An allegation of data fraud was not satisfactorily resolved by correspondence with the authors. We then went to the lead institution and asked for an investigation. Within 10 days we had a report clearing the authors, but interestingly using some of the exact same phrases the authors used in their responses to us. We felt that the report was too superficial and approached the other institution involved.
A new investigation was started; this investigation took many months. The report said there was insufficient justification to take the matter to formal assessment and the institution was not minded to investigate further.
We remain concerned. The second investigation asked the authors to provide some data for re-analysis: that came out close enough for the committee to be reassured. However, provision of the same data for re-analysis is likely to produce the same result. In our previous experiences, only checking of at least some of the case report forms would uncover fraudulent data. We are therefore not reassured that the paper is sound and we have no direct evidence (CRFs) that the data are genuine.
Questions for the COPE Forum
• When two institutional reviews have failed to investigate thoroughly enough to reassure editors, what further investigations might be warranted? And by whom?
• Is there sufficient doubt remaining for an expression of concern? Or should we accept the results of the investigations even if we consider them inadequate?
The Forum suggested that if the original data cannot be produced, it would be reasonable to retract the paper. No access to the primary data are grounds for retraction. The Forum asked if it would be possible for the journal to have access to the anonymised data?
The Forum agreed that an expression of concern would be appropriate if the journal believes that the institution has not done due diligence. It is not within the journal’s remit to carry out an investigation. The COPE retraction guidelines state that editors are welcome to issue an expression of concern if the investigation by an institution has not been fair or conclusive.
A suggestion was to contact an organisation that oversees these types of investigations at the institution. Is there a national body than could be contacted?
The role of the editor is to safeguard the literature and prevent readers from being misled, so an expression of concern is entirely warranted in this case.