Chapter 2 - Bioethical Considerations in Global Clinical Trials

Abstract

This chapter explains that globalization is now a powerful driver in biomedical research, creating myriad benefits and opportunities, yet fraught with ethical challenges. The operating principles of the World Health Organization's Initiative for Vaccine Research (IVR) argue for “capacity building” in Good Clinical Practice (GCP) and bio-ethics in the developing world. In 1997, the Centers for Disease Control and Prevention (CDC) and National Institutes of Health (NIH) published a study of randomized, placebo-controlled trials to test the effectiveness of short-course zidovudine (AZT) treatment in preventing perinatal transmission of human immunodeficiency virus (HIV). CDC noted, “the current standard of perinatal care for the HIV-infected pregnant women in the sites of the studies does not include any HIV prophylactic intervention at all”. Therefore, the Declaration of Helsinki was amended to include the principle of oversight of clinical trials by “Independent Committees”, a function now assignable to IRBs and ethics committees. In the developing world, ethical oversight often lags behind developed world's standards and assumptions. All vaccine trials should meet GCP and ethical and applicable regulatory requirements. Most institutes and clinical sites located in developing countries with a high prevalence of diseases such as malaria, tuberculosis or AIDS, have no experience in GCP, neither the capacity to conduct good-quality trials or ethical reviews. Capacity building for research institutes in developing countries to conduct such trials is therefore a priority. The understandable impulse to exclude, whether because of bad clinical experiences or unfortunate colonial histories, should be resisted.