Ethical Principles in Federal Regulations: The Case of Children and Research Risks
Williams, Peter C.
Journal of Medicine and Philosophy. 1996 Apr; 21(2): 169-186.
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 sudy: 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.
Accountability; Advisory Committees; Case Studies; Children; Constitutional Law; Decision Making; Due Process; Ethical Review; Ethics; Freedom; Goals; Government; Government Regulation; Growth Disorders; Guidelines; Hormones; Human Experimentation; Law; Legal Aspects; Minors; Nontherapeutic Research; Normality; Placebos; Public Policy; Random Selection; Regulation; Research; Research Ethics; Review; Risk; Risks and Benefits; Values;
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