Ethical issues in informed consent. Research on medical cost containment.

The decision to contain medical costs, which is a political and social decision, entails restriction of medical services. To guide public policy, research on the impact of such restriction must be carried out, but this type of research differs significantly from most other medical research. Difficult issues concerning informed consent arise, with potential conflicts among principles of maximization of good and minimization of harm to the patient, the patient's right to self-determination, and the utilitarian goal of maximization of collective welfare. We have discussed these principles in the context of relationships between patient and physician and between subject and investigator. Approaches considered include emphasis on retrospective studies, use of statistical techniques to formulate clinical decision-making rules on the basis of available data, three-celled randomization designs, and the role of the primary-care physician in maximizing patient autonomy and minimizing the potentially threatening aspects of informed consent for such studies.