The journal received a paper on an imaging technique which reported changes in a normal healthy volunteer. No adverse events were experienced. This study demonstrated the feasibility and safety of the imaging studies in a particular condition.
The paper was rejected on methodological and priority grounds but during the review process it was noted that no specific mention was made of ethics approval, despite the fact that an invasive procedure was carried out. It was, however, noted that the control subject was a member of the department and one of the authors.
The editor raised this with the corresponding author who responded that the study was done as part of a programme of work in both animals and humans which had ethics approval. There was, however, concern that were the subject a junior member of the department there would have been implicit coercion. In view of that, the editor requested a copy of the ethics approval. The issue was discussed at that time with the BMJ Ethics Committee and the course of action was thought appropriate.
The editor has subsequently received a translated letter from the local ethics committee approving the study but this has been dated recently (that is, since the issue was raised). However, it has also been explained that the subject was in fact the head of department.
The editor is of the view that the study should have had ethics approval but many studies have been performed by investigators upon themselves and the editor intended not to take this further. Is this the right course of action?
This case raised the issue of whether ethics approval is required to perform an invasive procedure on yourself. Most thought that in reality most individuals do not seek ethics approval and there have been many anecdotal instances of such cases in the past. As it transpired that the subject in question was the head of department and not a junior member of the department, and thus the issue of coercion was ruled out, the advice was to take no further action.