Ethical Approvals and Informed Consent

All research involving human participants, human tissue, or identifiable human data must have been conducted in accordance with the Declaration of Helsinki (current version) and approved by an appropriate ethics committee or institutional review board before the study began.

The Methods section must state:

• The name of the approving committee and the approval reference number;
• That written informed consent was obtained from all participants (or from a parent or legal guardian for minors or those lacking capacity), or the reason a waiver was granted and by whom;
• For registered trials, the registry name and registration number.

Editors may request a copy of the ethics approval letter and blank consent form at any time. Manuscripts without evidence of appropriate approval will not be considered. If a study was exempt from review, the manuscript must name the body that granted the exemption and the legal basis for it.

Retrospective ethics approval is not normally acceptable; the editor may consider such cases individually with reference to COPE guidance.

Consent for publication

Any manuscript containing details, images, or videos that could identify an individual (patient, participant, or other) requires written informed consent for publication from that person or their legal representative. This is separate from consent to participate. Anonymisation (e.g. black bars over eyes) is not sufficient on its own. State in the manuscript that consent was obtained; provide the form on request. Consent forms are not published.

Vulnerable populations

Studies involving children, prisoners, people with cognitive impairment, refugees, or other vulnerable groups must describe the additional safeguards used.

Last updated: 29 September 2026