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.
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.
