The Uganda HIV trial and the conflict between the ethical principles of beneficence and justice

In the early 1990s, a clinical trial was conducted in Uganda to test a shortened course of treatment to prevent the vertical transmission of human immunodeficiency virus (HIV) from mother to child. It was based on an extensive and costly treatment protocol in the United States. The means by which the Ugandan study was conducted provoked much debate related to ethics in biomedical research. The purpose of this dissertation was to carefully examine through a meta-analysis of the literature all the ethical issues raised by the conduct of the Ugandan study such as: standard of care, equipoise, placebo-control, exploitation and fair benefit as well as the prima facie principles of beneficence and justice. Attention was also paid to what is the ethical procedure to follow when these principles collide. The standard of care debate surrounding this study centered on the dilemma of whether to adhere to the standard of care found in industrialized Western societies or to adhere to the standard of the country where the research was being conducted. The question posed by normative ethics is whether the ethical course of action is determined by using the specifics of a case or by using international codes of ethics. Is equipoise a valid concept or an incorrect amalgamation of research and clinical treatment? Perhaps the most provocative research technique, placebo-control, is examined from both sides of the debate, with attention paid to its use from a medical and research design standpoint as opposed to a strictly ethical perspective. And the concept of fair benefits as a method of ameliorating exploitation is discussed using a similar case to the Uganda study as a means of comparing and contrasting pertinent ethical issues. The conclusion is that a careful and reasoned analysis of all the issues in each clinical trial should determine the ethical course of action. One cannot blindly follow overarching ethical principles or guidelines without considering all the unique problems and concerns intrinsic to each situation.