Cook-Deegan observed that many past events were not preventable. He used the examples of Sverdlovsk1 and Amerithrax2 as examples and argued that neither situation could have been prevented by the measures under discussion at the workshop. A workshop participant pointed out that the Sverdlovsk incident was partly accidental and complicated by the failure to admit what had happened and a government cover-up. Cook-Deegan concurred and observed that personnel decisions and laboratory oversight is critical. In Cook-Deegan’s view, complete risk characterization will never be possible, regardless of the level of risk-assessment expertise. Nevertheless, Cook-Deegan observed that the twin questions of whether to “perform” or to “publish” research will continue to arise in the foreseeable future and that we must have solid procedures in place for making determinations about how to address this. Cook-Deegan noted that one of the recommendations of the Fink Report was that such a mechanism should be developed for this purpose and observed that the Fink committee had recommended that the purview of existing institutional biosafety committees be expanded to include determinations about the threat of a research project’s potential misuse.

Cook-Deegan observed that emotions run so high in the current debate because there are deeply held opinions about scientific freedom. Given the strong culture of openness in the biological sciences, Cook-Deegan believes that the current deliberations should be based on a presumption that the strong tendency toward openness in life sciences research will remain. He added that this tendency will serve the U.S. well in its international relationships, as access to information will assist other countries in protecting themselves.

Ruth Berkelman, Rollins Professor and Director, Center for Public Health Preparedness and Research, Emory University and Director, Emory Preparedness and Emergency Response Research Center, defined the social contract as the giving up of certain rights in exchange for the benefit of the protection of society or the community. She discussed the example of policies surrounding clinical research studies on human subjects, policies that, while imposing a “burden” on the research enterprise, have ensured that such research proceeds in an atmosphere of public support and cooperation. In contrast, regulatory systems—national or international—to protect populations of people (and ecosystems overall) have not developed

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1 In 1979, an anthrax outbreak occurred in the city of Sverdlovsk (now named Ekaterinburg) in the Soviet Union. Anthrax infections occurred in livestock and humans who had eaten contaminated meat. The source of the pathogen was determined to be an accidental release of Bacillus anthracis (anthrax) spores from a military-run microbiology laboratory.

2 In September and October 2001, letters containing anthrax spores were sent through the U.S. postal system. As a result, twenty-two people are known to have been infected with anthrax. Five died. The FBI investigation of the mailings is known as Amerithrax.



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