# 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.