Controlled clinical trials: Some ethical issues

Abstract

Three basic ethical principles, expressed in the familiar requirements of codes of ethics for research, set the boundaries for clinical research. Beneficence requires that good be done, harm avoided or minimized, and that benefits justify harms. Respect for persons requires that the free choice of moral agents be honored and that protection be given to those of diminished autonomy. Justice requires an equal distribution of burdens and benefits except where an unequal distribution is justified by merit or need. Special problems in the application of these principles to clinical trials are discussed. The vulnerability of patients requires extra protection in the consent process, attention to matters of justice in the selection of subjects and in their compensation, and limitations on the type and amount of risks presented. Research must be described carefully so that research components and therapeutic components are clearly distinguished in order to facilitate the consent process, the risk-benefit analysis, and the provision of compensation. Randomization, though usually justified, may not be justified in some circumstances, and must generally be disclosed to patients. With attention to such special safeguards and concerns, clinical trials can be conducted ethically.