{"id":4934,"date":"2026-05-21T15:35:52","date_gmt":"2026-05-21T19:35:52","guid":{"rendered":"https:\/\/health.uconn.edu\/clinical-research-center\/?page_id=4934"},"modified":"2026-05-22T11:49:36","modified_gmt":"2026-05-22T15:49:36","slug":"econsent","status":"publish","type":"page","link":"https:\/\/health.uconn.edu\/clinical-research-center\/services\/informatics-core\/redcap\/guides-how-tos\/econsent\/","title":{"rendered":"eConsent"},"content":{"rendered":"
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e-Consent Framework<\/strong><\/h2>\n<\/div>\n

REDCap\u2019s e-Consent Framework allows study teams to obtain and document electronic consent through a REDCap survey. When configured appropriately, participants can review consent materials, provide required information and signatures, certify their responses, and generate a saved PDF copy of the completed consent documentation.<\/p>\n

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Important Compliance Reminder<\/strong><\/h3>\n

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.<\/p>\n

FDA-regulated studies:<\/strong> UConn Health\u2019s current REDCap production instance is not validated for 21 CFR Part 11 compliance. Studies requiring Part 11\u2013compliant electronic records or electronic signatures should not use the current production REDCap instance for that purpose.<\/p>\n<\/div>\n

What the e-Consent Framework Does<\/strong><\/h3>\n

The e-Consent Framework adds two important steps to the normal REDCap survey process:<\/p>\n