Monday, October 15, 2007

Memory Hole (15 October): UK research misconduct Hit-Squad announced

UK-PRI Hit Squad

6 years ago today: Research Misconduct - UK Clamp down promised

On 15 October 2001 it was reported that a UK "clamp down" on research fraud was pending, and a new body (a "hit squad") would emerge.

This is a joke.

The BBC news report of 15 October 2001 read:
  • Research fraud faces clamp down
  • UK doctors are calling for a national body which can send in "hit squads" where researchers are suspected of fiddling their results.
  • Fraudulent research misleads doctors and the public.
  • Professor Alberti, Royal College of Physicians said: There has been a tendency in the past for people to hush things up.
  • However, there is no set way of tackling institutions thought to be the source of fraudulent research.
  • Leading doctors stressed the urgency of the situation.
  • "At the moment the system is shambolic".
  • 'Must have teeth'
  • A national panel merely issuing advice would be not be much use - the new body should have the teeth to inspect research institutions, spot the offending researchers and deal with them.
  • "We need a rapid response".
  • One researcher, Dr Anjan Kumar Banerjee, falsified research into the gut disorder Crohn's disease. He substituted his own urine for that of 12 research subjects - his fraudulent research was published in the leading journal Gut. Dr Banerjee was suspended from the medical register for 12 (!) months by the GMC.

I repeat below part of an article I wrote for the Journal Radstats about the body that eventually emerged (the UK Panel for Research Integrity). There is far more to say, but we will leave this problem here for the moment. A previous post about UK-PRI is here

The UK panel for research integrity - In whose interest?

To the naïve, it might make sense that a national "Research Integrity Panel" should be established. University science is conducted in the public interest, and existing integrity bodies such as the MHRA and the General Medical Council have become increasingly implausible. Such a panel might ensure that attempts to distort the scientific record are properly investigated, exposed and corrected, and that institutions adhere to their own rules in terms of research integrity.

Most other developed countries have bodies which (at least to some extent) profess to do exactly that. Plans for a "UK Panel for Health and Biomedical Research Integrity" - (UK-PRI) have been in gestation for a decade or more. The "fathers" of that panel, Professor Sir Ian Kennedy and Professor Michael Farthing understood very well why such a panel was needed. Both are individuals of great integrity and wisdom. They understand the nature of the problem, the implausibility of internal university investigation, the attempts at obfuscation, and the very difficulties experienced by those who have attempt to state the truth in the face of considerable power. They have both written about these problems extensively.

In 1998 Professor Sir Ian Kennedy wrote (Cope Report 1998, ref 35):

"There has increasingly been the stated perception that the public interest means not staying quiet in the face of wrongdoing.....The witness fears that if s/he risks speaking out s/he will lose his/her job, promotion, or prospects of ever working again in the field. And it does not seem to matter to whom the witness chooses to speak--whether it is to the researcher whose work is in question, or to the line manager, or to the head of the institution. Abundant anecdotal evidence suggests that this fear is not misplaced". .... "it is suggested that they report their concerns to the "responsible authority." But herein lies a major problem. Currently, there is no institution which can fill the role of the "responsible authority"..... "Clearly, any whistleblowers protocol will be stillborn unless an appropriate "responsible (investigative) authority" is created at the same time. In the USA, this role at the Federal level is fulfilled by the Office of Research Integrity. The Danish Committee on Scientific Dishonesty was created precisely to serve as the agency to which complaints of research misconduct could be referred. …It investigates allegations of misconduct at arms' length from the editor, the researcher, and the organisation in which the researcher works. A similar body is urgently needed in the UK. Its creation would give both the whistleblower and the editor an independent arbiter to which they could turn. As a public body, its primary remit would be to act in the public interest."

That was an excellent summary of the problem and the required solution. As the new body continued gestating, these principles were forgotten. After a further five years of gestation, it was finally announced (36) in March 2005 that the birth would take place in October 2005. October came and went. In April 2006 UK PRI emerged. The headlines screamed "Panel to expose fraudulent medical research", "Watchdog eyes scientific fraud", "New panel calls on researchers to blow whistle and stamp out complacency over cheating" (37).

But what was born was not quite what was expected. UK-PRI is hosted by Universities UK, the body that promotes the interests of UK Universities. The body immediately faced criticism. Peter Wilmshurst, a consultant cardiologist who has exposed a number of research fraud cases, said "Your stakeholders have a stake in keeping research fraud under cover" (36) and "My concern is that this is set up under the auspices of UUK. If you look at the record of the universities, they have consistently concealed research fraud and protected the crooks." (37) The body has reportedly received some funding from the pharmaceutical industry - a critical mistake.

I am disappointed that we have moved so far from Sir Ian's vision and his clear understanding of where the problems lie. In March 2005 the University of Sheffield declined to allow UK-PRI to get involved with the problem in Sheffield, stating that UK-PRI was not an investigatory body, but that the MHRA (the UK drug regulator) would investigate. This was despite the fact that the MHRA had already stated they have no remit to investigate scientific misconduct in research involving licensed drugs. This is the way problems and those raising them get bounced from implausible pillar to implausible post.

It is not clear whether UK-PRI will be yet another such pillar or post but initial indications are that it will. UK-PRI now states that its major role is to "develop a programme of training" and "guidelines" and to "develop a robust national procedure". The body has no investigatory powers nor teeth of any description. What we now have is potentially worse than nothing at all. UK-PRI may assist to provide an impression that "all is well" and that those wishing to raise concerns really have somewhere to turn. That will cause others to offer even less support than they already do, and will surely cause further harm. I wondered whether they spoke to even a single person who had tried to raise concerns during their long gestation? There are already many perfectly good "procedures" and "Codes of Good Conduct" and other such cozy documents. These documents may not be perfect, but that is not where the problem lies. What we need is courage and some guts.

Having met with UK-PRI, I must report with some sadness that those raising concerns should not yet be encouraged that it is any easier to do so since April 2006.


35. Kennedy I. Whistleblowers. The COPE report, 1998.
36. White C. UK agency to combat research misconduct. British Medical Journal, 2005; 330: 616.
37. News reports on new integrity panel (Guardian April 12th 2006, THES April 14th 2006)
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