Agent Skills
› brycewang-stanford/Awesome-Journal-Skills
› nejm-ethics
nejm-ethics
GitHub用于确认NEJM投稿的临床伦理与研究诚信要求，包括IRB批准、知情同意、ICMJE利益冲突披露、作者署名标准、资金来源角色声明及数据共享声明。
Trigger Scenarios
方法部分未说明IRB/伦理批准或知情同意获取方式
未收集每位作者的ICMJE披露表
缺少临床试验必需的数据共享声明
作者署名、贡献或资金来源角色不明确或缺失
Install
npx skills add brycewang-stanford/Awesome-Journal-Skills --skill nejm-ethics -g -y
SKILL.md
Frontmatter
{
"name": "nejm-ethics",
"description": "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."
}
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.
Version History
- 1839142 Current 2026-07-05 14:05
