session 8: risk/benefit assessment

Upload: national-academies-of-science-engineering-and-medicine

Post on 02-Jun-2018

222 views

Category:

Documents


0 download

TRANSCRIPT

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    1/51

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    2/51

    Defining risk and benefit

    Assessing risks and expected benefitsCommunicating risks and expected benefitsOrganizing to reduce risks and increase

    expected benefits

    Overview

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    3/51

    For the research in question, the expected

    benefits are potentially reduced risks. As a result, the same methodologies apply

    to assessing risks and expected benefits.

    Risks and Expected Benefits

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    4/51

    Defining risk and benefit

    Assessing risks and expected benefitsCommunicating risks and expected benefitsOrganizing to reduce risks and increase

    expected benefits

    Overview

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    5/51

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    6/51

    Defining Risk

    The terms of all analyses embody values

    that favor some interests.When transparent, those assumptions can

    be controversial. An analytical-deliberative process is needed

    to create socially acceptable definitions.

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    7/51

    Defining Risk of Death

    probability of premature death

    vs.expected life-years lost

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    8/51

    Defining Risk of Death

    probability of premature death

    vs.expected life-years lost

    The choice of metric depends on whether adeath is a death or one values deaths ofyoung people more.

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    9/51

    Other Possible Bases for

    Distinguishing among Deaths Are the risks?

    distributed equitablyassumed voluntarilycatastrophicwell understood

    controllabledreadborne by future generations

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    10/51

    Fischhoff, B., & Kadvany, J. (2011). Risk: A Very Short Introduction . Oxford: Oxford University Press.

    Risk: A Very Short Introduction

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    11/51

    Defining risk and benefit

    Assessing risks and expected benefitsCommunicating risks and expected benefitsOrganizing to reduce risks and increase

    expected benefits

    Overview

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    12/51

    12

    Define outcomes in socially acceptable way.

    Identify factors believed to affect outcomes. Assess factors and interdependencies, based

    on observation and expert judgment.

    Assess the quality of the evidence.

    Risk (and expected benefit) Assessment

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    13/51

    RoutineTestingResults

    UtilityAwareness

    HealthDepartmentAwareness

    MediaCoverage

    ConsumerAwareness forPublic Systems

    Tap Test

    MedicalAwareness

    TriggerEvent

    Well Test

    ConsumerAwareness forPrivate Wells

    UtilityCommunique

    UtilityTreatment

    Options

    Consumption ofWell Water

    Consumption ofTreated Water

    AvertingBehavior for

    Public

    Systems

    AvertingBehavior forPrivate Wells

    SpecialStudies

    Joint TaskForce

    Heal th Effec tsontamination ofD r i n k i n g Wa t e r

    Info Sources

    MiscellaneousAnnouncement

    Casman, E., Fischhoff, B., Palmgren, C., Small, M., & Wu, F. (2000). Integrated risk model

    of a drinking waterborne Cryptosporidiosis outbreak. Risk Analysis, 20 , 493-509

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    14/51

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    15/51

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    16/51

    Design:identify better options, by understandingcomplex systems better.

    Decision:determine acceptability of risks (givenexpected benefits), by predicting outcomes.

    Analysis Must Fit Its Purpose

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    17/51

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    18/51

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    19/51

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    20/51

    We find that WASH-1400 was a conscientious and honesteffort to apply the methods of fault-tree/event-tree analysis to

    an extremely complex system in order to determine theoverall probability and consequences of an accident

    We have found a number of sources of both conservativismand nonconservatism in the probability calculations of

    WASH-1400 Among the former are inability to quantifyhuman adaptability during the course of an accident ..., whileamong the latter are nagging issues about completeness, andan inadequate treatment of common cause failure.

    We are unable to define whether the overall probability of acore melt given in WASH-1400 is high or low, but we arecertain that the error bands are understated. We cannot sayby how much. (p. vi)

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    21/51

    Our resulting increased understanding of the full spectrum ofreactor accident sequences has implications for nuclearpower plant design, siting, and planning for mitigation ofconsequences. (p. ix)

    There have been instances in which WASH-1400 has beenmisused as a vehicle to judge the acceptability of reactorrisks. In other cases, it may have been used prematurely asan estimate of the absolute risk of reactor accidents withoutfull realization of the wide band of uncertainties involved.Such use should be discouraged. (p. x)

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    22/51

    OBrien, M. (2000). Making better environmental decisions ; Cambridge, MA: MIT Press

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    23/51

    as sources of vulnerability and resilience

    Analyses Must Include Human Behavior

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    24/51

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    25/51

    London: George Routledge & Sons, 1921

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    26/51

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    27/51

    http://www.nap.edu/catalog.php?record_id=18512

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    28/51

    28

    "$

    Variability in observations

    Internal validity (how good were studies)

    External validity (how well do studies generalize)

    Pedigree (how good is underlying science)

    Analysis Must Recognize Limits

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    29/51

    Representing Uncertainty

    Campbell, P. (2011). Understanding the receivers and the receptions of sciences uncertainmessages. Philosophical Transactions of the Royal Society, 369 , 4891-4912.

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    30/51

    Morgan, M.G. & Keith, D. (1995). Environmental Science and Technology, 2 9, 468-476.

    Uncertain Climate Knowledge

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    31/51

    Uncertain Economic Knowledge

    Aikman, D,, Barrett, P., et al. (2011). Uncertainty in macroeconomic policy-making: art orscience. Philosophical Transactions of the Royal Society, 369 , 4798-4817.

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    32/51

    Defining risk and benefit

    Assessing risks and expected benefitsCommunicating risks and expected benefitsOrganizing to reduce risks and increase

    expected benefits

    Overview

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    33/51

    Communication RequiresBehavioral Research

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    34/51

    Communication RequiresBehavioral Research

    Because our intuitions are often faulty.

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    35/51

    Some Faulty Intuitions

    common knowledge effectfalse consensus effectfundamental attribution errorself-serving biasesmyths (panic, adolescents unique sense

    of invulnerability )

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    36/51

    http://www.pnas.org/content/110/Supplement_3

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    37/51

    http://www.pnas.org/content/111/Supplement_4

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    38/51

    http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm268078.htm

    FDA Risk Communication Advisory Committee

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    39/51

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    40/51

    Defining risk and benefit

    Assessing risks and expected benefitsCommunicating risks and expected benefitsOrganizing to reduce risks and increase

    expected benefits

    Overview

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    41/51

    Framework for Environmental Health Risk Management. Presidential/CongressionalCommission on Risk Assessment and Risk Management (I997).

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    42/51

    Source: Canadian Standards Association. (1997). Risk Management (CSA-850). Ottawa: Author.

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    43/51

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    44/51

    FDA. (2013). Structured approach to benefit-risk assessment for drug regulatorydecision making . Draft PDUFA V implementation plan (2/13). FY2013-2017.

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    45/51

    Recognizes scientific and policy judgmentin all analyses

    Quantifies the quantifiable, without ignoringother concerns

    Highlights ethical and political tradeoffs,rather than burying them in a metric

    Supports risk management

    Benefit-Risk Framework

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    46/51

    http://www.nap.edu/catalog.php?record_id=18870

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    47/51

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    48/51

    FDA Risk CommunicationAdvisory Committee (RCAC)

    http://www.fda.gov/oc/advisory/OCRCACACpg.html

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    49/51

    RCAC Recommendations

    Communication for Emerging EventsHave a consistent policy in all domainsProvide useful, timely information

    Address: risks and benefits, uncertainty,personal actions, FDA actions

    Audience needs should drive agencyanalyses

    Use standard formats; evaluate routinelyConsider needs of diverse populations

    http://www.fda.gov/oc/advisory/OCRCACACpg.html

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    50/51

    socially acceptable, technically sounddefinitions of risk (and benefit)

    strategic focus on design or decision, withproper disciplinary breadth andtreatment of uncertainty

    ongoing, scientifically sound two-waycommunication with stakeholders

    organization for transparency and learning

    Summary

    Risk/Benefit Analysis Requires

  • 8/10/2019 Session 8: Risk/Benefit Assessment

    51/51

    BooksFischhoff, B., Brewer, N., & Downs, J.S. (eds.). (2011). Communicating risks and benefits: An

    evidence-based users guide . Washington, DC: Food and Drug Administration.http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm268078.htm

    Fischhoff, B., & Chauvin, C. (eds.). (2011). Intelligence analysis: Behavioral and social sciencefoundations . Washington, DC: National Academy Presshttp://www.nap.edu/catalog.php?record_id=13062

    Fischhoff, B., & Kadvany, J. (2011). Risk: A very short introduction . Oxford: Oxford University Press.Fischhoff, B., Lichtenstein, S., Slovic, P., Derby, S. L. & Keeney, R. L. (1981). Acceptable risk . New

    York: Cambridge University Press. (NUREG/CR-1614).Kahneman, D. (2011). Thinking, fast and slow . New York: Farrar Giroux & Strauss.Morgan, M.G., Henrion, M. (1990). Uncertainty . New York: Cambridge University Press.Slovic, P. (ed.) (2000). Perception of risk . London: Earthscan.

    Research Articles Bruine de Bruin, W., Parker, A., & Fischhoff, B. (2007) Individual differences in adult decision-making

    competence (A-DMC). Journal of Personality and Social Psychology. 92 , 938-956.Fischhoff, B. (1992). Giving advice: Decision theory perspectives on sexual assault. American

    Psychologist , 47, 577-588.Fischhoff, B. (2011). Communicating the risks of terrorism (and anything else). American Psychologist,

    66 , 520-531.Fischhoff, B. (2012, Summer). Communicating uncertainty: Fulfilling the duty to inform. Issues in

    Science and Technology , 29 , 63-70 ,

    Fischhoff, B., Bruine de Bruin, W., Guvenc, U., Caruso, D., & Brilliant, L. (2006). Analyzing disasterrisks and plans: An avian flu example. Journal of Risk and Uncertainty , 33, 133-151.

    http://www.hss.cmu.edu/departments/sds/src/faculty/fischhoff.php Carnegie Mellon Electricity Center: http://wpweb2.tepper.cmu.edu/ceic/ Center for Climate and Environmental Decision Making: http://cedm.epp.cmu.edu/index.php Center for Risk Perception and Communication: http://sds.hss.cmu.edu/risk/ Center for Human Rights Science: http://www.cmu.edu/chrs/