A thesis published by a student was submitted by his guide for publication. One of the journal editors found the research unethical and asked for confirmation of ethics committee approval. The editor received a verbal commitment that the approval had been given prior to the research being started and the approval letter would be submitted in due course. However, on further investigation by the editorial team, based on strong suspicions, it was found that not only was the approval obtained post research but also that the subjects were not aware that they had been randomised into two groups for surgery. The only consent forms available were those for surgery and consent that their data could be used for research. There are long term implications of the research. The author wanted to prove that omission of an expensive drug in a third world scenario could lead to no change in results. There are over a dozen articles indicating the contrary. The author seemed to base his hypothesis on one article in the literature. Following the investigation, the article has been withdrawn by the author.
Is there any moral responsibility of the editorial team to report the matter further and, if so, what is the course of action? Can the editorial team take the stance that since the article is withdrawn it is no longer under the purview of the editorial team?
The committee were in agreement that the editorial team had a moral responsibility to take further action as there is a possibility that patients may be put at risk. The advice was that the editor should write to the ethics committee and/or the medical board to determine if approval had been obtained and whether it was obtained retrospectively. The editor should write to all of the authors informing them that he is contacting the ethics committee. The committee noted that the ethics committee may not be in a position to take any action and may in fact be part of the problem. If this is the case, the advice was to contact the authors’ institution and to inform the authors that this course of action is being taken. The committee emphasised that the editor should not get involved in an investigation. The institution should be presented with the facts and then allowed to investigate the matter themselves.