Biodefense Research and the U.S. Regulatory Structure: Whither Nonhuman Primate Moral Standing?

Abstract

Biodefense and emerging infectious disease animal research aims to avoid or ameliorate human disease and suffering arising from the natural outbreak or intentional deployment of some of the world's most dreaded pathogens. Research to develop medical countermeasures to these diseases faces a difficult challenge since the products usually cannot be tested for efficacy in human beings. The U.S. Food and Drug Administration's Animal Rule may be increasingly used to overcome this challenge by allowing researchers to translate animal data into medical countermeasures without human subject efficacy testing. Yet the Animal Rule also has significant implications for increased intensive nonhuman primate research. We argue that despite the common belief that nonhuman primates have a fairly high level of moral standing and the protections for animals that are crucial to the U.S. regulations guiding animal research, the Animal Rule specifically and the regulations generally raise serious problems for the attribution of moral standing to nonhuman primates. We argue, however, that the burden of proof is on a position denying all moral standing to nonhuman primates and compare the implications of the U.S. regulatory structure in this regard with some recent developments in the European Union.