Drug Trials, Doctors, and Developing Countries: Toward a Legal Definition of Informed Consent

Abstract

This article will examine the international human rights law-based limitations on clinical research, using the [hypothetical] Klezac trials in Z as a concrete example. To illustrate the unique informed consent issues posed by mentally ill subjects, the hypothetical is based on a psychotropic drug trial. A lesser developed country was chosen as the site for testing because clinical trials are often performed in such countries without documentation, regulation, or great expense. Although it is widely acknowledged that drug testing is performed in foreign nations, particularly in lesser developed countries, with less than full informed consent, there is little formal documentation of such studies. Documentation of clinical drug trials involving psychotropic medications is even more scarce. This article will conclude that informed consent is mandated by international human rights law and should be enforced to prevent grave abuses in clinical trials, particularly where mentally ill patients are involved.