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    The Gain-of-Function Deliberative Process (Carrie Wolinetz)

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    National Academies of Science, Engineering, and Medicine
    The document discusses the US government's deliberative process around gain-of-function (GOF) research. It notes that while some GOF studies could provide benefits, certain studies raise biosafety and biosecurity concerns if enhanced pathogens were accidentally or intentionally released. As a result, the USG initiated a process to re-evaluate GOF research risks and benefits, including a research funding pause. This involves risk/benefit assessments, input from the National Academies and NSABB, and will inform new USG policy on conducting GOF studies safely and responsibly. Stakeholder input is critical to developing effective new oversight policies.

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    © All Rights Reserved

    The Gain-of-Function Deliberative Process (Carrie Wolinetz)

    Uploaded by

    National Academies of Science, Engineering, and Medicine
    310 views12 pages
    The document discusses the US government's deliberative process around gain-of-function (GOF) research. It notes that while some GOF studies could provide benefits, certain studies raise biosafety and biosecurity concerns if enhanced pathogens were accidentally or intentionally released. As a result, the USG initiated a process to re-evaluate GOF research risks and benefits, including a research funding pause. This involves risk/benefit assessments, input from the National Academies and NSABB, and will inform new USG policy on conducting GOF studies safely and responsibly. Stakeholder input is critical to developing effective new oversight policies.

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    Carrie Wolinetz presentation - GOF 2

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    The document discusses the US government's deliberative process around gain-of-function (GOF) research. It notes that while some GOF studies could provide benefits, certain studies raise biosafety and biosecurity concerns if enhanced pathogens were accidentally or intentionally released. As a result, the USG initiated a process to re-evaluate GOF research risks and benefits, including a research funding pause. This involves risk/benefit assessments, input from the National Academies and NSABB, and will inform new USG policy on conducting GOF studies safely and responsibly. Stakeholder input is critical to developing effective new oversight policies.

    Copyright:

    © All Rights Reserved
    310 views12 pages

    The Gain-of-Function Deliberative Process (Carrie Wolinetz)

    Uploaded by

    National Academies of Science, Engineering, and Medicine
    The document discusses the US government's deliberative process around gain-of-function (GOF) research. It notes that while some GOF studies could provide benefits, certain studies raise biosafety and biosecurity concerns if enhanced pathogens were accidentally or intentionally released. As a result, the USG initiated a process to re-evaluate GOF research risks and benefits, including a research funding pause. This involves risk/benefit assessments, input from the National Academies and NSABB, and will inform new USG policy on conducting GOF studies safely and responsibly. Stakeholder input is critical to developing effective new oversight policies.

    Copyright:

    © All Rights Reserved
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    The key takeaways are that gain-of-function (GOF) research involving pathogens with pandemic potential is being re-evaluated due to biosafety and biosecurity concerns. A deliberative process and research funding pause have been implemented to carefully assess the risks and benefits of this type of research.

    Gain-of-function (GOF) research refers to studies that involve increasing the pathogenicity and/or transmissibility of potential pandemic pathogens. It is being re-examined due to concerns that engineered pathogens from these studies could accidentally or intentionally be released and cause a pandemic. While this research has benefits, it also carries inherent risks that require careful policy oversight.

    The GOF deliberative process is a US government effort to re-evaluate the risks and benefits of GOF research involving pathogens with pandemic potential. It includes risk and benefit assessments of GOF studies as well as input from the National Science Advisory Board for Biosecurity, National Academies, and other stakeholders to inform new US policy on this issue.

    The Gain-of-Function

    Deliberative Process
    Carrie D. Wolinetz, PhD
    Associate Director for Science Policy
    Office of Science Policy, NIH

    Promoting Global Health Security


    through Life Sciences Research
    A robust life sciences research endeavor is critical to promoting
    public health and well-being in light of evolving threats posed by
    microbial pathogens.

    USG supports a diverse life sciences research portfolio


    Research involving potentially dangerous pathogens have
    inherent biosafety and biosecurity risks
    Safely realizing the benefits of such research requires effective
    policies, practices, and oversight

    Strengthening Biosafety and Biosecurity


    in Life Sciences Research
    Recent lab incidents have spurred a series of policy activities
    by the USG aimed at reinforcing commitments to biosafety,
    biosecurity, and responsible conduct of research among all
    stakeholders.
    Safety stand-down and National Biosafety
    Stewardship Month
    Federal Experts Security Advisory Panel
    (FESAP) Report
    Fast-Track Action Committee on Select Agent
    Regulations (FTAC-SAR) Report
    Gain-of-Function Deliberative Process

    Gain-of-Function Research
    As part of a renewed emphasis on biosafety and biosecurity, the risks
    and benefits associated with gain-of-function (GOF) research are
    being carefully re-examined.
    Spending

    at NIH
    GOF studies are one approach to addressing fundamental scientific
    questions.
    GOF studies have the potential to:

    Help define the fundamental nature of host-pathogen interactions

    Enable assessment of the pandemic potential of emerging


    infectious agents

    Spending
    Outside
    NIH
    Inform public health and
    preparedness
    efforts

    Further medical countermeasure development


    4

    Concerns about Certain GOF


    Studies
    Certain GOF studies have raised biosafety and biosecurity
    concerns.

    Could engineered pathogens pose a pandemic threat if


    they were to be accidentally or intentionally released from
    a laboratory?

    Could the information generated from certain GOF studies


    be misused to threaten public health or national security?

    Policy questions:
    Under what conditions can these studies be safely
    conducted?
    Should this type of research be conducted at all?

    GOF Deliberative Process and


    Research Funding Pause
    Deliberative Process
    The USG announced a process to re-evaluate the
    potential risks and benefits associated with GOF
    research involving pathogens with pandemic potential.

    Research Funding Pause


    Deliberative process is accompanied by a pause in
    funding for projects that may be reasonably
    anticipated to generate influenza, MERS, or SARS
    viruses with enhanced pathogenicity and/or
    transmissibility in mammals via the respiratory route.

    GOF Deliberative Process

    Risk & Benefit


    Assessments (RBA)

    National Academies
    Convene public forums to
    generate broad discussion
    and receive public and other
    stakeholder input

    Gryphon Scientific conduct


    risk & benefit assessments
    of GOF studies

    NSABB
    Serves as the official
    advisory body for providing
    advice on oversight of this
    area of dual use research

    USG GOF
    Policy
    Development
    Process
    7

    The Charge to the NSABB

    Task1
    Adviseonthedesign,
    development,andconductofrisk
    benefitassessmentofGOFstudies

    Task2
    Provideformalrecommendations
    totheUSGontheconceptual
    approachtotheevaluationof
    proposedGOFstudies

    Deliverable1
    Frameworkforthedesignand
    conductofriskandbenefit
    assessmentsofGOFstudies

    Deliverable2
    RecommendationstotheUSG
    informedbytheresultsofthe
    riskandbenefitassessments
    andotherinput

    Timeline of Major Events in the GOF


    Deliberative Process

    Next Steps
    NSABB to finalize its findings and
    recommendations to the USG based on
    stakeholder feedback and additional inputs and
    analysis
    USG to consider NSABB recommendations on a
    conceptual approach to the evaluation of
    proposed GOF studies towards the development
    of new policy

    10

    Stakeholder Input
    Stakeholder input is critical to an effective policy
    development process.
    NSABB draft recommendations and meeting video archives
    available: http://osp.od.nih.gov/office-biotechnologyactivities/biosecurity/nsabb

    Future opportunities for stakeholder participation:

    NSABB meeting (Spring 2016)

    Email anytime to:

    [email protected]

    11

    Additional Resources

    NIH Office of Science Policy


    Website: http://osp.od.nih.gov/
    Blog: http://osp.od.nih.gov/under-the-poliscope
    Twitter: https://twitter.com/cwolinetznih
    Subscribe to the OSP listserv
    Send an email to [email protected]
    with Subscribe OSP_News in the message

    Science, Safety, Security (S3)


    http://www.phe.gov/s3/Pages/default.aspx

    12

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