Research Involving Humans, Animals and Patient Consent

Research involving people, identifiable personal data, human tissue, or animals is published only if it was ethically approved and conducted to recognised standards. This applies to every SSG journal. It covers clinical studies in MECOJ, and also questionnaires, interviews, and field surveys in engineering and management research.

• Studies involving human participants must have been approved by an appropriate research ethics committee or institutional review board before the study began. They must follow the Declaration of Helsinki (World Medical Association, latest revision).
• The Methods section names the approving committee, gives the approval number and date, and confirms that the study followed the approved protocol.
• If a study was exempt from review, the authors explain why and name the body that granted the exemption. Examples are anonymous surveys with minimal risk, or retrospective analysis of fully de-identified data, where local rules allow it. Editors may ask for the exemption letter.
• Approval obtained after the research is finished (retrospective approval) is accepted only where local regulations explicitly allow it. The editor decides case by case.

• Every participant, or their legal guardian, must have given informed consent. The article states how consent was obtained (written or verbal) and how it was recorded.
• Case reports and identifiable data: if a patient or participant could be identified, the authors must have written consent to publish. This applies to photographs, imaging, rare conditions, and detailed personal histories. The consent form is kept by the authors and given to the editor on request. Removing details to anonymise someone must not change the scientific meaning.
• Research with vulnerable groups needs extra safeguards, which the article describes. Vulnerable groups include children, prisoners, refugees, and people with impaired capacity.

Clinical trials must be registered in a public registry that meets the WHO International Clinical Trials Registry Platform criteria, before the first participant is enrolled. The registration number appears at the end of the abstract. Trials are reported using CONSORT. Other study types use the matching reporting guideline from the EQUATOR Network, for example:

• STROBE for observational studies
• PRISMA for systematic reviews
• CARE for case reports
• STARD for diagnostic accuracy studies

The completed checklist is uploaded with the submission.

Animal studies must have been approved by an institutional animal care and use committee, or an equivalent body. They must follow the 3Rs principles (Replacement, Reduction, Refinement) and national law. Animal studies are reported using the ARRIVE 2.0 guidelines.

Where relevant, authors report the sex and/or gender of participants following the SAGER guidelines, and explain how these were determined. Authors avoid stigmatising language, and justify any reporting of race or ethnicity.

Personal data collected for research must be handled in line with the data protection laws that apply where the research was done. Datasets that are shared must not contain anything that could identify a participant (see Data, Code and Materials Availability).