Individual skill
jama-ethics-registration
Use when verifying trial registration, IRB/ethics approval, informed consent, ICMJE authorship and conflict-of-interest disclosures, and the data-sharing statement for a JAMA manuscript. Confirms compliance; it does NOT design the study or write the abstract.
JAMA-Skills/skills/jama-ethics-registration/SKILL.md
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# Ethics, Registration & Disclosures (jama-ethics-registration)
## When to trigger
- A clinical trial's registration status or timing is uncertain
- IRB/ethics approval or informed-consent statements are missing from Methods
- Author roles, contributorship, or COI disclosures are incomplete
- A data-sharing statement is required and not yet drafted
## Prospective trial registration (ICMJE policy)
- Clinical trials must be **prospectively registered — before the first participant is enrolled** — in ClinicalTrials.gov or another ICMJE-accepted registry (e.g., a WHO ICTRP primary registry).
- A trial registered **after enrollment began** is retrospectively registered; ICMJE journals including JAMA treat this as non-compliant, and it generally cannot be remedied at submission. Disclose it transparently if it happened — do not hide it.
- Report the registry name and trial identifier in the abstract (Trial Registration line), the Methods, and any required submission field.