Draft rules threaten ethics review system

Academics are demanding changes to draft legislation that could remove them from the ethics committees that decide which medical experiments are carried out in the UK.

All National Health Service research involving patients, staff, medical records or stored tissue must be approved by such a committee, comprising healthcare experts and lay members.

Draft legislation on clinical trials could mean that ethicists, social scientists, historians and even statisticians would not be able to inform decisions on which of the 17,000 research proposals received every year should be allowed to go ahead.

The draft defines a lay member as "a member of an ethics committee, other than an expert member, who... is not a chairman, member or director of... a university or other body involved in the conduct of medical research".

Richard Nicholson, former president of the Association of Research Ethics Committees, warned that the proposed implementation of the European Clinical Trials Directive would bring the system of ethics committees to its knees in under a year.

He said: "The ramifications of the membership rules as written are profound. Many ethics committees will lose at least half their current membership and may not be able to recruit new members. It will destroy them."

Terry Stacey, director of the Department of Health's Central Office for Research Ethics Committees, agreed that the definition was "wrong" and unhelpful.

He said the legislation had aimed to reduce potential conflicts of interest between committee members, their universities and other research organisations but conceded: "It is very unlikely that you can say someone in the history department is closely related to clinical research interests." He said the next draft, due in the next few weeks, would remedy the problem.

The directive, which aims to harmonise clinical trials between academia and industry across Europe by setting compulsory standards, has also raised concerns over red tape.

Lord Turnberg, vice-president of the Academy of Medical Sciences, said: "If it goes through, it will pose an enormous administrative and organisational burden on researchers engaged in clinical trials. The amount of work that goes into regulation of trials is already quite heavy. It is using a sledgehammer to crack a nut."

Cancer Research UK has calculated that it would cost an extra £700,000 a year simply to comply with the directive.

This year, the DoH set up a joint working group with the Medical Research Council to address other concerns raised by academics after a consultation on the draft guidelines. Kent Woods, chair of the group, said it had made progress on the issues of increased cost and bureaucracy that the directive could incur on monitoring and auditing of trials.

The directive must be implemented by member states by May 2004.