## Q74 key (Research Consent Defect)

1. Immediately stop new enrollment and all 12 nonurgent implantations. Four scheduled subjects are known defective-form users and eight have unknown versions; neither group may proceed until scope and valid re-consent are resolved. Missed: subjects undergo research without material risk disclosure.
2. Continue the six routine safety visits and all medically necessary care. A compliance hold is not permission to abandon monitoring. Missed: corrective action creates new subject-safety harm.
3. Report the material noncompliance to the central ethics board within five business days and the regulator within seven calendar days, using the Wednesday 10:00 a.m. discovery time. Convene emergency ethics review tomorrow rather than waiting for full scope. Missed: uncertainty is used to let reporting clocks expire.
4. Submit corrected version 4.3 or an approved corrected form, a re-consent script, subject-notification plan, data-use proposal, and scope-investigation plan. No pending subject receives a nonurgent implant until the board approves and the subject signs corrected consent. Missed: an explanatory email after intervention is substituted for prior consent.
5. Contact all known version-4.2 subjects with approved disclosure. Re-consent those with remaining interventions; for completed subjects, obtain ethics-board direction on safety notice and continued data use. The nerve-weakness subject requires prompt candid notice that the experienced event was a known omitted risk and appropriate follow-up. Missed: the most directly affected subject remains uninformed.
6. Determine scope from consent-version inventories, signed PDFs, site screening and enrollment logs, electronic timestamps, document-system audit trails, and direct written certification from every site. Do not label all 62 affected or unaffected before those records arrive. Missed: the report contains a fabricated denominator.
7. Preserve every version and audit trail. Reject the proposed PDF replacement as falsification and spoliation; corrections must be additive and traceable. Separate counsel's analysis where appropriate but report operational facts accurately. Missed: NovaCrest converts a consent defect into data-integrity misconduct.
8. Previously collected data is not automatically destroyed or used without review. Quarantine decisions pending ethics-board direction, subject wishes, and scientific-integrity analysis. Missed: valuable data is either discarded unnecessarily or retained without oversight.