Research on children raises major ethical issues, the most important being the inability of the subjects to provide freely given informed consent. Committees in Canada and the United States charged with formulating recommendations for the protection of human subjects in research came to some fundamentally different conclusions. Two of these are discussed as they apply to children: first the distinction between therapeutic and non-therapeutic research, recognized implicitly by the National Commission and deliberately avoided by the Medical Research Council Working Group (...) ; and second, the looser relation between local committees and Council as defined by guidelines in Canada and the tighter relation between the institutional review committees and the Department of Health, Education and Welfare defined by regulations in the United States. (shrink)