EU clinical trials directive takes shape
Published: 3-Feb-2001
The final shape of the proposed directive on human clinical trials for medicines has now been agreed, following the acceptance of amendments from the European Parliament, by the EU Council of Ministers. MEP's had toned down the changes, in a successful bid to get them accepted. They included:
The need for written, dated and signed consent to take part in clinical trials;The need for the principal investigator always to be a doctor;Special protection for persons incapable of giving their informed consent;Allowing oral consent in exceptional circumstances and in the presence of witnesses for an illiterate person;Ensuring that the task of balancing benefits against risks in the case of a clinical trial belonged to an ethics committee;Insisting prior interviews are carried out in order to make sure that trial subjects are properly informed;For children, requiring informed consent of parents or a legal representative, for the child to be properly informed about the issues and for clinical trials to be designed to minimise pain, discomfort and fear;And similar requirements for psychiatric patients and others unable to give consent, who should be included in clinical trials.A Council statement said, 'This… aims to rationalise the documentational and administrative procedures implemented for the conduct of trials, while guaranteeing the same level of protection for patients'.
