International Protection of Persons Undergoing Medical Experimentation: Protecting the Right of Informed Consent

Abstract

This Article focuses on the right of informed consent to medical experimentation, the "process by which an individual voluntarily expresses his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the decision to participate." There are many barriers to the comprehension of risk and rational decision-making necessary for informed consent. These barriers are particularly acute in developing nations. The "short course" AZT trials in Africa are a modern example of this problem. In this paradigmatic case, science's quest for a cure has led to the erosion of principles of in-formed consent and the denigration of individual rights. Part II of this Article explains the short course AZT trials conducted on HIV-positive African subjects by U.S. physicians. In particular, Part II outlines violations of the research subject's right of informed consent. Part III describes the experiments of Nazi physicians during World War II, the trial of these physicians at Nuremberg, and the Nuremberg Tribunal's development of the Nuremberg Code, the foundation of modern international regulation of human experimentation. Part IV details the development of international regulation of human experimentation following the Nuremberg Code. Part V highlights the weaknesses of these international regulations insofar as they permitted involuntary medical experimentation with HIV-positive subjects in Africa to continue unabated. Part VI recommends the development of an international solution to guarantee the right of meaningful informed consent to each subject of medical experimentation and proposes the creation of an international convention for the protection of informed consent.