using.

    • Incorporate web links within the consent that allow participants to view pictures/videos of procedures, medical equipment, or explanations of key terminology.

    • Decrease participants' confusion due to variability in literacy levels and cultural diversity.

    • Improve the patient recruitment process and reduce the withdraw rates.

    • Enhance participant comprehension of the consent process by the addition of a set of simple questions at the end of the consent.

  2. Enabling the improved quality and efficiency of clinical studies through insight into the participant experience, improved data quality, and a fully electronic system

    • Linked with surveys to assess participant inclusion/exclusion criteria to allow a seamless workflow from recruitment to consent. 

    • Participant compliance increased by gathering metrics on their understanding of study aspects and reducing complex explanations, paperwork and quality risks.

    • Easily query databases to inspect compliance and provide numbers needed for review and approval processes

    • Quickly enable process efficiencies such as re-consent or remote consent. 

    • Reduce corrective actions for audits during an inspection of consent findings.

Resources about eConsent

View Vanderbilt's overview for REDCap eConsent
U.S. FDA: Use of Electronic Informed Consent Q&A

 

What does the REDCap e-Consent Framework do?

  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.
    The participant 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 under the PDF Survey Archive.
    The consent-specific PDF will have the values of the e-Consent Framework Options inserted at the bottom of each page in the PDF.
    These values (i.e., name, date of birth, etc.) are added to the PDF as extra documentation of the identity of the person who is consenting.

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