Family Practice Vol. 19, No. 2, 123-124
© Oxford University Press 2002
Editorial |
Research misconduct
Jones R. Research misconduct. Family Practice 2002; 19: 123–124.
Last year, 51 cases of major research misconduct were reported to COPE, the Committee on Publication Ethics in the UK. The Association of British Pharmaceutical Industries (ABPI) has identified a further significant number of high-profile cases of scientific fraud, and the General Medical Council (GMC) in the UK is overloaded with similar cases. There can be little doubt that our current mechanisms for preventing, identifying and acting on research misconduct are inadequate, and this was the reason for the third COPE seminar, set up to debate the proposition that the UK needs an independent review body to deal with biomedical research misconduct.
Fraud and misconduct can take place at many points along the research continuum, between the research question and the research publication. The process begins with trial design, issues of consent and confidentiality, and the need to obtain Research Ethics Committee approval, antedating the research process itself. The attitudes, beliefs and, indeed, honesty of researchers are likely to be tested along this route; given the alarming findings about the lack of honesty of a cohort of undergraduate medical students in the UK, it is perhaps unsurprising that misconduct occurs.1 Further opportunities for falsification occur at the output end of the research process, and peer review itself, particularly the selection of conference abstracts and papers, is fraught with problems. Finally, the publication of research papers offers a range of opportunities for unethical behaviour, including salami, prior, duplicate and multiple publication, gift authorship and falsification of results.
The definition of research misconduct needs to embrace many of these potential lapses, but also needs to be precise enough to ensure that any body engaged in its prevention or investigation knows exactly what it is doing. In 1999, the Royal College of Physicians' report included phrases such as ‘piracy, plagiarism and fraud' and ‘theft, fabrication and destruction'.2 A more recent definition would include fabrication, falsification, plagiarism and destruction of data in the course of proposing, carrying out and reporting research, including failure to follow protocols and collusion with others, permitting research misconduct. Publication misconduct also includes failure to publish, failure to declare conflict of interest and causing deliberate delays in the peer review process, often by bringing forward false criticisms of papers under review.
Sir George Alberti, President of the Royal College of Physicians, agrees that we need a national body of some kind, which would include among its activities prevention and monitoring of scientific fraud, and the establishment of institutional complaints procedures, through written guidelines, backed up by inspections. It would produce institutional and local policies for research conduct and define responsibilities for training research supervisors and researchers. Such a national panel would promote consistency of advice and action about research misconduct through the production of guidelines to advise institutions; its accountability remains to be determined.
There are already examples from other countries of structures that have been established to deal with research misconduct. Drummond Rennie, from the Journal of the American Medical Association, described how the Office of Research Integrity (ORI) was set up in the USA, and pointed out that discussions about research misconduct have now become routine since its establishment. The ORI was set up as a joint initiative between the American Association for the Advancement of Science and the American Bar Association. It has a statutory role, and follows scientific fraud through the funding tentacles of major federal funders such as the National Institutes for Health. It now has a science-wide remit, to monitor and act on research fraud in any institution in receipt of government research money.
In Scandinavia, research misconduct committees have been in operation since 1992 in Denmark, 1994 in Norway and 1997 in Sweden. Research misconduct is defined more broadly and less precisely than in the USA. These committees have both preventive and investigative roles, with sanctions being left to institutions, and with no appeal mechanisms. However, very few cases of scientific fraud are investigated in Scandinavia, perhaps eight significant cases per year, of which only about one-fifth turn out to be well founded. The discussion centred around whether or not these bodies should concentrate solely on health-related research, whether they should have a legal foundation or not, the extent of their preventive efforts and their relationship to existing research ethics bodies.
Proposals for a national panel for research integrity have been published recently in the UK.2 In this document, a broadly based, non-statutory body is envisaged, with a very broad remit, including education and the development and maintenance of standards, and audit, as well as a co-ordinating function for allegations or suspicions of misconduct in biomedical research. External clinical advice teams will be available to assist institutions in the investigation of research misconduct, and standard operating procedures, analogous to those developed by the ABPI, are also proposed.
The COPE conference took a similar, but distinct view. There was general agreement that there was a need for a national body of some description, mainly because of the uneven and often unsatisfactory response of institutions faced with scientific misconduct, the consequent need for national guidance on procedures and lines of communication and the evident inadequacy of current structures to provide these. There was general consensus that such a body would be non-statutory, and would derive its authority from the commitment of the research community and associated institutions; indeed, we thought that funding should be sought principally from the research community (including higher education institutions and research funders) rather than from central government. There was also general agreement that, as well as having a principal investigative role, it was inevitable that an educational/guidance and possibly audit role would also be required. However, the non-statutory approach did not work in the USA, and this important question remains to be settled.
We envisage that the new body, possibly a Council on Research Integrity, would expect institutions to undertake their own investigations of research misconduct, but would provide guidelines for doing this, and would be able to investigate problems directly in smaller institutions such as district general hospitals and Primary Care Trusts. ‘Whistleblowers', by whom most research misconduct is identified, would be able to approach the new body if there was concern about confidentiality or professional pressures within their institution. Sanctions against researchers involved in misconduct would be a matter for the Institution unless the law had been broken.
We published the COPE guidelines on publication ethics in Family Practice 2 years ago.3 During my editorship, I had not experienced a single case of research misconduct before the guidelines were published, and happily only one episode, an unsuccessful attempt at dual publication, has cropped up since. Indeed, I have been impressed by the professionalism, probity and efficiency of contributors to Family Practice and, almost without exception, to the sterling service provided by the very large number of colleagues who undertake the often thankless task of peer review for the journal. Our thanks to all of you.
References
1
Rennie SC, Crosby JR. Are ‘tomorrow's doctors' honest? Questionnaire study exploring medical students' attitudes and reported behaviour on academic misconduct. Br Med J 2001; 322: 274–275.
2 Stonier P, Lowe GDO, McInnes G et al. A National Panel for Research Integrity: a proposed blueprint for the prevention and investigation of misconduct in biomedical research. Proc R Coll Physicians Edinb 2001; 31: 253–255.
3
Committee on Publication Ethics. The COPE Report 1999. Guidelines on good publication practice. Fam Pract 2000; 17: 218–221.
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