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Does the average member of a research ethics committee (REC) or the average researcher really need yet more guidance? In the UK, the Department of Health, the National Research Ethics Service, the Medical Research Council, the Association of the British Pharmaceutical Industry, the General Medical Council, a number of medical Royal Colleges and a variety of other professional groups seem to be falling over each other in their enthusiasm to indicate how ethical review should be organised, considered or determined. Other countries may have less guidance, but in the UK there seems to be a surfeit of opinion and advice. Surely no more is needed.
Against this background, the UK’s senior professional medical body, the Royal College of Physicians (RCP) in London has just launched more guidance: the fourth edition of its Guidelines on the practice of ethics committees in medical research with human participants1 (hereafter called “the Guidelines”). With the lapse of more than 10 years since the last edition, some might wonder whether it isn’t time for the RCP to disengage from the increasingly regulated environment of ethical review of research. Why should the average REC member, the average investigator or those involved in research governance rush to obtain a copy of yet another publication?
The need for this document was debated well before the enterprise of producing it was begun. It was clear that any new document would require almost the entire rewriting of what had been produced previously—a job not lightly undertaken. The challenge was to produce a document that—along with the Department of Health’s Governance arrangements for NHS research ethics committees2 (GAfREC)—provides the REC member with the essential equipment to …
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