5

Governance and Oversight

The workshop’s final session focused on current regulatory policies and frameworks and their relevance to the H5N1 research controversy. Discussants considered current policies and examples where policies may require modification in order to achieve an acceptable risk/benefit balance. The panel paid considerable attention to the importance of maintaining strong and equitable international relationships and considered which actions may be required to ensure better governance of dual-use research.

Session moderator Lawrence O. Gostin, University Professor and Director, O’Neill Institute for National and Global Health Law, Georgetown University, opened the session by remarking on how the policy and regulatory issues raised by the Fouchier and Kawaoka papers related to both existing and potential governance of dual-use research of concern, both nationally and internationally. Gostin framed global health governance as multisectoral rules, institutions, and processes that collectively shape policy and health, both nationally and globally. He emphasized the importance of determining the trigger points at which policy measures can most effectively ensure the public’s safety and health. Gostin noted two key decision points: 1) the point at which it is determined whether specific research should be conducted and 2) the point of dissemination of research results. He noted that decisions are often influenced by desired outcomes and emphasized the importance of focused consideration of individual decisions.

Gostin considered three types of potentially applicable regulations. One type is government regulation effected by preconditions placed on research at the moment of funding. Such requirements might be applied at the level of the NIH or more broadly at the level of all research funded by the U.S.



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5 Governance and Oversight The workshop’s final session focused on current regulatory policies and frameworks and their relevance to the H5N1 research controversy. Discus- sants considered current policies and examples where policies may require modification in order to achieve an acceptable risk/benefit balance. The panel paid considerable attention to the importance of maintaining strong and equitable international relationships and considered which actions may be required to ensure better governance of dual-use research. Session moderator Lawrence O. Gostin, University Professor and D ­ irector, O’Neill Institute for National and Global Health Law, ­ eorgetown G University, opened the session by remarking on how the policy and regula- tory issues raised by the Fouchier and Kawaoka papers related to both exist- ing and potential governance of dual-use research of concern, both nationally and internationally. Gostin framed global health governance as multisectoral rules, institutions, and processes that collectively shape policy and health, both nationally and globally. He emphasized the importance of determining the trigger points at which policy measures can most effectively ensure the public’s safety and health. Gostin noted two key decision points: 1) the point at which it is determined whether specific research should be conducted and 2) the point of dissemination of research results. He noted that decisions are often influenced by desired outcomes and emphasized the importance of focused consideration of individual decisions. Gostin considered three types of potentially applicable regulations. One type is government regulation effected by preconditions placed on research at the moment of funding. Such requirements might be applied at the level of the NIH or more broadly at the level of all research funded by the U.S. 35

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36 PERSPECTIVES ON RESEARCH WITH H5N1 AVIAN INFLUENZA 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 evolu- tion 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 re- search 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 under- standing, can be reasonably anticipated to provide knowledge, information, products, or technology that could be directly misapplied to pose a signifi- cant 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 asso­ iated with the research should be mitigated. Fauci noted that the need c for risk mitigation raises the following questions: Should the experimental 1  National Institutes of Health, “United States Government Policy for Oversight of Life Sci- ences Dual Use Research of Concern,” March 29, 2012. (See Appendix B.)

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GOVERNANCE AND OVERSIGHT 37 design be modified? Does the experiment require increased biosecurity or biosafety? Are there countermeasures available for the microbe in question? The new U.S. policy will have repercussions at the institutional level— most notably, for the development of risk mitigation plans—and Fauci noted that a draft U.S. government policy for local institutional oversight of dual- use research of concern would be opened for public comment soon.2 In response to questions from the audience, he clarified that while a framework has been drafted that includes examples of approaches that universities and research institutions might choose to take, the framework is not itself a regulation; rather, it is an invitation for institutions to join a discussion about possible approaches for the implementation of the U.S. policy. Fauci stated that the U.S. government wants to ensure that the draft policy does not place burdensome requirements on institutions. In response to a question from Gostin about the degree to which bright lines are necessary, Fauci replied that when there is real or perceived disagreement within the scientific com- munity about whether certain experiments should be performed, an open, transparent dialogue that includes the media should take place. In response to a question from Gostin about the relative roles of governmental and insti- tutional mechanisms, Fauci emphasized that the weight of oversight should fall at the institutional level, long before publication becomes an issue. He urged that NSABB reviews be reserved for situations when involvement by an outside entity is critical. ROLE OF RESEARCH INSTITUTIONS Panelist Ann Arvin, Lucile Salter Packard Professor of Pediatrics and Microbiology and Immunology, Stanford University School of Medicine and Vice-Provost and Dean of Research, Stanford University, noted that research universities are all fully committed to partnering with the gov- ernment and international organizations in order to develop strategies to anticipate and mitigate the possible consequences of dual-use research of concern in the life sciences. She noted the effectiveness of current institu- tional mechanisms to ensure responsible research on recombinant DNA and select agents and toxins. Arvin noted that institutional biosafety commit- tees review experimental protocols, environmental health and safety staff ensure the safety of research facilities, and researchers receive training in biosafety—all of which create a culture of safety and openness. As to whether the current practices are robust enough to handle the emerging issues of dual-use research of concern, Arvin believes that addi­ tional efforts are necessary at the local level, that institutions need more 2  The draft policy was released for public comment in February 2013.

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38 PERSPECTIVES ON RESEARCH WITH H5N1 AVIAN INFLUENZA resources to meet those needs, and that the expectations placed on universi- ties need to be realistic. Arvin considered the new U.S. policy on the oversight of dual-use re- search to be very helpful as a foundation for new educational initiatives for researchers and students. She is in favor, however, of replacing the “dual- use” concept with “life sciences research of concern.” Arvin described several challenges that universities face with regard to life sciences research of concern. She noted that, in any given institution, it will be difficult to maintain awareness of dual-use research of concern, since such research is relatively rare. Arvin observed that institutional biosafety committees are traditionally charged with ensuring safety dur- ing the performance of research but lack training to estimate future threat risk. Biosafety committees, she noted, already draw from a much smaller pool than do committees overseeing human and animal subjects (which are themselves built only slowly and over time). Furthermore, she observed, their members may lack necessary specialized knowledge with regard to specific pathogens and host-pathogen interactions. Within an institution, she noted, the expert is often the person proposing the research. In re- sponse to a question from the audience, Arvin stated that an institution would, if necessary, seek expertise about risk/benefit from outside experts. She noted the value of assembling specialized knowledge and considering some issues in advance—a topic that is addressed in the new U.S. policy. In response to another audience question, she noted that institutions may want to have resources in place for when a researcher produces concern- ing results that were unanticipated. Arvin also observed that, as universi- ties will be working more closely with federal agencies on new questions pertaining to mitigation plans and details of scientific studies, openness and transparency are important to insure that valuable research is not unnecessarily impeded and that openness in research is maintained. Arvin reiterated the difficulty of predicting whether research programs could have harmful consequences. She emphasized that these uncertainties “be- come quite vivid at the point of local control.” She pointed out that when it is the researchers themselves stating that it is difficult to judge the risk of future harm, it may appear self-serving. She observed that it is important for others to assist actively when communicating with the public on this matter. IMPLICATIONS FOR INTERNATIONAL POLICIES David Franz, Former Commander, U.S. Army Medical Research Insti- tute of Infectious Diseases, spoke about U.S. communication efforts regard- ing life sciences research of dual-use concern in the context of international relationships.

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GOVERNANCE AND OVERSIGHT 39 Franz observed that, since its inception, the NSABB has produced webcasts, video conferences, and workshops and has held three roundtable discussions that involved 47 countries and included a WHO representative as a co-chair. Franz stated that the NSABB international panel seeks to meet its international colleagues as partners and aims to learn about their perspectives and the problems they encounter. Although the group remains small, the panel seeks to expand the network of those wrestling with ques- tions of responsible life sciences research. Franz noted that, despite advances made in building trust and commu- nicating NSABB’s activities and materials, other countries may choose to formulate policies that differ from those in the United States. Franz noted that, at every level, assessments are made of the value versus the cost of regulations and oversight and that global competitiveness is a factor in such assessments. Franz recognized that some level of risk is inherent in every operating infectious disease laboratory but called for leadership and bal- ance in the management of U.S. research laboratories. The International Arena from a European Perspective David Heymann, Chairman, Health Protection Agency, United King- dom, Head, Center on Global Health Security at Chatham House in Lon- don, and Professor, Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, discussed current international rules and regulations, the degree of consistency that they lend to decision making, and whether there can be true international partnerships. Heymann spoke of the difficulties encountered in the changing rela­ tionship between the concerns for commerce and health. Heymann ob- served that, prior to the outbreak of H5N1 in poultry in 2007, WHO member states had agreed to freely share virus samples, which were used to identify novel viruses and to create new vaccines. During the 2007 outbreak of H5N1, this agreed-upon mechanism for ensuring the reliable, timely transfer of viral samples was complicated by the Minister of Health of Indonesia, who requested a material transfer agreement for each virus that Indonesia provided to the WHO. The WHO did not invoke the Inter­ national Health Regulations, which would have required the transfer of the virus samples, but rather addressed Indonesia’s request by making a resolution that the issue be addressed by an international working group outside of the WHO governance mechanism. The Pandemic Influenza Pre- paredness framework, which was formulated in response, included provi- sions for material transfer agreements. As a second example of an area in which commerce and health regulations come into conflict, Heymann cited export control laws. In the case of the Fouchier manuscript, the Dutch government required, as stipulated by European Union (EU) legislation,

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40 PERSPECTIVES ON RESEARCH WITH H5N1 AVIAN INFLUENZA an export license because a portion of the research results were to have been redacted from the published manuscript. The Netherlands and other EU-member countries questioned the EU’s regulations and requested the WHO’s assistance in resolving this question. An audience member with experience in the negotiations surrounding the Pandemic Influenza Preparedness Framework at the WHO spoke to the virus-sharing question as an equity issue for the virus-providing countries, noting that the countries stopped freely sharing viral samples because, at least in part, they learned that the WHO was sharing them with the vaccine- development industry, and that the donating countries received nothing in return. The Indonesian request for a material transfer agreement was the result of a sense of inequity. This illustrates the fact that, for developing countries, the conversation goes beyond sharing of information and mate­ rials, and encompasses ethical issues about credit, compensation, and over- all concerns about mutual work in the interest of public health. As a result of such considerations, biosecurity may be of lower priority in developing countries than in developed countries. Heymann discussed his view on a way forward for research of dual-use concern. He called for an international framework on the ethical and social benefits of influenza research that would form a foundation for discussions about trade and public health. According to Heymann, such a framework might (1) create peer pressure for researchers to carry out research in s ­ ocially responsible ways, (2) lead to safer laboratories, and (3) be a map for national governments that want to create their own legislation. Intersections with and Contributions of the Biological Weapons Convention: A Model of a Multisectoral Approach Piers Millet, Deputy Head, Implementation Support Unit for the Bio- logical Weapons Convention, United Nations Office for Disarmament Affairs, spoke about the many strong intersections between the issues surrounding dual-use research and concerns that motivate the Biological Weapons Convention (BWC). The BWC is an international treaty that attempts to strike a balance between the outright ban of bioweapons and the peaceful use of pathogen research in the life sciences. There are 165 nation signatories of the BWC. Millet noted that, at review conferences of the Convention a decade ago, delegates hailed primarily from departments of defense or foreign affairs, whereas today the meetings include representative of departments of health, agriculture, trade, and the sciences. Signatory states commit to not developing, acquiring, or stock­ iling p biological agents or toxins other than for prophylactic, protective, or

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GOVERNANCE AND OVERSIGHT 41 other peaceful purposes and commit to withholding assistance from other n ­ ations or groups in contravention to the BWC, both directly and indi- rectly. Simul­aneously, states are not to interfere with the international t exchange of these agents, equipment, etc., for peaceful purposes. Millet discussed how, in 2008, BWC delegates held extensive discussions about the oversight of research. Elements of consensus from those discussions were that: (1) national frameworks need to apply in both the public and private sector and throughout the scientific life cycle; (2) measures should be proportionate to risks and should not unduly restrict permitted activi- ties; (3) stakeholders should be engaged at every point in the process; and (4) national, regional, and international frameworks should be harmonized. Issues relevant to the BWC bear directly on issues raised by the H5N1 controversy. At the BWC’s 7th Review Conference in December 2011, it was decided to continue the practice of holding annual meetings between the Review Conferences held every five years. The 2011 Review Conference established standing agenda items for the annual meetings. These include an examination of relevant advances in science and technology. Each year, delegates will examine issues such as: • Developments with potential uses both contrary to the BWC and beneficial to the implementation of the BWC; • Measures to strengthen biorisk management; and • Codes of conduct and other approaches to raise awareness of the risks and benefits of life science research and biotechnology. In addition, the science and technology topics slated for discussion in upcoming years are germane to discussions about dual-use research. The topics include enabling technologies such as DNA sequencing and synthe- sis, synthetic biology, systems biology, and bioinformatics (2012); disease (2013); pathogenicity, virulence, toxicology, immunology, and perhaps transmissibility (2014); and production, dispersal, and delivery technolo- gies for biological agents and toxins (2015). Discussion Will the U.S. attempt to create processes and norms be sufficient from an international perspective? Will informal outreach suffice or should the process be formalized? Dr. Franz suggested that, to date, current efforts for global engagement are sufficient. He noted, however, that “dual-use research of concern” per se is too narrow to encompass all of the issues globally, particularly in countries where human survival is a primary concern or where little or

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42 PERSPECTIVES ON RESEARCH WITH H5N1 AVIAN INFLUENZA no laboratory research is conducted. Franz suggested that a more globally inclusive term, e.g., “responsible life sciences research” might be more ef- fective in harmonizing discussions. Professor Gostin asked whether a regulatory body in the U.S. that makes a decision about whether or not to allow the publication of a paper is sufficient or whether the decision should be subject to international over- sight. Franz replied by saying that he believes it is important to consider the international community in the decision, especially if the decision leans in the direction of not publishing. He noted that his opinion was rooted in a public health perspective as well as in a perspective that favors international relationships based on mutual trust. Regarding the role and sufficiency of informal activities, Dr. Millet noted the importance of the direct connections that have been made be- tween scientific communities, e.g., the Inter-Academy Panel, International Union of Microbiological Societies, International Union of Biochemistry and Molecular Biology, and the International Council for Science. On be- half of the Biological Weapons Convention, these groups have addressed dual-use research, education, and other issues. Millet believes that from these informal processes, formal processes will have to emerge. Millet ob- served that this important, informal process—whereby a critical sense of community is established—is seriously underfunded. How do we reach a formal international consensus? Dr. Heymann ac- knowledged the difficulty of achieving an international consensus. He is confident that the United States will continue to play a leadership role in such a discussion, through meetings such as the current workshop. However, he believes that it will be difficult to align a framework created by the United States with a framework that might be developed through consensus by other countries such as Russia, China, India, and Brazil. He believes that we will need to begin with a set of universally accepted principles and then move over the next decade or more to hard norms and possibly a convention. What can we learn from other international agreements and the activi- ties of people in other scientific disciplines? Dr. Millet mentioned several examples that he believes are worthy of emulation. He noted that the Chemical Weapons Convention has had considerable success in engag- ing the private sector. He applauded the work being done by the biorisk management community and lauded the model and accomplishments of the Financial Action Task Force (which audits the laws and regulations regarding the financing of terrorism). Has the NIH’s position3 on the two research papers dampened scien- tists’ willingness to discuss these issues? Dr. Fauci offered clear affirmation 3 Anthony Fauci, Gary Nabel, and Francis Collins, “A Flu Virus Risk Worth Taking,” Washington Post, December 30, 2011.

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GOVERNANCE AND OVERSIGHT 43 of NIH’s support of the two studies in question. When asked whether the NIH is willing to entertain the possibility that approved research will be found, at some later date, to be indefensible, Fauci would only say that, regarding the experiments in question, an impartial panel decided that they were worth doing and worth publishing. He observed that there is rea- sonable debate taking place about gain-of-function studies and expressed support of studies that aim to remain ahead of what is likely occurring in the natural world. He agreed that discussions about the justifiability of this type of experiment should take place before the fact and be conducted by disinterested parties. The Moratorium on Research on Laboratory-modified H5N1. Dr. Fauci reminded the audience that the moratorium on laboratory-modified H5N1 was voluntary (though mandatory for intramural NIH research). He sup- ported extending the moratorium until questions related to specific research programs of concern are resolved, i.e., whether there are risks, and, if so, whether the researchers have an appropriate plan for mitigating the risks.4 Dr. Millet was not as optimistic that the voluntary moratorium would hold in light of the recent NSABB recommendation for full publication of the Fouchier and Kawaoka manuscripts. Professor Gostin concluded the session by revisiting the discussion’s central questions: Should specific research take place? If the research is conducted, should it be published? Who should decide what research is published? What partnerships are critical? What norms should prevail? Gostin asked the audience to consider a key question in light of their own circumstances: How can we ensure that the international community moves toward a consensus based on true partnerships and a genuine under­ standing of common values—a consensus that prepares us to face this situ- ation more effectively the next time it arises? 4  Researchers declared an end to the moratorium on January 23, 2013.

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