Professional, Ethical, and Human Review

Accountability

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.

Research ethics

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:

• participant rights and interests over research goals;
• privacy and confidentiality;
• scientific validity and a documented protocol;
• independent research-ethics review;
• informed consent;
• transparency and reporting.

This skill neither performs ethics review nor determines whether an activity is research, exempt, or authorized.

Clinical-record confidentiality

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.

Required reviewers by artifact

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

Review record

Record:

• reviewer role, not a fabricated name;
• scope reviewed;
• source version and data cut;
• unresolved conflicts and limitations;
• review date;
• decision in the authorized workflow;
• reference to the real sign-off record.

Do not place a signature, license number, direct contact detail, or copied approval document in a synthetic asset.

Prohibited claims

Never state that a script or checklist proves:

• clinical correctness;
• HIPAA compliance or de-identification;
• GCP compliance;
• CARE, CONSORT, SPIRIT, ICH, ACR, CAP, or CLIA compliance;
• ethics approval or informed consent;
• regulatory reportability;
• readiness for signature, filing, publication, or submission.

Permitted script language is limited to structural findings such as BLOCKED, STRUCTURE_COMPLETE_REVIEW_REQUIRED, or PROCESS_DOCUMENTED_REVIEW_REQUIRED.

Corrections and conflicts

• Never overwrite a source fact.
• Keep original and corrected versions linked.
• Expose conflicting sources and stop dependent claims.
• Require the responsible reviewer to resolve conflicts in the authorized system.
• Re-run structural and consistency checks after any correction.

No local script signs, timestamps an approval, files, transmits, or submits an artifact.