Ethics approval

•     Research involving patients, their data or samples must be approved by a registered institutional ethics committee before it begins and comply with the Declaration of Helsinki (current revision).

•     Research in India must follow the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) and, for trials of drugs and devices, the New Drugs and Clinical Trials Rules, 2019 and the Medical Devices Rules, 2017 as applicable. Research elsewhere must follow national regulations.

•     State the committee name, approval number and date in the Methods (blinded during review) and Declarations.

•     Retrospective chart reviews and audits also require ethics committee approval or a formal exemption; the authors’ own view that approval is unnecessary is not accepted.

Vulnerable patients

Additional safeguards are required for children (parental consent plus assent where possible), pregnant and labouring women (consent should not be sought during active labour or distress where avoidable), patients with cognitive impairment, prisoners and patients at the end of life. Authors must explain how undue pressure was avoided.

Safety monitoring

Interventional studies must describe safety monitoring, stopping rules and, where appropriate, an independent Data and Safety Monitoring Board. Serious adverse events must be reported to the ethics committee and regulators as required and summarised in the article.

Animal research

Animal studies (e.g., of anaesthetic agents or ventilation strategies) require Institutional Animal Ethics Committee approval, compliance with CCSEA (India) or national rules, and reporting per ARRIVE 2.0, including anaesthesia and analgesia provided to the animals.

Verification

Editors may request approval letters, consent forms and protocols at any time. Manuscripts lacking appropriate ethics approval or consent will be rejected; published articles may be retracted.