Potential Risks and Benefits of Gain-of-Function Research Summary of a Workshop (2015) / Chapter Skim
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Appendix A: Key Issues for Risk/Benefit Assessment for Gain-of-Function Research
Appendix A: Key Issues for Risk/Benefit Assessment for Gain-of-Function Research
Pages 77-86
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From page 77... ...
CHAPTER 2: ASSESSING RISKS AND BENEFITS 1. Although the major steps in risk assessment were first enunciated in a National Research Council report titled Risk Assessment in the Federal Government: Managing the Process, the basic steps in the process remain the same today: • azard Assessment: The determination of whether a particu H lar chemical (or microbiological agent)
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From page 78... ...
7. Risk assessments on low-probability/high-consequence events are not new, and because the roles of uncertainty and human factors are crucial in risk assessment, acknowledging and incor porating them are an important goal (Fischhoff, 2014a:11)
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From page 79... ...
10. Other areas of limitations in risk assessment include variability among observations, quality of the studies the analysis is based on (internal validity)
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From page 80... ...
. Routine virological methods involve experiments that aim to pro duce a gain of a desired function, such as higher yields for vaccine strains, but often also lead to loss of function, such as loss of the ability for a virus to replicate well, as a consequence (Subbarao, 2014:16)
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From page 81... ...
2. GoF research in the short term can be used to help adapt viruses to growth in culture for vaccines and to develop essential animal models for the study of emerging pathogens and escape muta tions with which to understand drug resistance and viral evasion of the immune system (Atlas, 2014:29)
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From page 82... ...
CHAPTER 5: POTENTIAL RISKS: BIOSAFETY AND BIOSECURITY 1. There was considerable support among attendees for David Relman's proposal to focus risk assessments on GoF experiments that involve the deliberate creation of viruses with a high degree of pathogenicity and transmissibility and perhaps with properties that would make the infectious agent impervious to currently available countermeasures.
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From page 83... ...
6. Because there have been relatively few bioterrorists incidents, uncertainty is endemic for most factors that would contribute to a biosecurity risk assessment (Koblentz, 2014:60)
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deliberative process, there will be special challenges for policy because of the global nature of GoF research. For example, one issue for the safety and security risk assessment cited by several participants would be the extent and impact of the diffusion of research capacity on the efficacy of policy options affecting U.S.-funded international research collaborations.
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From page 85... ...
d. International governance -- How to manage regulation or pro hibition in cases of research collaborations that cross borders?
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