In this paper, the author shows how research ethics committees must deal with illegality in the research protocol. He defines their legal duty by reference to the 2001 Clinical Trials Directive, and especially in the key areas of insurance, indemnity and no-fault compensation. The author is critical of the current GAfREC and recent guidelines issued by the Royal College of Physicians. He concludes that new rules are needed to replace the 2001 edition of GAfREC.

The temptation in clinical research to sacrifice the interests, the health, and sometimes even the lives of research subjects to the advancement of the interests of science and society, and to the advancement of researchers' own careers, is a hardy weed which can grow anywhere. Pursuant to a commendable EU Directive a new law, the Medicines for Human Use Regulations 2004 was brought into effect in the UK. That law makes it illegal for anyone to start a clinical trial unless (...) a Research Ethics Committee has expressed a favourable opinion upon its protocol. It gives to Research Ethics Committee members the legal power, and imposes upon them the legal duty, to protect research subjects from those who have strong financial and other temptations to mistreat them. The new law specifies what standard of protection the Research Ethics Committee members shall insist upon. The Royal College of Physicians, which has been reluctant to declare its own conflicting interests, in 2007 issued some guidelines which it hopes Research Ethics Committee members will follow. Those Guidelines on the practice of ethics committees in medical research with human participants urge Research Ethics Committee members to express a favourable opinion of clinical trials which they believe, for example, do not give to research subjects the protection the new law demands. But Research Ethics Committee members have a clear legal duty not to follow any course of conduct calculated to subvert the excellent and necessary 2004 law. (shrink)