Research ethics committees

Just as research supervisors need training in research methodology and supervision, so research ethics committees need appropriate training so that they can detect loopholes in project submissions that might lead to perpetration of dishonesty. Furthermore local research ethics committees (LRECs) have a responsibility under the International Conference in Harmonisation (ICH) Agreement on Good Code of Practice to approve researchers as well as research protocols.11 Whilst many LRECs do interview the research worker on a regular basis, problems obviously arise with the globalisation of research, multicentred trials, and collaborative projects. Multicentred research ethics committees (MRECs) cannot really know whether each investigator is properly schooled in research ethics or indeed is the appropriate person to undertake the submitted protocol.12'13 Indeed, in the previous edition of this book and in the Edinburgh Consensus Statement Publication, Wells12 described how two general practitioners fabricated LREC approval and how this could have been prevented. As Povl Riis wrote in his 1994 article on "Prevention and management of fraud in Theory": "Ethics and honesty/dishonesty are concepts of societies as a whole and not confined to the health sciences."2 He also suggested that the presence of a majority (by one) of lay members on seven regional research ethics committees and on the central committee (by two) had proved indispensable. He further stated:

In the Danish control system for scientific dishonesty within the health services the chairman is a high court judge, and the secretary also is a lawyer, but the members are scientists representing medicine, pharmacy and dentistry.When the system was established it was foreseen that lay membership would be a part of the ultimate system, following a planned revision after 2-3 years.When the necessary definitions and analytic procedures have been laid down, it should be no more difficult for lay people to participate in the control process than in the research ethics committees.

The practicalities of introducing such a system in the UK are profound as are the resource implications.

The fact that in the UK the proposals for the new-style General Medical Council (GMC)14 will comprise many more lay members than in the past attests to the pressures from society, an increasingly sophisticated and better educated public, and a radical change in attitudes to the medical and scientific communities with the acknowledgement that traditional "paternalism" is dead and gone.

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