The National Commission and research in pharmacology: an overview

Participation in research of children, prisoners, or those institutionalized as mentally infirm is problematic because it appears to violate one or the other of two fundamental ethical principles: the principle of respect for persons, which requires that subjects give voluntary and informed consent, and the principle of justice, which requires that vulnerable persons not bear burdens in order that others may benefit. The National Commission recommends that conditions of constraint be minimized so that prospective subjects can make truly voluntary choices, that special protections such as third-party permission and national review be brought to bear for non-comprehending subjects, and that vulnerable persons be used only when less vulnerable persons are not suitable subjects or when the research is designed to develop or evaluate therapeutic interventions intended to benefit the individual subject. These recommendations might have the practical effect of restricting certain types of research (e.g., Phase I drug testing), but they are less restrictive than other proposals, and they reflect a conviction that research using special subject populations can be conducted in accord with fundamental ethical principles.