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Session 3: Key Issues on Risks

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    What are the key issues on risks that

    need to be addressed in theassessments the NIH will undertake?

    David A. Relman, Stanford University

    Potential Risks and Benefits of Gain-of-FunctionResearch, National Academies of Science

    December 15, 2014

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    Issues related to risks

    !

    Properties of newly-created strains,consequences, alternative approaches

    ! S&T trends over time

    !

    Global distribution of risks & benefits,relative weights, justice

    !

    Types of possible misuse-safety, security

    !

    Moral & ethical responsibilities, trust!

    Risk assessment, mitigation

    !"#$% '()*"+, -./0

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    Consequences, alternatives

    !

    Possibility of unusually largeconsequences w/ high-path, high-transmit

    !

    Possible inability to contain, prevent

    illness/death, esp. in resource-poor areas!

    Risk of not doing experiment?! Knowledge, benefits almost always can be

    achieved with other experimental

    approaches: KOs, alternative geneticbackground, aggressive surveys of nature

    !"#$% '()*"+, -./0

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    Alan Moses, Berkeley Science Review

    Elowitz, Leibler; Nature 403:335, 2000 !"#$% '()*"+, -./0

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    Have sequence, make virus

    Influenza: Peter Palese, 1990Evermore efficient, cheap

    Today: How many are capable?

    !"#$% '()*"+, -./0

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    Digitalization of biological informationand procedures, outsourcing

    !"#$% '()*"+, -./0

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    Digitalization of biological informationand procedures, outsourcing

    !"#$% '()*"+, -./0

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    Digitalization of biological informationand procedures, outsourcing

    What does this mean?

    --Risk and benefit wherever information isused, not just at site of origin--Distributed efforts in life sciences--Not everyone that undertakes science

    research is represented in this room!--Governance, oversight?...Distributed!

    !"#$% '()*"+, -./0

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    What motivates scientists?

    ! Quest for knowledge

    ! Quest to help others

    (application of knowledge)! Idle curiosity

    ! Fame

    !

    Fortune / livelihood

    !"#$% '()*"+, -./0

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    2$3-.//

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    !"#$% '()*"+, -./0

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    Asynchrony: Growing power of the

    individual Capabilities of individuals in life sciences

    expanding rapidly; now comparable tothose of large organizations 10-20 yrs ago

    Individuals, small groups with mal-intenteasier to muster, radicalize

    New participants from alternativebackgrounds

    Risks of misuse are increasing

    !"#$% '()*"+, -./0

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    Misuse of biology: How big a risk?

    small number4 5big number6 7 big number 4 5big number6 8 99

    :$;()$*=?) ?@(

    capableindividuals

    ill-intended orirresponsible

    individuals

    +3D

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    small number4 5big number6 7 big number 4 5big number6 8 99

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    Misuse of biology: How big a risk?

    ill-intended orirresponsible

    individuals

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    Moral and ethical principles in science

    !

    public beneficence--maximize publicbenefits and minimize public harm (synthesisof Utilitarianism, Kantism)

    ! responsible stewardshipbetterment of all,

    esp those without representation, futuregenerations! intellectual freedom and responsibility! democratic deliberation--collaborative

    decision-making; iterative, deliberativeprocess!justice and fairnessglobal distribution of

    both benefits and burdens

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    Moral and ethical responsibilities ofscientists?

    !

    Modern science demands consideration ofmorality because of blurred line betweenbasic and applied science

    ! Justice involves cultivating virtue andreasoning about the common good

    (Michael Sandel)! I'm not asking scientists to sacrifice

    their careers, but just to spend a little

    bit of time thinking about theconsequences of their work. Science isplaying an increasingly important role inthe whole future of mankind (JosephRotblat, on leaving Bomb Project)

    !"#$% '()*"+, -./0

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    Are there experiments that should

    not be undertaken, because risksoutweigh benefits?

    or because benefits will only berealized in the indefinite future?

    yes

    !"#$% '()*"+, -./0

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    What is the nature of the socialand moral contract between

    scientists and society?

    profound

    !"#$% '()*"+, -./0

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    How should we address uncertainty

    about potentially large risks? Precautionary principle

    Uncertainty analysis

    Vulnerability science More extensive environmental monitoring

    Employ wide variety, varied expertise from

    natural and social sciences, humanities Importance of input from security

    communities (distinct expertise)

    !"#$% '()*"+, -./0

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    Narrow, specific definition of high risk expts

    Some experiments will not be funded

    Examples of related, but lower risk expts thatare fundable

    Standardizedreview, assessment approach forhigh risk expts; flexiblemechanisms

    Democratic, deliberative, iterativeprocess

    Neutralsponsors/hosts, w/o strong interest inany particular outcome (minimize COI!)

    International, collaborative (IAP, UNESCO?)

    How to move forward

    !"#$% '()*"+, -./0

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    Back to the Future?International Conference on Recombinant DNA Molecules

    Asilomar Conference Center, Pacific Grove, California, February 1975

    ">$(@Z*$EZ(%?g">CM

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