Informed Patient Consent

Authors should observe high standards with respect to publication ethics as set out by the Committee on Publication Ethics (COPE) and ICMJE recommendations for reporting about patients. Patients have a right to privacy that should not be infringed without prior informed consent. Identifying information should not be published in written descriptions, photographs and pedigrees unless the information is essential for scientific purposes and the patient (or parent or guardian) has given written informed consent for publication. Informed consent for this purpose requires the patient be shown the manuscript to be published. Identifying details should be omitted if they are not essential, but patient data should never be altered or falsified to attain anonymity. We understand that complete anonymity is difficult to achieve. For example, masking the eye region in photographs of patients is inadequate protection of anonymity. A statement addressing informed patient consent must be included as part of the manuscript under the heading ‘Consent’


Patient Consent Form
The journal requires at the point of submission that a consent form has been completed for any case report or clinical image in which an individual or a group of individuals can be identified. The list below outlines potential patient identifiers to be aware of.

  • Direct
  • Name
  • Initials
  • Address, including full or partial postal code
  • Telephone or fax numbers or contact information
  • Electronic mail addresses
  • Unique identifying numbers
  • Vehicle identifiers
  • Medical device identifiers
  • Web or internet protocol addresses
  • Biometric data
  • Facial photograph or comparable image
  • Audiotapes
  • Names of relatives
  • Dates related to an individual (including date of birth)
  • Indirect–may present a risk if present in combination with others in the list
  • Place of treatment or health professional responsible for care (Could be inferred from investigator affiliations)
  • Sex
  • Rare disease or treatment
  • Sensitive data, such as illicit drug use or “risky behaviour”
  • Place of birth
  • Socioeconomic data, such as occupation or place of work, income, or education (MRC requirement is for “rare” occupations only)
  • Household and family composition
  • Anthropometry measures
  • Multiple pregnancies
  • Ethnicity
  • Small denominators–population size of <100
  • Very small numerators–event counts of <3
  • Year of birth or age (Age is potentially identifying if the recruitment period is short and is fully described)
  • Verbatim responses or transcripts
More guidance can be found here: https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-11-9

Completed consent forms are not to be submitted to the journal. Completed forms should be held by the treating institution according to locally approved procedures. The consent form should be made available to the journal Editor if specifically requested.

If the patient or relatives of a deceased patient cannot be traced and consent cannot be obtained, the case report can only be considered for publication if it is sufficiently anonymised. The Editorial Board reserves the right to reject papers for which the ethical aspects are, in the Board’s opinion, open to doubt. Please contact the Editorial Office if you have any queries regarding consent.