Good clinical research is hard to do at the best of times, and there is a growing perception that the regulatory environment is making it increasingly difficult to plan and carry out clinical trials within a realistic time frame. A recent editorial in the BMJ claimed that the 2004 European Union clinical trials directive has hindered this process.1 Anyone who has tried to carry out a clinical trial, particularly a multicentre one, knows only too well the frustrations of seemingly endless negotiations during the review process. While research may be a moral duty^w1 in our search for better ways of caring, we must always be on guard against using patients and volunteers as a means to an end, as the TGN1412 tragedy recently emphasised.2

On 30 October 2006, the Department of Health announced that a model clinical trials agreement had been finalised—a remarkable achievement that should be welcomed by all stakeholders in clinical research in the United Kingdom.3 This provides a template that can be used by all National Health Service trusts for any clinical trial, …