Journals’ Best Practices for ensuring consent for publishing medical case reports: guidance from COPE

General principles around consent and consent forms for editors to use when developing forms for their journals' purposes. 

Key points

• The publication of case reports is a common practice in medical journals, and increasingly in basic science journals when an article illustrates a specific scientific point (e.g., a genetic phenotype). There is no doubt that case reports are valuable in the academic literature. However, they pose a specific ethical challenge for journals because, by their very nature, individuals in reports are highly identifiable.
• Journals must ensure that proper consent for publication has been obtained and that the individual(s) who is being reported on is aware of the possible consequences of that reporting.
• Publication consent forms should be required for any case report in which an individual or a group of individuals can be identified. This requirement also applies when a report involves deceased persons. Examples of identifying information are descriptions of individual case histories, photos, x-rays, or genetic pedigrees. A list of 23 potential identifiers has been published in BioMed Central’s Trials.
• Journals should not themselves collect the signed consent forms, because the receipt and storage of confidential patient information could subject them to cumbersome security requirements and potential legal liability under applicable privacy or patient information laws, such as the Health Insurance Portability and Accountability Act of 1996 in the USA.
  • Journals should make a blank copy of the form available on their website and require authors to attest that it, or a form that includes all the elements of the form, has been signed by the patient or a proxy.
  • If the patient or proxy has signed a form that differs from the form adopted by a journal, a blank copy of the form should be provided to the journal so that they can ascertain whether all the required elements were included.
  • Authors should also attest that the original of the signed form is held by the treating institution.