The authors wish to publish a case report that aims to characterise complex chromosomal abnormalities in a rare congenital syndrome. It describes, in detail, the clinical features of two newborn infants. When asked about consent to publish, the authors said they did not obtain it because the data were reported from existing clinical diagnostic test results and therefore did not constitute a systematic investigation and that no identifiable information was included in the manuscript.
The authors were told that consent was still needed and that they should attempt to obtain it from the children’s parents or next of kin. The authors said that it would not be possible to obtain consent from the parents since the mother of one child was now deceased and the other was lost to follow-up, but that they would attempt to obtain a waiver from their IRB. They provided a copy of an IRB approval letter with no specific mention of waiver of consent, but they did provide a copy of the application form which included a section where they provided a justification for not obtaining consent. The justification was that they were unable to obtain consent from the mothers and that the data they analysed was pre-existing clinical information and that no photographs or identifiable information would be published.
The authors feel that they have addressed the question of consent to publish and that their manuscript should proceed to publication. Despite the waiver from the ethics committee, one of the editors-in-chief feels that although consent would be burdensome to obtain, the study does not meet the other criteria set out by COPE to justify a waiver of consent: i.e. that the report is important to public health (or is in some other way important), and a reasonable patient would be unlikely to object to publication. Does the committee agree that an IRB waiver for consent for this study does not justify publication?
The Forum pointed out that consent to a treatment or intervention should not be confused with consent to publish. It is up to the journal to ensure that appropriate consent has been obtained and this is separate from IRB approval. If the balance of judgement is in favour of public interest, then the editor could consider publishing the cases, but only if the cases are completely anonymised with no identifying features. The Forum noted that this is a particular problem in paediatrics, which has often been discussed at the Forum. The Forum questioned whether it would be possible to write a comment on the general condition, without publishing the actual cases. Can a useful message be conveyed without giving specific details on the cases? In the end, it is a judgement call for the editor. He should try and obtain consent from anyone who is eligible or seek a balance of opinion from experts in the field and then decide whether or not to publish.