e-CONSENT

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REDCap’s e-Consent Framework allows study teams to obtain and document electronic consent through a REDCap survey, whether consent is obtained in person or remotely. Participants can review consent materials, provide required information and signatures, certify their responses, and receive a saved PDF copy of the completed consent documentation.

The framework provides flexible options for customizing the consent process to meet study-specific requirements. Consent forms can be displayed directly within the survey as either an inline PDF or rich text. The framework can also support context-specific consent forms using Multiple Language Management (MLM) and/or Data Access Groups (DAGs), allowing the appropriate consent form to be presented based on a participant’s selected language and/or assigned DAG.

Upon completion, the certification and storage functions automatically generate and securely store a PDF copy of the signed consent form, providing a standardized record of the participant’s consent.

Important: Before using REDCap for e-Consent, study teams should discuss the proposed consent process with the IRB and confirm that electronic consent is appropriate for the study. REDCap provides the framework and documentation tools, but the study team is responsible for building, testing, and obtaining approval for the consent process.

Key e-Consent Features: 

  1. Survey Participant Review and Attestation. Before the survey is submitted, participants are shown a PDF-style copy of their responses and must certify that the information is correct. Upon certification, REDCap saves a static PDF copy of the signed consent documentation in the project’s File Repository. These features help create a documented consent record.
  2. Consent Form Versioning. REDCap allows study teams to add consent versions so that the correct version of the consent form is displayed and documented. Once a REDCap e-Consent version number is used, it cannot be reused. Study teams should maintain clear version control between the IRB-approved consent document and the REDCap e-Consent version.
  3. Multi-Signature or Multi-Form Consent Workflows. Some studies may require signatures from more than one person, such as a participant, parent or guardian, legally authorized representative, or study staff member. These workflows should be planned carefully. In some cases, separate instruments may be needed for different signing roles, and additional PDF snapshot triggers may be used to combine multiple signed forms into one saved PDF.

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