Research involving humans and animals

Research reported in our journals must have been conducted ethically, and the article must show it. Editors will not send a manuscript for review where the required approvals are missing, and will retract a published article where they were never obtained.

Human participants

Research involving human participants, human material, human tissue or identifiable human data must comply with the Declaration of Helsinki and have been approved in advance by a named research ethics committee or institutional review board.

Every such article must state:

• The name of the approving committee or board and its institution.
• The approval reference number and date.
• That informed consent was obtained from participants, or the specific grounds on which the committee waived it.

Where a study was exempt from review, say which body granted the exemption and on what basis. A statement that “ethical approval was not required” without naming the body that decided so is not acceptable.

Informed consent

Consent must be informed, voluntary, documented, and obtained before participation. For participants who cannot consent for themselves, consent must come from a legally authorised representative, with assent from the participant where they are able to give it.

Consent to publish identifiable material

Written consent to publish is required for any case report, photograph, video, audio recording, pedigree or detailed description from which an individual could be identified — by themselves or by anyone who knows them. Removing names is not sufficient.

Masking eyes in a photograph does not achieve anonymity and is not accepted as a substitute for consent. Editors may ask to see the consent form. Where consent cannot be obtained because the participant has died or cannot be traced, the manuscript is considered only where the ethics committee has specifically approved publication.

Consent must be to publication in an open access journal under a CC BY licence, so participants understand the article will be freely redistributable.

Vulnerable groups

Research involving children, prisoners, people lacking capacity, or others in a dependent relationship with the researchers requires explicit committee consideration of the safeguards, and the article should describe them.

Clinical trials

Trials must be registered prospectively — before the first participant is enrolled — in ClinicalTrials.gov, an ICTRP primary registry, or another registry meeting ICMJE requirements. Give the registry and registration number in the abstract.

Retrospectively registered trials are considered case by case; where published, the registration date is disclosed and the reason stated. Report to CONSORT, and submit the protocol and the completed checklist. Trial protocols should follow SPIRIT. A data sharing statement is required — see [data sharing and availability](/data-sharing).

Animal research

Research involving animals must comply with the relevant national legislation and institutional rules, both of which must be named, along with the approving body and reference number. Report to the ARRIVE 2.0 guidelines, including species, strain, sex, age, housing, husbandry, sample size justification, randomisation, blinding, and humane endpoints. Studies involving procedures likely to cause pain or distress must describe the anaesthesia and analgesia used.

Field studies must state the permits obtained and, where protected species or habitats are involved, the licences under which the work was done.

Biosafety, biosecurity and dual use

Work with pathogens, genetic modification or hazardous materials must state the containment level and the approving biosafety committee. Editors may decline research where the risk of misuse outweighs the benefit of publication, and may consult the authors’ institution before deciding.

Human genetic and biobank material

State the source of samples, the consent under which they were collected, whether that consent covers the current use, and any material transfer agreement. Genomic data must be deposited in a controlled-access repository where participant privacy requires it.

Indigenous and community-based research

Where research involves Indigenous peoples or communities, describe the community consent, governance and benefit-sharing arrangements, and the data sovereignty arrangements agreed.

Sex, gender and diversity in reporting

Report the sex and, where relevant, the gender of participants and animals, disaggregate results where the analysis supports it, and explain any restriction to one sex. Where race or ethnicity is reported, say how it was determined and why it is relevant.

If approval is questioned

Where a reviewer, reader or editor questions whether approval or consent was properly obtained, the editor asks the authors for documentation and, if the response is inadequate, refers the matter to the authors’ institution. A published article affected in this way may carry an expression of concern and, if the position is not resolved, be retracted.