Research involving human participants, human material, or human data, must have been performed in accordance with the Declaration of Helsinki and must have been approved by an appropriate ethics committee. A statement detailing this, including the name of the ethics committee and the reference number where appropriate, must appear in all manuscripts reporting such research. If a study has been granted an exemption from requiring ethics approval, this should also be detailed in the manuscript (including the name of the ethics committee that granted the exemption). Further information and documentation to support this should be made available to the Editor on request. Manuscripts may be rejected if the Editor considers that the research has not been carried out within an appropriate ethical framework. In rare cases, the Editor may contact the ethics committee for further information.
If a study has not been granted ethics committee approval prior to commencing, retrospective ethics approval usually cannot be obtained and it may not be possible to consider the manuscript for peer review. The decision on whether to proceed to peer review in such cases is at the Editor's discretion.
Authors reporting the use of a new procedure or tool in a clinical setting, for example as a technical advance or case report, must give a clear justification in the manuscript for why the new procedure or tool was deemed more appropriate than usual clinical practice to meet the patient’s clinical need. Such justification is not required if the new procedure is already approved for clinical use at the authors’ institution. Authors will be expected to have obtained ethics committee approval and informed patient consent for any experimental use of a novel procedure or tool where a clear clinical advantage based on clinical need was not apparent before treatment.
For all research involving human participants, informed consent to participate in the study should be obtained from participants (or their parent or legal guardian in the case of children under 16) and a statement to this effect should appear in the manuscript. For manuscripts reporting studies involving vulnerable groups (for example, unconscious patients) where there is the potential for coercion (for example prisoners) or where consent may not have been fully informed, manuscripts will be considered at the editor’s discretion and may be referred to an internal editorial oversight group for further scrutiny. Consent must be obtained for all forms of personally identifiable data including biomedical, clinical, and biometric data. In the case of articles describing human transplantation studies, authors must include a statement declaring that no organs/tissues were obtained from prisoners and must also name the institution(s)/clinic(s)/department(s) via which organs/tissues were obtained. Documentary evidence of consent must be supplied if requested.