ABSTRACT

The ethical approach to experimentation in man has several components; two are more important than the others, the first being informed consent. The statement that consent has been obtained has little meaning unless the subject or his guardian is capable of understanding what is to be undertaken and unless all hazards are made clear. There is the more reliable safeguard provided by the presence of an intelligent, informed, conscientious, compassionate, responsible investigator. In the view of the British Medical Research Council it is not enough to ensure that all investigation is carried out in an ethical manner: it must be made unmistakably clear in the publications that the proprieties have been observed. An experiment is ethical or not at its inception; it does not become ethical post hoc — ends do not justify means. There is no ethical distinction between ends and means.