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nejm-ethics
Use to confirm clinical ethics and research-integrity requirements for an NEJM submission — IRB/ethics-committee approval and informed consent per the Declaration of Helsinki, ICMJE conflict-of-interest disclosures and authorship criteria, the role-of-the-funding-source statement, and the ICMJE data-sharing statement.
NEJM-Skills/skills/nejm-ethics/SKILL.md
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# Clinical Ethics & Integrity (nejm-ethics)
## When to trigger
- The Methods do not state IRB/ethics approval or how informed consent was obtained.
- ICMJE disclosure forms are not collected for every author.
- There is no data-sharing statement (required by ICMJE for clinical trials).
- Authorship, contributions, or the role of the funder are unstated or unclear.
## Human-subjects ethics
- [ ] **IRB / ethics committee approval** — named committee(s) and that approval was obtained before enrollment.
- [ ] **Informed consent** — obtained from participants (or legal surrogates); describe any waiver and its basis.
- [ ] **Declaration of Helsinki** — state the trial was conducted in accordance with it (and GCP for trials).