The Culture of Science and the Regulation and Litigation of Biodefense Research

Abstract

This article addresses the conflict of interest in America between research for humankind and national security. Professor Sutton examines the historical development of the select agent rules, the civil and criminal aspects of these rules, and how they have impacted the biodefense research community, including those members who have been found in violation of these rules. This examination of the development of the select agent rules captures some of the contrasting interests between the culture of science and the culture of law. This study can provide insight into the processes that drive science, which can be useful to lawmakers and regulators and to those in the legal academy in the interdisciplinary area of law and science. The development of environmental law and regulation through the 1970s and 1980s provides a model for examining the new regime of regulation of biodefense research through the select agent rules. Finally, this article considers whether the normative regulatory processes effectively achieve the legislative goals of national and homeland security in the area of life sciences biodefense research.

Keywords: research scientist, national security, select agent rules, biodefense research, culture of science, culture of law, environmental law, litigation, regulatory framework of select agents, regulations

JEL Classification: K19