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UniversityCouncilonAnimalCare Policy:AnimalUseProtocols Category:Administration Subject:RequirementsforAnimalUseProtocolsassociatedwiththeanimal-basedscienceprogram withinWestern’sresearchcommunity ApprovingAuthority:AnimalCareCommittee ResponsibleOffice:AnimalCareCommitteeOffice RelatedProcedures:ProceduresforAnimalUseProtocols EffectiveDate:07OCT2015 PreviousApprovalDates: Revised: Purpose Theobjectiveofthispolicyistooutlinecriteriaforthegeneration,reviewandapprovalofAnimalUse Protocols(AUP)associatedwithWestern’sanimal-basedscienceprogramtoensurealignmentwith currentfederalandprovincialandotherinstitutionalregulatorypolicies. Rationale CanadianCouncilonAnimalCare’sTermsofReferenceforAnimalCareCommittees(ACC)statesthat “noanimalsbeheldfordisplayorbreedingpurposes,orforeventualuseinresearch,teachingortesting projects,withoutpriorACCapprovalofawrittenAnimalUseProtocol”. OntarioMinistryforAgricultureandFoodandRuralAffairs’(OMAFRA)AnimalsforResearchActstates “Everyanimalcarecommittee….shallberesponsibleforco-coordinatingandreviewing,(a)theactivities andproceduresrelatingtothecareofanimals;(b)thestandardsofcareandfacilitiesforanimals;(c)the trainingandqualificationsofpersonnelthatareengagedinthecareofanimals;and(d)proceduresfor thepreventionofunnecessarypainincludingtheuseofanaestheticsandanalgesics,ineveryresearch facilityinconnectionwithwhichtheanimalcarecommitteeisestablished,havingregardtothe requirementsofthisActandtheregulations.” Additionally,OMAFRA’sAnimalsforResearchActstates“Theoperatorofaresearchfacilityshall,prior toconductinganyresearchprojectinwhichanimalsaretobeused,file,orcausetobefiled,withthe animalcarecommitteearesearchprojectproposalsettingforththenatureofallprocedurestobeused inconnectionwithsuchanimals,thenumberandtypeofanimalstobeusedandtheanticipatedpain levelthatanysuchanimalislikelytoexperience.” TheTri-Agency’sAgreementontheAdministrationofAgencyGrantsandAwardsbyResearch Institutionsstatesthataninstitutionshall: • Allowaccesstoresearchfundsonlyaftertheinstitution’sanimalcarecommitteeoranother animalcarecommitteedesignatedbytheInstitutionhasapprovedtheresearch,unlessthe activitiesinvolvinganimalswillonlytakeplaceinthefuture,inwhichcaseapartofthefunds maybereleasedtocoveronlyexpensestobeincurredbeforeanimalsareused;and UniversityCouncilonAnimalCare • Ensurethatapprovalbytheanimalcarecommitteeismaintainedforthedurationofresearch activitiesinvolvingtheuseofanimalsandthat,subjectto(ii),fundsareavailabletothe Recipientonlywhilethisongoingrequirementismet. Scope Thispolicyappliestoallanimal-basedscientistswithinWestern’sResearchCommunitywhouseanimals forresearch,teaching,testing,breedingordisplay. Policy AnimalUseProtocol(AUP)formcontent,reviewandapprovalpoliciesandprocessesmustbedeveloped andundertakeninaccordancewithallFederal,Provincial,andUniversitypolicystatutoryrequirements andguidelineswithparticularreferencetoCCAC’sguidelinesonanimaluseprotocolreview(1997);if anyAUPcontentisatvariancewiththeaforementionedguidelines,scientificandethicaljustification mustberequiredandapprovedbytheAnimalCareCommittee(ACC). PursuanttoexistingpolicyoftheUniversityandofthebroaderscientificcommunity,sincetheAUPis consideredtheintellectualpropertyoftheresearcher,itmustbemadeavailableonlyforconfidential usebyauthorizedindividualsandnotforunauthorizeddistribution. AUPsmustbesubmittedbyFacultymembersofWestern’sResearchCommunity,anACVSVeterinarian orLHSC-Lawsonappointedscientist,unlessotherwiseapprovedbytheACC. Allanimal-basedscienceanddisplaysmustbefullydisclosedwithinanAUP. AUPformcompletionsupport–AUPFacilitation–mustbeavailabletoanimal-basedscientists. AUPsmustbesubmittedusingeSirius,thewebbasedAUPmanagementsysteminusebytheACC. AllAUPdocumentation,includingsupportiveinformationasrequestedbytheACCtoensurethatall membersoftheACCunderstandtheAUP’sanimalimpact,mustbesubmittedtotheACCwithsufficient timetoallowforreviewandapprovalpriortoeitherexpirydate,renewaldate,orthedateatwhichthe researcherwishestostarttheproposedwork. ForcollaborativeprojectsinvolvingPIsfromtwoormoreinstitutionsinwhichtheanimal-basedworkis dividedbetweentheanimalfacilitiesoftheseinstitutions,theACCmustreceiveawrittenAnimalUse Protocoldetailingtheanimal-basedworktobeundertakenwithinthefacilitiesforwhichitis responsible. • • ThisAUPmustalsoprovideabriefdescriptionoftheprojectasawhole. Anyinteractionsbetweentheinstitutionsrelativetotheanimal-basedwork(e.g.transferof animalsfromoneinstitutiontoanother,specialrequirementstoensurethehealthandwelfare ofthetransferredanimals,etc.)mustbeunderstoodandacceptedbytheAnimalCare Committeesofeachoftheinstitutionsinvolved. Submitteddocumentationmustbereviewedusingtheappropriateworkflowforreviewandapprovalin accordancewithitsProtocolReviewType. AnyAUPwithan‘unfinished’or‘pending’statusmusthaveaworkflowdatelessthansixmonths,orit willberemovedfromtheeSiriusAUPmanagementsystem,unlessapprovedbytheACCChair. AUPsmustbeapprovedpriortotheprocurementand/oruseofanimalsinanimal-basedscienceand displayactivities. UniversityCouncilonAnimalCare FinalapprovalofAUPsbytheACCmustbeundertakenonlywhenthefollowingreviewshavebeen completedandapprovedbyresponsibleparties • • Reviews/ApprovalsundertakenbytheACC-EthicsReview Reviews/ApprovalsundertakenbypartiesexternaltotheACC- o ForallAUPs,asapplicable,AnimalCare(AC)FacilitySupervisorReview o ForAUPsinvolvingresearch,ScientificPeerReview o ForAUPsinvolvinganyhazardousandnewagent,material,andimagingdevice- OccupationalHealth&SafetyReview o ForTeachingAUPs,PedagogicalMeritReview WhenrequestedbytheACC,aPrincipleInvestigator(PI)mustsubmitaPilotStudytobecompletedand reportedupontoACCinadvanceofthetotalanimalworkasoutlinedwithinafullAUPsubmission ForPilotStudies, • • • apeerreviewofscientificmeritmustbeundertakenwhenaPIintendstouseaPilotStudyto exploreanewresearchdirectionthatisnotcoveredwithinthecontextofanexistingpeerreviewedresearchprogram. ACVSVeterinariansmustbeactivelyengagedinmonitoringandevaluationofexperimental subjectsduringthedurationofaPilotStudyandintheidentificationandrefinementof endpointsandmonitoringsheets. asubsequentcompleteAUPmustnotbesubmittedbeforethecompletionofthePilotStudy, theresultsofwhichmustbeincludedinthenewAUP.Theseresultsmustincludethe appropriatenessoftheendpointsandmonitoringcriteriaasdevelopedinconsultationwithan ACVSveterinarian. AllAUPsmustbereviewedbyanACVSVeterinarian,orcompetentdesignate,toensurealignmentwith currentveterinaryandregulatorystandardsofpracticerelatedtoanimal-basedproceduresoutlinedin theAUPunderreview. AllAUPsmustbereviewedbyAnimalEducatorstoensureallpersonnelhavesufficienttrainingrelated toanimal-basedproceduresoutlinedintheAUPunderreview. AllAUPsmustbereviewedbytheACFacilitySupervisorordesignateassociatedwiththeanimalholding and/oruseareaslistedwithintheAUP.Onceapproved,anAUPisvalidforamaximumoffouryearsto thelastdayofthemonthoftheinitialapproval,andmustundergoyearlyrenewalviaanAnnual ProtocolRenewalform.Amaximumofthreeone-yearrenewalsispermitted. Onamonthlybasis,allAUPformsthathavebeenapprovedbydesignatesoftheACCduringthe previousmonthmustbemadeavailabletothefullACC. Animal-basedscienceanddisplaysmustonlycontinuewhiletheassociatedAUPsmaintainan ‘approved’status. AssurancestofundingagenciesmustbeprovidedbyanACCdesignateviaResearchWestern’sGrants OfficefollowingACCAUPapproval. AnAUPholdermustsubmitanamendmenttotheapprovedAUPusingaProtocolModificationto informtheACCofanyandallchangesinadvanceofintroducinganysuchchangestoensurethat documentationalignswithpractice. AllProtocolModificationsmustbeapprovedbytheACCpriortoimplementation. UniversityCouncilonAnimalCare AsdeterminedbytheACC,whereaProtocolModificationinvolvesasignificantchange(s)inanimal utilizationorthedirectionoftheresearch,teaching,ortesting,afullAUPsubmissionmustberequired. PIsmustacceptresponsibilityforproceduresperformedonanimalsassociatedwiththeirAUPs. PIsmustensurethatindividualslistedintheirAUPhavefullongoingaccesstotheirAUPandhavefull understandingoftheirrolesasoutlinedwithin. PIsmustensurethatallindividualstoperformanyanimal-relatedproceduresapprovedwithintheir AUPswillcompleteallrelatedCCACandinstitutionalmandatorytrainingandwillbecompetentto performtheseproceduresinadvanceofundertakingthem. AllACC-approvedAUPsmustbeincludedinWestern’sPostApprovalMonitoringProgram. RegulatoryinformationfromAUPsmustbesentannuallytoCCACandOMAFRAusingregulators’Animal UseDataForms. AnyconcernsnotreadilyresolvedbyaccountablepartiesassociatedwithAnimalUseProtocolsand relatedprocessesandtimelinesmustbeforwardedtotheACCExecutiveTeamforconsideration. Definitions • AccountableParties–IndividualsdirectlyresponsibleforAUPpreparation,revieworapproval:PI andPIstaff,ACCdesignatesinvolvedinAUPreview,DepartmentalResearchOffices,ACVSsupport staff. • AnimalCareCommittee(ACC)–AsubcommitteeoftheUniversityCouncilonAnimalCare;the institutionalanimalcarecommittee“responsibleforoverseeingallaspectsofanimalcareanduse andforworkingwithanimalusers,animalcarepersonnelandtheinstitutionaladministration”; responsibletoensureanimalethicsandcareforanimal-basedscienceandanimaldisplaysdirectly associatedwithWestern’sResearchCommunityisinaccordancewithallregulatoryandinstitutional policiesandguidelines. • ACCCoordinator–AnadministrativerolededicatedtoprovidingtheACCandPIsandtheirstaffs withsupportforACCandAUP-relatedactivities,asoutlinedbyCCAC. • ACCExecutiveTeam-AsubsetoftheACCtaskedwithperformingpreliminaryassessmentsof concernsandrelatedevidencebroughtforwardtotheACC;developingrecommendationsforProject RefinementsandActionPlans;andassigningaspecificPIReptoincidentsastheyarise.Thissubset mustincludeatleastoneACCandACVSleader,anACVSveterinarian,ACCCommunityRep,anACC Coordinator,andanexperiencedanimal-basedscientistontheACC,ifnotrepresentedbytheACC leader. • AnimalCare(AC)FacilitySupervisor–Atrained,competentindividualresponsiblefortheoversight ofanareaorfacilitythathousesresearchanimalswhoisaccountabletotheACVSDirectorasregards animalhealthandwelfarerelatedmatters • ACFacilitySupervisorReview–Thereviewofanimalfacilityandhusbandry-relatedelementsofan AUPbyFacilitySupervisorsresponsibleforoversightofanimalfacilitiesidentifiedwithinanAUP. EachanimalcarefacilitysupervisormayseekadditionalinformationdirectlyfromthePIorviathe eSiriusAUPreviewprocessregardingfacility,hazards,animalhusbandryandprocurement requirementsinadvanceofproceedingwiththeanimalproject.PIsareencouragedtodirectly contactthefacilitysupervisorassociatedwiththeanimalhousingareaidentifiedwithinhis/herAUP inadvanceofAUPsubmission. UniversityCouncilonAnimalCare • • • • • • • • • • • • • AnimalDisplays–AlldisplaysofanimalsthatcanbeencounteredbyWestern’scommunityand/or publicatlarge.Displaysmayincludeaviaries,fishponds,andfishtankswithinclassrooms.Excluded fromthisrequirementaredisplaysinprivateoffices,e.g.fishtanks,cagedbirds. AnimalEducators–DesignatesoftheACCwhoadministerandprovideCCAC-mandatedAnimalCare andUseethicsandhands-ontraining. AnimalUseProtocol(AUP)–TheACC’smandatoryanimalethicsformthatcontainsdetailsofaAUP holder’sintendedlivevertebrateanimalcareanduse,whichmustbereviewedandapprovedbythe ACCinadvanceofanimal-basedscienceorpublicviewingofdisplayedanimals. AUPFacilitation–AnAUPpre-reviewserviceprovidedtoPIsortheirdesignatesthroughin-person dialoguewiththeACCCoordinator,anACVSVeterinarianand/ortheACVSSystemsAdministrator withthegoalofclarifyingACCexpectationsregardingAUPcontent,andtrainingPIsandtheirstaffon theeSiriusAUPmanagementsystem. AuthorizedIndividuals–AllpersonslistedinanAUP,ACCmembers,AnimalCarestaffs CategoriesofInvasiveness–LevelsassignedtoAUPsinaccordancewithCCACpolicy.Experiments involving: o A–Mostinvertebratesorliveisolates o B–Littleornodiscomfortorstress o C–Minorstressorpainofshortduration o D–Moderatetoseveredistressordiscomfort o E–Procedurescausingseverepainatorabovethepaintolerancethresholdof anaesthetizedconsciousanimals CCAC–TheCanadianCouncilonAnimalCareisanot-for-profitorganization,createdin1968to overseetheethicaluseandcareofanimalsinscience(research,teachingandtesting)throughout Canada. Concerns–Anythingraisedtoanymemberregardinganimalhealthand/orwelfare,humansafety, andAUP-relatedissues.ConcernswillbereviewedbyanACCExecutiveTeam,asappropriate. ConcernswillbecommunicatedtothePIbeforetheyareclassifiedaseitherIncidentsorNonCompliance. Designate–Anindividualwhoisadequatelytrainedandappropriatelyexperiencedwiththeanimals underhis/hercare/oversight,andwhoisauthorizedtoactonbehalfofeithertheACC,VP-Research, ACVSDirector,ACVSVeterinarian,aPrincipalInvestigator,oranAnimalCareFacilitySupervisor. EthicsReview–EthicsreviewofaproposedAUPbytheACCthatfocusesonthelevelofharmto animalsasbalancedbypotentialbenefitsandscientificmeritwithspecificapplicationofCCAC’s3Rs ofundertakinghumaneanimal-basedscience.TheACCfunctionsasamicrocosmofsocietytoreview AUPapplicationsbyapplyingtheguidelinesandpoliciesoftheCCACandusingtheirownexpertise, experience,values,andcommonsensetoreachdecisionsbyconsensusaboutwhatanimal-based workshouldbeallowedtoproceedandunderwhatconditions. OMAFRA–OntarioMinistryofAgriculture,FoodandRuralAffairs.Provincialregulatorsofanimalbasedscience.EnforcersoftheAnimalsforResearchAct OccupationalHealth&Safety(OH&S)Review–AreviewprocessexternaltotheACCunderthe responsibilityofinstitutionalsafetyofficersandResearchWestern’sAnimalResearchSafety Consultant.RequiredforAUPscontainingbiological,chemical,radioactive,imaging&laserdevices. PedagogicalMeritReview-Peerreviewforpedagogicalmeritofproposedanimaluseinteaching shallconsistof,atminimum,areviewatadepartmentleveltobesummarizedinthepedagogical UniversityCouncilonAnimalCare • • • meritreviewquestionscontainedwithintheAUPform,andconfirmedbytheChairofthe Department. PilotStudy–Astudylimitedtothefewestnumberofanimalsnecessarytoevaluatethe appropriateness,feasibilityandsuitabilityofaparticularanimalmodel,procedure,orstudydesignto meetdefinedscientificobjectivesthatiscompatiblewithFederal,Provincial,andUniversity regulations,guidelinesandpolicystatements. PrincipalInvestigator(PI)–Ascientistresponsibleforundertakinganimal-basedscienceinalignment withanapprovedAnimalUseProtocolandcurrentveterinarystandardsofanimalcare. ProtocolReviewType- • FullReview:AnimalUseProtocol,AnnualRenewalandProtocolModificationforms involvingthefollowingelementswillbeautomaticallyconsideredtorequirereviewbythe fullACC: o AllnewAUPs o AllC,DandElevelFullRenewalAUPs o Pilotstudiesthatinvolvelevel‘E’categoryofinvasivenessorethicallysensitive species; o Interim-approvedAUPs o AnyprotocolformuponrequestbyanyACCMember,ACVSVeterinarian,or regulatorybody(OMAFRA,CCAC); o AnnualRenewalsasrequestedbythefullACCand/orACCProtocolReview Committee; o ProtocolModificationsinvolving: § AnimalproceduralchangesinvolvingCategoryofInvasivenesslevel‘E’ § Useofanimalmodelsthatemployascites; § Multiplemajorsurvivalsurgeries; § Foodand/orwaterdeprivationresultinginpainordistressasdeterminedby thereviewingACVSVeterinarian; § Animalnumberincreaseabove100% § Additionofspeciesinvolvingrabbits,pigs,cats,dogs,sheep,NHPs. • DesignatedReview:TheDesignatedReviewprocessinvolvesanalternatingsubsetofACC membersincludingatminimumoneACVSVeterinarianordesignate,oneACCCommunity Rep,andoneACCChairorViceChair;otherexpertsareincludedasneeded. o ProtocolModificationsinvolving: § Chronicstudiescontaininganimalproceduralchanges; § Additionofspeciesthatdonotincluderabbit,pig,cat,dog,sheep,NHP; § Animalnumberincreaseupto100%; § Newagents,materials,ordevices. o AnnualRenewals; o FullRenewalsofBlevelAUPs o PilotstudyAnimalUseProtocolsubmissions,excluding‘E’CategoryofInvasiveness andethicallysensitivespecies; o InterimapprovaloffullAUPstobeusedinfrequently. • OfficeReview:TheOfficeReviewprocessisusedforrequestedminorchangestoanAUP whichneitherdeleteriouslyimpactanimalsnorrequirenewskills. o TheACCOfficemaygrantapprovalfor: UniversityCouncilonAnimalCare Staff&theirtrainingrequirements AUPtitlechange Grantinginformation AnimalSource(exceptinvolvingtransferofpreviously‘used’animals betweenprotocols) § AnimalStrain-additionofnon-geneticallymodifiedstrains § Animalnumberincreaseupto10% AnACVSVeterinarianordesignatemaygrantapprovalfor: § Housingoruselocationchange; § Euthanasiamethodchange(CCACacceptableonly); § Acuteproceduresonafullyanesthetizedanimalthatwillnotberecovered; § Analgesia&anesthesiaregimechange; § Achangetoalessinvasive,distressfulorpainfulprocedure; § Transferofanimalsbetweenprotocols(ProtocolTransfersinvolving previousanimaluse,excludingbreeders,moms&surplusanimals) § AnimalStrain–additionofgeneticallymodifiedstrains § Animalnumberincreasebetween11and25% § § § § o • • • • ScientificPeerReview–AreviewprocessexternaltotheACC.Wherescientificpeerreviewhasnot alreadybeendocumentedbythegrantingagency,theACCwillrequestconfirmationfromthe AssociateDeanofResearch(AD-R),ortheequivalent,fortheassociatedFacultythatscientificpeer reviewhasbeenundertakenatafacultylevelinaccordancewithCCAC’spolicy. • TheAD-Rwillprovideconfirmationofscientificpeerreviewbyaminimumoftwoqualified, arms-lengthpeerreviewerstotheACCofficeinatimelymanner. • TheAUPmayonlyreceiveethicalapprovaloncetheACCofficehasreceivedconfirmationof scientificpeerreview. ScientificpeerreviewwillberequestedforPilotsinvolvinganewresearchdirectionthatisnot coveredwithinthecontextofanexistingpeer-reviewedresearchprogram. UCAC–Western’sSenatecommitteeultimatelyresponsiblefortheAnimalEthicsandCareprogram directlyassociatedwithWestern’sResearchCommunity. Western’sPostApprovalMonitoring(PAM)Program–ACCAC-mandatedprogramundertakenby theACC.PAMencompassesregularassessmentofcoreAUPelementsincludingbutnotlimitedto animalprocurement,animalhousingandhusbandry,animalprocedures,animalmonitoring,sick animalresponse,animalhealth/proceduralrecords,andrelateddocumentation. Western’sResearchCommunity–Institutionsandtheirdepartmentsinvolvinganimal-based scientistshavingAnimalUseProtocolsunderthejurisdictionofWestern’sAnimalCareCommittee, theACC. RolesandResponsibilities Allstakeholdersareexpectedtodemonstratecollaborative,collegialcommunicationsandcommitment toactingoodfaith. AnimalCareCommitteemembersandassociatedreviewersareresponsibleto • beknowledgeableofandrespectinstitutional,provincialandnationalregulatorystandards • undertakeethicalreviewofsubmittedAUPs UniversityCouncilonAnimalCare • • completeAUPreviewsassignedtothemwithintheallocatedtime maintainconfidentialityofallmaterialreviewed PrincipalInvestigator(PI)isresponsibleto • treatallanimalswithrespectanddignity • beknowledgeableofandrespectinstitutional,provincialandnationalregulatorystandards • ensurethatallanimal-basedworkisdocumentedonhis/herAUP,andsubmittedthrougheSirius forreviewandapprovalbytheACCinadvanceofprojectcommencement • submitAUPdocumentationwithsufficienttimetoallowforreviewandapprovalpriortoexpiry datesorpriortoprojectcommencement • undertaketheAUPinpracticeasapprovedinprinciplebytheACC • providefullcopiesofhis/herAUPtothoselistedwithin • ensuretheirresearchstaffmemberswhodirectlyworkwithanimalsarelistedintheAUP, apprisedof,appropriatelytrainedandcompetentlyundertakeonlythoseproceduresina manneroutlinedwithintheapprovedAUP • seekguidancefromACCsupportstaffforthepreparationofhis/herAUPifunclearonACC expectationsand/orformcontent • submitProtocolModificationsforallchangestoanapprovedAUPinadvanceofimplementing thesechanges PIStaffisresponsibleto • treatallanimalswithrespectanddignity • beknowledgeableofandrespectinstitutional,provincialandnationalregulatorystandards • readandunderstandtheAnimalUseProtocol(s)withinwhichtheyareapprovedbytheACCas animalusers • receiverequiredtraininginanimalethicsandhandlingpriortoundertakinganyprocedures withinanapprovedAUP • informthePIandAnimalCareFacilitystaffofanyissuesassociatedwitheitheradeparturefrom orconcernsassociatedwiththeAUP ACCCoordinatorordesignateisresponsibleto • beknowledgeableofandrespectinstitutional,provincialandnationalregulatorystandards • manageallAUPdocumentationandrelatedreviewprocesses • maintainschedulesforreviewofdocumentation • provideguidancetoPIsandtheirstaffsforthepreparationofAUPdocumentationwhen requested • compileannualregulatoryreportsassociatedwithAUPs • provideAUPfacilitationservices ACVSVeterinarianisresponsibleto: • beknowledgeableofandrespectinstitutional,provincialandnationalregulatorystandards • provideguidancetoandACC,PIsandtheirstaffsforthepreparationofAUPdocumentation whenrequested • completeAUPveterinaryreviewswithintheallocatedtime • provideAUPfacilitationservices UniversityCouncilonAnimalCare References • MAPP7.12–PolicyfortheUseofAnimalsinResearch,TestingandTeaching • MAPP7.10–StandardizedTraininginAnimalCareandUse • MAPP7.15–PostApprovalMonitoringProgram • ConcernsIdentification,ProjectRefinementandCorrectiveResponsePolicyAnimalsforResearch Act • CCACguidelineson:animaluseprotocolreview(1997) • CCACpolicystatementon:scientificmeritandethicalreviewofanimal-basedresearch