Human Experiments

Human Experiments

Studies involving human subjects (including research on identifiable human material and data) must have been performed with the approval of an appropriate ethics committee and with appropriate participants’ informed consent in compliance with the Helsinki Declaration.

In the manuscript, authors should specify the name of the Institutional Review Board (IRB) or ethics committee (EC) or other relevant authority who approved the study protocol and provide the reference number where appropriate. If ethics approval was not required, or if the study has been granted an exemption from requiring ethics approval, this should also be detailed in the manuscript (including the name of the IRB/EC who made that decision).

For all research involving human subjects, written informed consent to participate in the study should be obtained from participants (or their parent/legal guardian where appropriate ) and a statement detailing this should appear in the manuscript. For studies involving vulnerable participants or participants at risk of potential coercion, detailed information regarding the steps taken to ensure informed consent must be provided. If consent was not obtained, please specify why and whether this was approved by the IRB/EC.

In line with the ICMJE recommendations on the protection of research participants, authors must avoid providing identifying information unless strictly necessary for the submission and participants’ identifiable attributes must be anonymized in the manuscript and its supplementary files, if any. If identifying information is necessary, authors must confirm that the individual has provided written consent for the use of that information in a publication. Manuscripts reporting a case report must include a statement detailing that written informed consent for publication was obtained and from whom. If the patient has died, consent for publication must be obtained from their next of kin. If the patient described in the case report is a minor or vulnerable, then consent for publication must be obtained from the parent/legal guardian.