A formal review and approval, or review and waiver, by an appropriate institutional review board or ethics committee is required for experimental studies involving humans or animals, and this must be included in the paper. When conducting research on human subjects, the Methods section should specify whether the study participants' informed consent was obtained orally or in writing.

When using private case information, authors are urged to get patient consent. If the case material is sufficiently disguised to prevent patient identification, or if the case vignettes are so brief that they do not contain identifying information, consent is not required.

When seeking consent, the author or authors should explain the publication's goal, the potential.