Abstract

The Nuremberg Code of ethical principles for experiments involving human beings has as its first requirement that “the voluntary consent of the human subject is absolutely essential.” Since the time of the trials that supplied its motivation the principles have been amplified and detail and distinctions have been added. For example, the Declaration of Helsinki, adopted by the World Medical Association in 1964, again laid down general principles related to voluntariness, balance of risk and benefit, and scientific soundness. However, it also noted that the ethical issues with regard to two distinctly different types of human experiment vary. These two types are clinical research and nonclinical biomedical research. In actuality, we may distinguish three types of human biomedical experimentation. Two of these are therapeutic and nontherapeutic experimentation. The first is directed primarily to the benefit of the experimental subjects who are being treated with some new experimental therapy for their ailment. In the second an experiment is designed to increase medical knowledge and uses volunteers who are healthy or whose illness is not related to the experimental study. One key difference between the ethical requirements specified by the Declaration of Helsinki for therapeutic and nontherapeutic experimentation was that the second approach required participation only by volunteers whom we assume are able to and do give their informed consent. However, in the first approach if consent were not obtained, the physician must specify the reasons and present these before an independent committee