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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.

Objections to prison research are based more often on opposition to the evils of prison life than to unethical practices and to the memories of atrocities committed in the name of science in Nazi prison camps during World War II. The National Commission's pronouncements on prison research specifically illustrate this general phenomenon. Having decided that research on prisoners can be performed ethically, and having learned that most prisoner volunteers bitterly resent being deprived of the opportunity to participate in research, the Commission has nevertheless stipulated prison conditions that cannot realistically be met and thus has de facto eliminated such research. The most serious potential loss is the elimination of the unique facility in Lexington, Kentucky--the Addiction Research Center. Predicting the addiction liability of drugs is not likely to be feasible in any nonprison setting, so that the addiction potential of new marketed drugs will be established in the future as it was in the past--by trial-and-error in patients, who will become the unwilling, uninformed research subjects in this area.