Department of Health and Human Services. Alternatively, the government might enact a government-wide dual-use policy, a proposal which has recently been discussed in Congress. A third type of regulation might be applied in close proximity to the research itself, from within the scientific community and at the level of the institution.

Gostin emphasized the international dimension of regulation of dual-use research of concern in the life sciences. He supported a “thoughtful international process” of regulation that carefully considers the burdens and benefits of regulations for low and middle-income countries that are involved in sharing information and biological specimens.

U.S. POLICY ON DUAL-USE RESEARCH OF CONCERN

Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, discussed both the evolution of U.S. policy on dual-use research of concern and its current status. Fauci described how the U.S. dual-use policy has been in effect, informally, for many years and, as a result of the H5N1 controversy, is in the process of becoming formalized, more transparent, and more proactive.

In decades of funding research with dual-use potential, Fauci stated that the NIH has never had an instance in which funded research was retroactively judged as having been funded or published improperly. In the few instances in which the NSABB had reviewed research of concern, the determination was made that the benefits offered to society by the research outweighed potential harm. However, Fauci asserted that the NIAID recognizes both the importance of carrying out reviews preemptively and of ensuring transparency. Fauci noted that oversight must stretch beyond the researcher and his or her colleagues and emphasized that it is important to recognize that people without a vested interest in the research are a part of the decision-making process.

Fauci discussed the newly issued U.S. government policy that defines dual-use research as “life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technology that could be directly misapplied to pose a significant threat [with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security].” 1 The policy defines both the types of experiments that are cause for concern and addresses the question of how potential risks associated with the research should be mitigated. Fauci noted that the need for risk mitigation raises the following questions: Should the experimental

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1 National Institutes of Health, “United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern,” March 29, 2012. (See Appendix B.)



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