Concerns were raised both about the accidental release of the newly constructed strains and about the possibility that the research results could be used by people seeking to do harm. While some argued that the research should not be published (or that it should not have been undertaken to begin with), others argued that openness is essential to the success of the scientific enterprise and that the insights gained as a result of the research might yield public health benefits that outweighed any risks associated with the research.

The two research papers were brought to the attention of the U.S. National Science Advisory Board for Biosecurity (NSABB),1 which weighed the potential benefits and risks of full publication of the research. In December 2011, the NSABB recommended that the papers be published absent certain details of the experimental design. In January 2012, the two research groups and other influenza researchers called for a temporary moratorium on research involving H5N1 influenza viruses that might lead to the creation of highly pathogenic, highly transmissible strains. In February 2012, the World Health Organization (WHO) convened a meeting of public health and influenza experts to discuss the manuscripts. Following that meeting, the WHO recommended that the manuscripts be published in full, but only after biosecurity and communication issues had been addressed. On March 29, 2012, the U.S. Department of Health and Human Services’ Office of Biotechnology Activities, which convenes and manages the NSABB, released a new policy for the oversight of life sciences dual-use research of concern.2 On March 29-30, 2012, the NSABB reconsidered the manuscripts, and in light of additional risk/benefit information, voted, although not unanimously, in favor of the publication of both revised papers in full.

The response of both the scientific community and the public to Fouchier and Kawaoka’s research illuminates the unsettled landscape of the current national and international governance and regulation of scientific research that could, either advertently or inadvertently, result in great harm.3 Traditionally, the scientific community has had a strong culture of openness, and when high risk research has warranted restrictions, those restrictions have taken the form of security classification mechanisms or the regulation of certain toxic or pathogenic microorganisms and substances.

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1 The NSABB is a federal advisory committee established in 2004 to provide “advice, guidance, and leadership” regarding federally-funded dual use research. See the website of the Office of Biotechnology Activities, “About NSABB,” http://oba.od.nih.gov/biosecurity/about_nsabb.html.

2 It is important to note that the new policy applies to all federally funded research, not just research funded by the Department of Health and Human Services.

3 In the context of this report, regulation is broadly defined to include rules, principles, statutes, or other forms of guidance.



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