ABSTRACT
Substantial differences exist among countries’ legal and regulatory systems. The question is, to what extent are these cross-national differences relevant in scientific research ethics and, in particular, how do they affect the governance of research with human subjects globally? I argue that the answer to that question differs substantially between U.S. researchers and those from other countries, especially (but not exclusively) developing countries. In brief, collaborating scientists’ need to master other countries’ laws and regulations is asymmetrical. U.S. researchers can generally rely on their nonU.S. collaborators to manage the legal and regulatory issues in their own countries; however, researchers from other countries who collaborate with U.S. colleagues or who undertake studies for sponsors in the United States need to know U.S. regulations on research with human subjects-and the research institutions where they work need to comply with the U.S. regulations-even when they differ significantly from their own. This imbalance is due to the dominant role the United States plays internationally in the governance of scientific research. I argue that this imbalance, though currently and unfortunately inescapable, is problematic for international scientific collaboration and is unjustifiable. All U.S. recipients of federal grants know their obligations to comply with the so-called “Common Rule,” the basic policy for the protection of humanresearch subjects of the Department of Health and Human Services (Federal Policy for the Protection of Human Subjects, 2005). The specific question here is, how does this set of regulations, which was developed for research in the United States, relate to the way research is governed around the world? I first examine the governance situation in the context of international research. In considering the role that U.S. regulations play in global governance, it is important to note what is problematic about the current U.S.-centric system. To this end, we need to look at the origins of the U.S. rules, the difficulties that the United States actually faces in trying to exert oversight, and finally, what happens when U.S. regulators’ attempts to oversee research institutions abroad lead to their ignoring important international issues. My views on this topic were greatly influenced by my four years as Director of
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Ethics, Trade, Human Rights and Health Law at the World Health Organization (WHO) in Geneva, Switzerland, an organization that is increasingly concerned about governance in a number of areas of public health and health care.
