Gain-of-Function Research Summary of the Second Symposium, March 10-11, 2016 (2016) / Chapter Skim
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3 Issues for U.S. Policy
3 Issues for U.S. Policy
Pages 39-52
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From page 39... ...
To that end, the speakers were asked to reflect, depending on their institutions, on the issues facing federal agencies in administering this regulatory framework as well as some of the strengths and weaknesses in the current policy framework and opportunities for optimizing oversight of this area of research. Gerald Epstein from the Department of Homeland Security reviewed the scope of the NSABB proposal in terms of who is covered, which pathogens and activities are covered, and what is required.
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From page 40... ...
Unfortunately, the law does not contain definitions of prohibited types of activity or agents, so he thought the level of subjective judgment involved in proving a violation makes prosecution difficult. Partly for that reason, the Select Agent Regulations were developed and expanded through a series of statutes.2 This is a comprehensive set of safety and security requirements governing any use of certain listed pathogens.
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From page 41... ...
Dr. Epstein commented that any additional development of policy related to GOF research would have to be embedded in the already existing frameworks, and the question of whether these existing procedures would have to be modified to fit the new one or whether they would sit on top would have to be determined as the policy process went ahead.
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From page 42... ...
The department-level review will also identify any additional risk mitigation measures that should be required, and it will determine whether a given proposal is acceptable for HHS funding. For proposals that are deemed acceptable, the funding agency within HHS will make the final funding decision.
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From page 43... ...
The Duke IBC does not use a specific dual use definition or threshold but has identified relevant research through the NIH study section or program officer, by the principal investigator's (PI's) answers on the recombinant DNA registration form, or by members of the IBC during the course of its research reviews.
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From page 44... ...
Jude has developed internal guidance on what they should consider. This included ensuring that no GOF virus is resistant to antiviral agents, that suitable vaccines are available, and that advice about the challenges of evaluating risks and benefits in "gray" areas, such as research altering host range and or tropism, is available.
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From page 45... ...
Allison Mistry from Gryphon Scientific also proposed updating the DURC requirements to reflect GOF studies of concern and to BOX 3-3 Perspectives on the NSABB Draft Recommendations and Broader Policy Frameworks • This is a good initial draft that provides guidance to PIs and Institutional officials. • The criteria for assessing GOF research are reasonable, but are not specific (terms "highly," "significant," and "likely" should be better defined)
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From page 46... ...
Both Dr. Frothingham and Gerald Epstein commented on the difficulties posed by the competing goals of protecting potentially sensitive information and ensuring transparency as part of gaining public trust.
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From page 47... ...
BEST PRACTICES TO INFORM POLICY DESIGN AND IMPLEMENTATION Philip Dormitzer from the Pfizer Vaccine Research and Development Unit, a member of the Symposium Planning Committee, introduced the session as a continuation of the earlier plenary session on the U.S. policy landscape.
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From page 48... ...
Dr. Fisher noted that the GOF framework focuses on specific agents of concern, or particular pathways of concern, potentially impacting BOX 3-4 Recommendations for Aligning Domestic and Foreign Policies Relevant to Gain-of-Function Research • Introducing Institutional Review Boards and Biological Weapons Convention guidance to foreign venture capitalists, incentivizing market entry through compliance.
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From page 49... ...
Dr. Moreno identified a number of questions that he thought needed to be addressed when considering policy options for dealing with GOF research, including the impact of terminology and the response to the term GOF; the implications of mutants -- both natural mutations and escape mutants; the potential for a generalized GOF policy being too broad to implement effectively; the adequacy of safety records for quantifying the risks of laboratory accidents; current levels of accident reporting; the need to address basic research and vaccine development activities where more acceptable or safer alternatives do not exist; determining the realities of the relationship between GOF methods and vaccine development; and the role of basic science during a health emergency.
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From page 50... ...
. Ethan Settembre from Seqirus provided an overview of the global influenza system that addresses variability in influenza viruses to develop and deliver candidate vaccine viruses.
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From page 51... ...
Among other topics, the discussion returned to considering different ways of defining GOF studies of concern. Philip Dormitzer pointed out that not all GOF research involves GOF studies of concern, and therefore not all the research needs to be overseen by any additional policy frameworks.
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From page 52... ...
Challenges in disease surveillance were discussed. While some participants suggested that knowledge produced by GOF research could be useful for detecting emerging pathogens, others noted the lack of current surveillance capacity.
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