Research Ethics

1.1 Human Subjects Research

All research involving human participants, human material, or human data must have received prior approval from an appropriate Institutional Review Board (IRB), Ethics Committee, or equivalent body. The manuscript must include:

  • The name of the ethics committee that approved the study
  • The ethics approval reference number or identifier
  • The date of approval
  • A statement that the research was conducted in accordance with the Declaration of Helsinki and local regulations

Studies lacking appropriate ethics approval will be rejected without review.

1.2 Informed Consent

For all studies involving identifiable patient data, case reports, or case series, informed written consent must be obtained from the patient or their legal guardian. A statement confirming that consent was obtained must be included in the manuscript. For case reports involving potentially identifiable patients, even after anonymisation, explicit consent for publication is required.

  • General repositories: Figshare, Dryad, Zenodo, Open Science Framework
  • If consent was waived by an ethics committee, this must be explicitly stated with the reason for the waiver.

1.3 Animal Research

Research involving animals must comply with institutional and national guidelines for the care and use of laboratory animals. The manuscript must include:

  • Details of the institutional and/or licensing committee that approved the experiments
  • The approval reference number
  • A statement confirming compliance with relevant guidelines (e.g., ARRIVE guidelines, NIH Guide for the Care and Use of Laboratory Animals)
  • Details of anaesthesia, analgesia, and euthanasia protocols where applicable

1.4 Clinical Trials Registration

In accordance with ICMJE policy, all clinical trials must be registered in a publicly accessible registry before the enrolment of the first participant. Acceptable registries include ClinicalTrials.gov, the Clinical Trials Registry - India (CTRI), the EU Clinical Trials Register, or any WHO-approved registry.

The manuscript must include the trial registration number and the name of the registry in both the abstract and the Methods section. Retrospective registration is generally not acceptable unless there is a compelling justification.

1.5 Reporting Guidelines

Authors are strongly encouraged to follow appropriate reporting guidelines for their study type. Commonly used guidelines include:

  • CONSORT: for randomised controlled trials
  • STROBE: for observational studies
  • PRISMA: for systematic reviews and meta-analyses
  • CARE: for case reports
  • STARD: for diagnostic accuracy studies
  • ARRIVE: for animal research

Authors should include a completed checklist for the relevant guideline as supplementary material.

1.6 Vulnerable Populations

Research involving vulnerable populations (e.g., children, prisoners, individuals with cognitive impairment, economically disadvantaged persons) requires additional ethical scrutiny. Manuscripts involving such populations must provide detailed justification for their inclusion and describe the additional protections implemented to safeguard their welfare.

Note:These policies are subject to periodic review and update. Authors, reviewers, and readers should check this page for the most current version. Material changes to policies will be announced via the journal website and communicated to registered users. For questions or clarifications about any policy, please contact the editorial office at support@kmedjournals.com.