Time to face up to research misconduct

Britain and many other countries are failing to respond to evidence of misconduct.

Every country that conducts scientific research experiences research misconduct. I can't support that statement with irrefutable evidence, but other countries that have looked for misconduct have found it.1 2 It would be strange if they did not find misconduct. Why should scientific research be the only human activity immune from crookery. Of the countries that conduct scientific research, only a minority—the United States, Denmark, Norway, Finland, Austria, and Australia—have a coherent system for tackling the problem. Other countries need a system for promoting scientific integrity, providing research into misconduct, and detecting, investigating and punishing misconduct when it does occur. We also need to study research misconduct, horrible as it might be, so that we can better understand its epidemiology.

Research misconduct is back on the British agenda after yet another case last week where the General Medical Council struck off a general practitioner for forging the consent forms of patients entered into a research study sponsored by a drug company (p 798).3 Dr Geoffrey Fairhurst was far from being a marginal member of the profession: he was vice chairman of his local medical ethics committee. Dr Fairhurst was the 16th doctor to be found guilty of serious professional misconduct after referral by the Association of the British Pharmaceutical Industry since the association began actively referring such cases in 1988.4 5 Other than those referred by the Association of the British Pharmaceutical Association, the General Medical Council has found only one other doctor guilty of serious misconduct for research misconduct—Malcolm Pearce, the obstetrician and gynaecologist who published a series of fraudulent papers, two of them in the same issue of the British Journal of Obstetrics and Gynaecology and two of them in the BMJ.6 This distribution of cases is explained not by research misconduct being concentrated among general practitioners doing drug company sponsored research but by drug companies having a highly effective system of auditing raw data and not being ashamed of reporting cases. Good for it and the General Medical Council for being willing to take swift action. But Britain needs much more.

This week also sees the publication of the second edition of Fraud and Misconduct in Medical Research by Stephen Lock and Frank Wells.1 A great deal of new material has been added since the first edition was published only three years ago. As the authors explain, we do not know the exact prevalence of research misconduct, but anybody inclined to dismiss misconduct as unusual might read Lock's chapter where he lists over 70 documented cases.7 Several surveys have shown that many researchers know of cases of misconduct, and that many of these cases have never been reported.7 A recent BMJ seminar heard Peter Wilmshurst, a cardiologist from Shrewsbury, describe many cases of misconduct, very few of them in the public arena because of institutions' reluctance to tackle them, junior researchers' fears of reprisals if they speak out, and England's repressive libel laws. Far from refuting Wilmshurst's assertions, editors and researchers attending the seminar gave corroborative details for some of the cases he reported and added other cases of their own.

Research misconduct is never off the agenda in the United States, but an important recent development has been the publication of the report of the Commission of Research Integrity.8 The commission was set up by the United States Department of Health and Human Services and Congress because of “the apparent inability of the scientific community and the federal government to deal adequately with misconduct in scientific research.”

One of the commission's many tasks was to define research misconduct. (It has chosen to use the term “research misconduct” rather than “scientific fraud” to avoid legal confusion.) The commission rejected the previously accepted definition of “fabrication, falsification, and plagiarism” because it is “neither narrow nor precise,” and decided instead on the definition reproduced in the box. This includes three main types of misconduct: misappropriation, interference, and misrepresentation. The definition meets both scientific and legal requirements and should prove useful to the bodies all over the world that must concern themselves with research misconduct.

The commission emphasises that the responsibility for preserving research integrity and pursuing research misconduct must lie primarily with individual scientists, research institutions, and professional societies. The report states that “research integrity is best fostered by developing and disseminating clear standards of behaviour in science and by reinforcing these standards through education and example at all stages of scientific development.”8 Accountants, who know a lot about fraud, call this “tone at the top”—corrupt leaders have corrupt followers. The commission advises that all institutions conducting research must have mechanisms for allowing fair, open, unbiased, accessible, and fact based investigation of complaint; and the institutions must treat “whistle blowers and those they accuse of research misconduct … with respect, fairness, and openness.” The commission includes in its report a “Whistle Blower Bill of Rights.” This states that “members of the scientific community with knowledge of research misconduct have an ethical responsibility to come forward. But few are likely to fulfil their responsibility in the absence of a system that provides a full review of concerns and effective protection from retribution.”

Britain lacks most of those structures and processes needed to mount an effective response to research misconduct. And its medical profession harbours a culture that prefers to sweep such problems under the carpet. Just as the thalidomide cases led to improved methods of ensuring drug safety, many hoped that the Pearce case would lead to an effective response to research misconduct. Unfortunately, it hasn't.

After the Pearce case, Lock argued in the BMJ for a central committee that would provide guidance on this difficult problem, promote prevention, offer impartial investigation, collect data, and sponsor research. The Royal College of Physicians bravely took up Lock's challenge and called a meeting to consider setting up a central body. At the meeting representatives of the Royal Society, the Medical Research Council, and the General Medical Council were scornful of the proposal and the initiative stalled. The college was understandably reluctant to push the matter in the face of such opposition, and it was worried about its legitimacy in taking the lead. The whole affair illustrates yet again the need for a body that can speak authoritatively for all of medicine and exercise leadership in the vital subjects like research misconduct.9 10

We join the Lancet this week in calling for the British medical profession to try yet again to tackle research misconduct effectively.11 Otherwise, government will have to do it—and doctors' ability to regulate themselves will be thrown further into doubt.12