Clinical Research in the Developing World

Economic Incentives Drive Poor Ethical Oversight

Abstract

The history of clinical trials covers a wide variety of scientific, ethical, and regulatory challenges. This paper delves into the present ethical complications of clinical research within developing countries. Here the definition of clinical research is broad, encompassing all trials aimed at evaluating a medical intervention. In principle, the paper focuses on the exploitative nature of clinical trials in developing countries.

I argue that there are two primary mechanisms of exploitation. The first is a lack of properly obtained informed consent and the second is an inequitable distribution of post-trial benefits. Next, I argue that the reason malpractice has ensued is due to economic incentives of governments involved, leading to weak ethical regulation, and as a consequence, ethical uncertainty among researchers. While there are other contributing factors, such as economic incentives of researchers and Contract Research Organizations (CROs), as well as racial discrimination that deserve attention, my paper does not discuss them.

Throughout the paper, I draw from research conducted and analyzed around the world. Case studies supporting my claims are drawn from India, the US, and China. Research regarding informed consent is drawn from all over Asia, Africa, and Latin America. The Asian countries include Thailand, India, the Philippines, and China, while the African countries include Kenya and Tanzania. Finally, the Latin American countries include Colombia, Brazil, and Mexico.