A journal received a paper from a single author, attributed to a UK institution, in which 10 children were operated on using two techniques, each child having one technique to one side and one to the other side, at the same operation.
The paper went to review, and neither reviewer spotted that this was a prospective surgical study on children, with no mention of consent or ethical approval.
The editor realised this after accepting the paper on the reviewer’s recommendations, and asked the author for evidence of ethical approval and parental informed consent.
The author, who is based in mainland Europe but has held a senior position in the UK, responded initially that the study had been discussed informally, and that since both treatments were current and acceptable, it had been felt that no specific ethical approval was required.
The editor then made enquiries of the trust medical director, suggesting that such a response might indicate failure of the author to understand the requirements for ethical approval and consent, and wondering if there were grounds for questioning whether there might have been institutional failure in this case.
At this point the author asked to withdraw the paper. Several emails followed, and then the author made the statement that in fact the paper referred to cases operated on in the USA and were covered by a blanket ethical approval in the institution in that country where he had worked previously, as a subset of a larger study group.
The editor has instituted enquiries with the director of that institution. The paper as submitted bore no reference to the unit in the USA, had only one author, was clearly badged as coming from the UK unit, and had no indication of ethical approval or parental consent.
It is probable that a true state of equipoise exists between the two treatments under study. The editor finds it surprising that language skills would be at the heart of this,
The author in an apology has stated that it was his poor understanding of English that led him to attribute wrongly the cases under study. He is at present apparently unaware that enquiries have extended to the USA.
Should any further action be taken, bearing in mind no response has yet (only two weeks later) been received from the USA?
It was agreed that the editor should pass his concerns onto the UK and US institutions. Although the paper was withdrawn, the editor still has a duty to pursue the issue and possibly there is also a case for obtaining the original data. The editor should formally ask the US institution to investigate the fact that the study may have been unethical. If no response is forthcoming, the editor should chase up the US institution after three months. The editor should inform the author that he has requested an investigation from the US institution. If misconduct is proved, then the editor should inform the author’s present employer.
As advised, the editor notified the director of the unit in the USA of his concerns and the recommendations of COPE, and notified the author of them also. No response from either has been forthcoming and the editor plans to follow up with a letter in one month.