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Flu vaccine investigator is suspended for four months for research fraud

BMJ 2012; 344 doi: https://doi.org/10.1136/bmj.e457 (Published 16 January 2012) Cite this as: BMJ 2012;344:e457
  1. Clare Dyer
  1. 1BMJ

A researcher on flu vaccines who forged colleagues’ signatures, asked a nurse to sign a false declaration, and recruited himself into a study under a disguised name has been suspended from practice for four months for research fraud.

Iain Stephenson, honorary consultant physician at the University Hospital of Leicester NHS Trust and a clinical senior lecturer at Leicester University, was the principal investigator in one study, an open label study, and a co-investigator in a second, known as the “prime boost study.”

Dr Stephenson’s actions, which also included destroying an original log sheet and replacing it with new sheets, were dishonest on a number of occasions and amounted to research fraud, a General Medical Council fitness to practise panel held.

Dr Stephenson admitted forging the signature of a colleague, Tristan Clark, six times on the vaccine log for the open label study and forging the signatures of Dr Clark and Karl Nicholson, professor of infectious diseases at Leicester, on their curriculum vitae in the study file.

The panel found that Dr Stephenson had recruited three volunteers into both the open label study and the prime boost study but “went to some lengths” to disguise this. He recorded that the three had been given the open label vaccine, when they had received only the vaccine for the prime boost study.

He admitted recording that the three volunteers had had the open label vaccine when they had not, asking the nurse to countersign the vaccine log, and forging Dr Clark’s countersignature.

The deception came to light after the nurse realised that what she had countersigned was incorrect and asked for her signature to be withdrawn. Dr Stephenson crossed out her signature but later replaced the log sheet with two new sheets.

He told the panel that he was “setting the record straight,” but the panel’s chairman, David Kyle, said that he had gone about it “in a wholly inappropriate and clandestine manner.” He added: “Were it not for the fact that, unknown to you, someone had made a copy of the original log sheet, the information on it would have been lost forever once you destroyed the original, and the panel has no doubt that you believed this to be the case.”

Mr Kyle said that the panel had been told there was considerable mitigation in Dr Stephenson’s case. His actions did not affect the quality of the research, and he was concealing shortcuts resulting from time pressures. Had he not forged the signatures and tried to hide the dual recruitment, he might not have been brought before the GMC at all.

His colleagues said that he was an excellent clinician; his previous career was unblemished; and, after he went though employers’ disciplinary procedures, the university and the hospital were happy to keep him as a doctor. His suspension will take effect after 28 days unless he appeals.

Notes

Cite this as: BMJ 2012;344:e457

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