Procedure for investigation of research misconduct – active treatment or sham intervention?
Authors: Peter Wilmshurst
Journal: Journal of the Royal Society of Medicine (2008)

The UK Research Integrity Office (UKRIO) has recently published a ‘procedure for investigation of misconduct in research’, which was prepared by the UK Panel for Research Integrity in Health and Medical Sciences.1 Its authors say ‘It provides organizations with a protocol for the investigation of allegations of misconduct in research that is thorough and fair to all parties’. This guide for self-regulation is misdirected. Universities in the UK do not lack procedures for investigations of research misconduct, but they consistently demonstrated lack of will to act.

The UKRIO and the UK Panel were set up in April 2006. At the launch the Vice-Chair of the Panel, Professor Michael Farthing, cited a report in Times Higher Education on the suspension of a whistleblower at the University of Sheffield as evidence that universities were not taking the issue of research misconduct seriously enough.2 The whistleblower in that case, Dr Aubrey Blumsohn, then asked the newly-formed UK Panel to investigate his complaint of research misconduct. Dr Blumsohn became so exasperated by the procedures and lack of progress by the Panel that he withdrew his complaint. Dr Blumsohn has used other means to make public his concerns about the research and the failings of the university. In 2007 the senior author of the research admitted that he and colleagues had incorrectly signed a declaration stating that they had ‘full access’ to data in the industry-sponsored research when they had not. The senior author also admitted that the published research contained ‘some errors and some poor practice’.3 Thus when dealing with the case cited by the Panel as an example of one needing attention, the Panel's own procedures resulted in withdrawal of a whistleblower's complaint.

To me the most striking feature of the Panel's procedure is the repeated statement that an individual making frivolous, vexatious and/or malicious allegations of misconduct in research should face disciplinary procedures. That is proper, but the document places so much emphasis on it that most genuine whistleblowers would wonder whether it would be better to remain silent.

When I spoke in September 2008 to the Director of UKRIO, Dr Andrew Stainthorpe, he said that in the two and a half years since it was formed the Panel has not completed or resolved a single case and it has no plans to publish any information, even anonymously, about any case investigated.

My interest in research misconduct started in 1982 when I was a research fellow investigating a drug for the treatment of heart failure; I was threatened with legal action in an attempt to induce me to conceal adverse findings in sponsored research.4 It took four years to expose what had happened and help came from Oxfam and The Guardian newspaper.5 Before I turned to them for help I had tried unsuccessfully to get official agencies, including the Department of Health, the Association of the British Pharmaceutical Industry and the General Medical Council, to take action. In the last 25 years of investigating research misconduct I have come to realize that research misconduct is much more common than the medical and research communities admit. My experience of speaking to whistleblowers is that when misconduct occurs many of the institutions where it happened not only fail to act, but they actively conceal misconduct.6 There are cases when it has taken a decade to expose misconduct after senior officials first knew that it had occurred. In some cases when whistleblowers turned to senior officials for help they were threatened that they would suffer unless they let the matter drop. Correction of the scientific record by retraction of publications and withdrawal of higher degrees gained dishonestly may never occur.

The reasons are not just cultural reluctance to discuss sordid matters. Science and medicine depend on the public's confidence that the process of obtaining evidence is honest and objective. Public realization that research misconduct is common would undermine confidence in all research. The academic establishment does not want that because they depend on the income from research.

The financial rewards from publishing positive outcomes of research can be an incentive for some researchers as well as manufacturers of drugs and medical device to ensure that findings are favourable. If misconduct is suspected, academics and managers may have to choose between their institution making a financial gain from publication of a positive but dishonest outcome in an industry-sponsored trial and the prospect of expensive litigation if they insist on publication of unwelcome results. Even in research sponsored by a charity the possibility that the institution may have to repay research grants may prevent proper investigation of allegations of misconduct. Fear that an institution's reputation might be affected by exposing research misconduct and the likelihood that it would reduce future investment can lead to cover-up.

The recognition by journal editors that research misconduct was more common than generally acknowledged led in 1997 to the formation on the Committee on Publication Ethics (COPE) to advise editors on cases when they suspect misconduct. Signing up to membership of COPE has become a sign of integrity for journals, but I know some journals that are members of COPE have failed to deal properly with allegations of research misconduct. COPE itself has no power. Its members can report suspected cases to the responsible institutions and national regulators, but particularly in cases of research submitted from abroad, the journals rarely hears whether an investigation took place and usually the suspicion is that misconduct was hushed up. The record of universities in the UK in investigating allegations of research misconduct is worse than in many other countries.

Will the provision of guidelines for self-regulation in cases of research misconduct help organizations that have previously shown themselves unwilling to deal with the problem? Despite the critical statements from Professor Farthing at the launch of the UK Panel for Research Integrity about the failure of the University of Sheffield to deal with the allegations brought by Dr Blumsohn, the University declined to allow the Panel to get involved in the case, stating that the Panel was not an investigatory body. UKRIO and the Panel have no power to compel the University of Sheffield or other academic institutions to deal with allegations at all, let alone in a principled and transparent manner. UKRIO is not independent, being dependent on UK universities for its office space. I believe that this document is a public relations exercise to convince us that action is being taken while the status quo is preserved.