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Electronic consent requires more than displaying a form on a screen. Participants need understandable information, an opportunity to ask questions and a reliable record of the version they agreed to; testing should examine this whole journey.
Map the consent journey
The joint FDA and OHRP eConsent guidance addresses information delivery, obtaining consent and documentation. Applicable consent and IRB requirements remain relevant. Watching a video or checking a box does not alone demonstrate an understandable, voluntary consent process suited to the participant population.
Prepare scenario tests
Map the steps from invitation to receipt of the signed document. Test language and visual accessibility, limited digital access, interrupted sessions, identity problems and routes for investigator questions. The purpose is to evaluate whether people can complete the intended process, as well as whether screens load correctly.
Check signature and document linkage
Verify the connection between approved content, signature time, signer identity and the copy provided to the participant. Retain earlier records when reconsent is needed. If production content differs from IRB-reviewed materials, pause release and assess the discrepancy before relying on the new flow.
- Test understanding and questions from the participant’s perspective.
- Link signatures to the approved document version.
- Exercise downtime and reconsent scenarios.
Review subsequent changes
Assess platform changes that affect content or identity workflows. Define downtime alternatives and subsequent reconciliation in advance. Retaining study-specific acceptance evidence rather than only a vendor demonstration helps investigators explain how the consent process actually operated for their participants.
Frequently asked questions
- Does an electronic signature alone prove informed consent?
- No. Information, voluntariness, questions and appropriate documentation must be considered together.
- Should participants receive a document copy?
- Yes. Establish an appropriate process for providing and accessing a copy under applicable requirements.