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).
• Special populations — additional protections for children, incapacitated adults, emergency-consent settings.

ICMJE conflict-of-interest disclosures

• Every author completes the ICMJE disclosure form; financial and non-financial conflicts are reported.
• The manuscript carries a disclosure / competing-interests statement; "ICMJE disclosure forms are available with the full text" is the typical NEJM phrasing.
• Disclose relationships even if the author judges them irrelevant — the editor decides relevance.

Authorship and contributions (ICMJE criteria)

ICMJE authorship requires all four: (1) substantial contribution to design or data; (2) drafting or critical revision; (3) final approval; (4) accountability for the work. Everyone meeting them is listed; everyone listed meets them.

• Contributors who do not meet all four go in Acknowledgments (with permission).
• Disclose medical writers and their funding source.
• State the corresponding author's attestation of data integrity and analysis.

Role of the funding source

• A role-of-the-funding-source statement is required: did the funder design the study, collect/analyze/interpret data, write the manuscript, or decide to submit?
• For industry-sponsored trials, state who had access to the data and who vouches for completeness and fidelity to the protocol.

Data-sharing statement (ICMJE)

ICMJE requires a data-sharing statement for clinical trials. Specify:

• What individual-participant data (and supporting documents: protocol, SAP, analytic code) will be shared.
• When (e.g., after publication, with an end date or "indefinitely").
• To whom and for what (e.g., researchers with a methodologically sound proposal).
• By what mechanism (repository, request to a committee) and under what conditions (data-use agreement).
• "No data will be shared" is a permissible statement but must be explicit and justified.

Patient privacy and other integrity items

• De-identify all data and images; remove PHI; obtain consent for any potentially identifying material (e.g., clinical photographs).
• Trial protocol publication — NEJM publishes the protocol and SAP with trials; ensure they are submission-ready (see nejm-study-design).
• Report plagiarism/originality status: the work is original and not under consideration elsewhere.
• Note any preprint posting and prior presentation.

Statement placement map (draft each as a named block)

Draft each statement as a block with a fixed home, then verify all blocks survived formatting:

• Methods — study conduct: named IRB/ethics committee(s), consent method (or waiver basis), Helsinki + GCP conformance.
• Methods — oversight (trials): who designed the trial, analyzed the data, wrote the first draft, and who vouches for data completeness and fidelity to the protocol; the protocol and SAP accompany the article.
• End matter: disclosure statement ("ICMJE disclosure forms are available with the full text"), funding acknowledgment, data-sharing statement.

Worked micro-example — data-sharing statement (before → after)

• Before (fails ICMJE): "Data are available from the corresponding author on reasonable request."
• After: "De-identified individual-participant data, with the protocol and statistical analysis plan, will be shared beginning 12 months after publication with researchers whose methodologically sound proposal is approved by the trial's data-access committee, under a signed data-use agreement."

The before answers none of the four ICMJE questions — what, when, to whom, by what mechanism.

Output format

【IRB/ethics approval + consent】 stated? Helsinki/GCP cited? yes/no
【Placement】 conduct/oversight/end-matter blocks all present after formatting? yes/no
【ICMJE disclosures】 all authors' forms collected + statement drafted? yes/no
【Authorship】 all 4 ICMJE criteria met by each author? contributors acknowledged? yes/no
【Role of funding source】 statement present + data-access/vouching for trials? yes/no
【Data-sharing statement】 what/when/to-whom/how specified (ICMJE)? yes/no
【Privacy】 de-identified, PHI removed, consent for identifying material? yes/no
【Next】 nejm-abstract

Anti-patterns

• Do not submit a trial without IRB approval and a consent description in the Methods.
• Do not omit the data-sharing statement — ICMJE requires it for clinical trials.
• Do not list honorary authors or omit qualifying contributors.
• Do not hide the funder's role, or who had full data access in a sponsored trial.
• Do not include identifiable patient information without explicit consent.