jama-ethics-registration

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.
• Systematic reviews/meta-analyses should register the protocol (e.g., PROSPERO) and cite it.

Ethics and consent statements (in Methods)

• Name the IRB / research ethics committee that approved the study (or state the basis for exemption).
• State that the study followed the Declaration of Helsinki (and Good Clinical Practice for trials, as applicable).
• State how informed consent was obtained, or justify any waiver.
• For studies with identifiable individuals (including images/case details), obtain and state consent for publication.

ICMJE authorship, contributorship, and disclosures

• Each author should meet the ICMJE four authorship criteria; non-qualifying helpers go in Acknowledgments.
• Provide a contributorship statement (who did what).
• Every author files an ICMJE Disclosure of Potential Conflicts of Interest form; summarize relevant financial and non-financial conflicts in the manuscript.
• Disclose funding sources and the role of the funder/sponsor (design, conduct, analysis, decision to publish).
• For trials, address access to data / statistical responsibility (which authors had full data access and vouch for the analysis).

Data sharing

• Provide a data-sharing statement (per ICMJE) for clinical trials and, increasingly, other study types: whether de-identified individual-participant data will be shared, what documents (protocol, statistical analysis plan), when, with whom, and by what mechanism.

Compliance gates JAMA enforces before review

At the Journal of the American Medical Association, an ICMJE member journal, several integrity items are hard gates: a manuscript that fails them is stopped regardless of merit. Treat each as pass/fail — registration before first enrollment (ID in abstract and Methods); a named IRB / ethics committee and the Declaration of Helsinki; consent described or its waiver IRB-justified; the four ICMJE authorship criteria with per-author COI disclosure; and the funder's role plus a concrete ICMJE-style data-sharing plan.

Worked example: registration timing (illustrative)

Vignette (illustrative): a multicenter randomized clinical trial, N = 2,600 adults with resistant hypertension, primary outcome 24-week change in ambulatory systolic blood pressure, mean difference -6.4 mm Hg (95% CI, -8.9 to -3.9). First participant enrolled March 3; registered April 18 — retrospective by ICMJE definition, ~6 weeks late.

Consequence and fix: generally not remediable; disclose the timing transparently, do not backdate. The effect estimate does not cure a registration-timing defect.

Reviewer pushback and the JAMA fix

• "Trial not registered before enrollment." Fix: state the dates plainly; if retrospective, disclose and accept the venue may decline — never hide it.
• "IRB approval obtained" with no committee named. Fix: name the specific IRB and the Helsinki / GCP basis.
• "Data available upon request." Fix: replace with a concrete plan — what data, which documents, when, by what mechanism.

Calibration anchors (hedge where uncertain): prospective-before-enrollment registration, the four ICMJE authorship criteria, the Declaration of Helsinki, and per-author COI forms are durable; the accepted-registry list and data-sharing wording evolve — confirm against current author guidelines.

Checklist

• Trial prospectively registered before enrollment; registry + ID reported
• Systematic-review protocol registered (e.g., PROSPERO) and cited
• IRB/ethics approval (or exemption) named in Methods
• Declaration of Helsinki (and GCP for trials) stated
• Informed-consent process described or waiver justified
• Consent for publication for identifiable individuals
• All authors meet ICMJE criteria; contributorship statement present
• COI disclosure forms collected; conflicts summarized
• Funding source and funder role stated
• Data-sharing statement drafted

Anti-patterns

• Unregistered trial, or registration after enrollment began
• "IRB approval obtained" with no committee named
• Honorary/guest authorship; ghostwriting
• Undisclosed industry funding or author conflicts
• Funder controlled analysis or publication decision, undisclosed
• "Data available upon request" used as a non-committal placeholder

Output format

【Trial registration】prospective + ID: ... / retrospective (disclose) / n.a.
【Protocol registration (review)】PROSPERO ID / n.a.
【IRB + Helsinki + consent stated】yes / fixes: ...
【ICMJE authorship + contributorship】complete / issues: ...
【COI + funding + funder role disclosed】yes / gaps: ...
【Data-sharing statement】drafted / missing
【Next skill】jama-writing-style