ABSTRACT
The CPMP Guidelines cover all phases of clinical trials and make recommendations for everything, from the qualifications of investigators, design of protocols and ethics committee approval, to issues of consent and liability for injury to subjects. The medical profession has traditionally had to conduct clinical research against the background of a society that desires and applauds new drug treatments for disease but at the same time has a deeply suspicious view of the use of human beings in medical experimentation. The exceptions to obtaining consent, such as acting out of ‘necessity’ to preserve life, are most unlikely to arise in clinical research. The position in relation to clinical research into mental illness, using the mentally handicapped as subjects, is equally unclear. The sole reference to ethics committees in the Medicines Act legislation appears in an Order relating to notification of clinical trial proposals.
