Research Ethics & Consent

Research published in BJHMR must meet the highest ethical standards. Because the journal publishes research involving patients, participants, their data and their tissue, the requirements below are central to editorial decisions, and authors must include statements addressing each relevant item, or explain why it does not apply.

Ethical conduct and approval

Research involving human participants, their identifiable data or their tissue must be conducted in accordance with the Declaration of Helsinki and all applicable national and institutional requirements, and must have received approval from an appropriately constituted research ethics committee or institutional review board before the research began. Authors must state the name of the approving body and the reference number, or explain clearly why formal approval was not required (for example for certain service evaluations or analyses of fully anonymised routine data).

Informed consent

Authors must obtain and document the informed, voluntary consent of participants (or their legal representatives) to take part in the research, including, where relevant, consent for the use of their data and tissue. Consent should be appropriate to the nature of the study and, where required, cover secondary use.

Consent to publish and patient privacy

For any case report, case series, or identifiable patient information, image or detail, authors must obtain written informed consent to publish from the patient (or next of kin), covering open-access publication under a Creative Commons licence. Identifying details that are not essential must be omitted; anonymisation must be effective (black bars over the eyes are not sufficient); and confidentiality must be protected throughout. The journal may request a copy of the consent documentation.

Clinical-trial registration

Clinical trials must be registered prospectively — before the enrolment of the first participant — in a registry that meets the standards of the WHO International Clinical Trials Registry Platform or the ICMJE (for example ISRCTN or ClinicalTrials.gov), and the registry name and number must be reported in the manuscript.

Vulnerable participants and sensitive data

Research involving children or other groups who may be vulnerable requires appropriate consent or assent and additional safeguards, which should be described. Sensitive personal data (including health data) must be handled in accordance with data-protection law (see the Privacy Policy), minimised, and anonymised or pseudonymised wherever possible.

Animal research

Research involving animals must comply with relevant welfare legislation and institutional approval, which must be stated, and be reported in line with the ARRIVE guidelines, describing the measures taken to reduce, refine and replace animal use.

Declarations

Each manuscript must include statements of ethics approval, consent to participate, consent to publish and (where applicable) trial registration, or state clearly that these are not applicable and why. The journal may request supporting documentation and may decline or retract work that does not meet these standards.