Ethical authorization

Research involving human participants, identifiable human material or identifiable data must be conducted under appropriate ethical oversight and applicable requirements. HNCBT expects the principles of the current WMA Declaration of Helsinki to inform such research. Protecting participants takes priority over publication objectives.

State the approving ethics committee or institutional review board, institution, approval identifier and the relevant approval timing. If the work was exempt, identify the body that determined the exemption and its basis. An author’s assumption that approval was unnecessary is not an adequate substitute for a documented determination. Retrospective approval does not automatically resolve the absence of required authorization at the time of the research.

Participation, consent and vulnerable populations

Describe how informed consent was obtained, or identify an authorized waiver and explain its scope. Research involving children or participants unable to consent must address consent from an appropriate representative and assent where applicable. Explain protections relevant to vulnerability, recruitment and access to care. An investigator’s clinical relationship must not be used to pressure a patient to participate.

Patient information and consent for publication

Consent to participate is distinct from permission to publish identifiable information. Obtain explicit consent for publication of recognizable photographs, clinical details or other identifying material. Remove unnecessary identifiers and assess whether combinations of details could reveal identity. Masking a name or part of a face does not necessarily make material anonymous. Do not upload signed consent forms containing patient identifiers as public supplementary files; retain them securely and provide confirmation through an appropriate route if requested.

Tissues, biobanks and secondary data

For patient-derived tissues, organoids, xenograft source material or stored samples, describe provenance, permitted use and the consent or authorization governing the work. Genomic and clinical datasets require careful consideration of re-identification risks and repository access conditions. Secondary analyses should identify the source and explain the ethical basis for the use, including any documented exemption. Public availability alone does not remove all ethical obligations.

Editorial assessment

The editor may request approval documentation, consent confirmation or additional safeguards. Material that cannot be published without compromising privacy must be removed or appropriately restricted. A study may be declined despite local approval when serious unresolved ethical concerns remain. Clinical trials must also satisfy Clinical Trial Registration.