Ethical principles in federal regulations: the case of children and research risks

Ethical principles play an important part not only in the promulgation of regulations but also in their application, i.e., enforcement and adjudication. while traditional ethical principles--promotion of welfare, freedom, and fairness--play an important role in both elements of regulation, some other kinds of ethical principles are significant as well. Principles governing the structure of decision processes should shape the structure and actions of agencies; principles of wise application should govern the work of those whose responsibility it is to apply regulatory language to particular situations. These points are demonstrated by investigating a case study: federal regulations designed to protect children involved in scientific research applied to a placebo study of the effects of recombinant human growth hormone on children of extremely short stature.