ABSTRACT

No single issue in the last two decades of the ethics of research has evoked as much controversy as the conduct of clinical trials in developing countries. Facets of the controversy include the following questions: Is there a single international standard for informed consent? Is there a role for community consultation and consent? Where should clinical trials first be conducted? Which standard of care, that of the host or that of the sponsor country, is the right standard? What is owed to research participants at the conclusion of the study? How to manage review of research by multiple ethics committees? Each of these questions ultimately emanates from global cultural diversity and inequities in the distribution of healthcare resources.