ABSTRACT

The regulation of clinical trials in the United Kingdom 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. Since the consent requirement is so fundamental, one would expect considerable judicial scrutiny of the circumstances under which it could be dispensed with. The gravity and urgency of the child’s condition would no doubt be highly relevant factors. If the child was suffering from a life-threatening condition, or some other highly dangerous condition which required urgent or immediate attention to save the child’s life or prevent a serious deterioration of the child’s health, then the researcher should be able to plead, in defence to an action for trespass to the person, that he had reasonable grounds to believe at the time that inclusion in the trial was medically necessary and in the best interests of a child.