Purpose and Scope
This policy applies to all submissions reporting research involving human participants, identifiable human data, or human biological material, wherever conducted. Ethical acceptability is a condition of publication independent of scientific merit: research that was not conducted ethically shall not be published, however sound its methods.
Ethics Approval
Authors shall state, in the manuscript, whether the research required ethics review and, where it did: the full name of the approving research ethics committee or institutional review board, the approval or reference number, and the date or period of approval. Documentation shall be provided on request. Where review was not required, authors shall state the basis for that position by reference to the applicable local framework, and the journal shall assess whether the explanation is credible.
Where a committee properly granted a waiver of consent — for example for secondary analysis of de-identified records or minimal-risk retrospective research — the waiver, its grantor and its scope shall be stated. Retrospective and archival studies remain subject to this policy: absence of participant contact does not remove the obligation of ethical oversight or privacy protection.
Research shall be conducted consistently with the principles of the Declaration of Helsinki and shall comply with all applicable legal, regulatory, institutional and ethical requirements. Where multiple applicable standards differ without direct legal conflict, the approach providing stronger protection for participants should ordinarily be followed.
Informed Consent
Participants shall have given voluntary, informed consent to participation, given by a person with capacity or by a properly authorised representative, documented as the applicable framework requires, and freely revocable. Consent processes shall address the purpose, procedures, risks, benefits, data handling and the voluntary nature of participation.
Consent for Publication of Identifiable Information
Consent to participate is not consent to publish. Where a submission contains information, images, recordings, genetic data, video, verbatim quotations or case details from which an individual could reasonably be identified — whether by the public, by clinicians, or by the person themselves or their family — the authors shall obtain and document explicit, specific consent for publication, informing the person of the nature of the publication and that it will be publicly and permanently available, including open access (F1). Anonymisation shall not be assumed sufficient where combinations of details permit identification. Concealing eyes with bars, cropping or similar measures do not substitute for consent. Where consent cannot be obtained because the person is deceased or untraceable, publication may proceed only where consistent with the applicable framework and with the interests of the person and their family, and the position shall be disclosed. Journals shall require a consent statement in every submission reporting identifiable individuals, including case reports.
Vulnerable Participants
Where participants may have limited capacity to consent freely or fully — minors, persons with cognitive impairment, persons in dependent relationships with researchers, prisoners, refugees, persons in acute distress, or communities in situations of unequal power — authors shall describe the additional safeguards applied. For minors, consent from a parent or legal guardian and, where appropriate to age and maturity, the child's own assent shall be documented; publication of identifiable information concerning a minor requires guardian consent and, where the person has since reached majority, ordinarily their own.
Privacy and Human Biological Material
Participant data shall be handled so as to minimise identifiability consistent with scientific validity; publication of raw identifiable data is prohibited without specific consent (E2 governs data availability; A5 governs personal data in the workflow). Research using human biological specimens, biobank material or genetic and genomic data shall additionally state the source of the material, the consent or governance arrangement under which it was collected and used — including whether consent covered the present use — and, where relevant, arrangements addressing return of findings and the interests of the donor community.
Research Using Public, Online or Observational Sources
Information being publicly accessible does not automatically remove ethical or privacy obligations. Research using social-media content, online communities, publicly accessible records, covert observation or naturalistic observation shall address the reasonable expectations of the persons concerned, the sensitivity and identifiability of the material, platform or community norms, and whether ethics review or consent was required. Quotations or combinations of details that enable search-based identification shall be treated as identifiable information unless a competent ethics body has approved another approach.
Audits, Service Evaluation, Quality Improvement and Educational Research
Authors shall classify audits, service evaluations, quality-improvement projects and educational research accurately and shall not use a service label to avoid review of activity that is in substance research. The manuscript shall state the applicable oversight determination, approval or exemption and the basis for it. Where such work uses identifiable records, vulnerable persons or interventions beyond ordinary service, the protections of this policy continue to apply.
Community-Governed Research, Human Materials and Genetics
Research involving community-governed data or materials, Indigenous peoples, identifiable communities, human tissue, biobanks, cell lines, organoids, stem cells, reproductive material, genetic or genomic information, human remains, or transplantation material shall disclose lawful and ethical provenance, the consent and governance basis for the present use, applicable material transfer or repository controls, and any access-and-benefit-sharing obligation. Where applicable, authors shall address community engagement, culturally appropriate governance and relevant international instruments such as the Nagoya Protocol. Material obtained through coercion, unlawful trade, organ trafficking or otherwise ethically unacceptable procurement shall not be published as legitimate research material. Cell lines and comparable resources should be authenticated and their source identified proportionate to the risk of misidentification.
Withdrawal, Stigma and Ongoing Participant Interests
Participant withdrawal shall be respected in accordance with the consent terms and the stage of the research, subject to lawful limits where data have been irreversibly anonymised or incorporated into completed analyses. Withdrawal of publication consent before publication shall ordinarily prevent publication of identifiable material. After publication, a later request does not automatically erase the scholarly record, but the journal shall assess privacy, dignity and safety and may take a record action under G2. Potentially stigmatising information shall be published only where necessary to the scholarly purpose and with proportionate safeguards.
The Journal's Role and Its Limits
A journal verifies that ethical documentation is present, internally consistent and credible, and may seek clarification, documentation or independent advice. A journal is not an ethics committee: it does not conduct ethical review of the study design, and it cannot grant, ratify or substitute for approval that was never obtained. Where approval appears to have been absent, inadequate, obtained after the research, or fabricated, or where the reported conduct raises serious ethical concern, the editor shall seek explanation from the authors and, where the concern persists, decline publication and refer the matter to the authors' institution or the named committee under C5. Post-publication discovery is handled under G2.
Standards and Guidance
Informed by the Declaration of Helsinki, the ICMJE Recommendations on protection of research participants, CIOMS international ethical guidelines, and the Declaration of Taipei on health databases and biobanks.