Tuesday, May 15, 2007

The birth and death of the UK Panel for Research Integrity - Part A

I laughed out loud when I read the today's Guardian article about the "new" UK research integrity panel (UK-PRI).

'Whistleblowing in the Wind?'
by Jessica Shepherd [Link].

Potential customers beware.
You should treat any offer of support from UK-PRI in the same way you would treat the offer of fellatio from a crocodile.


There is a lot more to say on this topic (so stay tuned).

At least the journalist involved had the good sense to realise what she was dealing with.

Whistleblowing in the wind?
A new hotline for those who suspect malpractice in medical research has not been universally welcomed.
Jessica Shepherd reports [Link]
Tuesday May 15, 2007 The Guardian


The UK Research Integrity Office and its hotline has no investigatory powers - but they can give advice. Photograph: Linda Nylind

In just nine months, Malcolm Pearce went from being considered a highly accomplished gynaecologist-researcher to a fraudster who potentially harmed patients. He had published two papers in the British Journal of Obstetrics and Gynaecology on work that never took place. Had it not been for a whistleblower, he might never have been found out and struck off the medical register.

The fact that his case was dealt with speedily, protecting the rights of both the accused and the whistleblower, was unusual, according to Dr Stephen Lock, a former editor of the British Medical Journal, writing in the publication at the time of the case, in 1995. "In most other medical institutions in Britain, nothing would have happened; the affair would have been brushed under the carpet, and the whistleblower would probably have been hounded out of his or her job," he said.

That was more than 10 years ago and hopefully things have changed. But Britain is still lagging behind its neighbours when it comes to preventing research misconduct. The Scandinavian countries, Germany, France and the US have had organisations to investigate fraud or monitor investigations for more than 10 years. Ours - the UK Research Integrity Office - was set up only last year.

"We have been relatively late with this," admits Professor Michael Farthing, who is vice-chair of a panel that looks into research integrity in health and biomedical sciences, of which the UK Research Integrity Office is a part.

But, as if to catch up, the UK is now attempting what is thought to be a world-first: a hotline for those who suspect research misconduct. The hotline, which went live on Friday, for the moment covers only medical research - the most common form of research misconduct - but there are plans to expand into all disciplines. It is aimed at anyone who suspects malpractice, from a minor tinkering of data to plagiarism, fabrication and falsification.

Dr Andy Stainthorpe, who runs the UK Research Integrity Office, who will man the helpline between 8am and 8pm every weekday, says he is expecting anything between 10 and 100 calls a month. "It could be a university administrator who calls, or the person whose responsibility it is to handle allegations of misconduct, like the pro vice-chancellor for research," he says.

What can callers expect? "Investigations into research misconduct rest solely with employers - so, a university or an NHS trust in this case," says Stainthorpe. "The helpline exists to give impartial and independent advice to callers on how to handle allegations of research misconduct.

"If someone phones up, I will discuss the issues with them and could also pass the matter on to a panel of experts in the UK who have tackled those issues before. We can give callers confidence by letting them know whether what they are observing might be misconduct or not. Cases are rare and quite often callers won't have come across one before. It is useful to seek guidance from someone who has handled something like it previously."

Stainthorpe says he has had experience of "several" cases of research misconduct in his role at the Research Integrity Office and in places where he has previously worked. "There is no reason why a caller should not just go to their pro vice-chancellor for research if that is the person who deals with research misconduct in their institution," he says.

And that is why the research community has not altogether welcomed the hotline - or the creation of the Research Integrity Office. Sir Iain Chalmers, editor of the James Lind Library in Oxford, which documents the evolution of fair tests of medical treatments, says: "There's not much point in making allegations of research misconduct to the helpline. The organisation behind it has no powers of investigation. It is actually very unfair to the people who make the allegations because it could be that their allegations are brushed aside ultimately.

"It is also unfair to those who are alleged to have practised misconduct. As long as the office and the helpline have no investigatory powers, justice will not be done."

Dr Hugh Davies, the ethics adviser to the National Patient Safety Agency, describes the helpline as "problematic". He says: "It's one way to deal with research misconduct, but it could encourage unfounded accusations of research misconduct, and how is it going to deal with that?"

To which Stainthorpe replies: "There is the potential that we will waste a bit of our time, but it is better that we are here for those who need us. This is a three-year experiment. The helpline will be reviewed in six months. We don't know what the size of the issue is yet, and we need to get more hard evidence of incidents in order to know more about the scale of the problem."

And Farthing concedes: "This is not the solution to research misconduct at all - it opens another opportunity for people to raise their concerns."

Another opportunity is needed. A study published in Nature in 2005 claimed that a third of US scientists had engaged in serious research misconduct in the past three years. Of the 3,200 scientists who took part, less than 1% said they had falsified data, but more than 12% admitted to tolerating a misuse of data by their colleagues.

"It would be very difficult to say we in the UK are any different," says Farthing. "I have to say that my inclination is that there is a rise in research misconduct. There are huge pressures on people to perform. There is huge competition among academics. They need to get their next grant."

Despite concerns that cases of research misconduct are growing, Chalmers says there is evidence to show universities, academic journals and the government do not take allegations of malpractice seriously enough. This, he says, is in direct contrast to the pharmaceutical industry, which has set up a system of "forensic examination" into allegations of misconduct.

"Universities are in a difficult position. They are not the most appropriate organisations to judge themselves. They want to keep their reputation unblemished. If it is a senior member of staff who is being alleged to have practised research misconduct, how do they deal with that? It is a great embarrassment."

Embarrassment is the least of it. The cost of medical research misconduct can just as easily be human lives.


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2 comments:

Anonymous said...

http://news.bbc.co.uk/1/hi/health/1182881.stm

"The way research misconduct is dealt with in the UK is in serious need of reform, an expert has warned. Professor Michael Farthing has called for an independent body to deal with the problem.

He said the medical profession cannot be left simply to conduct internal inquiries.

Professor Farthing, chairman of the Committee on Publication Ethics, was concerned that the case was only brought to book by the intervention of an external whistleblower.

This was despite the alleged concerns of colleagues, other members of staff at King's College Hospital, London, and the findings of an internal inquiry, which were allegedly not in Dr Banerjee's favour.

Writing in Gut, Professor Farthing said: "This will do nothing to reassure the public that the medical profession is still fit to self-regulate."

Internal reviews, he says, are not independent enough to afford whistleblowers the protection they need. "

So why oh why did we end up with this Professor and why did you participate?

Anonymous said...

http://news.bbc.co.uk/1/hi/health/1182881.stm

"The way research misconduct is dealt with in the UK is in serious need of reform, an expert has warned. Professor Michael Farthing has called for an independent body to deal with the problem.

He said the medical profession cannot be left simply to conduct internal inquiries.

Professor Farthing, chairman of the Committee on Publication Ethics, was concerned that the case was only brought to book by the intervention of an external whistleblower.

This was despite the alleged concerns of colleagues, other members of staff at King's College Hospital, London, and the findings of an internal inquiry, which were allegedly not in Dr Banerjee's favour.

Writing in Gut, Professor Farthing said: "This will do nothing to reassure the public that the medical profession is still fit to self-regulate."

Internal reviews, he says, are not independent enough to afford whistleblowers the protection they need. "

So why oh why did we end up with this Professor and why did you participate?