Several years ago, a third party contacted the journal with concerns about data irregularities in two randomised controlled trials published about 10 years ago. Both of the papers were published before the journal had strict requirements on data upload to a public repository and availability.
The journal sent an initial email to the corresponding author of both papers (the same author for both papers) notifying them of the concerns and requesting information on the study dataset, ethics approval letter, original protocol, original SAP and the randomisation list. The author responded by threatening legal action against the editor-in-chief and did not provide the requested documents.
A year later, the journal contacted the corresponding author again, requesting the same information. The author responded to the second request stating that the original data for the studies had been destroyed/was not accessible because only hard copies were available in patients‘ files and on an old computer. Standards in record keeping require authors to keep data for 15 years.
The journal published an expression of concern for both articles, stating that concerns regarding the validity of the data in both articles had been raised, and that the journal had requested the data from the authors. The third party contacted the editor-in-chief again, suggesting that the papers should be retracted.
The journal sent a third notice to the author requesting the same information. The author responded stating that the situation was currently being investigated by their university. No further correspondence has been received.
Question for the Forum
- Should the journal retract these articles because the data cannot be verified?