Ethical, scientific and clinical issues in ethanol administration research involving alcoholics as human subjects.

Research involving the administration of ethanol to human subjects has been conducted with some regularity since the 1960s. The purpose of this paper is to provide a broader discussion of the ethical and clinical issues pertaining to the administration of ethanol to subjects with a history of alcohol dependence and to assess the potential benefits and risks of ethanol administration research. Three kinds of investigation are reviewed: (1) basic scientific research on alcohol dependence and related disabilities; (2) clinical research that involves ethanol administration as part of the treatment; and (3) studies that have evaluated the short- and long-term effects of ethanol administration on the health and wellbeing of alcoholic research participants. It is concluded that ethanol administration research has not only contributed to the fund of knowledge about basic mechanisms of alcohol dependence; it has also advanced the scientific understanding of treatment. Moreover there is no compelling evidence that participation in ethanol administration research per se has adverse effects on alcoholic research subjects. In the interests of developing a practical approach to the ethical dilemmas posed by ethanol administration research, an ethical review process is suggested that takes into account the principles of respect for people, beneficence, and justice by tailoring the risk/benefit analysis to four types of research subjects: alcoholics recruited directly from the community, subjects recruited from residential treatment settings, recovering alcoholics, and alcoholics in outpatient treatment.