Gain-of-Function Research Summary of the Second Symposium, March 10-11, 2016 (2016) / Chapter Skim
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2 The Draft National Science Advisory Board for Biosecurity Policy Framework, the Risk and Benefit Assessment, and Insights for the Policy Process
2 The Draft National Science Advisory Board for Biosecurity Policy Framework, the Risk and Benefit Assessment, and Insights for the Policy Process
Pages 9-38
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; consideration of ethical values and decision-making frameworks; analysis of the current policy landscape and potential policy options; preliminary findings from the NSABB WG's analyses; draft recommendations for the NSABB's consideration; and a number of important questions for further consideration. He reviewed key inputs into the work of the NSABB WG.
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, describing it as rigorous and comprehensive and representing a monumental amount of work. The scope of the RBA addressed biosafety risks and biosecurity risks as well as benefits from GOF research.
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POLICY CHOICES 11 FIGURE 2-1 U.S. government policy frameworks for managing risks associated with life sciences research.
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general, oversight mechanisms for GOF studies of concern should In be incorporated into existing policy frameworks. The risks associated with some GOF research of concern can be identified and adequately managed by existing policy frameworks if those policies are imple mented properly.
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. He said that the NSABB WG was also considering a new question: "What type of body should be tasked with the high-level review of GOF research of concern.
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ii. assessment of the overall potential risks and benefits associated with the An project determines that the potential risks compared to the potential benefits are justified.
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FIGURE 2-2 A conceptual approach for the review, funding, and oversight of gain-of-function research of concern. NOTE: GOF = gain-of-function; PI = principal investigator.
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, that included lifting the moratorium on GOF research; seeking an international consensus; securing national and international agreement to restrict the performance of GOF studies of concern; designating a board; establishing clear red lines for GOF studies of concern; and requiring the purchase by research institutions of specific liability insurance policies (Lipsitch et al., 2016)
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The outcomes from discussions held in other countries about GOF research were highlighted. Filippa Lentzos from King's College London, for example, in a comment made via the Web, noted findings from these discussions of the • Lack of clear and convincing justifications for GOF studies of concern; • Role of personal or institutional interests in agenda setting; • Global dimension of GOF research of concern and the need for an international solution; • Potential for accidents, abuse, and malpractice, and the intricate relationship between trust and accountability; • Instability of political contexts and changing security environ ments, and the need for transparency in biodefense-related research; and • Need for clear red lines on the most dangerous GOF experiments that apply to the public, private, and military sectors.
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In this respect, Marc Lipsitch from Harvard University noted that the original GOF experiments that prompted the international controversy were initially believed to have met only two of these criteria, and eventually met only one. Thus, those experiments would not be subject to any of the oversight provisions under discussion.
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If two studies show equal scientific merit and neither is considered of concern, then -- other things being equal -- would it be better to fund the less risky study if one cannot fund both? • Questions as to the efficacy of the existing arrangement for address ing biosecurity information risks were raised by Dr.
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had already been reviewed in detail at the January 2016 NSABB meeting.2 The purpose was therefore to build on those prior discussions to consider how risk assessment more broadly could serve the important roles that the NSABB's draft findings and recommendations, including its proposed conceptual approach for making decisions about GOF studies of concern, had given to judgments about risks and benefits. Rocco Casagrande from Gryphon Scientific provided an overview of the RBA (Gryphon Scientific, 2015)
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Other key findings from the biosafety assessment included • Manipulating GOF seasonal influenza strains at the BSL3 level may compensate for the increase in risk posed by the modified strains, largely because the extra system of respiratory protection decreases the risk of a laboratory acquired infection. • Some of the manipulations that could theoretically increase risk may not be achievable or desirable.
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The information biosecurity risk assessment analyzed "the risk that a malicious actor might misuse the information in publications describing GoF research" (Gryphon Scientific, 2015: 212)
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properly than for a PAPR to be defective. He also cited the difficulty posed by having no risk benchmark for work with wild type pathogens and the difficulty posed by restriction of the RBA to influenza and coronaviruses.
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of investiga tion, which was the purpose of the Gryphon Scientific analysis. Louis (Tony)
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• The performance of a decision rule can be evaluated for a stream of simulated projects with specified risk, cost, benefit, and information/uncertainty charac teristics and proposer response characteristics. • we know enough about GOF research to simulate realistic project proposals If and decision rule performance, then simulation-optimization of decision rules can lead to better (higher-performing)
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5. "Solution-focused" analysis of GOF and public choice may require wholly new institutional arrangements, not just incorporation into existing policy frameworks.
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.4 The need for additional resources to undertake focused research to fill data gaps was highlighted by Gigi Kwik Gronvall from the UPMC Center for Health Security. Shortages of data on benefits and risks were felt by several participants to apply to infectious disease research and emerging areas of life science research more broadly.
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He also suggested that the RBA was a missed opportunity to explore the international opportunity costs associated with different decisions on GOF studies of concern, from a moratorium on relevant research, through increased oversight, to taking no additional steps. The shortcoming of existing arrangements in identifying and miti gating biosecurity information risks was noted by some participants, including Victoriya Krakovna from the Future of Life Institute, Dr.
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THE SCIENCE OF SAFETY AND THE SCIENCE OF PUBLIC CONSULTATION Baruch Fischhoff from Carnegie Mellon University, a member of the Symposium Planning Committee, opened the session by explaining that there had been a successful session at the first Academies GOF symposium, which offered an introduction to the lessons from research into human factors, public consultation, and risk assessment to inform the preparations by NIH and the NSABB for the RBA. This year the planning committee had organized another session focused on the insights that social science research can offer about the design and implementation of federal oversight for GOF studies of concern.
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Dr. Huising presented key findings from studies of safety culture in biology laboratories.
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He cited the conclusion in the RBA that "The state of knowledge of the rates and consequences of human errors in life science laboratories is too poor to develop robust predictions of the absolute frequency with which laboratory accidents will lead to laboratory acquired infections" (Gryphon Scientific, 2015: 3) to underscore the relevance for GOF policy deliberations.
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Monica Schoch-Spana from the UPMC Center for Health Security outlined four basic considerations for the design of public deliberations.
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She also noted that each of these categories of the public had been engaged in past discussions on GOF studies of concern, with the affected public implied in the RBA, affected publics and the pure public noted in the ethics analysis, and partisan publics reflected in relevant publications and comments.
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3. Which process enables the public to fulfill its purpose -- The use of three types of processes in the GOF deliberative process were reviewed: communication, a form of transparency through put ting out information for the public -- for example, press releases, educational websites, and summary reports such as those made available by the first Academies GOF symposium and the NSABB GOF meetings, as well as making the RBA available online; consul tation, a means of gathering input, such as through enabling public c omments on draft NSABB recommendations and to the U.S.
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Discussion The resulting discussion further elucidated specific aspects of the presentations. The importance of additional data gathering on accidents and associated human factors research was a repeated theme.
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Ruthanne Huising said that the new regulatory framework developed in Canada had a nonpunitive reporting system that offered potential lessons about dealing with privacy issues and offering useful feedback. Given what he saw as the difficulties of implementing a non unitive p system in high-containment laboratories, Andrew Kilianski, a National Research Council Fellow from the Edgewood Chemical Biological enter C Aberdeen Proving Ground, made the specific suggestion to conduct research focused on the possible relationships between human error by graduate students under minimal-containment standards and other indicators of their proficiency.
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as examples worth studying for approaches to providing a diversity of views and participants. She commented on the need for more efforts to collect and share best practices about ways to improve biosafety, biosecurity, and what she called "bio-credibility." The potential additional burden imposed on scientists involved with GOF studies of concern from participating in further public deliberation exercises was raised by Margaret Kosal from the Georgia Institute of Technology.
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discipline. "We need the leaders in these disciplines to model the importance of these values and normative expectations in research.
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