Gain-of-Function Research Summary of the Second Symposium, March 10-11, 2016 (2016) / Chapter Skim
Currently Skimming:
5 Summing Up
5 Summing Up
Pages 71-86
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 71... ...
Dr. Fineberg invited Charles Haas ("Informing the Policy Framework: The Risk and Benefit Assessment")
|
From page 72... ...
Barry Bloom shared reflections from two sessions, first on behalf of Michelle Mello ("The Policy Landscape: United States") and then from the panel he had moderated ("The Policy Landscape: International Dimensions of Gain-of-Function [GOF]
|
From page 73... ...
The panel ists suggested public trust, but in her view, this is both hard to assess and a narrow measure. The NSABB may wish to think (in relation to its Key Finding 2)
|
From page 74... ...
The session included major presentations on the groundbreaking progress made by the European Union (EU) , which showed that it was possible to have discussions and bring policies from 28 countries to a common focus, and bring scientific academies in almost all of those countries to a consensus on the scientific policies that would govern this research.
|
From page 75... ...
Baruch Fischhoff offered his comments on the session devoted to "Informing Policy Design: Insights from the Science of Safety and the S cience of Public Consultation." He began with some nomenclature, using the term "social science" for those not familiar with that part of the world to include social, behavioral, and decision science. Behavioral science is the study of individuals; it is psychology, microeconomics, neuro cience, and s other social sciences.
|
From page 76... ...
That is on the demand side. On the supply side, the social science community may lack the incentives for addressing biological science issues because its incentive scheme is to publish on relatively narrow topics.
|
From page 77... ...
Another very interesting point was that some of the case studies he offered where mechanisms of control of infectious agents of concern were lost not due to any malicious intent but due to the necessities facing people operating under difficult circumstances. There are circumstances where consultative mechanisms might help, where forms of assistance might help, and also where incentives need to be created to encourage people to limit risks when there is no capacity to regulate their behavior.
|
From page 78... ...
Finally, Ethan Settembre had discussed some of the lessons of the first H1N1 pandemic in 2009 and then the H7N9 outbreak response in 2013, making the point that GOF research is an inherent part of the routine business of vaccine production. Unintended consequences of GOF policy choices therefore needed to be considered.
|
From page 79... ...
Another was to simply accept that nations that were carrying out GOF research would develop their own sets of regulatory frameworks. Another was to allow the efforts that are ongoing in areas like the United States and the European Union to begin to crossfertilize each other and to bring together groups that would then allow for voluntary harmonization without going to an international organization like the World Health Organization (WHO)
|
From page 80... ...
Her concern was how to avoid recapitulating the history of Institutional Review Boards (IRBs) , which she characterized as being very slow to design, much less to put in place the sort of "learning" oversight system where there is a systematic effort to gather experience and share lessons learned and also to identify unjustified variations in how the rules are applied.
|
From page 81... ...
The RAC refined the principles, and he thought the same approach should be taken for GOF studies of concern. What is needed is to create a learning process, an iterative process, where there is appropriate consultation from the national back to the local and eventually the local learns how to handle the cases and the burden on the national board diminishes.
|
From page 82... ...
He thought the policy that will be promulgated ultimately needs to be capable of dealing with GOF research, and increasingly, experiments that intend to develop entirely novel organisms with capacities and capabilities that are not currently even expressed in existing micro rganisms. And if one thinks that broadly, defining a phe o notypic space that involves virulence, and involves transmissibility, and involves resistance to treatment, if that is how one wishes to characterize it, one could imagine placing imaginably any organism at a point in space that has those three attributes defined.
|
From page 83... ...
She was not sure there is clarity across the academic community at any one point in time about who is planning and doing what. Her second question related to the experience with the Select Agent rules, which were implemented in 300 various labs with a substantial range in the quality of performance.
|
From page 84... ...
• He thought it was very important conceptually to make a clear distinction between general GOF research, which is accepted as a valuable and commonly used technique, and specific GOF experi ments resulting in the creation of novel pandemic pathogens that is beneficial. For example, the Gryphon Scientific benefits assessment had concluded that a portion of the studies it assessed provided unique benefits.
|
From page 85... ...
Casagrande from G ryphon Scientific, came from John Kadvany from Policy & Decision Science in Menlo Park, California, prompted by publications suggesting that GOF research has characteristics of so-called potential "normal accidents," in which a technology combines highly negative outcomes (e.g., a nuclear plant meltdown) with unquantified and perhaps unquantifiable scenarios falling outside even the most complete probabilistic risk analysis.
|
From page 86... ...
One was that the pathogen to be constructed was one that might occur by a natural process, so that there was a reasonable expectation nature might get there first. If it is not something nature might do on its own, one could not argue the work was to defend against a potential natural development.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.