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Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
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4

International Policy

INTERNATIONAL DIMENSIONS OF GAIN-OF-FUNCTION RESEARCH

Barry Bloom from Harvard University, a member of the Symposium Planning Committee, introduced the session by noting that, as had already become clear in earlier discussions, the issues related to gain-of-function (GOF) research were not confined to the United States. This session would provide background and insights about the international dimensions of GOF research and illustrate the ways in which various organizations outside the United States have been contributing to the discussions from the beginning.

Ruxandra Draghia-Akli from the Health Research Directorate of the European Commission introduced the European Union (EU) innovation framework Horizon 2020. With a budget of €79 billion, the program is intended to support research and development that is increasingly complex, interdisciplinary, and costly, and that also requires a critical mass. It provides a vehicle for increased collaboration across the 28 countries of Europe. The Horizon 2020 framework covers a broad range of research and development activities; most relevant to GOF research is the section on Societal Challenge 1: Health, Demographic Change and Wellbeing, with a budget of €7.4 billion. The research funded under this framework has to have civil or public health applications. Any dual use potential is unintentional.

There has been no specific call for proposals on GOF research according to Dr. Draghia-Akli, but under the health calls, proposals were encour-

Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

aged to strengthen research on prediction, identification, modeling, and surveillance of newly emerging infectious diseases in humans, and to identify factors promoting the emergence of pathogens with human pandemic potential from pathogens with a zoonotic background and related prevention strategies. Both of these areas could potentially result in proposals involving GOF research. Five EU-funded research projects with GOF elements were identified: (i) EMPERIE (European Management Platform for Emerging and Re-emerging Infectious Disease Entities, 2009-2014); (ii) PREDEMICS (Preparedness, Prediction and Prevention of Emerging Zoonotic Viruses with Pandemic Potential using Multidisciplinary Approaches, 2011-2016); (iii) ANTIGONE (Anticipating the Global Onset of Novel Epidemics, 2011-2016); (iv) AntiBotABE (Neutralizing antibodies against botulinum toxins A,B,E, 2010-2015); and (v) TIRAMISU (Humanitarian Demining Toolbox, 2012-2016).

Dr. Draghia-Akli then outlined the ethics review processes that research undergoes in Horizon 2020.

  • During proposal preparation, applicants are asked if their proposal has an exclusive civilian focus on research and if their research uses or produces goods or information that will require export licenses in accordance with legislation on dual use items.
  • Ethical screening is carried out for each successful proposal by at least two ethics experts, drawing on a variety of different backgrounds, including law, philosophy, medicine, and biology.
  • A full ethical assessment for all proposals containing potential dual use issues is carried out by at least five ethical experts.
  • At the end of the whole process, the ethics report determines if the project has clearance, requiring no further action; conditional clearance, requiring changes to be made to the description of work (such as requirements for permits, follow-up, or ethical audits); or no clearance, meaning that the project will not be funded.

There has also been specific dialogue with stakeholders in the European Union on GOF research, including the European Society for Virology, which has a common policy for scientific research and publications; the Foundation for Vaccine Research, which has called for a comprehensive risk–benefit assessment of GOF studies of concern; and the European Academies Science Advisory Council (EASAC), which established a working group in autumn 2014 to explore consensus on key questions, identify further GOF issues, and clarify options for policy development. The European Union acknowledged the need to improve awareness and best practices among members of the scientific community and to promote an underlying culture of responsibility, given the potential for

Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

accidental release and misuse. The European Union also welcomed the EASAC working group recommendations (EASAC, 2015a; see the comments by Volker ter Meulen).

Dr. Draghia-Akli provided three different approaches toward implementation within the European Union: researcher-based approaches, as used in the United Kingdom; researchers being overseen by institutions, as used in the Netherlands; and supervision by a national agency, as used in France.

Volker ter Meulen, the chair of the EASAC working group, introduced his institution. EASAC was formed in 2001 to enable European national academies of science to collaborate in giving advice to EU policy makers (e.g., the European Commission and Parliament). Its membership comprises all EU national academies of science plus Norway and Switzerland, and its objective is to deliver consensus outputs to provide a means for the collective voice of European science to be heard. Dr. ter Meulen explained that the EU scientific community had expressed differing views to the president of the European Commission in 2013 on relative benefits and risks of GOF influenza virus (H5N1) research (European Society for Virology, 2013; Foundation for Vaccine Research, 2013). As a result, the European Commission and its chief scientific adviser requested EASAC to clarify and advise on these issues. EASAC brought together scientists, nominated by its member academies, who represented a mix of expertise and a wide range of views about the GOF controversy. The group sought to find areas of consensus as well as issues that had not been resolved. Its report also offered recommendations about what further analysis would be necessary to assess future options for research with potentially pandemic pathogens. The report also identified which of the European Union’s current regulations applied to GOF research, how national- and EU-level responsibility should be divided, and what best practices already exist at the national level that could inform other countries.

During the course of this work, EASAC identified a range of critical issues to consider when addressing GOF research as well as key messages, which are summarized in Box 4-1.

EASAC has subsequently produced messages to academies of science worldwide, policy makers in EU institutions, and EU member states as well as to research funding bodies, regulatory bodies, professional societies, and others in the scientific community. It has also worked to catalyze further broad engagement via member academies.

Dr. ter Meulen concluded by providing some insights for strengthening international consideration of GOF issues, including the importance of addressing differences in understanding and in systems between countries and regions; ensuring layered, integrated approaches; building

Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

links between researchers, policy makers, and other stakeholders; and a continuing commitment to public engagement.

Silja Vöneky from the University of Freiburg discussed the German Ethics Council (GEC) report on biosecurity from 2014 (German Ethics Council, 2014). Dr. Vöneky introduced the GEC, noting that it is an interdisciplinary independent counsel of experts whose 26 members are appointed by the president of the German parliament. She reviewed recent work exploring options for biosecurity for research and health and noted that the GEC report explored biosecurity issues but not biosafety because the regulatory regimes associated with biosafety are much more developed.

Dr. Vöneky presented five recommendations for future GOF research based on the findings of the GEC report (see Box 4-2). These recommendations reflected those proposed for use within Europe, focused on five different areas of governance: raising the level of awareness on biosecurity among the scientific community; elaborating national biosecurity codes of conduct; reviewing research funding; making specific national recommendations tailored to national needs; and developing European and international initiatives.

In the German context, Dr. Vöneky recalled that the GEC had recommended that an appropriate definition of the research of concern should be included in an act of parliament; the definition should be further developed by detailing relevant groups of experiments in a statutory instrument or regulation; and a list of agents associated with the research should be developed. She commented that the list of agents will need to be updated to reflect advances in the life sciences, suggesting that it should not be listed in legislation.

Dr. Vöneky noted that it was difficult to assess the impact of these recommendations over the year since they were made. She highlighted

Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

progress in Germany in the promulgation of codes of conduct to address DURC issues, and she discussed the implementation of such codes in a number of research institutions.

Dr. Vöneky also highlighted a number of other results that might be relevant to GOF discussions. She believed that soft measures, such as requirements connected to funding, might be less suitable in the EU context. She suggested that measures to evaluate and manage risks associated with GOF research would need to be either codified by states into appropriate laws and regulations or contained with other legal frameworks such as constitutions or international treaties because of competing interests between the rights and freedoms of science and scientists and rights associated with the right to life and health for other parts of the population. Dr. Vöneky noted that the work undertaken by the GEC revealed that existing legal rules governing GOF research in Germany and Europe are insufficient and need to be more coherent. She highlighted internal inconsistencies around the publication of results and funding arrangements.

Dr. Vöneky concluded by stressing the need to balance scientific freedoms and responsible research with the need for proportional measures that do not unnecessarily impede research but do help to manage risks. She reflected on thresholds for GOF studies of concern, suggesting that such a concept might usefully capture experiments that might result in pathogens, which increase the danger of an epidemic of a severe human disease. She felt that such experiments should not be undertaken unless a direct, concrete, and overwhelming benefit for life or human health is probable.

Keiji Fukuda from the World Health Organization (WHO) explained that the world is currently facing a broad mix of issues and uncertainties related to genetic technologies and their potential to do harm, such as GOF research. Other approaches, such as synthetic biology, offer ways to generate novel organisms. Furthermore, Dr. Fukuda noted that the nature of these challenges is evolving as access to the necessary technologies changes: for example, through the emergence of cheaper technology and the advent of private community laboratories. Dr. Fukuda also noted that the entry into force of the Nagoya Protocol on sharing the benefits of biological resources also impacts this space. Furthermore, he recalled that developments, such as the WHO Pandemic Influenza Preparedness Framework deal with not only the movement of viruses but also the movement of sequence information. Dr. Fukuda noted that while these are critical international issues, global awareness of them and how they intersect remains minimal. He highlighted the lack of a clear strategy and outstanding questions as to whether they should they be dealt with separately or were better addressed together. Dr. Fukuda recalled that while

Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

risk assessment can be a scientific and precise process, risk perception, tolerance and management are cultural, political, and, at the global level, consensus based. Dr. Fukuda presented four options for further work on GOF research (see Box 4-3).

Discussion

Barry Bloom led a moderated discussion among the panelists. They explored opportunities for interaction between U.S. and European efforts to address GOF research, with Dr. Draghia-Akli expressing how beneficial such exchanges on common policy problems could be. The importance of information exchange was repeatedly expressed. One panelist felt that the European Union was likely to be flexible about approaches to the biosecurity aspects of GOF research, but noted that given the highly developed arrangements already in place there may be less opportunity to influence biosafety policy. The complexity of the European regulatory architecture was also noted, with one panelist suggesting that additional measures were added but rarely replaced existing arrangements. A trend toward the European Union engaging international partners was highlighted, especially through the development of principle-based voluntary frameworks that could be implemented by partners. Past collaborations between the United States and the European Union were noted on health and biomedical related policy development: for example, bringing together funding agencies to streamline work on rare diseases. Past examples also included collaboration on sensitive issues, such as data and sample sharing.

Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

Panelists also considered options for attempting to ensure that GOF studies of concern were conducted only under appropriate safety conditions. At the suggestion of Barry Bloom, panel members discussed precedents used elsewhere for the prequalification of appropriate laboratories, assessing them against predetermined capabilities: for example, those used for quality control of laboratories used by United Nations agencies. Several participants supported such an approach but highlighted that it would be necessary to consider carefully what the desirable capabilities would be. Other participants felt that the GOF studies of concern context was considerably more complicated than the purposes for which prequalification has been used in the past, and they suggested that the desirable capabilities would be too context dependent for such an approach. They also noted that the number of relevant facilities might be larger than those found in other areas where prequalification has been used.

An open discussion followed and consideration of prequalification of laboratories continued. Gavin Huntley-Fenner questioned which international organization might oversee such an approach. WHO, the International Standards Organization, and the United Nations Educational, Scientific and Cultural Organization were discussed. Keiji Fukuda stressed the importance of any hosting organization being perceived to be neutral and having the trust of key stakeholders.

Issues around standards and harmonized approaches were also explored. Harvey Fineberg, chair of the Symposium Planning Committee, noted that in certain cases—such as for the approval of medicines, drugs, and other medical devices—there was still a notable degree of difference in what is approved, and when, despite a comparatively common agreement on the characteristics to be assessed, relatively straightforward measurements, and well-established decision-making processes. Other participants noted that in the European context, while risk assessment might be carried out collectively, regulatory approval still happened at the national level. Some participants suggested that the chances of creating a common system for GOF studies of concern in the short term were small, especially given the absence of a common definition. Other participants noted that the number of scientists and laboratories potentially conducting GOF studies of concern was currently limited and that there might be opportunities to develop common standards— for example, for biosafety precautions—among the relevant community.

The possibility for developing common approaches between the United States and Europe was also explored, with Silja Vöneky suggesting that reaching such an agreement might help jump-start a broader international process. Michael Callahan felt that a broader buy-in from the start would help legitimize the process. To underscore that argument, Piers Millett from Biosecure transmitted the views on GOF of the 112 states that

Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

comprise the Group of Non-Aligned Movement and Other States under the Biological Weapons Convention (BWC) by reading aloud from the Group’s statement to the BWC.1

There was also an exploration of whether harmonization efforts should be scientist-led or state-led, with different participants favoring different models. Some participants noted that, at present, GOF studies of concern were largely confined to public institutions, enabling governments to play a leading role. Others noted that only a limited number of states had so far shown an interest in GOF studies of concern, suggesting that a scientist-based, bottom-up approach may help increase government interest around the world. There were also discussions of whether a formal approach was needed, requiring international instruments, or a more informal approach might be more suitable, perhaps through appropriate guidelines such as those used to underpin international efforts on infection prevention and control. Participants also discussed the value of strengthening a culture of responsible research among relevant scientific communities, noting that they had key insights into the risks associated with GOF studies of concern.

The changing distribution of research capacities, sources of funding, and the markets they serve were also discussed. Some participants noted that these developments complicated efforts to address GOF studies of concern, and others noted that it required additional efforts to understand a broader variety of motivations for and contexts within which GOF research might be conducted. Participants discussed incentivizing industry participation, alternative funding strategies and business models in general, and public–private partnerships in particular, for dealing with changes in markets, funding and demographics. Participants provided a number of examples of successful precedents, including the Innovative

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1 The statement is “there have been recent advances demonstrating the increasing sophistication of synthetic biology, together with other enabling technologies, which have benefits, together with the potential for uses contrary to the provisions of the Convention. All states must conduct such activities in a transparent manner, in order to build the confidence of other States Parties. There is a need to regulate these activities, to ensure that they do not lead to any concerns related to ethics, safety and security as well as any uses contrary to the Convention. This has assumed added importance in the light of reports concerning experiments that have been taking place on highly contagious virulent flu strains like H5N1, as well as the production of several new strains of viruses that are both contagious and deadlier than the 1918 Spanish flu that killed almost 50 million people, and the discovery of the deadly smallpox variola virus dating back to the 1950s. Such regulation must, however, be undertaken in a manner that does not hamper scientific and technological developments that are in keeping with the spirit and letter of the Convention, which are of benefit, more especially to developing countries.” It is available at http://www.unog.ch/80256EDD006B8954/(httpAssets)/DF2D9E3CAA6D5FEDC1257EA400369E6E/$file/NAM+Statement+on+S&T+MX+2015-3+final.pdf.

Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
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Medicine Initiative in the European Union, and global networks for building preparedness for emerging epidemics.

OPPORTUNITIES TO HARMONIZE GOF RESEARCH POLICY AND PRACTICE

Ronald Atlas from the University of Louisville, a member of the Symposium Planning Committee, introduced the session. The plenary on the first day provided participants with an awareness of the international context within which the GOF controversy has evolved. The purpose of this session was to look ahead, to explore the potential for increasing international coordination of policy and practice for GOF studies of concern. What are the opportunities in different regions, including those where the research is performed and those where the pathogens of concern are endemic? What roles might national governments take in fostering efforts at coordination? What are some of the international venues, such as regional or international organizations, where discussions could take place and policy options could be developed? What are the roles for national and international scientific organizations?

George Gao from the Chinese Academy of Sciences and the Chinese Center for Disease Control and Prevention began by discussing risk and benefit. Dr. Gao discussed an example of the H7N9 influenza virus, noting that study of the virus could be directed at finding a mutation in the receptor binding site that might be responsible for allowing the virus to switch from an avian to a human host and allow the virus to transmit to humans. Dr. Gao noted, however, that checking all possible genetic combinations is infeasible, and, given the importance placed on finding the mutations responsible, a GOF approach proved most efficient.

Dr. Gao stressed the importance of international collaboration, cooperation, and harmonization. He recalled one case where two researchers, one in the United States and another in China, were collaborating on research connected to Golden Rice. The contents of the underpinning agreement were different in Chinese and English, which led to misunderstandings and substantial impediments to the research. He felt that harmonization was needed on more than just policy development and that it was necessary to have oversight of the research being undertaken. He suggested that it is important to monitor what is happening in laboratories. Dr. Gao noted the need for a suitable international forum for discussions at the government level. He felt that it was important for top officials in many countries to engage with this issue. He suggested, however, that in many countries there were still opportunities for greater domestic harmonization of relevant rules and regulatory approaches.

Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

The interests of scientists often drive the direction and approaches to research, Dr. Gao noted. Therefore, he felt that it was important to engage with individual researchers on these issues. He believed that GOF experiments should be done in highly regulated laboratories and undertaken only by the best scientists.

Gabriel Leung from The University of Hong Kong began by considering GOF research in context. He noted that this was a discussion of risk to humans and, to a lesser extent, ecological security. He underscored that this was an international issue because pathogens do not respect borders. Dr. Leung suggested this is also a global security issue, not only a U.S. national health security concern. He felt that the primary outcome of policy discussions should be conclusions as how best to keep the global population safe from potential consequences of pathogens that were highly virulent, highly transmissible, and/or resistant to public health interventions.

Hazard analysis, according to Dr. Leung, was a critical control point. He highlighted lessons that might be learned from food safety experiences. Dr. Leung suggested that it was necessary to look for the weakest link in the global supply chain and argued that, in the case of GOF studies of concern, it was a lack of public health preparedness. He recalled that the majority of countries around the world had self-declared their inability to meet core requirements under the International Health Regulations. He suggested that investing in global capacity to respond to disease minimizes the proportion of GOF studies of concern that would then be of concern. To this end he commended the recommendations of the recently released report of an international commission hosted by the National Academy of Medicine on which he had served (Commission on a Global Health Risk Framework for the Future, 2015).

Dr. Leung noted that a highly organized regime for governance of GOF research was important for obtaining human security. He felt that the issue had been largely ignored elsewhere in the world. While he acknowledged that a national policy in the United States would have a global impact, he noted that its relevance should not be overestimated. Stringent arrangements in the United States, or a ban on GOF studies of concern, according to Dr. Leung, would not stop risks to the global population from research carried out in other countries.

Dr. Leung also argued that overly burdensome regulations can lead to unanticipated consequences—perhaps driving GOF research underground or possibly relocating it to other countries without such regulations. He expressed concern over how the broad findings of the National Science Advisory Board for Biosecurity might be translated into guidance and implemented by IBCs in institutions. He felt that greater clarity, especially as to what is (and what would not be) permitted, was needed,

Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

as was more guidance on the implementation of the proposed policy framework.

Dr. Leung provided a number of specific reactions to the inputs to the symposium (see Box 4-4) and concluded that responsible science with robust oversight of GOF studies of concern is warranted, but it should “not squeeze the lifeblood out of scientific enterprise.” He felt that the balance between the two must be clearly defined and continually fine-tuned.

Nisreen AL-Hmoud from the Royal Scientific Society of Jordan noted that understanding life processes is becoming ever more important in terms of health, nutrition, and industrial application. Dr. AL-Hmoud suggested that the Middle East and North Africa (MENA) region lags behind other parts of the world in addressing issues in life sciences research.

Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

She stressed the importance for the region of greater progress in ensuring that natural diseases are contained as soon as possible; that harmful consequences of research are minimized; and that laboratories operate safely—both for their workforces and for the communities in which they are situated.

While controversies around research involving highly pathogenic avian influenza virus and the Middle East respiratory syndrome coronavirus (MERS-CoV) have generated considerable discussion and debate among virologists, public health scientists, and experts in the United States and certain other parts of the world, a considerable need for raising awareness about GOF research persists in the MENA. This is needed for laboratory directors and policy makers as well as for life scientists. For maximum benefit, Dr. AL-Hmoud argued that policies and practices aimed at reducing and managing risks should be planned in a holistic manner as part of national safety and security strategies. She noted that, while some countries have begun to develop such plans, many others have not.

Dr. AL-Hmoud noted that while risks vary from region to region, and from one country to another, without a common methodology for assessing risks and for having appropriate policies and practices to manage and mitigate these risks, any international effort will be neither comprehensive nor effective. The countries in the region have explicitly recognized the need for comprehensive scientific strategies, and Dr. AL-Hmoud reviewed efforts under the Biosafety and Biosecurity International Conference series as an example.

Dr. AL-Hmoud stressed the public health impact of coronaviruses, in particular MERS-CoV, and she recalled that the antigenic relationships among the different coronaviruses or how these relationships influence the capacity of different strains to emerge in human populations remains uncharacterized. While she noted progress in relevant tools and information, Dr. AL-Hmoud also stressed that important research questions need to be explored further and they must address potential issues around security and select agent status. She highlighted opportunities for the MENA region to learn from the experiences of other regions, to adopt best practices, and to develop networks of experts.

Dr. AL-Hmoud discussed the importance of developing systematic programs that strengthen human capacity for safe and secure handling, importing, and exporting pathogens to strengthen the oversight of GOF research. She highlighted the need for certain infrastructure and policies at the national level. Dr. AL-Hmoud suggested that these programs should offer considerable regional and international benefits by reducing risks from pandemics and epidemics, regardless of whether they are natural, accidental, or deliberate. To reduce the risk of biological accidents, Dr. AL-Hmoud called for better safety standards and practices,

Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

and improved designs and procedures for security systems at biological facilities. In relation to GOF research, Dr. AL-Hmoud also noted the need for better education and training, more awareness raising, detailed consideration of unintended consequences, and broader adoption of best practices and codes of ethics.

Michael Selgelid from Monash University in Australia suggested that too much of the deliberative process and decision making on GOF research had been restricted to scientists. He argued that there had not been sufficient involvement of the general public and that there was a need for greater engagement of a wider range of stakeholders, including those from other countries.

Dr. Selgelid felt that some policy decisions, especially on risks affecting the global community, could only be made by an international body. He suggested that GOF research poses issues of global justice, including sharing of the benefits of this research. If the risks are universal, there may be issues if the benefits are available only to some of the countries. Dr. Selgelid felt this was particularly important for medical countermeasures. He also noted that a decision to conduct GOF studies of concern in only maximum-containment facilities would effectively preclude the majority of countries from undertaking such work. Dr. Selgelid suggested that WHO was the most legitimate international body to make decisions about GOF research. He discussed the possibility of creating a new WHO committee, similar to the body that oversees smallpox research, to undertake such a task. Dr. Selgelid also discussed the possibility of developing a new stand-alone body for the oversight of GOF studies of concern.

Dr. Selgelid noted that some countries are more likely to be exposed to risk from GOF research than others, especially where vaccines or therapeutics available in richer countries are not available in poorer countries. He noted that differences in access to basic healthcare could also result in an uneven risk distribution from GOF studies of concern.

He highlighted a number of lessons from earlier discussions of DURC. For example, he reviewed findings from the 2010 WHO guidance document Responsible Life Sciences Research for Global Health Security (WHO, 2010) (see Box 4-5). Dr. Selgelid also identified a number of approaches for harmonizing GOF research policy. He noted possibilities for gathering greater input from other countries bilaterally. He discussed a collective international harmonization process to create a level playing field. He also considered a more formal international governance regime for policy making and decision making. Dr. Selgelid reviewed the possibilities for using different frameworks, either by strengthening existing treaties or by creating new international agreements or compacts. He cautioned that these more formal arrangements would be difficult to achieve and involve a great deal of work. He also noted more standards-based approaches to

Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

governance, discussing the framework in place governing human subjects research and suggesting that the ethics governance regime might be expanded to include oversight of GOF studies of concern.

Discussion

The discussion that followed expanded on ideas and concepts introduced during the presentations. Participants explored the comparative advantages of using a standards-based approach based on the existing ethics governance regime. Michael Selgelid again argued this might be easier than a treaty-based approach because it could take advantage of existing policy frameworks and offer logistical benefits. Participants also discussed whether international harmonization might be best achieved through international organizations or international scientific bodies. Some participants felt that both approaches should be pursued in concert. Opportunities for using insurance requirements to harmonize GOF approaches were also discussed, and David Stanley introduced a concrete proposal from the Future of Humanity Institute to utilize the grant making process to address potential risks (Cotton-Barratt et al., 2016). The institute proposed to “price the expected value of any damages that could result from GOF research into the price of the grant being considered.

Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

Then they could either require grantees to purchase liability insurance to cover the possible damages from this or, alternatively, require a payment to the state or non-state body to cover the expected cost of that research.”

The reasons for seeking international input and harmonization were explored. Christopher Park from the Department of State outlined three objectives for seeking greater interaction, including (i) to get greater clarity as to foreign views on U.S. measures; (ii) to change behavior of individual researchers, perhaps best achieved through international scientific bodies; and (iii) trying to change behavior of other governments, requiring different approaches either through multilateral settings or coalition building. He also noted that if the intent was to address laboratory biosafety issues, it would require engaging one set of actors in associated settings, while a separate community and associated forums would be necessary for addressing biosecurity information risks. Another participant highlighted the importance of engaging the human and animal health communities, given the zoonotic nature of relevant diseases.

Keiji Fukuda from WHO stressed the importance in successful international efforts of a common understanding of the nature of the risk being addressed. He offered the negotiation of the International Health Regulations, the WHO Pandemic Influenza Preparedness Framework, and measures to address antimicrobial resistance as examples. He then suggested that such an international common understanding does not exist with regard to GOF studies of concern and that international engagement might be better focused on reaching a technical agreement on the nature of the risk posed by this research.

Participants also discussed three options for balancing national action against a broader international approach: to act now solely at a national level; to act now at a national level but send a clear message as to the desirability of subsequent international engagement; or to begin working on a full international policy process from the outset. Several participants felt that, given the international nature of the risks being addressed, the first option was not appropriate for GOF research. The same participants suggested that the decision as to whether the second or third approach was more suitable should be based on the resources available, the preexisting levels of international concern, and the level of need for international consensus. Another participant suggested that if sufficient resources could not be secured from the outset, it might be better not to initiate an international process rather than have to abandon it after a short while. Some participants highlighted the value of the Global Health Security Agenda as a model for building an international partnership with opportunities to shape the process.

One question raised during the discussion was who should determine the criteria for classifying research as GOF studies of concern or

Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×

for identifying specific research proposals that meet those characteristics. Dr. Selgelid suggested that it might usefully be based upon a mutlilayered analysis with institutional, national, and then international stages—relevant research would be identified at each of these levels and then passed on to the next level for further consideration.

The potential for additional oversight measures for GOF studies of concern to reduce interest in GOF research was raised again. Some participants pointed out that in some cases, such as certain types of research involving human subjects, this was acceptable and appropriate. Gabriel Leung suggested that the longer-term impact would be to discourage scientists from entering into research fields connected to emerging or reemerging pathogens. This was disputed by others, such as Marc Lipsitch from Harvard University.

Participants also discussed possible reactions by international partners, such as China, if the United States decided to introduce an oversight framework for GOF studies of concern. George Gao felt that China would certainly look closely at such a regime.

Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
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Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 54
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 55
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 56
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 57
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 58
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 59
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 60
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 61
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 62
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 63
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 64
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 65
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 66
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 67
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 68
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 69
Suggested Citation:"4 International Policy." National Academies of Sciences, Engineering, and Medicine. 2016. Gain-of-Function Research: Summary of the Second Symposium, March 10-11, 2016. Washington, DC: The National Academies Press. doi: 10.17226/23484.
×
Page 70
Next: 5 Summing Up »
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On March 10-11, 2016, the National Academies of Sciences, Engineering, and Medicine held a public symposium on potential U.S. government policies for the oversight of gain-of- function (GOF) research. This was the Academies’ second meeting held at the request of the U.S. government to provide a mechanism to engage the life sciences community and the broader public and solicit feedback on optimal approaches to ensure effective federal oversight of GOF research as part of a broader U.S. government deliberative process.

The first symposium, held in December 2014, examined the underlying scientific and technical questions surrounding the potential risks and benefits of GOF research involving pathogens with pandemic potential. The second symposium focused on discussion of the draft recommendations regarding GOF research of a Working Group of the National Science Advisory Board for Biosecurity. This report summarizes the key issues and ideas identified during the second symposium.

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