After a number of appeals and revisions, and having satisfied ourselves about the results being “too good to be true”, we eventually accepted a paper. In September 2007, we received a letter from the head of the institute (and also a member of the university ethics committee) expressing concern about the paper. The allegations were: the funding source could not be that acknowledged; the authors affiliations were not correct (some authors who were stated as being at his institute had never been members); and the trial had not been submitted to the local ethics committee. The authors provided us with a document signed by the head of the institute (complainant) stating that the author in question had been a member of his institute in the year that the trial was conducted. They also provided legal advice that they had complied completely with the law in force at the time of the trial. This was verified by the Minister of Health who sent a letter saying he had approved the trial as required by law. The authors acknowledged that the funding was erroneously attributed.
We are publishing a correction that makes clear the authors’ affiliations and the funding source, but we have no further concerns about ethics approval.
The Forum agreed that the editor had done everything he should and had followed the correct course of action.
This case was brought to our attention by the head of institute (and member of the ethics committee) who told us that authors affiliations were incorrect and that ethics approval had not been appropriately sought. Our investigation suggested that ethics approval did meet the legal requirements and we stated in the previous report that we had no further concerns about the ethics of the study. Now new problems have become apparent.
It seems that there is a difference in legal opinion about the ethics approval requirements in force at the time of the study. There appear to be inconsistencies in the timings of submissions and approvals. Furthermore, there is currently a legal case against the authors concerning consent.
We have issued an expression of concern and are awaiting the outcomes of the court case and other investigations.
We issued an expression of concern as we were made aware that there has been an investigation launched into the conduct of the study (after a patient’s court case and a parliamentary question) and that the trial registration number was invalid. The investigation has now been concluded. We are studying this at the moment and are considering taking further steps.
The editor told the Forum that the journal has now issued a retraction of the paper and published an accompanying editorial on co-authors’ responsibilities. The corresponding author still denies any wrong doing and the co-authors are claiming it has “nothing to do with them”. The Dean of the institute has been dismissed.