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Press release: Inquiry into research fraud completed

22 October 2008

Inquiry into research fraud completed

In May 2007 a case of alleged research fraud was reported to the Vice-Chancellor of Lund University, Göran Bexell. The report concerned suspected irregularities in a study of a technology for fetal monitoring, known as STAN (ST analysis of fetal ECG). An inquiry conducted by an external investigator now draws the conclusion that data were manipulated in the study. The Vice-Chancellor has therefore decided that the study should be subjected to further inquiry.

In May 2007 Associate Professor Ulf Hanson, Uppsala, reported a case of suspected research fraud to Vice-Chancellor Göran Bexell. Bo Ahrén, Dean of the Medical Faculty, at the behest of the Vice-Chancellor, appointed Professor Kari Teramo of Helsinki University Hospital to examine any irregularities in the study.

Professor Kari Teramo has now submitted the report on his inquiry to Vice-Chancellor Göran Bexell. Kari Teramo draws the conclusion that data were manipulated in the STAN study. He also thinks that, since the discrepancies are solely in favour of STAN, this a strong indication that the data were deliberately manipulated.

“I am grateful for the thorough job done by Kari Teramo,” says Vice-Chancellor Göran Bexell, who goes on to say: “The inquiry shows that we cannot rule out that fraud has occurred in the research study, but there are still some unclear points. I have therefore decided that we shall hand over the matter for continued inquiry outside Lund University.”

The continued inquiry is intended to answer the question how this could happen. At present it is uncertain who will handle the case, since there is no body in Sweden today for the investigation and trial of fraud in research. The Vice-Chancellor hopes to able to ascertain within one week where the matter will be dealt with.

“Lund University, like all universities, is extremely careful to handle cases of research fraud in a correct and penetrating manner. It is therefore important that we carry on the inquiry,” Göran Bexell continues. “This is a complicated case, with many players, a large amount of material, and it is word against word. That is why the inquiry has taken such a long time. I am aware that a further inquiry will mean that even more time is needed, but it is essential that everything is examined thoroughly.”

The Dean of the Medical Faculty, Bo Ahrén, welcomes a further inquiry:

“A medical discussion of the STAN technology has been going on for several years. It is therefore important that we achieve clarity as to whether there has been fraudulent behaviour in the study,” he says. “It is of great significance for all those involved, not least for the research group that does not agree with the conclusions of the inquiry.”

For further information contact:

Vice-Chancellor Göran Bexell, telephone +46-46-222 70 01, Dean Bo Ahrén, telephone +46-46-222 80 84.

Associate Professor Göran Lingman of the Department of Obstetrics and Gynaecology, Lund, can answer questions about the STAN technology and how it is used in delivery wards. Göran Lingman has not been involved in the research study that is now being investigated. Telephone +46-46-17 25 60, e-mail goran.lingman@med.lu.se

Background

STAN (ST analysis of fetal ECG) is a technique for fetal monitoring in labour. STAN is used together with the traditional CTG (cardiotocography) monitoring to determine whether the fetus risks suffering hypoxia (oxygen depletion) during labour.

The allegation of research fraud concerns a study by researchers at Lund University published in The Lancet 2001: “Cardiotocography only versus cardiotocography plus ST analysis of fetal electrocardiogram for intrapartum fetal monitoring: a Swedish randomised controlled trial.” The study compared children who were monitored during labour with either CTG alone or CTG along with STAN. The study showed that the children who were monitored with STAN displayed fewer signs of oxygen depletion than children who were not monitored with STAN. The trial was a multicentre study with three maternity wards participating, at the university hospitals in Göteborg, Lund, and Malmö. As a result of the study, STAN is found today at maternity wards all over Sweden and also abroad.

After 12 incidents which were reported in accordance with the Act on Professional Activity in the Field of Health and Medical Care, a group in the scientific council of the National Board of Health and Welfare decided, in consultation with the responsible research group, to review the study. The review was conducted by Associate Professor Ulf Hansson. His conclusions led him to report suspected research fraud to the Vice-Chancellor of Lund University.

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