When is the Risk Minimal Enough for Children to be Research Subjects?

Abstract

When should research involving children as subjects be permitted? This difficult and pressing problem is often presented in the form of a dilemma: If we do research involving children as subjects, then we do so using individuals who cannot give informed consent. If we do not, then children as a group are denied many of the benefits of research including therapeutic advances, the possibility of good information about therapies, and the repudiation of dangerous and discredited therapies. Robert Levine shows how the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (The National Commission) tried to find a morally defensible solution to the question of when children may be enrolled as subjects in research. They held that with appropriate review, safeguards, consent from guardians, and assent from the child, children may be enrolled if the study on balance holds out direct and appropriate benefit to them or if the study is not too risky. Levine served as a consultant to the National Commission and shows sympathy (which I share) for the solution proposed.