It took 20 years to achieve a set of widely accepted regulations in the US. In the hope that examination and understanding of this experience might prevent a great deal of reinvention of wheels, we will summarise what we believe are the essential elements. First, however, consider the catalysts:
• Repeated, dramatic incidents resulting in publicity showing that research institutions operated in ignorance, denial, and cover-up; and there was recurrent shaming of institutions in the media. (This is the present position in the UK.)
• A few powerful politicians, highly sceptical of the establishment's reassurances that all was well, repeatedly exposing the thinness of these reassurances, pushing for regulation, and, finally, exasperated by the "do-nothing" approach of science, forcing regulation to be tied to the continuance of federal research funds. (This is not happening in the UK, where, in a vacuum, the role has been, to some extent, taken over by a few courageous and outspoken medical editors, starting with Stephen Lock [BMJ] and continuing with Richard Smith [BMJ], Richard Horton [Lancet] and Michael Farthing [Gut], with COPE (Committee on Publication Ethics); and by Frank Wells and his notable efforts with the investigation of cases of misconduct in clinical research.)
• Numerous meetings attended by representatives of science, lawyers, administrators, and legislators.
• The establishment of oversight offices predicated on the assumption that research misconduct was basically a clinical research problem. Followed by a gradual realisation that misconduct can occur in every branch of research, from mathematics to the humanities, and that administering its regulations would be much easier if all researchers were governed by the same rules.
• Learning from experiment and hard experience. The "scientific model" did not work when the unfairness and illegality of the process was exposed (usually by lawyers or journalists). Scientists had to learn that processes for appeal were necessary, and that investigation and adjudication should be separated. Gradually a case law built up, and the process was absorbed into those of administrative law.19-21
• Greater education all round. Everyone concerned came to realise that it is beneficial to assure that students - no matter who their mentor -receive certain baseline information about good practice, and that, because scientists were mortals, it made sense to have processes in place to deal efficiently and routinely with those who strayed.
Constantly retarding the process of reform are several factors. Many distinguished scientists cannot accept that scientific misconduct can occur until it happens near them and they have to deal with it. More generally, it seems to be a human trait to seek power without accountability, so scientific organisations can be expected to oppose all regulation, including any amendment to even previously-condemned regulations.
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