ABSTRACT
Biomedical research in France has been globally regulated since implementation of the Huriet-Serusclat Law. This law has been reviewed several times and has recently undergone important changes with the introduction of the Law of 9 August 2004 relating to the policies of public health. Indeed, the Directive requires that the Member States introduce 'the measures necessary for establishment and operation of Ethics Committees'. However, the nature and the powers of the authorities created by the French legislation ought to be clarified, in particular as to what constitutes an 'ethics committee'. The specific texts relating to the issue grant the Commission Nationale de l'Informatique et des Libertes (CNIL) the task of controlling the use of personal data, notably in relation to biomedical research, once it has received an opinion from the National Consultative Committee on the Processing of Information in the Health Sector.
