ABSTRACT
The regulation of clinical trials in the UK is the subject of numerous professional and administrative guidelines issued by the Royal Colleges, the Department of Health and public funding bodies such as the Medical Research Council. Research which is intended to have therapeutic value and to benefit the individual directly would come under the heading of 'medical treatment' to which the principles apply. For the research to be lawful in the case of minors who lack the mental capacity to consent, the risk-benefits ratio must be such that the benefits to the patient should outweigh the risks so that participation in the trial could be deemed to be in the best interests of the individual concerned. Since the consent requirement is so fundamental, one would expect the considerable judicial scrutiny of the circumstances under which it could be dispensed with.
