Automation may organize verified facts but cannot assume professional accountability. A named, qualified human must review each domain and take responsibility in the authorized system.
The ICMJE Recommendations, updated January 2026, retain four authorship criteria: substantive contribution; drafting or critical review; final approval; and accountability for accuracy and integrity. Writing assistance alone does not confer authorship. An AI system cannot be an author or approve a manuscript.
The World Medical Association states that the 2024 Declaration of Helsinki is the current official version. It applies to medical research involving human participants, including identifiable material or data, and emphasizes:
This skill neither performs ethics review nor determines whether an activity is research, exempt, or authorized.
AMA Code of Medical Ethics Opinion 3.3.2 states that information recorded in patient care is confidential regardless of form and identifies access restriction, audit capability, security/integrity, retrieval, sharing, third-party access, and disposition as responsibilities for electronic records.
Use institution-controlled systems for real clinical records. Local draft manifests should contain source locators and hashes rather than PHI.
| Domain | Reviewer responsibility |
|---|---|
| Clinical case facts | Qualified clinician verifies facts, uncertainty, chronology, and interpretation |
| Radiology | Qualified radiologist authors findings/impression and communication status |
| Pathology | Qualified pathologist selects protocol/version and authors diagnosis |
| Laboratory | Authorized laboratory professional verifies released result, method, status, and corrections |
| Statistics | Qualified statistician verifies analysis set, estimand, method, denominator, missingness, and output |
| Safety | Qualified safety professional verifies coding, seriousness, severity, causality, expectedness, and reportability |
| Privacy/legal | Authorized reviewer verifies data use, consent/authorization, disclosure, de-identification method, and jurisdiction |
| Regulatory | Qualified professional verifies adopted guidance, regional requirements, format, and submission process |
| Publication | All accountable authors verify content and current journal instructions |
Record:
Do not place a signature, license number, direct contact detail, or copied approval document in a synthetic asset.
Never state that a script or checklist proves:
Permitted script language is limited to structural findings such as BLOCKED, STRUCTURE_COMPLETE_REVIEW_REQUIRED, or PROCESS_DOCUMENTED_REVIEW_REQUIRED.
No local script signs, timestamps an approval, files, transmits, or submits an artifact.