The way forward for the UK lessons from elsewhere

As stated earlier, the Darsee affair was 30 years ago, and it is now over 12 years since Stephen Lock, the then editor of the BMJ, published the results of a personal survey "Misconduct in medical research: does it exist in Britain?"40 Lock indeed concluded that it did and that urgent action should be taken to prevent the problem by establishing an organisation

They continue: "We expect that this paper will be given the fullest possible dissemination by the sponsoring bodies and that the three Royal Colleges of Physicians and the Faculty of Pharmaceutical Medicine will convene at the earliest opportunity a meeting with the General Medical Council and appropriate partners to establish and consider the remit of the national panel."

In an angry polemic last year, three members of COPE berated the medical and scientific community for doing so little since Lock's first enquiry.40

As stated earlier the UK lags behind many other countries and most institutions have scant experience of dealing with allegations of research misconduct. The knowledge that robust systems are in place for detection and investigation should act as a powerful deterrent. Earlier in the USA the OSI developed an unfortunate relationship with the research communities mainly because it adopted a confrontational approach. The new ORI has developed a better partnership approach and subsequently there is more confidence in its procedures.

Evans43 commenting on data from the ORI says:

There continue to be a number of investigators who are disciplined by the US Health Authorities and the (ORI). The most recent report by ORI presented an analysis of 150 scientific misconduct investigations which were completed between 1993 and 1997. The 150 investigations resulted in 76 findings of scientific misconduct and in 74 findings of no misconduct. Falsification was the most frequent type of misconduct that resulted in investigation, fabrication was second and plagiarism was third. There were about 1,000 allegations but no action was possible on two thirds of them. This was because the allegation did not contain sufficient specific information to proceed, or the whistle-blower was unknown, or unable or unwilling to provide additional data. Falsification and fabrication accounted for 86% of the investigations and 91% of the misconduct findings. Audits of studies in cancer and leukaemia suggested a very low incidence of misconduct in clinical trials (two instances over 11 years). It is not clear whether the audits were effective, since one institute passed the audit but was subsequently found to have problems.

The Nordic countries have also adopted a less confrontational approach and eschewed rigid definitions of research misconduct in favour of sound judgment. Their experience of seven years indicated that, of 68 allegations received, 47 were investigated and nine cases of research misconduct were identified. Whilst that may seem a small number, it only takes one case to undermine public and patient confidence in medical research.

As discussed earlier, in the UK the responsibilities must be with the employing authorities. Whilst such arrangements are in place in some organisations such as the MRC, many of the largest employers, for example the NHS and the universities, are light years behind. As George Radda, Chief Executive and Secretary, MRC has written:

Good research practice (GRP) is a key preventive strategy that underpins scientific integrity. GRP is concerned with the organisation of research; it governs the processes and conditions whereby studies are planned, carried out, monitored, recorded and reported. It permits the quality and integrity of data to be verified and ensures that the fruits of research are applied and/or exploited appropriately. In essence, GRP is an attitude to work. The MRC has recently prepared detailed guidance on GRP for its staff. As with the MRC's procedure for dealing with allegations of scientific misconduct and guidelines on good clinical practice in clinical trials, we hope that this information will interest the broader research community and welcome feedback on our approach.44

As discussed earlier the NHS may find it easier to incorporate GRP into NHS research under the umbrella of Clinical Governance, than the universities.

The MRC has a stepwise approach (Box 17.2).44'45

Box 17.2 MRC's stepwise approach to scientific misconduct

• Preliminary action To determine whether the allegation falls within our definition of scientific misconduct.

• Assessment To determine whether there is prima facie evidence of scientific misconduct.

• Formal investigation To examine and evaluate all relevant facts to determine whether scientific misconduct has been committed and, if so, the responsible person(s) and seriousness of the misconduct.

Universities are more problematic since the medical schools within them are not autonomous and are answerable to their parent organisations. Any codes of practice in the arena of research misconduct would have to be agreed with the Committee of Vice Chancellors and Principals (now Universities UK) and adapted to the needs of individual universities.There is also the old argument about the disposition of responsibility when academic university employees undertake clinical research on honorary NHS contracts. Other medical organisations can and must play an important role. Thus, the medical royal colleges have published guidance in the area, particularly the Royal Colleges of Physicians (London) and Edinburgh.45 They of course can exert a disciplinary role and can withdraw fellowships etc. from any found guilty of research misconduct. The Royal Societies (UK) and the recently founded Academy of Medical Sciences can also promote high standards and COPE, and the GMC likewise.

The GMC did indeed initiate a meeting of the representatives of the medical royal colleges and heads of medical schools to discuss the way forward, and out of this a committee was established. It has set in train a review of the 1991 Royal College of Physicians guidance45'46 and with advice from others has a goal aimed at supplying transparent advice to universities and to the GMC itself. As part of this effort all UK medical schools were asked to submit their guidance and procedures within the framework of the GMC 1998 publication on Good medical practice.21 As a result the GMC plans to produce a document on Good practice in research in the near future (GMC, 2001 personal communication).

Finally, the need for a separate overarching body to oversee good practice in medical research really requires an urgent airing at the highest level, with involvement of all interested parties. This can only be done by collaboration and dialogue together with representatives of patients and the laity, research institutions, royal medical colleges, hospitals, commercial laboratories, pharmaceutical companies, the law, politicians, and the GMC.

As a glance at any UK newspaper will reveal, public confidence in medicine, science, and scientific research is arguably at an all time low, and a concentrated effort to show that their concerns are taken seriously must be the best way forward and is of paramount importance for the good-standing of the scientific community.

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