lancet-ethics

name	lancet-ethics
description	Use to satisfy The Lancet's clinical-ethics and research-integrity requirements — ethics-committee approval and informed consent under the Declaration of Helsinki, the Declaration of interests, ICMJE author contributions, the role-of-the-funding-source statement, the data-sharing statement, patient and public involvement, and SAGER sex/gender plus equity reporting.

Ethics & Research Integrity (lancet-ethics)

When to trigger

• Preparing the ethics, contributions, conflicts, funding, and data-sharing statements.
• The manuscript lacks a Declaration of interests or a role-of-the-funding-source statement.
• Sex/gender or race/ethnicity reporting is missing where the study warrants it.
• A reviewer or editor flags consent, integrity, or funder-influence concerns.

Ethics approval and consent

• Named ethics committee / institutional review board approval(s), with the approving body and (where available) reference number, for every participating site/country.
• Informed consent obtained (or a documented waiver with justification); consent for publication where identifiable.
• Conduct stated to follow the Declaration of Helsinki (and Good Clinical Practice for trials).
• For multi-country studies, confirm local approvals and any community/ethics considerations in LMIC settings.

Declaration of interests (The Lancet's term for COI)

• A Declaration of interests for all authors (financial and non-financial), following the ICMJE disclosure form; "[Author] declares no competing interests" is explicit, not assumed.
• Covers grants, consultancies, honoraria, patents, advisory roles, and relevant personal relationships, within the relevant disclosure window.

Authorship — ICMJE criteria

• Each author meets all four ICMJE criteria (substantial contribution; drafting/revising; final approval; accountability).
• Author contributions described (who did what — design, data, analysis, writing); note who verified the underlying data.
• Contributors who do not meet authorship criteria are acknowledged; any medical writers disclosed.

Role of the funding source (Lancet-specific, required)

The Lancet requires an explicit role of the funding source statement that addresses:

• What the funder did and did not do (e.g., role in design, data collection, analysis, interpretation, writing).
• Who had full access to the data (often "all authors had access to the data," or named authors).
• Who had final responsibility for the decision to submit for publication.
• A typical sentence: "The funder had no role in study design, data collection, analysis, interpretation, or writing of the report. [Named authors] had full access to all the data and had final responsibility for the decision to submit for publication."

Data sharing statement

• A data sharing statement specifying what data will be shared (e.g., de-identified individual participant data), with what (data dictionary, protocol, SAP), to whom, when, by what mechanism, and under what conditions. Follows ICMJE data-sharing requirements (mandatory for clinical trials).

Patient and public involvement (PPI)

• State whether and how patients/the public were involved in design, conduct, or dissemination — or that they were not, with reasons.

Sex, gender, and equity reporting

• Apply the SAGER guidelines: report participants by sex and/or gender, justify any single-sex study, and analyse/report sex/gender differences where relevant.
• Report participants' race/ethnicity where relevant, with the classification rationale, and use the PROGRESS-Plus equity lens for who was (and was not) represented.
• Address generalisability across the populations the result is meant to serve, especially for global-health work.

What Lancet editors check among the declarations

The Lancet treats the declarations block as load-bearing. Editors verify the journal-specific role of the funding source statement, an ICMJE-compliant data-sharing statement (a blank one is non-compliant for a trial), ethics approval for every site, and SAGER sex/gender reporting.

Worked micro-example (illustrative — not a real statement)

A hypothetical multi-country trial, public funder.

Role of funding source (illustrative): "The funder had no role in design, analysis, or
  writing. AB and CD had full data access and final responsibility for submitting."
Data sharing: de-identified IPD + protocol + SAP on request after 9 months.

Reviewer / editor-pushback patterns and the venue-specific fix

• "The role-of-the-funding-source statement is missing." → Add the explicit statement covering funder role, data access, and final responsibility to submit.
• "The data-sharing statement is blank." → State what will be shared, with whom, when, and how — or justify "none"; ICMJE makes this mandatory for trials. Confirm any current consent-documentation requirement in the journal's author guidelines.

Output format

【Ethics approval + consent】 committee(s) + Helsinki + consent (all sites)? → gaps
【Declaration of interests】 all authors, ICMJE form, explicit "none" where applicable? yes/no
【Authorship】 ICMJE 4 criteria + contributions + data verifier? yes/no
【Role of funding source】 funder role + data access + final responsibility to submit? yes/no
【Data sharing statement】 present + ICMJE-compliant? yes/no
【PPI】 stated? yes/no
【SAGER + equity】 sex/gender reported; race/ethnicity where relevant; PROGRESS-Plus? yes/no
【Next】 lancet-submission

Anti-patterns

• Do not omit the role-of-the-funding-source statement — The Lancet requires it explicitly.
• Do not leave the data sharing statement blank for a clinical trial; "no data shared" must be stated and justified.
• Do not report a mixed-sex study without sex/gender-disaggregated reporting (SAGER).
• Do not assume "no competing interests" — each author must declare explicitly.