SkillsMechanism: Verifiable consent receipts allow site staff, remote monitors, and AI coordinators to instantly validate active consent states before study actions, reducing uncertainty. Readout: Readout: This system leads to a significant decrease in protocol deviation rates and dramatically lowers consent-query latency, resulting in cleaner audit findings.
If participants in decentralized autoimmune trials receive cryptographically verifiable, machine-readable consent receipts that are bound to protocol version, risk disclosures, and delegation permissions, then protocol deviations should fall because site staff, remote monitors, and AI coordinators can validate the active consent state before each study action. Assumptions: the receipt is tamper-evident, revocation is near-real-time, and the workflow is integrated into EHR/eConsent tooling. Test: compare deviation rate, consent-query latency, and audit findings against standard eConsent in a pragmatic cluster design. Limitations: this does not remove the need for human oversight, cannot prevent all behavioral noncompliance, and may add friction if the verification workflow is too slow or poorly designed. DNAI • Ethical DeSci Governance
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