At last the United Kingdom has the prospect of a research ethics committee system that works. That is the main message I take from the report of the inquiry led by Rod Griffiths, director of public health in the West Midlands, into the monitoring of clinical research in North Staffordshire.
The lessons learned have been developed into statements setting out the responsibilities of National Health Service bodies to ensure that future research is conducted ethically.
The inquiry started 15 months ago, after parents complained that premature babies, born in Stoke-on-Trent in the early 1990s, had been used in a trial of a negative pressure ventilator without parental knowledge or consent. Other paediatric research projects, including one in which normal babies were kept in low oxygen overnight and a study of covert video surveillance to detect child abuse, were also examined.
The report does not make definite findings of fact or apportion blame - it was not within Professor Griffiths's terms of reference to do so and such issues are left to the General Medical Council and the police - but it does examine the controls on medical research. Professor Griffiths and his team make clear there were many failings in North Staffs.
When in 1966 the UK set up research ethics committees (RECs), it was the first country in Europe to do so. While the Royal College of Physicians has provided helpful advice to these committees, the Department of Health has provided no support. The UK is now the only country in Europe not to have legally binding regulations on the conduct of medical research. One result is that research investment, which a decade ago would have come to the UK, goes elsewhere. In return for spending about Pounds 10 million a year to support RECs, pharmaceuticals industry sources estimate that the UK could benefit from Pounds 500 million in research investment.
The Griffiths report requires the Department of Health to publish a comprehensive framework for research governance, including guidance on the constitution and working of RECs. It also requires NHS trusts to make available to researchers "all current guidance about research". Most importantly, it requires health authorities to ensure that adequate administrative support is available for ethics committees, that staff have an induction programme, and that "continuing training and development is available".
Perhaps the most important lesson is that all the developments will be taken forward by the Research and Development Directorate of the NHS. Those responsible for research in the NHS are absolutely committed to its being conducted ethically.