Gainoffunctionresearch:advicefrom

EASAC

VolkerterMeulen
ChairofEASACWorkingGroup
CochairIAP,InterAcademyPartnership

WhatisEASAC?
EuropeanAcademiesScienceAdvisoryCouncilformedin2001toenable
Europeannationalacademiesofsciencetocollaborateingivingadviceto
EUpolicymakers(e.g.EuropeanCommissionandParliament)
ComprisesallEUnationalacademiesofscience(plusNorway,Switzerland)
CoresecretariatinHalle,GermanyandnetworkingofficeinBrussels,
Belgium
Objectivetodeliverconsensusoutputstoprovideameansforthe
collectivevoiceofEuropeansciencetobeheard
ProgrammescoverBiosciences,EnvironmentandEnergy:sustained
interestinpolicyissuesrelatingtocontrolofinfectiousdiseases
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EASACGoFresearchproject:whythis
collectiveacademyworkattheEUlevel?
Drawingonanalysis,commitmentandpriorworkbyEASACmember
academiesandinternationaldiscussion(2012)
Researchandregulationissues,andsocietalimplications,arerelevantfor
allEUMemberStatesandforcollaborativeEUresearch(Horizon2020)
andforprovisionofsharedinfrastructure,e.g.biocontainmentfacilities
ScientificcommunityexpresseddifferingviewstoPresidentofEuropean
Commissionin2013onbenefitriskinGoFinfluenzavirus(H5N1)research
RequestfromEuropeanCommissionandChiefScientificAdvisertoEASAC
toclarifyandadviseonissues

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EASACgoalsfortheproject
Bringingtogetherscientists,nominatedbyacademies,witha
broadrangeofexpertiseandviews
Toexplorewherethereisconsensus
Toclarifywhichissuesarestillunresolved
Toadviseonwhatadditionalanalysisisneededtoassessfuture
optionsfortheresearcharea

EmphasisingwhichcurrentEUregulationsgovernresearch
andwhatgoodpracticealreadyexistsatnationallevel
IdentifyingwhatisnationalorEUlevelresponsibility
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EASACprojectoutputs
FirstmeetingofworkinggroupinNovember2014;report
peerreviewedJuly2015,publishedSeptember2015
EASACmessagesdirectedto:
Academiesofscienceworldwide
PolicymakersinEUInstitutionsandMemberStates
Researchfundingbodies,regulatorybodies,professionalsocietiesand
othersinthescientificcommunity
Catalysingfurtherbroadengagementviamemberacademies

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ScopeoftheEASACproject:addressing
criticalissuesforGoFresearch

Selfgovernanceandscientificresponsibility
Benefitriskassessment
Researchreviewandmanagementsystems
Researchmoratoriaandalternatives
Bioethics issuesandplaceinresearchreview
Biosecurityadvisoryissues mechanismsandadvisorybodies
Publicationofsensitiveinformationandoptionsformanagement
Publicengagement andtheresponsibilitiesofacademies
Globalcontext andhowtoinformdiscussionandactionworldwide

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IntroductiontoEASACrecommendations
Emphasisingalayeredapproachwithintegrationof
responsibilitiesandactionatresearcher,researchinstitution,
researchfunder,nationalandinternationallevels
Focusonvirologyresearchbutrecommendationsarealso
relevantmorebroadlyinmicrobiology
Focusonbiosafetybutbiosecurityalsorecognisedasvery
important(continuingattentione.g.inIAPBiosecuritywork)
Someissuesremaincontroversialbuttheoutputsrepresent
EASACWorkingGroupconsensus
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EASACkeymessages:Selfregulationand
harmonisation
Goodpracticerequires conformingwithregulations/safety
conditions/codesofconduct,justifyingproposedresearch
Selfregulationmeans checksandbalancesonresearch
withinthescientificcommunity,requiresraisingawarenessof
researchersandtheirinstitutions,withneedforeducation
Attentiontobiosafetyissues atallstagese.g.inproposal
Academiesofsciencehaveacontinuingrole inpromoting
biosafetyandbiosecuritynormsandsupportingauditof
researchpractices
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EASACkeymessages:Benefitrisk
assessment
Notaonceandforall calculationbutcontinuing,collective
commitmenttounderstandandcommunicatetheissues
Incommensurableparametersmeasuredinriskandbenefit
donotallowavaluefreedeterminationtobemade
Canbenefitbequantifiedasprospectivepublichealthimpact
ordescribedintermsofgenerationofscientificknowledge?
Academiesandlearnedsocietiesneedtocontinueto
promotediscussionacrossscientificcommunityandwith
otherstakeholders
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EASACkeymessages:EU/nationalactivities
andorganisationsinbiosafety/biosecurity
Collatingavailableinformation apossibleroleforEuropean
Commission(DGSante)HealthSecurityCommittee
ImportanceofguidanceforresearchfundedbyHorizon2020
aswellasatnationallevel
Importanceforallresearchersandtheirinstitutions
conformingwithEUregulationsasimplementednationally
NonewEUlevelbodyisrecommended
MemberStatesshouldhaveclearnationaladvisoryapproach
andgovernancemechanismwithstatutorypowers
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HowdoesEUcurrentlymanageresearch?

OverarchingEUlegislation
DirectiveoncontaineduseofGMOs
Directiveonprotectionfromrisksrelatingtoexposuretobiologicalagentsat
work(containmentlevel3and4laboratories)
Regulationoncontrolofexportofdualusetechnology
LegislationisimplementedbyMemberStateswithenforcementbytheir
regulatoryauthorities
Practicalproceduresforbioriskmanagement
e.g.WHOandOECDguidance,developmentofISOStandard
Codesofconduct
e.g.IAP/IAC2012,LeopoldinawithDFG2014

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Casestudyoflayerednationalframework
formanagingresearch:UK
Infrastructure

NationallegislationimplementsEUDirectives
Institution/individualrequiresappropriatetraining,equipment
andfacilities(inspected),healthprotection,nationalguidance

Institutional
assessment

BiologicalSafetyCommittee,peerandseniorresearch
managementconsideration,ethicalreview
Justificationofresearchapproach(alternatives),minimisingrisk

Healthand
SafetyExecutive
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NationalHSEContainedUseproposalreview,consulting
scientificadvisers
Notifiedexperimentcannotbeginunlesspermissiongranted

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EASACkeymessages:Publicationof
sensitiveinformation
Researchersandtheirinstitutionsallhaveresponsibilitytomakedecisions
aboutpublishingsensitiveinformation
Journalsshouldbeencouragedtoseekappropriateadvice,includingfrom
securityexperts
EuropeanCommissionsExportControlRegulationisaninappropriateand
ineffectivevehicletoblockpublication
EuropeanCommission(DGResearch)attemptstoraiseawarenessabout
revisionofthisRegulationarewelcome researchersshouldcontinueto
informpolicymakersabouttheissues

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EASACkeymessages:Publicengagement
Trustandopennessarecrucialforresearchersandtheir
institutions
Academiesandothersinthescientificcommunityshould
activelyparticipateinpublicdialogue articulatingobjectives
forresearch,potentialforbenefitandrisk,andbiorisk
managementpracticesadopted
EASACiscommittedtocontinuingworkingwithacademiesto
promoteengagement

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Inconclusion:
EASAChasmaderecommendationsfortheEUandMember
Statesbutitisvitaltowidenthediscussionworldwide:
Addressingissuesforvariabilityinunderstandingandinsystems
betweencountries/regions
Ensuringlayered,integratedapproaches
Buildinglinksbetweenresearchers,policymakersandother
stakeholders,withcontinuingcommitmenttopublicengagement

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