A paper was submitted to our journal describing a study in which children received general anaesthesia for a minor operation. The authors chose to induce anaesthesia with a mask and 8% sevoflurane inhalation for 8 minutes. The aim was to study the EEG over various brain areas to see where the epileptogenic activity is located. The reason for doing the study was that it has been shown that sevoflurane can cause epileptogenic activity on the EEG. Clinical convulsions have also been seen but much less often. Hence the authors deliberately gave a high concentration for 8 minutes because they wanted to provoke this epileptogenic activity to study it more closely. I asked them what information they had given to the parents (according to the manuscript, informed consent had been given). They replied that they had not given them the information that this could happen and why the investigation was performed. I also doubt that the ethics committee knew the true reason for doing the study.
This case resembles many I have seen over the years. The study was approved by the authors’ university ethics committee. My question is whether we, as journal editors, always must follow that judgement or whether we have an independent obligation to make our own judgement about whether a study is ethical.
The Forum were unanimous in their view that this appears to be unethical behaviour on the part of the authors. The editor should ask to see copies of the information given to parents and the consent forms as it was felt that this information was probably inadequate. Further advice was to write to the authors’ institutions and inform them of the authors’ actions, and also to contact the ethics committee. It was suggested that, if receipt of the documents confirms lack of transparency or failure to obtain informed consent, the editor may wish to report the authors to the GMC or other equivalent regulatory authority.
In answer to the editor’s initial question, the Forum agreed that an editor does not always have to follow the judgement of an ethics committee and he does have an obligation to make his or her own judgement about whether or not a study is ethical.
The editor has written to the authors of the article and awaits their answer. The editor is considering perhaps consulting some international experts on this topic for their advice.
Update (February 2009)
This was an investigation which was accepted by the local ethics committee, and a professor of anaesthesiology was among the committee members. So the committee must have known what they were doing. However, the editor is absolutely confident that the patients/parents were not given the all of the information about the objective of the investigation.
The editor contacted a few eminent international people within this field asking privately for their opinion but none answered. For the editor, it was a difficult decision ethically as well as diplomatically. The article was accepted but the editor did inform the authors that this article would be used for future discussion around research and publishing ethics. In fact the editor has already included this story in a lecture which he gave in