臨床研究と生命倫理ジャーナル

概要

How Can Clinical Research Trials Conducted in Developing Countries Minimize Exploitation

Madhuvanti Mukherjee

Western scholars, pharmaceutical companies, and academic institutions are and have been conducting research in developing countries for many years. These locations boast substantial cost savings, expedited timelines, and little to no regulatory oversight, making them attractive to developed-world researchers. Residents of these communities are impoverished, often illiterate, unemployed, and with untreated health conditions. Because established ethical protocols for international research are often compromised or misconstrued by researchers and their sponsors, these individuals are left vulnerable to exploitation and abuse.

In this paper, I explore how current utilization of ethical guidelines is enabling exploitation. I identify ethical questions regarding subject recruitment, informed consent, standard of care, and the post-trial obligations of researchers. I then examine specific situations in which exploitation occurred because of drug, vaccine, or clinical trials. I conclude by offering recommendations to create a more streamlined approach to international research that takes into account the experiences and needs of vulnerable populations. This approach helps ensure that participants are fully involved in the ethical approval process; able to choose whether or not to participate without any undue influence or pressure; treated with the standard of care best suited to their context and surroundings; and reasonably given access to any interventions proven effective during the course of the trial. A respect for beneficence, justice, and self-autonomy should guide researchers’ interactions with subjects before, during, and after the trial.