Publishing Policies

Ethics in research

Requirements for research involving people, animals and clinical trials.

Research involving humans

Research involving people, identifiable material or identifiable data must demonstrate independent ethical oversight and respect for participants.

Authors identify the ethics committee or review body, approval or exemption reference, and the standards under which the research was conducted.
Informed consent for participation and, separately, consent for publication of identifiable information must be reported when applicable.
Editors may request protocols, approval letters or consent documentation and may reject work when participant protection or lawful data use cannot be established.
The current Declaration of Helsinki is a reference framework when relevant; local law and institutional requirements also apply.

Animal studies must document ethical approval, welfare safeguards and reporting appropriate to the design.

Authors identify the approving body, permit or protocol reference, species, procedures and measures taken to reduce harm.
The manuscript should explain sample-size reasoning, allocation, blinding and humane endpoints when applicable.
ARRIVE or another applicable reporting standard should be used, and deviations should be explained.
Editors may request original approvals or consult an independent specialist when welfare or reporting is unclear.

Prospective clinical studies must make registration, protocol identity and complete reporting traceable.

Applicable trials should be registered in a publicly accessible registry before enrolment of the first participant unless a justified exception is documented.
The registry name, identifier, registration date and access link are supplied at submission and published with the article.
Authors explain material differences between the registry, protocol, analysis plan and submitted report.
CONSORT and the relevant extension should be used for randomized trials; protocols and statistical analysis plans should be available when ethically and legally possible.