Keep it real

Research misconduct is a serious issue, one that governments around the world are taking increasingly seriously. In Western Europe, the US and elsewhere, governments have moved to support national policies for setting standards for the responsible conduct of research - and the investigation of allegations of misconduct. If the UK is to maintain its reputation for sound and honest research, it must do so, too. But it is equally important and urgent to recognise which body should spearhead work in this area, and to build a consensus on the way institutions, funders and the state should support and pay for it.

The campaign in this country to establish a national approach to standards for publication and research integrity is not new: it started well before I became involved in the mid-1990s. So what explains the continued deafening silence of successive UK governments on this issue? Is it assumed that someone else is doing the job, or that there is no job to do?

Research quality in the UK is second only to the US and in terms of value for money, when citations are set against the proportion of gross domestic product spent on it, Britannia rules the brainwaves. But competition is strong and is growing. Science is vital to the future of our economy, which makes the lack of public engagement with research integrity by any relevant minister or secretary of state over the past 20 years all the more dispiriting.

So far, the UK has been lucky. In the past decade it has not suffered a major research misconduct scandal - unlike the US, Germany, Norway, the Republic of Korea, Japan and Australia. In the wake of the global bad press generated by such incidents, Norway and the Republic of Korea are minded to put research fraud in the same criminal domain as its financial counterpart.

It would not be true to say that the UK has been entirely spared such cases (with the most visible examples occurring in health and biomedicine), but somehow we have escaped the national disgrace heaped on others. I would suggest to all those in the coalition with an interest in maintaining our impressive standing in the global research league that it is dangerously complacent to believe that we could not be touched in the future. All our major global competitors have had a humiliating experience in the past decade and been forced to take action. When will our turn come - and how can we be ready when it does?

First, some history. In the late 1990s, I and a number of other medical journal editors realised that Stephen Lock, a former editor of the British Medical Journal, had been right to argue (in a 1988 article in the BMJ and subsequently in other forums, including an episode of the BBC’s Horizon programme in 1995) that research misconduct was alive and well in the UK. In 1996 and 1997, a series of editorial articles appeared in medical journals - the BMJ and The Lancet among them - calling for the problem to be tackled: in 1997, I added my voice and wrote about the examples of research misconduct I had encountered during my first year as editor of Gut, which included instances of plagiarism and duplicate publication. A small group of us started an informal self-help group, which we called the Committee on Publication Ethics (Cope). We had no idea it would grow into a organisation with more than 7,000 members worldwide.

Cope supports editors in dealing with the challenges of research and publication misconduct. Its work marks the UK out as a leader in driving up standards of publication ethics, yet it has received neither recognition nor financial support from any of the past three governments for this significant achievement. As far as I am aware, none of them has even acknowledged its existence.

In 1999, there was a further development when a consensus conference on misconduct in biomedical research, held at the Royal College of Physicians of Edinburgh, agreed that the UK needed a national body to develop and promote good practice, provide assistance with the investigation of alleged misconduct, and collect, collate and publish information on the subject.

It was not clear who should take this sound suggestion forward. The Royal College of Physicians of London tried but failed. The Academy of Medical Sciences was suggested, but its leadership preferred to debate whether research misconduct actually existed in the UK. (I understand that the AMS agreed to undertake an investigation of alleged research misconduct but after a very difficult experience decided not to engage further.)

A memorable seminar held by Cope in 2003 arrived at a consensus: the employers of researchers (namely universities and NHS organisations in health and biomedicine) were ultimately responsible for dealing with misconduct allegations. It was therefore agreed that they should be the focus for any new integrity body, backed by research funders, Universities UK, the NHS and the Higher Education Funding Council for England.

A group of enthusiasts crafted a proposal that defined the mission and objectives of a body initially called the UK Panel for Health and Biomedical Research Integrity. This led to a three-year grant-funded pilot project, launched in 2006. Initially, progress was slow. Nonetheless, the panel published several important and now widely accepted guidelines and its advisory service for stakeholders, “whistleblowers” and the public grew year on year. This service became the UK Research Integrity Office. Early on, those using the service asked UKRIO to extend its brief in health and biomedicine, and the organisation was soon advising on cases across the sciences, social sciences and the arts and humanities. Today it deals with more than 60 cases a year, as well as providing external, independent experts to assist with investigations of alleged research misconduct.

When the pilot project came up for review in 2010, some of UKRIO’s initial supporters wanted to expand its remit and funding. Others, however, were keen to close it down without thinking through what would follow. Much of the discussion about the organisation’s future can be seen in the Science and Technology Committee’s 2011 report Peer Review in Scientific Publications, which wandered into the question of what the UK was doing about research misconduct (see below). The cross-party Commons committee clearly saw that UKRIO was the only show in town, but there was little support for it among some senior members of the original stakeholder group. Why? Was it the modest cost? Or did unresolved questions of ownership and control play a larger part?

Rather than close down, UKRIO left its host organisation UUK, found a new location and registered as a limited company. It is now a registered charity supported financially by more than half of the UK’s research-intensive universities, the NHS and the Royal Society. Much of UKRIO’s advisory work is delivered by committed volunteers from the research community.

What do the main research funders and UUK make of this? Earlier this week, they published the Concordat to Support Research Integrity (see box, right), which is meant to chart how the UK can steer clear of the embarrassments suffered by other research-intensive nations. I hope it achieves this goal. It has taken a long time to work out what the concordat should say, and it remains unclear how its authors intend to turn this statement of values into action.

I strongly believe that research in the UK is among the best in the world and that serious misconduct remains a relatively rare event (although we have slim evidence about its true magnitude). However, the larger number of minor breaches may actually be more harmful than the major cases that make the headlines. UKRIO will next month publish a report on the experience it has gathered over its five years as an advisory service and it would be happy to compile a prospective inventory of UK cases that are examined each year, reported on a voluntary basis.

Over the years, both Cope and UKRIO have attracted criticism for not having the remit to carry out independent investigations of alleged research misconduct. But this is to misunderstand how they reinforce good practice among those that do have primary accountability. The two organisations bring to the table the important influence of an independent, expert “third party” - the principle that there should always be an external adviser on an investigatory panel. Having this collective conscience offsets the incentives for the kind of institutional cover- up that we know went on in the past. When a letter to a head of institution clearly states that a whistleblower has received advice from Cope or UKRIO, it reduces the risk that a defenceless person’s proper concerns will be swept aside. It is no longer a private matter that can be controlled within the organisation.

I support the concordat, but it is not enough. Some have called for a statutory regulator with powers to conduct independent investigations, a body with “teeth”. Be careful what you wish for. I thought this might be a viable option in 1999, but I can now see the pitfalls. Many countries that have gone down this route have pulled back. By sustaining an expert service such as UKRIO, we give visible expression to our research institutions’ professional responsibility.

Buck up, Britain. The government and research leaders should take action to support and encourage excellence in research integrity, not sit on their hands until - as has happened in other countries - a scandal drives them towards legislation.

Great pretenders: phoneys who fooled the world (for a while, at least)

The Republic of Korea’s stem-cell researcher Hwang Woo-suk’s claims in the mid-2000s to have pioneered a revolution in treatment for major diseases made him a national hero in his native land.

The professor at Seoul National University already had a high profile after claiming to have cloned cows and pigs, claims that won him millions of pounds in grants from the government of the Republic of Korea. But he shot to international fame in 2004 after publishing a paper in Science in which he claimed to have become the first person to create a human embryonic stem cell using so-called somatic cell nuclear transfer.

In 2005, Hwang went one better and published another Science paper in which he reported he had created stem-cell lines from the skin cells of patients - a technique that promised personalised cures for a range of maladies including Alzheimer’s disease. His announcement later that year that he had created the world’s first cloned canine only confirmed his status as the top dog in global cloning research.

Hwang’s apology later in 2005 for paying egg donors and using donated eggs from his own researchers - both of which breached ethical guidelines - initially prompted a wave of patriotic public support for him within the Republic of Korea. However, it ebbed away the following year when an academic investigation panel convened by Seoul National - in response to a colleague’s allegations - concluded that his two Science papers contained “intentional fabrication”. The university sacked him.

Hwang’s expulsion and a government ban on his carrying out stem-cell research was followed by fraud and embezzlement charges. In 2009, he was cleared of the former but convicted of the latter.

The judge said he had “truly repented for his crime”, but still gave Hwang a two-year prison sentence, suspended for three years.

Other high-profile research fraudsters include Jon Sudbø, the Norwegian oncologist and former associate professor at the University of Oslo, who published a series of high-profile articles during the early 2000s that in 2006 were proved to be faked.

One of the papers, an entirely fabricated 900-patient study published in The Lancet in 2005, was described by the journal’s editor, Richard Horton, as the biggest scientific fraud ever perpetrated by a single researcher.

Oslo revoked Sudbø’s doctorate in 2006 after an inquiry concluded that most of his work, including his thesis, was fraudulent.

Last year, Dutch social psychologist Diederik Stapel returned his doctorate voluntarily to the University of Amsterdam after admitting to fabricating a large number of papers.

Mr Stapel was also fired from his position as professor of cognitive social psychology at Tilburg University. The faked papers date back to 2004. Mr Stapel was famous for studies with eye-catching conclusions, such as the claim that meat eaters are more antisocial than vegetarians.

Investigations by three universities into the full extent of his misconduct are ongoing.

United front on research ethics

The Concordat to Support Research Integrity is UK research funders’ preferred approach to the misconduct issue, having decided in 2010 not to renew funding for the UK Research Integrity Office.

The document, backed by the government, the research councils, the Higher Education Funding Council for England, the Wellcome Trust and Universities UK, sets out the responsibilities of funders, universities and researchers.

The final version of the concordat, published on 11 July, says prime responsibility for investigating allegations of misconduct and punishing transgressions lies with employers, who should establish “transparent, robust and fair processes”. It recommends that they nominate a senior member of staff to oversee the area. Universities should develop confidential mechanisms for reporting allegations of misconduct, it continues, and also ideally nominate a person or body to act as a “confidential liaison for whistleblowers”.

The document draws heavily on the “consensus statement” agreed earlier this year at a meeting on research ethics convened by the Committee on Publication Ethics and the British Medical Journal.

However, it does not adopt the statement’s call for universities to subscribe to UKRIO and to report to it the results of misconduct inquiries. It also rejects calls from some quarters - including the Commons Science and Technology Committee - for the creation of a regulatory body to oversee research integrity.

Hefce and some other funders are thought to be looking at linking funding to compliance.

Underwhelmed by oversight

In July last year, a cross-party committee of MPs described the oversight of research integrity in the UK as “confused” and “highly unsatisfactory”.

While the UK had the UK Research Integrity Office, the Committee on Publication Ethics, and would soon have a concordat setting out principles in the area, in other countries, the Science and Technology Committee said, there was more “stringent” oversight.

“The [US] Office of Research Integrity has a mandate to oversee institutional investigations of alleged misconduct in publicly funded research,” it noted in its report, Peer Review in Scientific Publications, adding that a similar external regulator was needed in the UK.

Asked by the committee why funding to UKRIO had been scrapped, Rick Rylance, chief executive of the Arts and Humanities Research Council, said there was a need to “disentangle various functions caught up within” UKRIO and for “a cross-disciplinary and cross-organisational arrangement to…link up the various assurance mechanisms that each funder has, to look at consistency and so on. That will be done…through a concordat arrangement largely run through [Universities UK].”

Sir Mark Walport, director of the Wellcome Trust, told the committee he believed “very strongly” that responsibility for ensuring research integrity “lies with the employers”. “That is why we support moving to a concordat.

“Frankly, we did not believe that UKRIO in the form that it was constituted was delivering what we needed.”

However, UKRIO argued that the UK needed continued access to its expert support.