Human Research Ethics Online Training

Australia’s National Statement states that unless proposed research has merit, and the researchers who are to carry out the research have integrity, the involvement of human participants in the research cannot be ethically justifiable. Researchers are required by the Statement and the Australian Code for the Responsible Conduct of Research to follow recognised principles of research conduct and to conduct research honestly.

Although scientific fraud may not always impact directly on research participants, the ethical “fall out” from such fraud can be far-reaching.

Consider the admission of fraud by the Norwegian oral cancer researcher Jon Sudbø.

Sudbø (a dentist and formerly a consultant oncologist and researcher) had published a report of a study suggesting that non-steroidal anti-inflammatory drugs (e.g. ibuprofen) reduced the risk of oral cancer in smokers. The report appeared in the Lancet in October 2005 [1].

Another researcher at the Norwegian Institute of Public Health noticed that the data set that had reportedly been used to draw data from was not open at the time of the study and raised the alarm.

Sudbø has since admitted to fabricating the data for 900 patients in the study report and using fictional data in at least two other papers. Of the 38 articles published by him since 1993, 15 have been condemned as fraudulent by the independent Committee of Inquiry established to investigate the scandal.

Sudbø’s findings had been used by other researchers around the world to inform cancer treatments and other research studies. The Committee of Inquiry was unable to rule out any negative impacts on cancer patients. Additionally, these fraudulent studies diverted significant resources from other, legitimate research.

[1] Jon Sudbø, J.J. Lee, S.M. Lippman, J. Mork, S.Sagen, N. Flatner, A. Ristimaki, A. Sudbø, L. Mao, X. Zhou, W. Kildal, J.F. Evensen, A. Reith, A.J. Dannenberg (October 2005). Non-steroidal anti-inflammatory drugs and the risk of oral cancer: a nested case control study. The  Lancet 366 (9494):1359-1366. R. Horton (February 2006). Retraction – Non steroidal anti-inflammatory drugs and the risk of oral cancer: a nested case control study. The Lancet 367 (9508): 382

Image: Dr Jon Sudbø (source Norwegian Radium Hospital, Oslo)