<p>Figure 1</p>

The people responsible for commissioning research in the UK government departments agree: They are spending public money and they must make scientists more accountable. But researchers, already dogged by paperwork and procedure, fear the introduction of yet more layers of bureaucracy. That civil servants, and not scientists, set the new standards makes matters worse. Researchers argue that rather than promoting high-quality research, government bureaucrats are simply making it more difficult.

The Department for Environment, Food, and Rural Affairs (DEFRA), which has a €321 million science budget, is a striking example. The first department to appoint a senior-level chief scientific adviser, DEFRA is moving to exert more control over the research it commissions.

John Sherlock, a civil servant who heads the quality assessment and liaison team in the department's science directorate, is a key figure in its new science management strategy. Sherlock has been in government for some time,...

CODING QUALITY

The result is a new code of practice for research, which is now being enforced by DEFRA, the Food Standards Agency (FSA), the Biotechnology and Biological Sciences Research Council, the Natural Environment Research Council, and the agriculture and rural affairs departments in Wales, Scotland, and Northern Ireland.

The code emphasizes quality of process, as opposed to the quality of science, aiming to ensure that the results of research are appropriate, rigorous, and repeatable. Full compliance with its terms will be a proviso of research grants by June of this year. In the longer term, DEFRA and the FSA want laboratories to apply for formal external accreditation.

This code is not popular. Scientists warn that it will mean extra bureaucracy and extra expense, and that the process of external accreditation will be even worse. Peter Cotgreave, the director of the campaign group Save British Science, describes it as an insult to researchers. "If people produce outstanding scientific results year after year, to expect them to go through another validation process is just silly," he says.

Ian Haines, the head of the UK Deans of Science Committee, concurs. He warns that the new accountability requirements will shut out less-established departments that do not have millions to spend on infrastructure. "It is making it more and more difficult for anyone to break into research," he argues.

Sherlock concedes that researchers do express concern about his plans, but he insists that the department is doing the right thing. "Initially if people are not compliant, it will cost them time and effort, there is no question," he says. "But it will bring benefits. For instance, there will be less need to rework research, as it will be right first time."

Sherlock is not sure yet how much difficulty people will have in adhering to the code, but he scheduled a "friendly audit" of key research organizations for this past December. He is keen to assert that this is not a stick with which to beat scientists. "If they are complying they haven't got a problem," he contends. "If the labs are having problems complying, there's something badly wrong."

Sherlock may face an uphill struggle. He maintains that researchers have been given ample opportunity to air their grievances. However, Haines says most universities remain completely unaware of the code or the June deadline. "There wasn't a consultation in any real sense about this," Cotgreave says. "I think many people must be treating it with contempt. Of course that is slightly unwise, as they won't back down; they will make researchers do it."

Some see the code as another example of DEFRA's tendency to smother research in red tape. One senior scientist, who wishes to remain anonymous, says the department is generally guilty of 'nanomanagement.' He adds that DEFRA's internal processes are far from transparent. "How does DEFRA make decisions? I wish I knew."

Other researchers say Sherlock is a typical civil servant who is distanced from the scientists at the bench and does not understand their needs. But Sherlock's manager, Howard Dalton, a professor and researcher, offers a potentially different example.

Dalton's appointment to the new post of DEFRA's chief scientific adviser in May 2003 looked set to herald a change. He reports directly to ministers, suggesting a promotion for science within the department. And he works one day a week at the University of Warwick, keeping him in touch with bench scientists. Dalton was billed as the outsider who would come in and shake things up.

But nine months later there is some skepticism about whether Dalton, who is a firm believer in the new code of practice, will succeed in transforming the culture. Cotgreave is less dubious. "Howard Dalton is a real scientist working at Warwick and shouldn't be hamstrung as much as the other civil servants," he says. "You still hear people saying DEFRA is not on the ball, but I don't think that's his fault."

A HEALTH UPGRADE

Dalton's counterpart in the Department of Health, John Pattison, also has a strong academic pedigree. The department's director of research, he is professor of medical microbiology at University College London, where he previously was vice provost for medicine. Pattison says this "helps enormously" in understanding the science base, though his current agenda to modernize research in the NHS is met with some suspicion. "There is something oxymoronic about talking about modernization and research in the same sentence," says David Gordon, the dean of the University of Manchester's medical school and chair of the Council of Heads of Medical Schools.

Pattison is particularly keen to promote better collaboration. His team is developing a framework agreement for research, which aims to formalize and direct partnerships between universities and NHS bodies. This has yet to be officially announced, but it is already being met with trepidation. Universities UK, which represents university vice chancellors across the country, says one partnership model won't suit every institution. "In practice on the ground, universities and NHS bodies generally work pretty well together. Formalization of those partnerships might be excessive," Gordon warns.

Gordon says all researchers are being penalized unfairly as a result of recent scandals such as those at Alder Hey and Bristol Hospitals, where organs were removed and stored without consent. "That has created an atmosphere where a degree of formalization has been put in place that in 99% of the time is not appropriate," he explains.

Pattison also is responsible for the introduction of a new research governance framework, which highlights the need for a clear allocation of responsibilities. There has been considerable anxiety about this and what it will mean for universities. Central to this concern is the framework's use of the new term "research sponsor," which Universities UK says "muddles existing roles between universities and trusts." Some universities have expressed concerns that if trusts become sponsors, they will have extra muscle with which to dominate the universities.

Pattison is adamant that the sponsors will remain, partly because they are part of the new EU clinical trial directive. But, he insists he is in discussion with the Medical Research Council "to try and avoid [the requirement] becoming too onerous." He denies any suggestion that he might be trying to micromanage research, but he acknowledges that the current climate is not easy for researchers. "Researchers might say we are putting difficult rules and regulations into place, and when you add them all up they are quite a burden," he says. "We appreciate that, and we are always looking at ways to try and streamline things."

Such an attitude might be cause for optimism. Gordon points out, however, that Pattison is due to retire soon, and no one is sure whether or how he will be replaced. To compound this uncertainty, the department is also currently recruiting two new deputy directors of research and development. Gordon observes, "What they do will set the tone of how well work is done in the future."

Anna Fazackerley afazackerley@yahoo.co.uk is a freelance writer in London.

UK Research Practice Code

Schedule

Until May 2004 Researchers must be aware of the code and work towards compliance.

June 2004 onwards: Full compliance with the code will be expected.

2006: Both DEFRA and the FSA will expect all labs to be externally accredited.

Key requirements

Managers have a responsibility to ensure a climate of good scientific practice.

Project plans must be developed in collaboration with the funding body, including risk assessment.

The organization must have processes in place to assure the quality of research.

All samples and experimental materials must be comprehensively labeled and tracked.

All research procedures and methods must be documented. The project leader must regularly review the records of each scientist.

Applies to research commissioned by Department for the Environment, Food, and Rural Affairs; Food Standards Agency; Biotechnology and Biological Sciences Research Council; Natural Environment Research Council; and agriculture and rural affairs departments in Wales, Scotland and Northern Ireland.

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