Ethical Approvals and Informed Consent
Research involving human participants
- The research must comply with the current version of the Declaration of Helsinki.
- Approval by an institutional review board or ethics committee is mandatory, and the reference number must be given in the manuscript.
- Informed consent must be obtained from all participants or their legal representatives.
- Specific consent is needed to publish any information that could identify a person.
- Confidentiality and privacy must be maintained.
- Where local or indigenous knowledge is reported, the community's consent and its terms should be stated.
Case reports
- Written informed consent for publication is required from the person concerned or their legal guardian.
- Signed consent forms must not be sent to the journal, because that would itself breach confidentiality. Authors keep them and confirm in the manuscript that they hold them.
Research involving animals
- The research must comply with institutional, national or international animal welfare guidelines, such as the Guide for the Care and Use of Laboratory Animals.
- Approval by an institutional animal care and use committee, or its equivalent, is required, with the reference number in the manuscript.
- The manuscript must describe the steps taken to minimise suffering and the number of animals used.
Clinical trial registration
Where a clinical trial is reported, it must be registered in a public database and the registration number given in the manuscript. Randomised trials must follow the CONSORT 2010 guideline.
Non-compliance
Manuscripts lacking the required statements are returned for clarification before review. Under COPE guidelines, a manuscript may be rejected, or a published article retracted, where ethical requirements were not met.
