Potential Risks and Benefits of Gain-of-Function Research Summary of a Workshop (2015) / Chapter Skim
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2 Assessing Risks and Benefits
2 Assessing Risks and Benefits
Pages 7-20
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From page 7... ...
research has been on hazard assessment. This encompasses occupational health risks, but needs to go beyond this to risks to the members of the public near research sites as well as global risks for pandemic organisms.
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From page 8... ...
As a consequence, the GoF research debate has jumped directly into the risk characterization stage without the benefit of the missing intermediate analyses and the dissection of the exposure and dose response issues that may make considerable differences in how the risk characterization is framed. It was Haas's view that the current risk characterization picture contains too many lumped parameters, combining factors dealing with environmental effects, host properties, and infectious agents.
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From page 9... ...
He recommended a book, Risk: A Very Short Introduction (Fischhoff and Kadvany, 2011) , in which the authors use simple conceptual frameworks from decision theory and behavioral research to explain the science and practice of creating measures of risk, how scientists address risks using historical records, scientific theories, probability, and expert judgment, and what cognitive scientists have learned about how people deal with risks and how these lessons apply to diverse examples and demonstrate how understanding risk can improve making choices in everyday life and public policy.
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From page 10... ...
ASSESSING RISKS AND (EXPECTED) BENEFITS Fischhoff noted these key needs for risk assessments: • Socially acceptable outcomes defined • Factors that are believed to affect outcomes identified • Factors and interdependencies assessed based on observation and expert judgment • Quality of the evidence assessed Fischhoff urged policy makers to have a clear idea of what the purpose of a particular risk/benefit analysis is so that the analysis suits its purpose.
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From page 11... ...
He also noted that the literature from nuclear power and other sectors makes clear that human behavior must be taken into account as both a source of vulnerability and a source of resilience. Although human error is clearly a problem, human innovation can also rescue difficult situations.
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From page 12... ...
Consider human capabilities as well as limitations 5. Expect disproportionate number of human factor scenarios vs.
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From page 13... ...
He stressed the importance of risk communication and taking account of behavioral research that demonstrates how humans tend to make faulty intuitive judgments. He cited two special issues of the Proceedings of the National Academy of Sciences (PNAS)
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From page 14... ...
These subgroups faced enhanced exposure to the H1N1 virus because of social, economic, and behavioral elements. They faced greater susceptibility to influenza because of the high prevalence of chronic disease and immunosuppression, and they had impaired access to timely and trusted health information, vaccination, and treatment.
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From page 15... ...
Why Is Engaging the Public Valuable? Schoch-Spana noted that there is a valuable summary in the 2008 NRC report Public Participation in Environmental Assessment and Decision Making, which identified three important justifications for deliberative processes: improving product quality, enhancing legitimacy, and building capacity.
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From page 16... ...
Considerations for the NIH and the NSABB Schoch-Spana concluded with two points that she believes merit further attention for broad public engagement in the proposed GoF assessment -- nested engagement and enduring structures. Broader publics at local, national, and global levels could participate in public engagement exercises that are national in scope, diversely populated, and involve technically and ethically complex health security matters, for example, how does one distribute scarce medical resources in an influenza pandemic?
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From page 17... ...
Such efforts would enhance the scientific literacy of citizens as well as the capacity of scientists, their sponsors, and their regulators to represent their work in broadly meaningful ways. Her final takeaway message was "How a decision is made is just as important for many people as the outcome of that decision." SUMMARY OF RISK AND BENEFIT OVERVIEW Fischhoff summarized as follows the tasks to be accomplished by the risk/benefit assessment that the NIH plans to conduct: • Define the risks and benefits; • Assess the risks and expected benefits; • Communicate the risks and expected benefits; and • Organize to reduce the risks and increase the expected benefits.
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From page 18... ...
Fischhoff also reiterated the importance of considering and evaluating human factors in scientifically sound ways and that public engagement should be treated as an opportunity to increase the public's literacy and to build trust in a community. This means reaching out, pulling the community into the process, and taking its opinion seriously.
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From page 19... ...
He believes that one of the best things to come out of the risk assessment would be to convince ourselves and the public that we considered the issues in depth and that whatever decision we made was not pulled out of thin air, but rather the result of a careful deliberative process. Fineberg also asked Fischhoff whether there are special issues that should be considered in a situation such as that posed by GoF research where there is a very small likelihood of a catastrophic possible outcome.
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From page 20... ...
The precautionary principle may be the only arrow in their quiver, but it may make objectors appear to be demanding zero risk and unwilling to accept any kind of trade-off.
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