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 role of the REC is to aim for a fair and effective trial protocol and to provide to potential trial subjects sufficient information to allow them to make a rational decision on whether to participate in it or not. The members are medical specialists and members of the public together fitted to these tasks. In his paper ‘Illegality in the research protocol: the duty of research ethics committees under the 2001 Clinical Trials Directive’ Roy-Toole has made a number of (...) suggestions on how to improve the function of the RECs, but he has not given persuasive evidence to show that the RECs themselves are the most effective bodies to implement possible legal requirements to improve medical research. (shrink)