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Introduction

THE H5N1 CONTROVERSY

The submission for publication of a scientific manuscript is typically an unremarkable event. When, however, it became public knowledge in December 2011 that two research groups, working independently, had recently submitted manuscripts for publication in Nature and Science that reported on their work on mammalian transmissibility of an H5N1 avian influenza strain—a lethal strain with suspected pandemic potential whose worldwide behavior had been monitored closely in recent years—the information caused a vigorous and far-reaching international debate about the appropriateness of and communication of the researchers’ work, the risks associated with the work, partial or complete censorship of scientific publications, and dual-use research of concern in general.

Using well-known techniques, the groups had selected for influenza strains highly transmissible between ferrets, identified and sequenced the strains’ genetic mutations, inserted the mutated genes into a new virus, and, by observing the behavior of the newly constructed viruses, demonstrated a causal link between the mutated genes and degree of transmissibility between mammals.

The research projects were led by Ron Fouchier at Erasmus Medical Center in Rotterdam, the Netherlands, and Yoshihiro Kawaoka at the University of Wisconsin, Madison. The work identified mutations in the H5N1 HA gene. When the mutated gene was inserted into another influenza strain (H1N1), the resulting strain was more transmissible between ferrets, mammals whose response to influenza infection is thought to be predictive of the human response.



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1 Introduction THE H5N1 CONTROVERSY The submission for publication of a scientific manuscript is typically an unremarkable event. When, however, it became public knowledge in December 2011 that two research groups, working independently, had recently submitted manuscripts for publication in Nature and Science that reported on their work on mammalian transmissibility of an H5N1 avian influenza strain—a lethal strain with suspected pandemic potential whose worldwide behavior had been monitored closely in recent years—the in- formation caused a vigorous and far-reaching international debate about the appropriateness of and communication of the researchers’ work, the risks associated with the work, partial or complete censorship of scientific publications, and dual-use research of concern in general. Using well-known techniques, the groups had selected for influenza strains highly transmissible between ferrets, identified and sequenced the strains’ genetic mutations, inserted the mutated genes into a new virus, and, by observing the behavior of the newly constructed viruses, demonstrated a causal link between the mutated genes and degree of transmissibility ­ between mammals. The research projects were led by Ron Fouchier at Erasmus Medical ­ ­ Center in Rotterdam, the Netherlands, and Yoshihiro Kawaoka at the Uni- versity of Wisconsin, Madison. The work identified mutations in the H5N1 HA gene. When the mutated gene was inserted into another influenza strain (H1N1), the resulting strain was more transmissible between ferrets, mam- mals whose response to influenza infection is thought to be predictive of the human response. 1

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2 PERSPECTIVES ON RESEARCH WITH H5N1 AVIAN INFLUENZA 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. ­ ational Science Advisory Board for Biosecurity (NSABB),1 which weighed N the potential benefits and risks of full publication of the research. In Decem­ ber 2011, the NSABB recommended that the papers be published ab- sent 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 Febru- ary 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 ad- dressed. 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, a ­lthough not unanimously, in favor of the publication of both revised p ­ apers in full. The response of both the scientific community and the public to F ­ ouchier and Kawaoka’s research illuminates the unsettled landscape of the current national and international governance and regulation of scien- tific 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. 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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INTRODUCTION 3 The debate over the Fouchier and Kawaoka manuscripts indicates that there are significant issues related to high risk life sciences research that must be addressed, including the need to further clarify how both informa- tion and materials are handled in a world where sensitive information and materials are generated at an accelerating pace. Recognizing that the H5N1 research is only the most recent scientific activity subject to widespread attention due to safety and security concerns, on May 1, 2012, the National Academy of Sciences’ Committee on Sci- ence, Technology, and Law, in conjunction with the National Academy of Sciences’ Board on Life Sciences and the Institute of Medicine’s Forum on Microbial Threats, convened a one-day public workshop. The workshop was organized by an ad hoc committee “for the purposes of (1) discussing the H5N1 controversy; (2) considering responses by the National Insti- tute of Allergy and Infectious Diseases (NIAID), which had funded this research, the WHO, the U.S. National Science Advisory Board for Bio­ security (NSABB), scientific publishers, and members of the international research community; and (3) providing a forum wherein the concerns and interests of the broader community of stakeholders, including policy m ­ akers, biosafety and biosecurity experts, non-governmental organizations, international organizations, and the general public may be articulated. The workshop was to “examine possible points of intervention from research conceptualization through publication” and to “discuss the current regula- tion and oversight of research whose results may raise bio-security concerns in the U.S. and abroad and . . . consider alternative mechanisms for the oversight and governance of such research.” Workshop participants were asked to look toward the future and con- sider new paradigms for the evaluation, oversight, and communication of research identified as warranting special consideration; to evaluate the po- tential need for enhanced biosafety and biosecurity oversight; and to reflect on how a new mechanism might be structured and implemented. This workshop summary has been prepared by the workshop rappor- teurs as a factual summary of what occurred at the workshop. The statements made are those of the rapporteurs or individual workshop participants and do not necessarily represent the views of all workshop participants, the plan- ners of the workshop, or the National Academies. DUAL-USE RESEARCH In general, dual-use research is defined as research undertaken to gen- erate information that may be used to protect national security or public health but which, if misused, may cause harm. Dual-use research concerns effectively emerged in the mid-20th century, particularly in the context of wartime nuclear research and concurrent advances in biological knowledge

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4 PERSPECTIVES ON RESEARCH WITH H5N1 AVIAN INFLUENZA and laboratory technologies. Dual-use research and the question of how or whether to regulate it raises difficult questions about scientific freedom, communication of scientific knowledge, and access to that knowledge. Proposals to limit access to scientific research forcefully encounter deeply held values in scientific communities around norms of openness, access, and transparency. As scientific knowledge and technologies move forward and as fears have grown that these technologies could be used for harm, society must continually assess both the benefits of research of concern and how best to regulate it. Regulatory precedents for governing such research were established in a fundamentally different era, an era when sensitive information was available to a small, select group, the primary areas of the research were physical and chemical (rather than biological), and the principal aggressors were nation states. The flurry of activity in the winter ­ and spring of 2011/2012 ignited an important debate about research under­ taken in a very different world; a world where extraordinary advances in the biological sciences and biotechnology are common, a wired, technically sophisticated world, and a world where scientifically savvy individuals work to protect public health and safety and, in some cases, to cause harm.