We have discussed the enormous importance of exact definition, if the process adopted is to be fair and acceptable, since it is obviously unfair for any scientist to be accused of misconduct if there is no clear statement of what constitutes misconduct. Indeed, a basic foundation of the rule of law is that the laws should be specific and published. The Edinburgh Consensus conference was a very important step in beginning to address the problem in the UK, but when we apply our criteria to the definition in the Consensus Statement (Figure 2.4) we find it wanting.
What is good about it?
It recognises that every case of scientific misconduct weakens our trust in science. It also mentions that it goes beyond "FF&P", which we believe to be important, and it recognises that changes may be necessary in the future.
And what is bad?
The Consensus Report is an early stage in an evolutionary process that will probably take years, so it is unfair to criticise it severely, but it is worthwhile to note its deficiencies because they help to tell us what needs to be done.
Was it universal?
The composition of the Consensus meeting, which was largely made up of people interested in clinical research, seemed to suggest a role for the
Consensus Statement (Preamble and Definition only)
Patients benefit not only from good quality care but also from good scientific research. We all expect high standards of scientific and medical research practice. The integrity, probity, skill and trustworthiness of scientific and medical researchers are essential if public confidence is to be assured. In the design and execution of biomedical and healthcare research, public participation is essential. The Joint Consensus Conference on Misconduct in Biomedical Research was convened in order to debate, address and offer guidance on key questions because "every single case [of fraud and misconduct] reduces public confidence, abuses the use of public and charitable funds, and causes insult and frustration to the vast majority of careful, honest workers".1
The definition of research misconduct
Behaviour by a researcher, intentional or not, that falls short of good ethical and scientific standards
No definition can or should attempt to be exhaustive. It should allow for change. The definition should not be read as being restricted to fabrication, falsification of data and plagiarism. It is intended to cover the whole range of research misconduct.
1 Rennie D, Evans I, Farthing MJG, Chantler C, Chantler S, Riis P. Dealing with research misconduct in the UK [and other articles]. BMJ 1998;316:1726-33.
Figure 2.4 Joint Consensus Conference on Misconduct in Biomedical Research 28-29 October 1999.
General Medical Council. However, a proposal that the General Medical Council serve as the fulcrum of a UK system fails the test of universality. As in the US, concern first started when misconduct was found in clinical research, which, of course, seems rather too close to home for most people. But it is a widespread problem. An organisation established to discipline physicians cannot realistically police scientific misconduct when, even in clinical research, most projects involve numerous co-workers with different degrees and expertise, some of them completely outside medicine. Some mechanism must be found to broaden the scope of regulation and enforcement.
Was it official?
The Edinburgh Consensus Report, developed as it was in a closed meeting, even though a good start, and even though it was immediately published, was not issued by any body with the mandate and legal power to make its recommendations happen. Nor was it developed with a broadly-based enough input to build sufficient understanding to produce a result that will be widely accepted.
The definition of research misconduct proposed by the 1999 Joint Consensus Conference is neither specific nor does it provide clear guidance on the meaning of its critical terms. Indeed, it is so vague, nonspecific, and all-encompassing, that it is unworkable.What are "good ethical standards"? In which field? In what circumstances? By whose judgment? There are whole areas of research - for example, research on stem cells, or on aborted fetuses - where ethical scientists hold strongly divergent opinions about "good" standards. Worst of all, the definition includes unintentional behaviour that falls short of good scientific standards. To give an example, one of us (DR) used to conduct physiologic experiments at high altitude in Nepal. Once a whole batch of specimens was ruined because DR had not known that dry ice would be unavailable during a religious holiday. As a result, the results obtained were incomplete and the differences not statistically significant. I had not met the "good scientific standards" set out clearly in my protocol, devised with my colleagues in the US. If this sort of thing is misconduct, as it clearly would be under this strange definition, how could anyone ever dare to attempt science? In addition, the statement that the definition "is intended to cover the whole range of research misconduct" is circular.
As to "clear and fair process", though the specifics of handling accusations of misconduct are essential ingredients of any successful system, the Consensus Report says little or nothing specific about procedures, so most of the elements necessary for a useful system are undefined or absent. The US experience illustrates that getting the process right matters as much as having the right definition. In fact, one could posit that the low-key acceptance of the new government definition in 2000 is rooted as much in the growing comfort that proceedings - if never pleasant - are not unfair or biased by design. Much can be learned from the American experience with process, both by those with institutional responsibilities, and those who are caught in a specific situation.19-21
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