Issues in human experimentation.

Abstract

The current status of two difficult and controversial issues--confidentiality of preliminary results of clinical studies and compensation for research-related injuries--is outlined. The principle of not publicizing results of clinical research until enough data have been accumulated to give statistically valid support for conclusions is in conflict with the principle of ready availability to the public of results of government-conducted and government-sponsored research. New legislation may be required to resolve the problem. The lack of a mechanism to compensate research subjects for unanticipated injuries that are not the result of negligence is a barrier to obtaining truly informed consent. A plan for overcoming this problem through Department of Health, Education, and Welfare regulations has been proposed and awaits implementation.