Pressure to publish
In the UK the relatively recent introduction of the peer reviewed rating of research, the Research Assessment Exercise (RAE) within academic institutions and the consequent effect on the allocation of resources brings its own new scrutinies and pressures on research performance. Furthermore, the number of publications rather than any inherent assessment of quality is often used in NHS and academic appointment committees, so that financial pressure becomes inherent in these processes. Until the quantity issue is replaced by quality, this will remain undesirable, and possibly a pressure towards research misconduct.34
Whilst pressure to publish may well be the commonest cause, most investigations into research misconduct have rarely examined the motivation in depth. Scientific success is often achieved by the prolific output of research papers and this can have general knock-on effects including the following: academic promotion, discretionary points and merit awards leading to higher salaries, lucrative "consultancies", tenure of appointment, and increased research grant income. Of course in order to respond to these pressures, the "salami" approach to publication may be employed, resulting in multiple publications on virtually the same subject.
In the UK many medical researchers also undertake onerous clinical duties for the NHS and thus their time itself is very pressurised, which in itself may lead to research misconduct. As Forbes wrote,35 "The overt signs of a researcher on the fast track are the number of publications in a very short space of time." He cites the Darsee affair, when 18 research manuscripts and about 100 other reports appeared in four years. Forbes also concludes that other high profile examples may have resulted from pressure to publish:
1974: William Summerlin, Sloan Kettering Institute - faking skin transplants. 1977: Robert Gullis, Birmingham University - faked research results for PhD and 11 papers.
1981: Michael Briggs, Deakin University, Australia - forged data on oral contraceptives.
1985: Robert Slutsky, University of California - 137 papers in seven years (48
questionable and 12 fraudulent). 1993: Roger Pauson, St Luc's Hospital, Montreal - falsified data on breast cancer trials.
Despite all this, however, Rennie, writing in the BMJ in 199 8,36 believes that we should all stop whingeing about the awful pressures of "publish or perish", as he thinks that we should stop being led astray by pretending that we know the motives when we can only speculate! He says that we have little credible evidence on what motivates misconduct or indeed, on the other hand, what motivates the conduct of honest equally stressed colleagues. A good point! He cites, "laziness, desire for fame, greed or an inability to distinguish right from wrong", and says there is an urgent need to encourage investigation in this area, including confidential experimental audits.37
These are easier to identify and have clearly been a major pressure in several notable instances. This may often be a problem when the pharmaceutical industry is involved, when investigators receive payment in relationship to the number of patients recruited to the protocols, the number who are followed up, and who undergo continuing evaluation. However, as described earlier, the industry has better control over this with its systems of checks and balances. Of course, the industry is hugely motivated to prevent research misconduct. A company loses on average £650 000 (US $1m) a day in delay on registering a new drug. As Lars Breimer pointed out:38
Conducting a trial to good clinical practice standards costs about £20000 (US $32 000) a patient.Thus if a 25-patient study has to be repeated and 100 days are lost a company can lose over £1m (US $1.6m); in the case of a 400-patient study requiring two years from start to finish it can lose about £500m (US $800 m). In addition, the reputation of the company is at stake. In the UK companies hand over the evidence to the institution where the person works and lets it act in the investigation, detection and outcome. If officers of medical schools or district general hospitals were to find themselves facing a bill of £500m plus legal costs, they would soon devise a fair and efficient system of investigating alleged misconduct.
Forbes35 quotes other examples where money was the main motivation. Other cases with a financial motive include:
• JP Sedgwick, High Wycombe, UK - a family doctor in an antihypertensive trial; 121 records forged.
• 1988: VA Siddiqui, Durham, UK - faked data from an antidepressant trial.
• 1990: K Francis, Coventry - faked records in an antibiotic trial.
• 1991: S Kumar, Hornchurch - faked records in a hypertension trial.
• 1991: L Pandit, Wimbledon - faked records in trial of CAOD.
• 1991: D Latta, Glasgow - faked records in a hypertension trial.
Duff39 also drew attention to other not so commonly cited potential causes as quoted below:
• New factors necessitate a change in research management.
• Globalisation of research activity makes it impossible to assess reliability through personal knowledge of others in the same field.
• Developments, such as bibliometrics, the research assessment exercise, and the link between research success and promotion, demand a stream of research publications.
• The expectation of institutions to generate income from their intellectual property (IP) has increased.
• Computer-based data acquisition, record-keeping, and display technologies increase the scope for falsification.
A strong case exists for all institutions to adopt the highest standards of record-keeping. The 1996 International agreement on trade-related aspects of intellectual property (TRIPs) recommends bound, consecutively-numbered notebooks, with numbered pages that are read and signed regularly by an independent scientist. In practice, there are many benefits beyond the securing of IP: diligent record-keeping, better project planning; a permanent and defensible record; a strong deterrent to falsification; early detection of irregularities; easier confirmation of veracity. Adopting TRIPs-compatible standards is a practical move, available to all research institutions, towards reducing fraudulence in science.
Documentation in this area is not good but in the absence of any other motivation it seems reasonable to conclude, given the prevalence of psychological morbidity and psychiatric illness within the general population, that this must be a relevant factor.
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