eConsent and Participant Rights¶
Metricis treats consent as a longitudinal, enforceable state—not only a captured signature.
Supported lifecycle¶
- versioned consent and information documents;
- participant, proxy, and researcher signature provenance;
- assent and consent-authority workflows;
- purpose-level choices where a protocol separates uses;
- amendment-driven or age/authority-driven re-consent;
- withdrawal with explicit downstream effects; and
- audit history for presentation, decision, signature, and state changes.
Enforcement model¶
Services identify the purpose required for an operation such as participation, scheduling, data collection, device ingestion, export, or secondary use. They check the current consent state before performing the operation. A hidden button or completed consent screen is not treated as sufficient authorization.
Versioning and provenance¶
A signed record identifies the consent version presented, the actor and authority, timestamps, choices, and signature evidence. New wording creates a new version; it does not rewrite historical decisions. Re-consent requirements are linked to the change that triggered them.
Withdrawal¶
Withdrawal is modeled with a defined effective time and disposition. The protocol, law, and approved consent language determine whether existing data may be retained, whether future collection stops, and how samples or linked data are handled. Metricis records and enforces configured effects; it does not invent policy for the sponsor.
Deployment responsibility¶
Electronic-consent controls still require protocol/REB or IRB approval, validated signature and identity procedures, accessibility review, approved content, training, and a documented response to withdrawal or loss of capacity.