In 1989 a report from the Institute of Medicine in the USA4 highlighted the importance of training new scientists in research standards and ethics. Indeed, in the USA as elsewhere, training is now required for, amongst others, those enrolling in research training and in receipt of grants from the National Institutes of Health (NIH) or the Alcohol, Drug Abuse, and Mental Health Administration (ADAMHA). In the UK, the Medical Research Council (MRC) requires that the code of Good Research Practice (GRP) is adhered to.5'6 Ten years ago, a survey of more than 2000 biomedical trainees (clinicians and basic scientists, medical students, graduates, and postdoctoral fellows) at the University of California in San Diego found that 23% had no training in research ethics, 36% had observed some kind of scientific misconduct and 15% would be willing to select, omit, or fabricate data to win a grant or publish a paper.7
Even more alarming was a report that, in a survey of 1000 students in UK universities by Newstead and colleagues in 1994, 12% admitted copying from a neighbour during an examination and 8% stated that they had taken crib sheets into the examination hall (Independent, 26 March 1994).
In the UK in 1998, a paper in the Association of Medical Schools in Europe Newsletter (AMSE) drew attention to the extensive repercussions and fall-out from research misconduct, drawing extensively on the USA experience, which is discussed by others in this book. The University of Chicago responded by developing a two-year "scientific integrity" programme and concluded that, when a new researcher joins an institution (university, medical school, research institute, or hospital), research misconduct will not be tolerated.8 This bottom-up approach is really the only practical way of creating the right culture, which must start with undergraduate education (both medical and scientific) and extend within the framework of lifelong learning and continuing educational and professional development. In order to achieve this, however, systems must be in place to ensure formal training of those responsible for research supervision and the establishment of written codes of best practice. In the case of the fraudulent papers published by Pearce and colleagues (1995) (see Chapter 4), no such procedures were in place, and some of the younger investigators were the hapless victims of the gross research misconduct.9 In the case of Davies in 1999 (see Chapter 4), younger colleagues participating in the research were subjected to threats and abuse for failing to comply with the demands of the senior investigator. It is to their credit that they blew the whistle, which initiated the investigations resulting in Davies being erased from the Medical Register by the GMC.
Every institution engaged in research must have a manual of good practice that clearly states the responsibilities of both the research worker and the supervisor. It should be made clear that there must be regular discussions between the two about the data and the progress of the research. Access to raw data must be readily available and subject to external review when appropriate. It must also be explicit that the raw data do not belong to the individual researcher or supervisor but to the institution itself.10 This requires meticulous recording and accessibility of research data, and these records cannot "travel" (except in duplicated form) with the research worker or supervisor; the raw data must also be available for at least ten years after publication. In the main, the pharmaceutical industry, for obvious reasons, has long had these good practices in place, which probably accounts for the fact that most proven examples of research misconduct arise from within the industry, attesting and providing "evidence" that their procedures expose fraud more effectively than in other domains of the scientific community. In this regard external audit by examiners who demand to see the raw data should be welcomed, and the assistance of trained statisticians employed. If this had been the case, it is arguable that one of the Pearce papers might not have been published, although in truth uncertainty about this still exists.9 As discussed in Chapter 18, editors and their teams have an important role to play.
Whilst it may be relatively easy for the right research culture to be established in an individual organisation, multicentred trials and collaborations carry their own difficulties, especially when conducted across international boundaries and differing cultural backdrops. At the outset, transparency must be the name of the game, and issues of authorship clearly spelt out at the beginning as well as a contractual obligation that, if any allegation of misconduct is made against any collaborator, they must agree to cooperate with any ensuing enquiries.
Having the correct procedures in place with the relevant documentation as outlined in the previous paragraph is all very well but, unless there is a robust system of monitoring in place, then we may be whistling in the wind. Clearly within universities, medical schools, and hospitals this should be done within divisional structures with the research supervisor reporting to the head of department and then to the divisional head. Such reportings need to be supported by regular unannounced visits or vivas, where the research student and supervisor are subject to "external" scrutiny. It must also be clear to all what the institution's policy is for investigating and managing any allegations of misconduct.
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