In October 2000, a journal published a retraction of a February 2000 publication of a research paper. In the same issue the dean of the corresponding author’s medical school reported the findings of an investigational committee that found, contrary to what was stated in the paper:
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There was no ethics committee approval for the study.
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Written informed consent had not been obtained.
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The signatures for the researchers in the release form had all been written by the corresponding author (note from ed: it is unclear what “release form” this is).
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Only 101 of 135 case report forms from patients could be provided by the corresponding author to the committee.
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Only 27 patients’ files could be retrieved from the hospital archive for data verification
The committee also noted that two co-authors were not involved in any misconduct because one did a single clinical assessment and the other was a statistician. The committee concluded that “some fabrication and falsification might have taken place”, but noted that the “issue will be finalised” by a higher education council and “later probably” in a court of law.
The co-author who did the assessment only also had a letter published in the October issue, stating that he was surprised to see his name on the paper as he was “totally unaware” of the patients enrolled, had done nothing in the running of the trial, and had not signed a copyright form. Two other co-authors also stated that they were unaware of the paper and they had not signed anything as a co-author.
A final letter in that group was by the corresponding author. He:
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Admitted to writing signatures on the submitted manuscript for the two co-authors, about which he said “I do, however, now feel it was a mistake to write their names in my handwriting, even though they had approved the inclusion of their name previously” (that is, six years before the paper was submitted).
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Pointed out that the acceptance letter had been faxed to this pair and they did not withdraw responsibility as co-authors.
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Pointed out that this same pair had given press interviews about the study under the journal’s news embargo.
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Pointed out that one of the pair co-authored (that is, with the paper’s corresponding author) an editorial in a foreign language journal (year 2000, date unknown, but it cited the main publication).
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Said he signed the copyright agreement on his own.
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Had been ambiguous about approval by the existing ethics committee in his hospital (a committee that did not exist at that time), whereas the “study was approved under the supervision of the ex-chief of one of the hospital departments”. He said his ambiguity was a mistake for which he apologised.
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Pointed out that all patients had given oral informed consent (the paper said “written”, and he admitted this disparity was a mistake).
In May 2006, the corresponding author sent a letter for publication in the retracting journal, asking for a retraction of the retraction, on the grounds of a ruling by a series of high courts in his country. His covering note for the letter and/or the letter itself states that the court(s):
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“Unambiguously declared” his innocence about any forging of signatures.
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Felt it unimaginable that the co-authors had been unaware of the submitted paper.
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Established that all 135 patients were registered at the hospital.
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Found that the claim about fabrication and falsification of the data was invalid.
The retracting journal would appreciate guidance about what to do next.
The committee agreed that nothing should be done unless the claim of exoneration is verified. This would involve obtaining a transcript of the proceedings or at least the rulings of the High Court. It was also suggested that transcripts of the judgements from the original investigational committee should be sought, again in an effort to establish the veracity of the claims. The advice to the editor was not to retract the retracted paper until he was in possession of all of the details of the case.
The journal have had all of the High Court rulings translated. These were rulings only, not the proceedings. The rulings exonerate the author of the retracted paper in all matters, including: being innocent of forging signatures; no data falsification or fabrication; all 135 patients in the study had been “registered” at the hospital; and the co-authors did know about being authors. The courts also ruled that it was wrong for the main author to have been dismissed (I understand that he got his job back).
One court ruled that signing other people’s signatures was “according to ongoing practice”, an act that caused “no harm”. One court ruled that “there is no regulation that requires the permission of an ethical board”. One court ruled that the fact that not all the case files could be shown to the university’s investigational committee was “the fault of the administration” and not the main author.
We have been unable to obtain the report of the university’s investigational committee. The Faculty of Medicine’s Dean at that time told us, in January 2007, that his published letter (at the time of the retraction) was a translation of the committee’s decision, which included the suggestion of data falsification and fabrication.
The then Dean still maintains that misconduct occurred. As his published letter said: not all case report forms could be found, and only some patients’ files could be found in the hospital archive. The court ruled that all the patients were “registered” at the hospital, which is not the same as being randomised into a study there.
The two translated affidavits from patients that say they were being treated state that their “file from the archive” cannot be found and that they had been given a “template” file. Both affidavits (with virtually similar wording in translation) were made on the same day with the same notary; the wording makes no mention of being in a study, although that is implied. Neither patient says that they remain on the drug being tested (perhaps treatment should be limited anyway, perhaps the drug is not licensed or available). The retracted paper showed few losses over 12–65 months of follow-up: 67 were in the experimental group, 65 completed; 68 were controls, 65 completed. Our journal recognises that nothing in this paragraph proves misconduct.
We do not know why the author of the retracted paper published a letter in which he admitted misconduct. This letter appeared in the same issue of our journal as the retraction. The author admitted to writing signatures for co-authors, being ambiguous about ethics committee approval and saying that consent was written when it was oral. The author ignored the point about data falsification and fabrication.
Because a court of law has different standards of collecting and assessing evidence, and reaching a judgment, and because the author of the retracted paper has admitted three types of misconduct, our journal is not minded to retract the retraction.
A remaining option is to ask the retracted author why he made those admissions.
A sticky point for our journal is that, despite published letters that disown authorship, some of the co-authors do seem to have known about the paper before or at the time of publication (gave a press conference, co-wrote an editorial). We see that as a separate issue which no one has yet complained about. One of the co-authors is now dead.
Your advice would be appreciated.
In this complicated ongoing case, the committee’s only advice was to perhaps ask the author again for an explanation as to why he published a letter in which he admitted writing signatures for co-authors, being ambiguous about ethics committee approval and saying that consent was written when it was oral. The general consensus was that the editor should publish the author’s letter about wanting a retraction of the retracted paper and perhaps an accompanying editorial could highlight the details of the case. It was also noted that courts’ decisions are based on different levels of evidence and dependent on local legal rules, and editors’ decisions might therefore differ.
Further update (August 2007)
The editor felt that for there were no grounds for retraction. The editor decided not to publish the letter requesting the retraction. The journal considers the case now closed