importationwwwaaa13.com

RICIACUCDC#002.
36Effective3/21Page1of31IACUCPRINCIPLESANDPROCEDURESOFANIMALCAREANDUSEInstitutionalAnimalCare&UseCommittee,ComparativeMedicine&ResearchIntegrity&Compliance,OfficeofResearch,UniversityofSouthFloridaOLAWPHS#A-4100-01;USDA#58-R-0015;AAALAC#000434I.
UniversityPrinciplesandProceduresRegardingUseofAnimalsinResearch,Teaching,orTesting.
.
1II.
InstitutionalOfficial…2III.
InstitutionalAnimalCareandUseCommittee…2IV.
ResearchIntegrity&ComplianceandResearchGrantsRegardingAnimalCareandUse…………….
8V.
ComparativeMedicine…8VI.
PreclinicalGLPStudies…10VII.
OccupationalHealthandSafety…11VIII.
CertifyingAdequacyofPersonnelTrainingandExperience…11IX.
ReportingDeficienciesinAnimalCareorTreatment…14X.
SuspensionandAppealProcessofAnimalUsePrivileges…14XI.
Transportation,RelocationorReassignmentofAnimals…16XII.
AvoidanceandAlleviationofResearchAnimalPainandDiscomfort…16XIII.
AnesthesiaandAnalgesia…19XIV.
ControlledSubstances…19XV.
SurgicalTechniquesandPost-operativeCare…20XVI.
MultipleSurvivalSurgicalProcedures…22XVII.
AntiserumProduction…22XVIII.
MonoclonalAntibodyAscitesProduction…24XIX.
AnimalIdentificationandAnimalMedicalRecords…24XX.
AnimalEuthanasia…26XXI.
AnimalAcclimationandConditioning…27XXII.
AnimalFacilities…27XXIII.
StudiesofWildAnimalsInorFromNaturalSettings…27XXIV.
ConflictofInterest…30XXV.
PublicRecords…31I.
UniversityPrinciplesandProceduresRegardingUseofAnimalsinResearch,Teaching,orTestingI.
1.
TheUniversityofSouthFlorida(University)affirmsthatrespectforallformsoflifeisaninherentcharacteristicofbiologicalandmedicalscientistswhoconductresearchinvolvinganimals,thattherespectfultreatment,careanduseofanimalsinvolvedinresearchisanethicalandscientificnecessity,andthattheuseofanimalsinresearchandteachingcontributestotheadvancementofknowledgeandtheacquisitionofunderstanding.
I.
2.
TheUniversityhasestablishedandprovidesresourcesforanAnimalCareandUseProgramthatismanagedinaccordancewiththeGuidefortheCareandUseofLaboratoryAnimals(Guide)(viewableathttps://grants.
nih.
gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.
pdf),theAnimalWelfareAct,(viewableathttps://www.
nal.
usda.
gov/awic/final-rules-animal-welfare-9-cfr-parts-1-2-and-3),Title9CodeofFederalRegulationsSubchapterA,"AnimalWelfare",Parts1-3(AWA),(viewableathttps://www.
nal.
usda.
gov/awic/final-rules-animal-welfare-9-cfr-parts-1-2-and-3),thePublicHealthServicePolicyonHumaneCareandUseofLaboratoryAnimals(PHSPolicy),(viewableathttp://grants.
nih.
gov/grants/olaw/references/phspol.
htm),UniversityPolicy#0-308,UseofAnimalsinResearch,Testing,andTeaching,(viewableathttp://regulationspolicies.
usf.
edu/policies-and-procedures/pdfs/policy-0-308.
pdf)andtheInstitutionalAnimalCareandUseCommittee'sIACUCPrinciplesandProceduresofAnimalCareandUse(IACUCPrinciplesandProcedures)(viewableathttp://www.
research.
usf.
edu/dric/iacuc/docs/IACUCPolicies.
pdf.
ThesewrittenIACUCPrinciplesandProceduresandallassociatedrelevantdocumentsarereviewedandupdatedsemi-annuallybyaquorumoftheregularmembersoftheIACUC.
TheUniversityprogramandfacilitiesforanimalcareandusearefullyaccreditedbytheAAALACaccessibleathttp://www.
aaalac.
org/.
RICIACUCDC#002.
36Effective3/21Page2of31I.
3.
PreclinicalstudiesthatsupportorareintendedtosupportapplicationsforresearchormarketingpermitsforproductsregulatedbytheFoodandDrugAdministrationshouldbeconductedinaccordancewithTitle21CodeofFederalRegulationsPart58GoodLaboratoryPracticeforNonclinicalLaboratoryStudiesViewableathttps://www.
accessdata.
fda.
gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.
cfmCFRPart=58.
I.
4.
StudiesofwildanimalsinorderivedfromnaturalsettingsareconductedinaccordancewiththeGuidelinesoftheAmericanSocietyofMammalogistsfortheUseofWildMammalsinResearch,viewableathttp://www.
mammalsociety.
org/uploads/Sikes%20et%20al%202011.
pdf,theGuidelinesforUseofFishesinResearch,viewableathttp://fisheries.
org/docs/policy_useoffishes.
pdf,theGuidelinesforUseofLiveAmphibiansandReptilesinFieldandLaboratoryResearchathttp://www.
asih.
org/sites/default/files/documents/resources/guidelinesherpsresearch2004.
pdf,andGuidelinestotheUseofWildBirdsinResearchathttps://www.
aaalac.
org/accreditation/RefResources/SS_WildBirds.
pdf.
II.
InstitutionalOfficialII.
1.
TheInstitutionalOfficialisappointedbytheUniversityPresidentandistheadministrativeofficialresponsiblefortheAnimalCareandUseProgram.
OverallprogramdirectionisasharedresponsibilityoftheInstitutionalOfficial,DirectingVeterinarian,andInstitutionalAnimalCareandUseCommittee(IACUC).
TheInstitutionalOfficialhasappointedanIACUC,includingalternates,whichisresponsibleforoversightandevaluationoftheanimalcareanduseprogram,itsproceduresandfacilitiestoensurethattheyareconsistentwiththerecommendationsoftheGuide,AWA,PHSPolicy,UniversityPolicy#0-308,andtheIACUCPrinciplesandProcedures,andarefullyaccreditedbyAAALAC.
III.
InstitutionalAnimalCareandUseCommitteeIII.
1.
NewIACUCmembersarerequiredtocompletethetwoweb-basedtrainingmodulesviewableathttp://www.
aalaslearninglibrary.
org/entitled"EssentialsforIACUCMembers"and"WorkingwiththeIACUC".
IACUCmemberswithVAaffiliationmustalsocomplete"WorkingwiththeVAIACUC.
"NewIACUCmembersarerequiredtoattendaformalsessionoforientationandtrainingbytheIACUCadministrativestaffregardingthefunctionsoftheIACUC,andtheregulations,principlesandproceduresthatgoverntheUniversity'sAnimalCareandUseProgram,asitemizedinPHSPolicyIV.
B.
1-8.
IACUCmembersoralternatesthatdonotcomplywithtrainingrequirementsareprovidedwrittennotificationfromtheIACUCChairpersonthattrainingrequirementsmustbecompletedwithin30days.
FailuretocomplyaftersaidwrittennotificationcanresultindismissalfromtheIACUCbytheInstitutionalOfficial.
III.
2.
TheIACUChasauthoritytoreview,approve,orrequiremodificationinordertosecureapproval,ordisapproveproposedresearchorteachingusingvertebrateanimals,reviewthefacilitiesandprogramforanimalcareanduse,includinglaboratoriesoutsideofanimalfacilitieswhereproceduresareperformed,reviewand,ifwarranted,investigateconcernsinvolvingthecareanduseofanimals,preparewrittenreportsofitsevaluations,makerecommendationstotheInstitutionalOfficialconcerninganyaspectoftheanimalcareanduseprogram,andsuspendanyactivityinvolvinganimalsthatdoesnotconformtotheGuide,AWA,PHSPolicyortheIACUCPrinciplesandProcedures.
III.
3.
TheIACUCconsistsofnotlessthanfivemembers,eachofwhomfulfilloneormoremembershipcategory(s),either(1)aDoctorofVeterinaryMedicinewithtrainingorexperienceinlaboratoryanimalscienceandmedicinewhohasdirectordelegatedprogramresponsibilityforactivitiesinvolvinganimalsattheinstitution,(2)apracticingscientistexperiencedinresearchinvolvinganimals,(3)amemberwhoisnotaffiliatedwiththeUniversityotherthanasamemberoftheIACUCandisnotamemberoftheimmediatefamilyofapersonwhoisaffiliatedwithUniversity,and(4)amemberwhoseprimaryconcernsareinanonscientificareaandwhorepresentsgeneralcommunityinterests.
IACUCmembershipincludesatleastonerepresentativefromtheCollegeofHealthSciences,theCollegeofArtsandSciences,theJamesA.
HaleyVeteran'sAdministrationHospital,andtheH.
LeeMoffittCancerResearchCenter.
IACUCmembershipincludesabiologistwhocanprovidetheIACUCwithanunderstandingofthenatureandimpactofproposedfieldinvestigations,thehousingandcareofthespeciestobestudied,andtherisksassociatedwithmaintainingwildvertebratesincaptivity.
III.
4.
IACUCmembersandalternatesareappointedbytheInstitutionalOfficial,andarelistedontheIACUCrosterssubmittedtothePHS.
Multiplealternatesareappointedtofulfilloneormoreofthefourspecificmembershipcategoriesmentionedabove.
Analternatemayserveforanyregularmemberprovidedthealternatefulfillsthespecificmembershiprequirement(s)oftheregularmemberforwhomhe/sheissubstituting.
IACUCmembersmustattendeachregularmonthlymeetingandmustnotifytheIACUCadministrativestaffofplannedabsencespriortoprotocolreviewassignments.
WhenanIACUCmemberisunabletoattendameetingafterprotocolreviewassignmentshavebeenmade,theIACUCmembermustmakeelectronicreviewentriesdirectlyontheelectronicIACUCapplicationusingtheApplicationsforResearchCompliance(ARC)systemforeachassignedprotocolpriortothemonthlymeeting.
Whenaregularmemberisunavailabletoserve,theIACUCadministrativestaffidentifyanalternatethatfulfillsthesamemembershiprequirement(s)oftheabsentRICIACUCDC#002.
36Effective3/21Page3of31regularmemberandarrangesfortheirparticipationtoensurethatthecommitteeisproperlyconstitutedatalltimes.
AlthoughmembersandalternatesmaynotcontributetoaquorumoractinanofficialIACUCcapacityatthesametime,alternatesareencouragedtoattendallIACUCmeetings.
AlternatesreceivethesametrainingandorientationasIACUCmembers,andareexpectedto"votetheirconscience"asopposedtorepresentingthepositionoftheregularmember.
TheInstitutionalOfficialcandismissIACUCmembersoralternatesabsentfrommorethanthreeregular(orassigned)monthlymeetingsinacalendaryear.
III.
5.
Alllivevertebrateanimaluse,includingfieldactivities,conductedbyUniversityfaculty,students,orstaff,orsupportedbyUniversityfunds,mustfirstbedescribedinadraftIACUCapplicationusingtheARCsystemandbepre‐reviewedbyUniversityveterinarianspriortoitssubmissiontotheIACUCforfullcommitteereview(FCR)ordesignatedmemberreview(DMR),asappropriate.
Allvertebrateanimalusemustbeproposedto,andapprovedbytheIACUCasanIACUCprotocolpriortotheinitiationofthatactivity,regardlessofwhereitwillbeperformed.
Activitiesinvolvingwildanimalsinnaturalsettings(fieldactivities)thatwillnotalterorinfluencetheactivityofthestudyanimalsorotherspeciesinthestudyarea(i.
e.
,unobtrusiveobservationalstudies),willnotimpacttheanimal'senvironment,andwillnotimpactthehealthorsafetyofinvolvedpersonnelneednotbeproposedtotheIACUC.
AnIACUCprotocolapplicationoraspectofanapplicationthatdescribesproceduresnotpreviouslyencounteredorthathavethepotentialtocausepainordistressthatcannotbereliablypredictedorcontrolled,maybeproposedasalimitedpilotstudy,designedtoassessboththeprocedure'seffectsontheanimalsandtheskillsoftheresearchteamconductedunderIACUCoversight.
Insuchcases,theIACUCwillrequiretheprotocoltobelimitedtoandconductedasapilotstudy,whichstipulatesthenumberofanimalstobeused,andtherecordkeeping,oversight,andIACUCreportingintervalsandcontentrequirementstobeusedregardingoutcomes.
ItisthePrincipalInvestigatorsresponsibilityforsubmittinganoutcomereportofthepilotstudytotheIACUCinthetimeframerequestedbytheIACUC.
TheoutcomereportwillbeusedtobytheIACUCasfollows:toevaluatewhetherasubsequentlargerstudyisjustified;whethertoreleasepilotstudystatusandpermitprotocolmodificationsallowingasubsequentlargerstudy;andusedtodefineclinicalendpoints.
III.
6.
PrincipalInvestigators(PI)developingapplicationsforVAfundedMeritReviewgrants,whicharereviewedandapprovedbytheVACentralOffice,mustsubmittheanimalcomponentfortheirresearchprojecttotheIACUCusingtheVAAnimalComponententitled"AnimalComponentofResearchProposal"(ACORP)"viewableathttp://www.
research.
va.
gov/programs/animal_research/.
VAR&DreviewmustbesecuredpriortoIACUCreview,andmustreflectanassurancefromtheVAthatallparticipatingpersonnelaredocumentedasIACUCcertified,withspecies-specifictechnicalexperience,andothertraining(e.
g.
,asepticsurgery).
AllACORPapplicationstotheIACUCwillbeassignedaprimaryreviewerthatisaVAresidentscientistoradministratorfamiliarwiththeACORPformatandaregularmemberoralternatememberoftheIACUC.
PIsdevelopingapplicationsfortheDepartmentofDefensemaysubmitapplicationsforreviewusingtheDepartmentofDefenseAnimalUseProtocol.
III.
7.
PIsthatintendtocreate,orhaveotherscreatemicelocallybypronuclearmicroinjectionofDNA,orbyblastocystmicroinjectionofembryonicstemcellsthathavebeenelectroporatedwithDNA,orbyothermethodsofgeneticengineeringinvolvingrecombinantDNA,mustfirstsecureIACUCapproval,whichdescribesthegenotypeorlineofmicetobecreated,andiscontingentonapprovalofaNon-ExemptRecombinantDNARegistrationapplicationbytheInstitutionalBiosafetyCommittee.
AllcoloniesoflocallyproducedormaintainedmicemustberepresentedbyanapprovedIACUCmurinecolonyonlyprotocol.
MurinecolonyonlyprotocolsmustbeamendedbydirectmodificationofanapprovedIACUCprotocol,wheneveraspectsofanemergentphenotype,recurringclinicalcondition(s),orunanticipatedoutcomearerecognizedthatwerenotdescribedintheoriginalapplication(refertoIACUCPrinciplesandProceduresXII.
13).
ResearchusesoflocallyproduceduniquelinesofmicemustbedescribedinanIACUCresearchprotocol,andtheproducedmicetransferredtotheapprovedresearchprotocolsusingaRequesttoReassignResearchAnimalsform.
Suchprotocolsdescribingtheresearchusesoflocallyproducedmicemustalsobesimilarlyamendedorelectronicallymodified,asappropriate,wheneveraspectsoftheemergentphenotype,recurringclinicalcondition(s),oranunanticipatedoutcomearerecognized.
III.
8.
TheIACUCdraftapplicationmustbesubmittedforveterinarypre-reviewusingtheARCsystembytheveterinarypre-reviewsubmissiondeadlineviewableathttp://www.
research.
usf.
edu/dric/committees-meetings.
asp#iacuc.
UniversityveterinariansarerequiredtoprovideapplicantswithcommentsandsuggestionsthatmayhelptheIACUCbetterunderstandtheproposedresearchinvolvinganimalsbymakingdirectentriesontothedrafte-IACUCapplicationwithin7daysofitssubmissionforveterinarianpre-review.
ApplicantsmaychoosetorevisetheirIACUCapplicationbyincorporatingchangessuggestedbyveterinarians.
Makinganyaddendum,change,orelaborationsuggestedbytheveterinariansdoesnotinanywayguaranteeorconstituteanapprovalbytheIACUC,butshouldhelptheIACUCunderstandbettertheresearchplaninvolvinganimals.
III.
9.
ApplicantsmustsubmittheirapplicationinitsfinalformtoResearchIntegrity&ComplianceusingtheARCsystempriortotheIACUCsubmissiondeadlineinordertomakethatmonth'sIACUCmeetingagenda.
SubmissiondeadlinestotheIACUCareestablishedbyResearchIntegrity&Compliance,areviewableathttp://www.
research.
usf.
edu/dric/committees-meetings.
asp#iacuc,andaredatesbywhichtheapplicationmustbereceivedRICIACUCDC#002.
36Effective3/21Page4of31infinalform.
Applicationsnotsubmittedwithinsixty(60)daysofreceiptoftheveterinarypre-reviewarenoteligibleforinclusioninanIACUCagenda,andtobecomeeligiblemustberesubmittedforasecondveterinarypre-reviewpriortosubmittingtoResearchIntegrityandComplianceforinclusiononanagenda.
AConflictofInterest(COI)DisclosureFormmustalsobesubmittedusingtheARCsystemforeachnewIACUCapplication.
ApplicationswillnotreceivefullIACUCapprovaluntiltheConflictofInterest(COI)DisclosureFormhasbeensubmittedandamanagementplanisinplace(asappropriate)foreachnewapplicationandrenewal.
InformationregardingCOIandtheCOIdisclosureformareathttps://www.
usf.
edu/research-innovation/research-integrity-compliance/ric-programs/conflict-of-interest/index.
aspx.

III.
10.
ThenarrativeofthePHSfundingagencygrant,withallapprovedrevisions,thatwillsupporttheproposedanimalusemustaccompanytheprotocolapplicationtotheIACUC(otherthanamurinecolonyonlyapplication),asanelectronic-versionuploadedtotheIACUCapplication.
ThePHSfundingagencygrantnarrativeshouldincludethefacepageandresearchplanofthegrantapplication,whichdescribethespecificaimsoftheresearchandthemethodsinvolvingvertebrateanimals,andspeciesofanimalsthatwillbeused.
Protocolapplicationswithotherproposedsourcesoffunding(e.
g.
,non-PHS,departmentalorcorporate)neednotbeaccompaniedbyagrantproposal,butComparativeMedicinewillnotfillrequestsforanimalsorserviceunderaspecificIACUC-approvedprotocoluntilanassociationbetweenfiscalsupport,anIACUCprotocol,andanaccountorpurchaseordernumberisassuredinwriting.
TheprimaryreviewingmemberoftheIACUCmustcomparetheIACUCapplicationandthePHSfundingagencygrantproposalandensurethattheyarecomparableinscope,(i.
e.
,theprotocolrepresentsanaspectofthegrantproposalormatchesitentirely).
ApprovalofanIACUCprotocolapplication,otherthanamurinecolonyonlyapplication,withproposedsupportfromaPHSfundingagency,iscontingentoncomparableprotocolandproposaltitlesandnarratives.
III.
11.
TheIACUCmeetingscheduleisviewableathttp://www.
research.
usf.
edu/dric/committees-meetings.
asp#iacuc.
WhenadditionalIACUCmeetingsarerequired,reasonablenoticeisgiventotheIACUCandpublicbypostinganoticetohttp://www.
research.
usf.
edu/dric/committees-meetings.
asp#iacuc,atleast72hoursinadvanceofthespecialmeeting.
IACUCmembersarerequiredtoattendeachmonthlymeetingandmustnotifytheIACUCadministrativestaffofplannedabsencespriortoprotocolreviewassignments.
IACUCmembersoralternatesmayattendmonthlymeetings,andmayparticipateinsemiannualreviewsofprogramand/orfacilities,remotelyconductedbytelecommunicationsinaccordancewithcriteriaprovidedinNOT-OD-06-052(e.
g.
,semiannualreviewoftheFloridaKeysMarineLaboratorysatellitefacility,orduringapandemic).
III.
12.
NewIACUCapplicationsarereviewedeitherbyfullIACUCcommitteereview(FCR)orusingadesignatedmemberreview(DMR)process.
EachIACUCapplicationisdesignatedaprotocoltypebytheapplicantPIaseither"researchorteaching","wildlife","murinecolonyonly","antiserumproductiononly",or"tissueuseonly".
Theprotocoltype"researchorteaching"describingResearchPainCategoryBandCproceduresandACORPapplications,notpreviouslyproposedandapprovedasapriorIACUCapplication,areaddedasanagendaitemtothenextregularIACUCmeetingforFCR.
Protocoltypesresearchorteaching"thatarethirdyearrenewals(i.
e.
,replacinganexpiring,previouslyapprovedprotocol),andnew"researchorteaching"protocolapplicationsdescribingonlyResearchPainCategoryAprocedures(ACORPpaincategoryC),"wildlife"applications,"murinecolonyonly"applications,"antiserumproductiononly"applications,and"tissueuseonly"applicationsareallsubjecttoDMR.
III.
13.
WhenusingDMRprocedures,thedesignatedreviewer(s)cannotwithholdapprovalofaprotocol.
TheoutcomesofDMRareapproval,requiresmodification(s)tosecureapproval,orrefertofullcommitteeforreview.
ProtocolssubjecttoDMR,arereviewedasfollows.
Within3daysofreceiptofthenewapplication,anymemberofthefullIACUCcanaskforclarificationsorrevisionsoftheIACUCapplication,orcancallforareviewoftheapplicationatthenextregularIACUCmeeting.
IfFCRiscalled,theclarifiedorrevisedIACUCapplicationisreviewedbythefullIACUC.
Iftherearenoclarifications,revisionsorfullIACUCreviewrequestswithinthreedaysofreceiptoftheapplication,theapplicationisreviewedbyadesignatedIACUCmember.
Thedesignatedmemberreviewerassumestheresponsibilityforthefullcommitteeingrantingunanimousapproval,requiringmodification,orreturningtheprotocolforFCR.
MembersforDMRareappointedbytheIACUCChair.
AnnuallyorwhenevertheIACUCmembershipchangestheIACUCChairprovidestheResearchIntegrityandComplianceadministrativestaffwithaspreadsheet/gridwithDMRassignments.
TheIACUCChairreviewsresearchprotocolcategories/areasofexpertise(e.
g.
,murinecolonyonly,tissueuseonly,proceduralchanges,etc.
),determineswhichIACUCmember(s)canbetaskedforaspecificDMRrole,dependingonthenatureoftheapplicationorproposedmodification,andmatchestheIACUCmemberforDMRtotheirareaofexpertise.
Atanytimeduringthisprocess,anyIACUCmembermayrequesttoview/reviewthemodifiedapplication,ormayrequestFCRoftheapplication.
Whenconsideredcompleteandappropriate,thedesignatedmemberreviewerapprovestheapplication,andthisapprovaliscommunicatedtothefullIACUCmembershipatitsnextregularmonthlymeeting.
AnyIACUCapplicationthatisaddedasanagendaitemtothenextregularIACUCmeeting,ornotapprovedbythedesignatedmemberreviewer,isthenreviewedbythefullIACUCatthenextregularmonthlymeeting.
WrittenIACUCapprovalisrequiredpriortoimplementinganyanimaluse.
RICIACUCDC#002.
36Effective3/21Page5of31III.
14.
Theprotocoltype"researchorteaching"describingResearchPainCategoryBand/orCprocedures,andACORPapplications,notpreviouslyapproved,areaddedasanagendaitemtothenextregularIACUCmeeting.
EachprotocoladdedasanagendaitemtotheIACUCmeetingispresentedbyaprimaryreviewingIACUCmemberusingentriesmadedirectlyontheIACUCapplication.
AfterverballypresentingtheirfindingsregardingtheapplicationtoaquorumoftheIACUCmembers,theprimaryreviewingIACUCmemberproposesamotiontoeitherapprovetheapplication,requiremodificationstosecureapprovaloftheapplication,ordisapprovetheapplication.
IACUCmemberslistedasparticipatingpersonnelontheIACUCapplicationmustleavetheroomduringthepresentationanddiscussionoftheprotocolandarenotpermittedtoparticipateorvote.
NoIACUCmemberparticipatesintheIACUCrevieworapprovalofaresearchprojectinwhichthememberhasaconflictinginterest(e.
g.
,ispersonallyinvolvedintheproject)excepttoprovideinformationrequestedbytheIACUC.
IACUCmemberswhohaveaconflictinginterestinaproposedprotocoldonotcontributetotheconstitutionofaquorum.
Afterdiscussionandamotionismade,themotionisseconded,andthefullIACUCcommitteevotes.
Iftheapprovedmotionis"RequiresModificationtoSecureApproval,"itisunderstoodthatallmembersoftheIACUC,inattendanceornot,forgoafullreviewoftheto‐berevisedapplicationinfavorofthedesignatedprimaryreviewingIACUCmember'sreview.
AllIACUCmembershaveagreedinadvanceinwritingthatthequorumofmemberspresentataconvenedmeetingmaydecidebyunanimousvotetousethisdesignatedmemberreviewsubsequenttofullcommitteereviewwhenmodificationisneededtosecureapproval.
ThisunderstandingispartofeachIACUCmember'sinitialorientationtoregulatoryprocesses,processesthatareagreeduponinadvanceinwritingusingaformentitled"OrientationandCertificationofNewIACUCMembers".
Thisformdocumentstheuseofdesignatedmemberreviewsubsequenttofullcommitteereviewofaprotocolapplication,whichallIACUCmembersagreetobyunanimousvote.
NewACORPapplicationsandACORPapplicationsfoundto"RequireModificationtoSecureApproval"arereviewedbyaminimumoftwodesignatedreviewingmembersaffiliatedwiththeVA.
Oncemembershavechosenthisdesignated‐memberreview,thentheprimaryreviewer(s)assumestheresponsibilityforthefullcommitteeingrantingunanimousapproval,requiringmodification,orreturningtheprotocolforfullreview.
Atanytimeduringthisprocess,anymembermayrequesttoview/reviewthemodifiedapplication,ormayrequestfullcommitteereviewoftheapplication.
III.
15.
TheapplicantPIcanannuallyrenewanIACUC-approvedprotocolforuptoatotaloftwoadditionalone-yearrenewals,ifre-approvedbytheIACUC.
AnychangestotheIACUC-approvedprotocolmustbewithinthescopeoftheoriginalhypothesisandproposedwork,andmustbedescribedbydirectmodificationoftheprotocolusingtheARCsystem.
III.
16.
ProtocolChangestoexistingprotocolsarereviewedadministrativelyandbyaveterinariantodeterminesignificanceonacase‐by‐casebasisIII.
17.
ChangesthatarehandledadministrativelyasanamendmentincludeachangeinthecertifiedresearchpersonnelotherthanPI,title,fundingsourceotherthanfederalsources,orstrainofthesamespeciesifjustifiedinwriting.
AmendmentsproposedtoanIACUCprotocolaresubmittedbydirectmodificationoftheapprovedprotocol.
RequeststoaddnewresearchpersonnelarereviewedfirstbyResearchIntegrity&CompliancetovalidatethatalldocumentsrequiredofIACUCcertificationhavebeencompletedandsubmittedviatheARCsystem.
III.
18.
Changesthatarehandledbydocumentedveterinarianverificationandconsultation(VVC)asauthorizedbytheIACUCarechanges(a)toanesthesia,analgesia,sedation,orexperimentalsubstances,(b)inAVMAapprovedmethodsofeuthanasia,(c)induration,frequency,type,ornumberofproceduresperformedonananimal,(d)increasinganimalnumbers,and(e)tochangeoraddfederalfunding.
Suchchangesmustbejustifiedinwriting,withinthescopeoftheoriginalstudyobjectives,andconformtoComparativeMedicine(CM)StandardOperatingProceduresviewableathttps://www.
usf.
edu/research-innovation/comparative-medicine/documents/cmdc/c096-req-to-reassign-research-animals.
docandtoCMdrugformulariesviewableathttps://www.
usf.
edu/research-innovation/comparative-medicine/anesthesia-analgesia-therapeutics.
aspx.
RequesttochangeoraddfederalfundingtoaresearchorteachingprotocolmustbeaccompaniedbyportionsofthegrantnarrativeidentifiedinIII.
10,above.
TheveterinarianservesasasubjectmatterexpertandverifiescomplianceoftherequestedProtocolChangewiththisIACUCPrinciple.
ThisconsultationwiththeveterinarianisdocumentedintheARCprotocolhistory.
TheveterinarianmayreferanyrequestedProtocolChangetotheIACUCforfullcommitteereview(FCR)ordesignatedmemberreview(DMR).
III.
19.
WhenusingDMRprocedures,thedesignatedreviewer(s)cannotwithholdapprovalofaprotocol.
TheoutcomesofDMRareapproval,requiresmodification(s)tosecureapproval,orrefertofullcommitteeforreview.
ChangesthatareconsideredsignificantrequiringFCRorDMRincludethosethatchange(a)fromnon-survivaltosurvivalsurgery,(b)resultingingreaterpain,distress,ordegreeofinvasiveness,(c)newhousingoruselocationoutsideofComparativeMedicinemanagedfacilities,(d)species,(e)studyobjectives,(f)PrincipalInvestigator,or(g)impactingpersonnelsafety.
Whenthechangerequestisforanewspecies,ResearchIntegrity&CompliancefirstvalidatesthatthatthePIandstaffARCprofilesidentifythenewspeciesofinterest,andiftherequestisforunvaccinatedoruncharacterizedcarnivores,pregnantsheep,goats,cattle,ornonhumanprimates,thatanewupdatedHealthandRiskAssessmentforEmployeeSafetyintheCareandUseofAnimalsformhasbeencompletedanduploadedtoARCbythePIandstaff.
ChangesconsideredRICIACUCDC#002.
36Effective3/21Page6of31significantrequiringFCRorDMRarereviewedbythefullIACUCmembership.
Within3daysofreceipt,anymemberofthefullIACUCcanaskforclarificationsorrevisionsoftheProtocolChange,orcancallforFCRatthenextregularIACUCmeeting.
Iftherearenoclarifications/revisionsorFCRrequestswithinthreedaysofreceiptoftheprotocolchange,itisreviewedbyadesignatedIACUCmember.
Ifclarifications/revisionsarerequested,thePIwillbegiventheopportunitytorespondandincorporatethesechangesintotheapprovedprotocol.
Whenrevisionsareincorporated,therevisedProtocolChangeisreviewedbyadesignatedIACUCmemberassignedbytheIACUCchair.
Whenconsideredcompleteandappropriate,thedesignatedmemberreviewerapprovesthechange,andthisapprovaliscommunicatedtothefullIACUCmembershipatitsnextregularmonthlymeeting.
AnyProtocolChangethatisaddedasanagendaitemtothenextregularIACUCmeeting,ornotapprovedbythedesignatedmemberreviewer,isthenreviewedbythefullIACUCatthenextregularmonthlymeeting.
WrittenIACUCapprovalisrequiredpriortoimplementinganychanges.
III.
20.
AmendmentsandProtocolChangesmaybecommunicatedtothefundingagencyatthediscretionofthePI.
Afterthreeyearsallcontinuingstudiesmustbecompletelyre‐describedinanewapplicationtotheIACUCIII.
21.
IACUCapplicationsdescribingmentorshipofprecollegestudentsarereviewedbytheIACUCifthePIattachesallapplicableschool,county,and/orstateforms,includingparentalpermission,theprecollegestudentiscertifiedforanimalusewithinthePI'slaboratory,andthePIassuresthattheyortheirdesignatedstaffwhoarenamedontheapplicationwillcontinuallydirectlysupervisetheprecollegestudentwhileananimalcarestaffmemberisavailableinthefacilityduringtheconductoftheproposedresearchinvolvinganimals.
AsUSFPolicy6-038prohibitsminorsfromworkingorvolunteeringinananimalhousingorusearea,requeststocertifyprecollegestudentsasqualifiedforunescortedaccesstoananimalfacilityarenotgranted.
III.
22.
IACUCapplicationsdescribingteachingortraininglaboratoriesmustassuretheIACUCinwriting,underwhicheverSectionoftheApplicationisdeemedappropriate,thattheyortheirdesignatedIACUC-certifiedstaffwhoarenamedontheapplicationwillcontinuallydirectlysupervisethestudentsattendingthelaboratory,andthatpriortothelabcommencing,willdiscusswiththestudentsthepotentialrisksandhazardsasassociatedwiththeirinvolvementinthelaboratoryinvolvinganimals,andwilldocumentthisdiscussionbyhavingallattendingstudentscompleteaStudentSafetyinTeachingLaboratoriesInvolvingAnimalsformwhichthePIwillsignandprovidetotheIACUCbeforethelabcommences.
III.
23.
Alllivevertebrateanimalsusedinresearch,teaching,ortestingattheUniversity,oratUniversity-affiliatedhospitalsorinstitutes,orbyUniversityfacultyatothersitesotherthanstudiesofwildanimalsinnaturalsettings,mustbeprocuredbyComparativeMedicine,andhousedandcaredforwithinoneoftheAAALAC-accreditedanimalfacilitiesmanagedbyComparativeMedicine,unlessdeclaredinwritinginresponsetoitem6.
1.
2oftheIACUCapplicationandapprovedbytheIACUC.
Procurementofcryopreservedmouseembryos,oocytes,orspermatozoafromMutantMouseRegionalResourceCentersorotherextramuralsourcescanbearrangedbythePI,whichinformsComparativeMedicineoftherequestandarrivalofthesebiologics.
WhendescribedinanIACUC-approvedprotocol,thesecanbeusedorimplantedinsurrogateshousedinquarantine,whicharesubjecttohealthevaluationspriortoreassignmentorrelocation.
III.
24.
TheUniversityIACUCdoesnotregulateactivitiesinvolvinganimalsconductedwhollybynon-Universitypersonnel,offcampus,andnotsupportedbyUniversityfunds.
However,inordertodocumentthatappropriatepracticesofacquisition,use,anddispositionofvertebrateanimaltissuesarefollowed,andwithappropriateconsiderationofoccupationalhealthandsafety,andpublicrelationsissuesassociatedwiththeiruse,anIACUC"tissueuseonly"applicationcanbesubmittedwheneververtebrateanimaltissuesarerequestedfromanotherinstitution,orIACUC-approvedprotocol,orothersource.
TheserequestsfortheuseofanimaltissuesarereviewedbytheIACUCusingthedesignatedmemberreviewprocess.
TissueusesthatwillnotimpactthehealthorsafetyofinvolvedpersonnelneednotbeproposedtotheIACUC.
III.
25.
Useoftissuesfromanimalseuthanatizedforotherpurposesorderivedfromothersources(i.
e.
,slaughter-house,orbiologicalsupplyhouses)reducestheoverallnumberofanimalsusedinresearchandteaching,andisencouragedbytheIACUC.
WhenworkingunderanIACUC-approved"tissueuseonly"protocol,animalsmaynotbeeuthanatizedforthesolepurposeofderivingthetissues,andnoprotocol-specificantemortemmanipulationsmaybepartoftheprotocol.
Tissuesmayonlybederivedasaby-productfromanimalseuthanatizedunderotherIACUC-approvedprotocols,orfromothersources(e.
g.
,slaughter-housetissues).
III.
26.
Inter‐institutionalcollaborationsinvolvinganimalusehavethepotentialtocreateambiguitiesabouttheresponsibilityforanimalcareanduse,andIACUCoversight.
IfactivitiesinvolvinganimalsaretobeconductedatanotherinstitutioninvolvingUniversitypersonnel,orsupportedbyUniversityfunds,thereshouldbeaformalwrittenunderstanding(e.
g.
,acontract,memorandumofunderstanding,oragreement)whichspecifiesresponsibilityofoffsiteanimalcareanduse,animalownership,andIACUCreviewandoversight.
Whenapplicable,thiswrittenunderstandingshouldindicatethatthecollaboratinginstitutionhasanassuranceonfilewiththePHS,thatitsprogramforanimalcareanduseisaccreditedbyAAALACInternational,thattheirIACUChasapprovedtheproposedanimaluse,andthattheUSFIACUCwillbeinformedRICIACUCDC#002.
36Effective3/21Page7of31ofanyissues,concernsorverifiednoncompliancerelatedtotheactivityconductedatthecollaboratinginstitution.
Inordertoensurecleardefinitionandunderstandingoftheplannedcollaboration,wheneverthecollaboratinginstitutionhasagreedtoperformasignificantportionoftheanimaluseaspectsofaresearchgrantorcontractawardedtotheUniversity,theUniversity'sIACUCshouldbeprovidedwithwrittenevidencethatthecollaboratinginstitution'sIACUChasapprovedtheactivity.
Thesedocumentsmustbereceivedfromthecollaboratinginstitutionpriortoinitiatinganywork.
Inaddition,theIACUCmustbeinformedofanyissuesraisedbythecollaboratinginstitution'sIACUCduringtheirinspectionoftheactivity,program,orfacilitywhilehostingtheresearchactivity.
AlthoughtheIACUCdoesnotreviewtheanimaluseaspectsofcustomcommercialpolyvalentormonoclonalantibodiesbycommercialvendors,wheneverPHSfundsareusedtoarrangeforsuch,thevendormusthaveanassuranceonfilewithOLAWandshouldprovideacopyofsuchtothePI,andifaninternationalvendor,issubjecttoUSDAimportationregulations.
TheIACUCrecognizesthatwildvertebrateanimalsowned,housedandcaredforbyinstitutions(e.
g.
,zoologicalparks,aquariums)neighboringtheuniversityanditsaffiliatesmay,onoccasion,benefitfromtheemergencyanimalmedicaldiagnosticortherapeuticcapabilitiesoftheanimalprogramanditsfacilities.
Toensurethatallsuchemergencyanimalmedicalinter-institutionalcollaborativeeffortsareappropriatelyconducted,aformalwrittenunderstanding(e.
g.
,acontract,memorandumofunderstanding,oragreement)shouldbeestablishedinadvancebytheownerofthehostingfacility(e.
g.
,CAMLS)withtheneighboringinstitution(e.
g.
,zoologicalparkoraquarium),whichspecifiesresponsibilitiesofanimalcareandownership,mechanismsofIACUCreporting,andthesource(s)ofequipment,supplies,andprofessionaltechnicalsupportofdiagnosticortherapeuticprocedures.
III.
27.
AnimalsnotdescribedinanIACUC-approvedprotocolarenotpermittedwithinUniversityanimalfacilities,orUniversityresearch,teaching,ordiagnosticlaboratories.
III.
28.
Thetitleandnarrative(i.
e.
,specificaims,researchplanandmethods,andspeciesofanimalstobeused)ofanIACUCapplication(otherthanamurinecolonyonlyapplication)mustmatchthetitleandnarrativeofthePHSfundingagencygrantorcontractthatsupportstheproposedresearchactivityinvolvinganimals.
IfanactivityinvolvinganimalsthatisdescribedinanIACUC-approvedprotocolissupportedbymultiplegrantswithdifferenttitles(e.
g.
,oneresearchgrant,onepostdoctoralfellowship,anddepartmentalfunds),oragrantisawardedlaterduringthe3-yearapprovalperiodoftheIACUCprotocolthatsupportstheapprovedactivityinvolvinganimals(i.
e.
,grantnotfundedduringyearoneoftheprotocol,butawardedduringyeartwo),thePImustinformtheIACUCbymodifyingtheIACUCprotocol.
AsingleIACUCprotocol(otherthanamurinecolonyonlyapplication)cannotbeusedtorepresenttheanimaluseactivitiesofmultiplePHSagencyresearchgrantsorcontractseachwithbudgetstopurchase,maintain,anduseanimals.
AsingleresearchgrantorcontractmayberepresentedbymorethanoneIACUC-approvedprotocol.
III.
29.
Iftestsubstance(s)thatarepotentiallyhazardousaretobeadministeredtoanimals,priorauthorizationofuseofthetestsubstance(s)bytheappropriateSafetyCommitteeisrequiredbeforeapprovalbytheIACUC.
ApprovaloftheIACUCapplicationinvolvinghazardousmaterialsnotpreviouslyproposedbythePIandapprovedbytheIACUC,canbecontingentonapre-performancemeetinginvolvingthePIandrelevantstaffthatrepresentstheapplicant'slaboratory,ComparativeMedicine,theIACUC,andtheappropriateSafetyCommittee(s).
Thispre-performancemeetingmaybehelpfultoensurethatallinvolvedpersonnelareawareoftheprecautions,containmentpractices,facilities,protectivedevices,disposalanddecontaminationprocedures,andothernecessarysafetyproceduresthatmustbefollowedtoprotectpersonnel,andpreventaccidentalanimalexposuretothehazardousmaterial.
TheIACUCmayalsorequireapre-performancemeetingwheneveranapplicantPIproposesinfrequentlyusedspeciesortechniques,orproposessurgicalorteachingproceduresinvolvinganesthetizednon-rodentmammals.
Thispre-performancemeetingmaytakeplacebeforeorafterIACUCapprovaloftheprotocolatthediscretionoftheIACUC,butmustoccurbeforeinitiationoftheIACUCapprovedactivity,andensuresthatappropriatepersonnel,equipment,supplies,recordkeeping,andpracticesofanimalcareandusehavebeenidentifiedandwillbeemployed.
III.
30.
TheIACUC,assistedbythestaffofResearchIntegrity&ComplianceandComparativeMedicine,conductobservationalpostapprovalmonitoring(PAM)andperiodicauditsofactiveanimaluseprotocols,inspectssatellitefacilities,andinspectslaboratoriesoutsideofmanagedanimalfacilitieswhereinanimalsareused.
Theseaudits,andinspections,andobservationalPAMserveasanadditionalreviewoftheeffectivenessoftheanimalcareanduseprogram,andareinitiatedduringeachsemi‐annualinspectionoffacilitiesandprogrambytheIACUC,orwhenevernecessary.
Theseaudits,inspections,andobservationalPAMensurethatinmanagedfacilities,satellitefacilities,andinlaboratorieswhereinanimalsareused,sufficientanimalcareandclinicaloversightisprovidedandrecorded,thatanimalpain,distress,ordiscomfortareanticipated,avoided,oralleviated,thatworkareasareunclutteredandadequatelydecontaminated,thatcurrentsuppliesandproceduresareused,thatappropriatelysanitized/sterilizedinstrumentsareused,andthattherisksofallhazardsareminimized.
Indeterminingwhichprotocolstoaudit,satellitefacilitiesandlaboratoriestoconductPAM,theIACUCisespeciallyinterestedinensuringthegoodpracticesofprotocolsinvolvingsatelliteanimalhousing,PainCategoryCprocedures,survivalsurgery,theadministrationoruseofhazardousmaterials,ortheuseofcontrolledsubstances.
Inaddition,inaccordancewiththeVAHandbook,duringeachsemi-annualProgramReview,theIACUCmustensurethatIACUCrecordsrepresentingatleast5percentofthetotalactiveVAprojects,oraminimumoffiveprotocols,arerandomlyRICIACUCDC#002.
36Effective3/21Page8of31reviewedtodetermineifappropriatedocumentationofinitialreview,approvalletter(s),annualandtriennialapprovals,modifications,andinvestigatorcorrespondencearepresent,andpresenttheirsemi-annualsummariestotheIACUC.
III.
31.
TheIACUCreviewstheanimalcareanduseprogramandinspectsanimalfacilities,andlaboratoriesoutsideoffacilitieswhereanimalsareusedatleastevery6months.
DuringthesereviewsandinspectionstheSemi-AnnualProgramandFacilityReviewReportiscompleted.
Deficienciesidentifiedareclassifiedaseither"major"(i.
e.
,thosewhichaffectanimalwelfare),or"minor",andaschedulebywhichcorrectionswillbeaccomplishedisassigned.
Eachsemi-annualreportisreviewedandsignedbyamajorityofIACUCmembers,includesanydissentingviewsoropinions,andissubmittedtotheInstitutionalOfficialforhisreviewandsignature.
Eachreportincludeschangesmadetotheprogramandanitemizationofimprovementsthatneedtobemadetothefacilities.
ComparativeMedicineprovidesadraftofresponsestodeficientitemstotheIACUCChairpersonwhointurnprovidestheInstitutionalOfficialwithadetailedwrittenassuranceofhowallitemsofnoncompliancewereresolvedinatimelymanner,whensoaccomplished.
IACUCmembersmustattendandcontributetoinspectionsandmustnotifytheIACUCadministrativestaffofplannedabsencespriortoaninspectionasassignedbytheChairperson.
TheInstitutionalOfficialcandismissIACUCmembersandalternatesthatdonotcontributetoinspections.
III.
32.
Applicationsproposingtohouseanimalsfor>12hoursatsatellitefacilitiesoutsideofComparativeMedicine‐managedanimalfacilitiesmustdescribeinappropriatesectionsoftheapplication(e.
g.
,"SpecialHusbandry")methodsthatwillbeusedforensuringandrecordinganimalhealthandenvironmentalquality,includingwheneverrelevant,(1)howanimalswillbetransportedtothesatellitefacility,(2)thetransportenclosure(s)thatwillbeused,(3)theperiodoftimethattheanimalswillbehoused,(4)thecaging/aquaria/primaryenclosure(s)thatwillbeused,(5)theintervalsofoversightandmethodsformaintainingappropriatelivingconditionsthatcontributetotheanimal'shealthandwell‐being,includingtheirdietandfrequencyoffeeding,(6)howprimaryandsecondaryenvironmentalconditionswillbemaintained,cleaned,sanitized,and/orcontrolled,(7)thefactorsthatwillbemonitoredtoensurethatthesemethodsofanimalmaintenancewillcontributetothehealthandwell‐beingoftheanimals(e.
g.
,appearance,behavior,activity,growth),(8)thatoversightandcarewillbedocumentedonformsprovidedbyComparativeMedicine,(9)anemergency/disasterresponseplanthattakesintoaccountbothpersonnelandanimals,and(10)thatthePIwillassistwithtrackingsatellite-housedresearchactivitiesbyreportingtheinitiationofeachepisodeofsatellitefacilityanimalhousingtotheIACUCc/oResearchIntegrity&Complianceatintervalsappropriatetothestudy,butatleastsemiannually.
ReportedanimalnumbersaretabulatedbyComparativeMedicine.
Laboratoriesoutsideofanimalfacilitieswhereproceduresinvolvinganimalsareproposed,describedinitem6.
3.
1ofanIACUCapplication,arereviewedbyComparativeMedicineveterinarianspriortoIACUCapprovaloftheapplicationtoensureproposedlaboratoriesareappropriatelylocatedandequippedfortheproposeduse.
III.
33.
Non-membersoftheIACUCthatattendIACUCmeetingsmustsitquietlyawayfromthetable,andarenotallowedtoparticipateindiscussionsunlessquestionsaredirectedtothembytheChairperson.
QuestionsregardinganimalcareandusecanbesubmittedtoUSFHealthSciencesOfficeofCommunications,PublicAffairsOfficeattelephone974-3300,orfax974-5422.
IV.
ResearchIntegrity&ComplianceandResearchGrantsRegardingAnimalCareandUseIV.
1.
ResearchIntegrity&ComplianceprovidestheIACUCwithclericalsupportservices,andassiststheIACUCwithitsfunctionsofoversightandevaluationoftheanimalcareanduseprogram.
IV.
2.
ResearchIntegrity&CompliancemaintainsbothpaperandelectronicfilesofIACUCprotocolsandmodifications,andnotifiesapplicantsofIACUCactions.
PrincipalInvestigatorsdevelopingapplicationsforVAfundedMeritReviewgrants,whicharereviewedandapprovedbytheVACentralOffice,mustsubmittheanimalcomponentfortheirresearchprojecttotheIACUCusingtheVAAnimalComponententitled"AnimalComponentofResearchProposal"(ACORP)viewableathttp://www.
research.
va.
gov/programs/animal_research/.
AllACORPapplicationstotheIACUCwillbeassignedaprimaryreviewerthatisaVAresidentscientistoradministratorfamiliarwiththeACORPformatandaregularmemberoralternatememberoftheIACUC.
IV.
3.
ApplicantPIsmustrespondtoallcommunicationsfromResearchIntegrity&ComplianceregardingIACUCdeliberationspromptlyandnolaterthanthedesignatedtimeframeinthecommunication.
FailuretorespondwithinthedesignatedtimewillresultinResearchIntegrity&ComplianceinformingtheIACUCofthisnon-responseandrecommendingadministrativeclosureofthestudyorpendingapplication.
IV.
4.
ResearchIntegrity&CompliancemaintainsresearchpersonnelIACUC-certificationfiles,whichcontainthecurriculumvitaeofeachprincipalandsecondaryinvestigator,andrecordsdocumentingthetrainingandexperienceofallresearchandanimalcarestaffmemberstoensurethatallinvolvedpersonnelhaveadequateknowledgeandabilitytoperformtheirdutiesofanimalcare,use,andtreatment.
RICIACUCDC#002.
36Effective3/21Page9of31IV.
5.
TheapplicantPrincipalorSecondaryInvestigatormusthaveafacultyappointmentwiththeUniversityoranappropriateappointmentwiththeJamesA.
HaleyVeteran'sAdministrationMedicalCenter,H.
LeeMoffittCancerCenterandResearchInstitute,orNewCollegeofFlorida.
ExtramuralresearchinterestsinvolvinganimalsmaybeledbyanextramuralIACUCcertifiedscientist,assumingtheextramuralentityhasawrittenunderstandingonfilewithaprogrammemberinstitution,allcostsofinfrastructuralservicesarefullyreimbursed,andintheeventresourcesbecomelimited,facultyandintramuralscientistinterestsareshownpriority.
IV.
6.
Allindustry-sponsoredprotocolswillbesubjecttoIACUCfeesforthereviewandcontinuedoversightofanimalresearch.
(InvestigatorsareencouragedtochargetheIACUCfeesasdirectcostintheirbudgets)V.
ComparativeMedicineV.
1.
ComparativeMedicineservesasanadvocateforallanimalshousedatUniversityfacilities,andimplementsandadministerstheAAALAC-accreditedAnimalCareandUseProgram.
V.
2.
ComparativeMedicineprovidesveterinaryoversightofanimalhealthandwell-being,guidanceandassistancewithveterinarymedicalandsurgicaltechniques,servicesofdiseasesurveillance,diagnosisandtreatment,animalhusbandryandnutrition,zoonosiscontrol,hazardcontainment,andsanitation.
V.
3.
ComparativeMedicineprovidessupplies,andminorportableequipment,andcoordinatesthemaintenance,repair,replacement,andcertificationofminorportableequipment.
V.
4.
TheDirectorofComparativeMedicinehasmanagementandadministrativeauthorityregardingallaspectsofanimalcareanduse,includingtheprocurement,placement,management,husbandry,monitoring,use,andmovementofanimalsinvolvedinresearchandteaching,andregardingtheuseofallrooms,areas,andequipmentwithinanimalfacilitiesontheUniversitycampuses,andatUniversity-affiliatedhospitalsorresearchinstitutes.
V.
5.
Toensureappropriateveterinaryclinicalcareandmedicalmanagementofallanimals,veterinariansareauthorizedtoassessanimalconditions,treatanimals,relieveanimalpain,and/oreuthanizeanimals.
Althoughveterinary,animalcare,andhusbandrystaffmaymakecontributionstoresearchprotocolsinvolvinganimals,thePIandassociatedresearchstaffnamedontheIACUC-approvedprotocolserveastheprimaryattendingcliniciansofallanimalshousedonbehalfofthatprotocol.
Assuch,thePImustprovidecoordinatedplanning,cleardirection,andpreparedleadershipforallprotocolsundertheirdirection.
ThePImustensurethatallpracticesofanimalcareandusemeetorexceedtherequirementsofapplicableprinciplesandproceduresandareinaccordancewithcurrentestablishedveterinarymedicalandnursingprocedures.
ThePIandresearchstaffareresponsibleforprovidingadequateclinicaloversight,andpost-operativeorpost-proceduralcareoftheanimals,foranticipatingandalleviatinganimalpainordiscomfortwheneverpossible,foridentifyingtheearliestpossibleclinicalendpointthatcontributestothespecificaimsoftheresearch,andformaintainingcompleteanimalmedicalrecords,withentriesmadeinsufficientdetailandatintervalsspecifiedbytheseIACUCPrinciplesandProcedures.
V.
6.
CurrentUSPgradepharmaceuticalandbiologicalproductsmustbeusedinanimaltherapeuticapplications,andinallaspectsofanimalresearchwheneveravailable.
Useofnon‐pharmaceutical‐gradesubstancesinanimalsrequireswrittenscientificjustificationtotheIACUC,andawrittenassurancethatnon‐pharmaceutical‐gradesubstancepreparation,reconstitution,and/orcompoundingwillresultinsubstancesthataresterile,safe,effective,andofanappropriatecomposition(e.
g.
,purity,concentration,pH,osmolality)andshelf‐life,thatsuchpreparationswillbecomposedbyappropriatelytrainedandexperiencedpersonnel,andthatadverseanimalwelfareoutcomesrelatedtonon‐pharmaceuticalgradesubstanceusewillresultinitscessationofuse,andawrittennotificationbythePItotheIACUCdescribingthecircumstancesoftheadverseevent.
Biologics,especiallythoseoriginallyderivedfrom,orseriallypassaged-throughrodents,havethepotentialtosurreptitiouslytransmitrodentpathogenicagents.
Characterizationsofrodentbiologicsaspathogen-freeareassociatedwiththeIACUCprotocoldescribingtheirusebyuploadingsuchdocumentationtoitem15.
13.
2b.
V.
7.
ComparativeMedicinehasauthoritytoestablishfeeratesforservicesrendered,toinvoicefor,andtocollectcompensationfromgrant,contract,departmental,orotheraccountsforservicesrenderedtopartiallymeetthecostsofadministeringtheAnimalCareandUseProgram,andarelistedatServices,PerDiems,Equipment,andFees.
ComparativeMedicinewillnotfillrequestsforanimalsorserviceunderaspecificIACUC-approvedprotocoluntilanassociationbetweenfiscalsupport,anIACUCprotocol,andanaccountisassuredinwriting.
AResearchServicesAgreementand/oraletteroncompanyletterheadindicatingacommitmenttofundaproposalmaybeusedtodocumentcorporatesupport.
AmemorandumfromthedepartmentalChairpersonorothersignatureauthorityontheaccountmaybeusedtodocumentdepartmentalsupportofaproposal.
ThePImustensurethatallcostsinvoicedtoagrantaccountareallocabletothepurposeofthegrant.
CostsallocabletooneprotocolmaynotbeshiftedtoanotherinordertomeetRICIACUCDC#002.
36Effective3/21Page10of31deficienciescausedbyoverruns,orforotherreasonsofconvenience.
Rotationofchargesamongprotocolsoraccountsbymonth,orthemonthlypercentdistributionofchargesamongaccountswithoutestablishingthattherotationscheduleorpercentdistributioncrediblyreflectstherelativebenefittoeachprotocolandgrantaccountisunacceptable.
AlthoughPrincipleIII.
28permitsmultipleaccounts,includingmultiplePHSagencyresearchgrantaccountsinsupportofmurinecolonyonlyapprovals,thePImustensurethattheproportionofcolonycostsreimbursedbyeachaccountaccuratelyreflectstherelativebenefitofthecolonytothespecificaimsofeachsupportinggrantaccount.
ComparativeMedicinewillalsonothonorrequestsforanimalsorservicesunderanIACUC-approvedprotocoluntilallpre-performancesafetyandlogisticalmeetingshaveoccurredandbeendocumentedinwritingbyComparativeMedicine.
V.
8.
Populationdensityandhousingspacecanaffectanimalreproduction,metabolism,immuneresponses,andbehavior.
ComparativeMedicineensuresthatallstandardoperatingproceduresareinaccordancewiththeanimalhousingspacerecommendationsgivenintheGuide,viewableathttp://grants.
nih.
gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.
pdfwiththefollowingvariances.
Staticmicroisolatorcagingformiceprovides63in2offloorspace,sufficientforfouradultmice,oronefemalewithnursinglitterandhermonogamousmalemate,orfivemicethatareeach25gbodyweight.
Malesofaggressivestrains(e.
g.
,BALB/c,SJL,andFVB)mayneedtobehousedatevenlowerdensities.
Micemaybebredinamaletofemaleratioof1:1,1:2,or1:3.
Ifmicearebredina1:1monogamousratio,themaleandfemalebreedersandtheirlitterofpupsmaybekepttogethercontinuouslyuntilthepupsareweaned.
Giventhestrongpostpartumestrous,andrelativelyshort21daygestationand21daylactationofmice,afemalethatiscontinuouslyhousedwithamalemaybepregnantwithhernextlitterwhilenursingacurrentlitter.
Consequently,pupsofcontinuouslyhousedmonogamousbreedersmustbeweanedpromptlyat21daysofage,orwheneverthesubsequentlitterisborn,whicheverisearliest.
Ifmicearebredina1:2or1:3harems,eachfemalemustberemovedtoaseparatecagewhenobservedtobepregnant,exceptwhennurslingmiceareeuthanatizedpromptlybypostnatalday7(e.
g.
,asasourceofcellsortissues),inwhichcasetheharemmaybehousedcontinuouslytogether.
Weanlingsarecountedasadultsat28daysofageoratweaning,whicheverisearliest.
WheneverComparativeMedicinestafffindovercrowdedmousemicroisolatorswithoccupantsthatexceedtheselimits,thecagesareflaggedbyanoticeonthecageandanemailissenttotheprincipalinvestigatorand/orresearchstaffimmediatelyand,ifnoresponse,24hourslater.
Theresearchlaboratorymustcorrecthousingdensitiesofmicethatexceedthelimitssethereinwithin48hours,orComparativeMedicinewillseparatetheanimalsasdeemedappropriate,andachargewillbemadetotheprincipalinvestigator'sresearchaccount.
V.
9.
TypicalHVACsystemperformanceinFlorida,whenprovidingtheGuide'srecommendedfresh-airchangesperhour,mayresultinanoccasionalrelativehumidityreadingthatexceedstheGuide'srecommendedhumidityrangeforbriefperiodsinanindividualhousingroom(i.
e.
,lessthan10consecutivedays).
FacilitymanagersshouldnotifytheAssistantDirectorwheneverrelativehumidityreadingsarelessthan20%humidityorgreaterthan80%humidityforaperiodof10daysormore.
FacilityManagersshouldalsonotifytheAssistantDirectorwheneverrelativehumidityreadingsarelessthan15%humidityorgreaterthan85%humidityformorethan2days.
TheAssistantDirectorwillnotifyphysicalplantstaffandaskthattheyevaluateHVACsystemperformance.
Ifrelativehumidityreadingsremainoutofrangeoneweekafternotifyingphysicalplant,theAssistantDirectorwillaskthePItoconsiderwhethertheseconditions,ortheuseofportablehumidifiers/dehumidifiersorairconditioners,introducevariablesthatmayaffecttheintegrityoftheirresearch.
LimitationsinHVACsystemperformancemayresultintemperatureandhumidityreadingshigherthantheGuide'srecommendationforstorageofnaturalingredientdiets.
FacilitymanagersshouldnotifytheAssistantDirectorwhenevertemperaturereadingsaregreaterthan74degreesFahrenheitorgreaterthan70%relativehumidityformorethan2days.
TheAssistantDirectorwillnotifyphysicalplantstaffandaskthattheyevaluateHVACsystemperformance.
Ifrelativehumidityreadingsremainoutofrangeoneweekafternotifyingphysicalplant,theAssistantDirectorwillconsiderwhethertheseconditions,ortheuseofportablehumidifiers/dehumidifiersorairconditioners,introducevariablesthatmayaffecttheintegrityofthefeed.
Feedisutilizedinafirst-in,first-outmannertominimizethedurationofstorage.
V.
10.
Althoughphysicalseparationofanimalsbyspeciesisrecommendedtopreventinterspeciesdiseasetransmissionandtoeliminatethepotentialforanxietyandphysiologicandbehavioralchangesduetointerspeciesconflict,theIACUCacknowledgesthatitispossibletoachievetheseaimsbyothermeans.
Multiplespecieswillonlybehousedinthesameroomwhenthereisnoaddedriskofdiseasetransmissionbetweenspecies.
Whenmultiplerodentspeciesareheldinthesameroom,aseparateairsupplywillbemaintainedbymeanssuchastheuseofindividuallyventilatedmicroisolatorcagesthataredeliveredHEPA-filteredseparateventilation.
Differentspecieswillnotbevisuallyconnectedinadjacentcages,andallprimaryenclosuresofonespecieswillbeopened/changedonecageatatimeinaccordancewithstandardprocedures.
Thechangingstationorbiosafetycabinetwillthenbedecontaminatedinaccordancewithstandards,followedbyaglovechangepriortoallprimaryenclosuresofthesecondspeciesbeingopened/changedonecageatatimeinaccordancewithstandards.
RICIACUCDC#002.
36Effective3/21Page11of31V.
11.
Priortodepartureofemployment,facultymustcompleteanout-processingchecklistwiththeAssistantDirector,whichdelineatestheaffectedIACUCprotocols,describesthefinaldispositionofanimals,thedispositionofanyPI-ownedequipmentandsupplies,ensuresthatallcostswillbecovered,andensuresthataccesstoanimalfacilitieshasbeenwithdrawn.
VI.
PreclinicalGLPStudiesVI.
1.
Preclinicalstudiesevaluatingmedicaldevices,investigationalhumanoranimaldrugs,biologicalorelectronicproducts,orfoodadditivesthatsupportorareintendedtosupportapplicationsforresearchormarketingpermitsforproductsregulatedbytheFoodandDrugAdministration(FDA)shouldbeconductedinaccordancewithTitle21CodeofFederalRegulationsPart58GoodLaboratoryPracticeforNonclinicalLaboratoryStudies(GLPStudy)viewableathttps://www.
accessdata.
fda.
gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.
cfmCFRPart=58.
VI.
2.
ApplicantsmustdeclareintheIACUCapplicationwhetheraproposedstudywillbeconductedinaccordancewith21CFR58regulations,andattachacopyoftheGLPStudyprotocolgeneratedjointlybytheGLPTestingFacilityandstudysponsor.
VI.
3.
ThePIandGLPTestingFacilitymanagementmustcontactComparativeMedicineanddeclareinadvancetheirintentiontoperformaGLPStudy,andreceivewrittenapprovaloftheGLPStudyprotocolfromtheDirectorofComparativeMedicine,aswellasapprovalofthematchingIACUCprotocolfromtheIACUCbeforeinitiatinganywork.
VI.
4.
TheGLPStudyDirectorandQAUmustbeidentifiedbytheGLPtestingfacilitymanagement,andallprovisionsregardingrecord-keeping,auditing,dataarchivingandretrieval,testinstrumentcalibration,andtestarticleidentification,handling,andstorageaccomplishedordescribedintheGLPStudyprotocolinaccordancewith21CFR58.
VI.
5.
ThefinalreportandalldataresultingfromtheGLPStudymustbefiledwiththeGLPTestingFacility.
VII.
OccupationalHealthandSafetyVII.
1.
MedicallytrainedoccupationalhealthprofessionalsareinvolvedwiththeIACUCintheplanningandmonitoringof,andassessparticipationintheOccupationalHealthandSafetyProgram.
HealthAdministrationsandEnvironmentalHealth&Safetyofficesoffertoallpersonnelwhowillbeworkingwithanimals,informationregardinghealthmonitoring,potentialzoonosis,andhealthassessments,immunizations,andsafetyproceduresrelatingtotheiranimalcontactand/orexposures.
Fieldstudiesarealsoreviewedbytheseofficestoensurethattheproposedfieldstudydoesnotcompromisethehealthandsafetyofpersonsinthefield.
VII.
2.
NewresearchandanimalcarepersonnelmustsubmitacompletedHealthandRiskAssessmentforEmployeeSafetyintheCareandUseofAnimalsformtotheARCsystem.
.
Amedicalevaluationandhealthhistoryarerequiredbyoccupationalhealthprofessionalsforthoseindividualswithrelevantanimalcontact,thecollectionofwhichcomplieswithallfederal,stateandlocalHIPAAregulationsforprivacy.
Everysixyears,allIACUC-certifiedpersonnelmustprovidearevisedHealthandRiskAssessmentforEmployeeSafetyintheCareandUseofAnimalsform.
PersonnelwhosedutiesrequireaccesstoananimalfacilitybutwhosedutiesdonotincludeworkingwithanimalsmustsubmitacompletedPersonnelEnteringAnimalFacilitiesHealthandRiskAssessmenttotheIACUC.
VII.
3.
IndividualsdeterminedtobeatriskasdeterminedbycompletionoftheHealthandRiskAssessmentforEmployeeSafetyintheCareandUseofAnimalsformareencouragedtocompleteaHealthHistoryAssessmentformandconsultwithahealthcareprovider.
Amedicalevaluationandhealthhistoryarerequiredbyoccupationalhealthprofessionalsforthoseindividualswithrelevantanimalcontact,thecollectionofwhichcomplieswithallfederal,stateandlocalHIPAAregulationsforprivacy.
Whenspecialconsiderationsaredeclared,includingtheproposeduseofinfectiousagentsrequiringbiosafetylevelIIIcontainment,ortheuseofunvaccinatedoruncharacterizedcarnivores,pregnantsheep,goats,cattle,ornonhumanprimates,,whichrequireadditionalhealthservices,ResearchIntegrity&Complianceensuresthatat-riskpersonnelmakearrangementsforhealthservices,andreceiveswrittenconfirmationthathealthserviceshavebeeninitiated,documentationofwhichisuploadedtotheresearcher'sprofileintheARCsystem.
VII.
4.
Informationregardingpotentialzoonosisandpracticesofpersonnelhygienewhichlimitexposureandriskofcontractingzoonosisareprovided.
Thenatureofnoxious,toxic,hazardous,infectiousorcarcinogenicagentsorcompoundswhenusedarepostedonthedooroftheroomcontainingtheanimalcollectionexposedtosuchagents.
VII.
5.
Individualsareexpectedtonotifytheirsupervisorofsuspectedhealthhazards.
Wheneverworkrelatedaccidents,injuries,orillnessesoccur,individualsarerequiredtoreportthesetotheirsupervisor.
RICIACUCDC#002.
36Effective3/21Page12of31VII.
6.
Vigilanceforzoonosisisanimportantaspectofanyprotocolinvolvinghumanandotherxenografttransplantation.
ThePImustconsiderthepotentialforexchangeofinfectiousagentsbetweennaturalandforeignhosts,includingthepotentialforinapparentinfection,whenplanningorconductingresearch-involvingxenotransplantation.
ThePImustproposeinwritingtotheIACUCtheappropriateprecautionsthatwillbeinstitutedregardinghealthcharacterizationsofthedonor,monitoringoftherecipientanimal,andanyhandling,management,andcontainmentpracticesofthebiologics,graft,orrecipientanimalthatwillbeusedforasufficientlylongperiodoftimetominimizetheriskthatpathogensmayariseandposeahazardtopersonnelorotheranimals.
VII.
7.
Animalsadministereduncharacterizedprimarytumorresections,tissueexplants,blood,orotherpatient-derivedxenograftsarehousedinABSL-2containmentinaccordancewithSOP408.
VII.
8.
Researchandanimalcarepersonnelmustconsulttheoccupationalhealthphysicianwheneverresearchisproposedthatinvolvesunvaccinatedoruncharacterizedcarnivores,pregnantsheep,goats,ornonhumanprimates.
VIII.
CertifyingAdequacyofPersonnelTrainingandExperienceVIII.
1.
Allpersonnelmusthaveadequateknowledgeandexperiencetoperformtheirdutiesofanimalcare,use,andtreatment.
VIII.
2.
AllpersonnelmustbesufficientlyfamiliarwiththeAWA,PHSPolicy,Guide,andtheseIACUCPrinciplesandProcedures,sothattheircare,treatmentanduseofanimalswillbeinaccordancewiththeseprinciples.
VIII.
3.
Allpersonnelinvolvedinlivevertebrateanimaluse,treatment,orcaremustbecertifiedbytheIACUCasqualifiedtoperformtheirduties,andnamedontheIACUCprotocolapplication(s)towhichtheywillcontribute.
TheIACUCoverseesandevaluatestheeffectivenessofthetrainingprogramatleastsemi-annually.
Allprogrampersonneltrainingmustbedocumented.
VIII.
4.
AllresearchpersonnelmustcompletetheAALASLearningLibrarycourseentitled"Laws,Regulations,Policies,andtheGuide–USFOrientationLessons"andprovidethecertificateofcompletion,whichdocumentsthattheyhavereceivedtraininginanimalcareanduselegislation,IACUCfunction,ethicsofanimaluseandtheconceptsoftheThreeRs,methodsforreportingconcernsaboutanimaluse,occupationalhealthandsafetyissuespertainingtoanimaluse,animalhandling,asepticsurgicaltechnique,anesthesiaandanalgesia,andeuthanasia.
VIII.
5.
NewPrincipalandSecondaryInvestigators,andotherresearchpersonnelwithasignificanthistoryofworkwiththespeciesrequested,whichhasbeendocumentedbythepublicationofmultiple,peer-reviewedreportsofresearchinvolvingtherequestedspecies,arerequiredtoprovideacopyoftheircurriculumvitaetodocumentthispriorexperience.
VIII.
6.
AllnewpersonnelusinglivevertebrateanimalsmustcompleteaHealthandRiskAssessmentforEmployeeSafetyintheCareandUseofAnimalsform.
Annually,allresearchpersonnelmustreviewtheirHealthandRiskAssessmentforEmployeeSafetyintheCareandUseofAnimalsform,andwhendeclaringanychanges,mustuploadtoARCtheupdated,completedform.
VIII.
7.
Allnewpersonnelusinglivevertebrateanimalsmustcompletetheappropriateorientationform.
PersonnelrequiringaccesstoananimalfacilitymustcompletetheFacilityOrientationofResearchStaffformandcontactthelocalfacilitymanagersothatageneralorientationandprotocol-specific,and/orspecies-specifictrainingcanbeensuredorarranged.
PersonnelplanningstudiesofwildlifeinnaturalsettingmustcompleteanOrientationofField&WildlifeResearchStaffform.
PersonnelplanningstudiesthatonlyuseanimaltissuesinareasoutsideofanimalfacilitiesmustcompleteanOrientationofResearchPersonnelUsingTissuesOutsideofAnimalFacilitiesform.
VIII.
8.
TobecomeeligibleforIACUCcertification,allnewresearchpersonnelmustprovidesixcompleteddocumentstoResearchIntegrity&Compliance:a)FacilityOrientationofResearchStaffform,orOrientationofField&WildlifeStaffform,orOrientationResearchPersonnelUsingAnimalTissueOutsideFacilitiesform),b)HealthandRiskAssessmentforEmployeeSafetyintheCareandUseofAnimalsform,c)CertificateofcompletionfortheAALASLearningLibrary(LL)courseentitled"Laws,Regulations,Policies,andtheGuide–USFOrientationLessons",d)Curriculumvitaeorresume,andifplanningtouserodentse)acertificateofcompletionoftheAALASLLcourseentitled"BasicRodentBiomethodologies",andf)acertificateofattending"BasicRodentBiomethodologies–WetLabTraining",otherthanthePI.
CompletionoftheAALASLLbiomethodologycourseisrequiredpriortowetlabtrainingattendance.
IfplanningtouseUSDAregulatedspecies,allpersonnelmustuploadtotheirARCprofileacertificateofcompletionofCMinpersontraininginthebasicbiomethodologyofthatspecies.
RICIACUCDC#002.
36Effective3/21Page13of31VIII.
9.
PrincipalInvestigatorsproposingrodentsurvivalsurgicalproceduresandallpersonnelintendingtocontributetotheperformanceofsuchproceduresmustprovidetheIACUCwithacertificateofcompletionfortheAALAS(LL)courseentitled"AsepticTechniqueinRodentSurvivalSurgicalProcedures"asanuploadtotheappropriatesectionoftheirARCprofile.
AllpersonnelintendingtodirectlyimplementrodentsurvivalsurgicalproceduresmustprovidetheIACUCwithacertificateofcompletionofwetlabtraininginsuchproceduresprovidedbyCMasanuploadtotheappropriatesectionoftheirARCprofile,priortoIACUCprotocolapproval.
CompletionoftheAALASLLasepticsurgerycourseisrequiredpriortowetlabtrainingattendance.
IfIACUCcertifiedComparativeMedicinestaffwillserveasthesurgeon(s),onlyAALASdidactictutorialtrainingofthePIneedbeprovided.
PersonnelproposingsurvivalsurgicalproceduresinUSDAregulatedspeciesmustuploadtotheirARCprofileacertificateofcompletionofCMinpersontraininginasepticsurgicaltechniqueinthatspecies,priortoIACUCprotocolapproval.
ComparativeMedicineprovidestrainingtoresearchersconductingsurvivalsurgicalprocedurestoensurethatgoodsurgicaltechniqueispracticed,including,asepsis,gentletissuehandling,minimaldissectionoftissue,appropriateuseofinstruments,effectivehemostasis,andcorrectuseofsuturematerialsandpatterns.
VIII.
10.
PrincipalInvestigatorsandallpersonnelproposingtouseimmunedeficientmicemustuploadtotheirARCprofileacertificateofcompletionfortheAALASLLcourseentitled"HandlingandUseofImmuneDeficientMice".
AllpersonnelintendingtodirectlyhandleanduseimmunedeficientmicemustalsouploadacertificateofcompletionofCMinpersontraininginsuchprocedures,priortoprotocolapproval.
Personnelproposingphysicalmethodsofeuthanasiawithoutthebenefitofanesthesia(e.
g.
,decapitation,cervicaldislocation)mustuploadtotheirARCprofileacertificateoftrainingandproficiencyissuchprocedures,priortoIACUCprotocolapproval.
Personnelproposingphysicalmethodsofeuthanasiawithoutthebenefitofanesthesia(e.
g.
,decapitation,cervicaldislocation)mustuploadtotheirARCprofileacertificateoftrainingandproficiencyissuchprocedures,priortoIACUCprotocolapproval.
ComparativeMedicineoffersformalhands‐onwet‐laboratorytraining.
Curriculamayvarydependingonneedasrequestedbyresearchfacultyorstaff,orasrequiredbytheIACUC,andmayincludebasicanimalneeds,properanimalhandling,routesandmethodsofsubstanceadministration,properpre‐proceduralandpost‐proceduralcare,asepticsurgicaltechnique,methodsofanesthesiaandanalgesia,useofequipment,andmethodsofeuthanasia.
Attendanceandcurriculaaredocumented.
VIII.
11.
Pre-performancemeetingsofprotocolsconductedinaccordancewithIACUCPrincipleIII.
29mustensureanddocumentthat:a)personnelcontributingtoprotocolsinvolvinghazardousmaterialhavebeen/areprovidedsafetytraining,clearlydefinedprocedures,appropriatepersonalprotectiveequipment,understandthehazardsinvolved,andareproficientinimplementingrequiredsafeguards,b)personnelcontributingtoprotocolsinvolvingsurgicalproceduresconductedinnonrodentmammalshavebeen/areprovidedtrainingingoodsurgicaltechnique,including,asepsis,gentletissuehandling,minimaldissectionoftissue,appropriateuseofinstruments,effectivehemostasis,andcorrectuseofsuturematerialsandpatterns,c)personnelcontributingtoprotocolsinvolvinginfrequentlyusedspeciesortechniqueshavebeen/areprovidedtraininginappropriatepracticesofanimalcareanduse,recordkeeping,anduseofappropriatesuppliesandequipment.
VIII.
12.
ComparativeMedicineprovidestrainingand/orcoordinatesandprovidestechnicalassistancewithspecies-specificorprotocol-specifictechniqueswheneverneworinfrequentlyusedspeciesortechniquesareintroducedorre-introducedtocampus,oradditionalindividualinstructionisrequestedbyresearchfacultyorstaff,and/orrequiredbytheIACUC.
VIII.
13.
Researchpersonnelintendingtorequest,possess,oruseanycontrolledsubstanceinresearchorteachinginvolvinganimalsmustalsofirstregisterwithComparativeMedicinec/otheAssistantDirectorbycompletingaCertificationofResearchPersonnelUsingControlledSubstancesforminaccordancewithIACUCPrinciplesandProceduresXIV.
2.
VIII.
14.
ResearchpersonnelarekeptapprisedofupdatesthatreflectchangesinStandardOperatingProcedures,IACUCPrinciples,processes,technology,legislation,andotherrelevantareasbytransmittingsuchupdatesbyemailtoallIACUCcertifiedfacultyandstaff,andbypostingsuchupdatesathttps://www.
usf.
edu/research-innovation/research-integrity-compliance/ric-programs/iacuc/announcements.
aspx.
VIII.
15.
AllresearchpersonnelareresponsibleforannuallyreviewingtheirpersonnelprofileintheARCsystem,anddeclaringanyupdatesorchanges,includingreviewingandupdatingasappropriatetheirHealthandRiskAssessmentforEmployeeSafetyintheCareandUseofAnimals.
VIII.
16.
TheIACUCannuallyre-certifiesallresearchandanimalcarepersonnelastotheadequacyoftheirtrainingandexperienceusinganimals.
AchangeinthecertifiedpersonnelcontributingtoanIACUCapprovedanimalusemustbeRICIACUCDC#002.
36Effective3/21Page14of31declaredinadvancebythePIandapprovedbytheIACUCpriortosuchpersonnelmakingcontributionstoprotocol(s),usingprocessesdelineatedinIACUCPrincipleIII.
17.
VIII.
17.
IndividualswhocomplywiththesePrinciplesandProcedureswillbegrantedanARCregistrationnumberbytheIACUCc/oResearchIntegrity&Compliancetobeusedinapplicationsforuseofanimalsinresearch.
ResearchstafforotherindividualsinvolvedinanimalcareanduseactivitiessuspendedbytheIACUCcanhavetheircertificationsrevokedbytheIACUC.
IndividualswithoutacurrentcertificationnumbercanbedeniedaccesstotheservicesandfacilitiesofComparativeMedicine.
VIII.
18.
PrincipalInvestigatorscanrequestthatvisitingscientistsbegrantedescortedhands-onaccesstoanimalsand/oranimalfacilitiesinordertocollaborate,assist,orinstructinthePI'sIACUC-approvedactivitiesbyprovidingtheIACUCchairviaemailatiacuc@research.
usf.
eduwith(1)amemorandumnamingthevisitingscientist,namingtheinstitutionfromwhichhe/sheoriginates,identifyingthedatesoftheirplannedpresencewithinfacilities,andassuringthatthePIortheirdesignatedIACUC-certifiedstaffwillcontinuallyescortthevisitingscientistduringtheconductofactivitiesinvolvinganimals,and(2)aletteronletterheadfromthevisitor'soriginatinginstitutionwhichdocumentsthatthevisitingscientistoriginatesfromaninstitutionwithanOLAWassuranceoranAAALACaccreditationifapplicable,andthatthevisitingscientistiscertifiedforanimalcareanduseactivitiesbytheoriginatinginstitution'sIACUC.
AdditionaldocumentationofcompletionofhealthcareservicesbythevisitingscientistmayberequestedbytheIACUCwhenconsideringsuchrequestsforaccesstoanimalsand/oranimalfacilities.
OncetherequireddocumentationisreviewedandapprovedbytheIACUCChairorhisdesigneethevisitcanproceed.
VIII.
19.
AllpermanentanimalcareprogramstaffarerequiredtobecertifiedbytheIACUC,toprepareforandreceivecertificationbytheAmericanAssociationforLaboratoryAnimalScience(AALAS),andmaymakedirecttechnicalcontributionstoapprovedprotocolsasstipulatedinIACUCPrincipleV.
5whenassignedbyComparativeMedicinemanagement.
Toensureappropriatelytrainedandexperiencedanimalcarestaffareassignedprotocol-specificduties,ComparativeMedicinemanagementmaintainsatableofdegreesandcertificationsearnedandalogofwet-labspecies-specifictrainingsanddocumentedproficienciesinmethodsofsurgical,anesthetic,andtechnicalprocedures(CMDC259)foreachofitsstaff.
IX.
ReportingDeficienciesinAnimalCareorTreatmentIX.
1.
Reportingconcerns,deficiencies,orobservationsmaderegardingtheadequacyorappropriatenessofthefacilities,program,principles,orprocedurescontributestotheoversight,development,andimprovementoftheprogramforanimalcareanduse,andcontributestotheresolutionoftheconcernordeficiency.
IX.
2.
Deficienciesinanimalcare,use,recordkeeping,ortreatment,andadverseeventsinanimalcareorusemustbereported,andcanbereportedtoComparativeMedicineveterinarians,oradministrativestaff,ortotheIACUCc/oResearchIntegrity&Compliance,ordirectlytotheIACUCChairperson,orIACUCViceChairperson,ortotheInstitutionalOfficialoftheAnimalCareandUseProgram.
IX.
3.
Thisreporting-feedbackmechanismofobservationsmaderegardingthepracticesofanimalcareandusewithintheselaboratories,contributesanimportantoversight,assistsinthecontinuousdevelopmentoftheanimalprogram,andincludesamechanismforanonymityviewableathttps://secure.
ethicspoint.
com/domain/en/report_custom.
aspclientid=14773.
IX.
4.
Suchreports,suggestions,complaints,orcomplimentsaremadewithprotectionofthereportingindividualfromanydiscriminationorreprisal.
IX.
5.
ReportsofconcernsregardinganimalwelfareareimmediatelyforwardedtoComparativeMedicineforassurancebytheveterinariansthataconcernforanimalwelfareisnotongoing.
Aveterinariancaninterruptanyactivitythatjeopardizesthewelfareofananimal.
IX.
6.
Allreportsofallegedanimalwelfareconcern,deficiency,ornoncomplianceareforwardedtotheIACUCc/oResearchIntegrity&Compliance.
ThesubjectPrincipalInvestigatorisinformedoftheallegationinwritingbytheIACUCChairpersonandmaybeaskedtorespondinwritingand/orinvitedtomeetwiththeIACUCtorespondtoquestionsregardingtheallegeddeficiency.
IX.
7.
TheIACUCdeliberatesregardingthereportedallegeddeficiencyatitsnextregularlyscheduledmonthlymeeting,ortheIACUCChairpersoncancallanemergencyquorumtodiscusstheissueinadvanceofaregularmeetingifdeemedRICIACUCDC#002.
36Effective3/21Page15of31necessary.
TheIACUCChairpersoncanchoosetoinviteinvolvedpersonneltothemeetingtowhomquestionscanbedirected.
TheIACUCreportsthefindingsofitsdeliberationstothePIandtheInstitutionalOfficial.
IX.
8.
Anyseriousorcontinuingnon-compliancewithPHSPolicy,anyseriousdeviationfromtheprovisionsoftheGuide,andanysuspensionofanyactivitybytheIACUCiscommunicatedbyComparativeMedicineviatelephonetotheOfficeofLaboratoryAnimalWelfare(OLAW)inatimelymanner.
AfterIACUCreview,institutionalresolution,andreportingtotheInstitutionalOfficial,theInstitutionalOfficialsubmitsaformalreportdescribingthecircumstancesandactionstakentoOLAWandotherrelevantagencies.
X.
SuspensionandAppealProcessofAnimalUsePrivilegesX.
1.
TheIACUCmaysuspendanactivitythatitpreviouslyapprovedifitdeterminesthattheactivityisnotbeingconductedinaccordancewiththeAWA,theGuide,ortheseIACUCPrinciplesandProceduresorwhentheactivitydoesnotmatchthedescriptionoftheactivityoriginallyapprovedbytheIACUC.
X.
2.
TheIACUCmaysuspendanactivityonlyafterreviewofthematterataconvenedmeetingofaquorumoftheIACUCandwithasuspensionvoteofamajorityofthequorumpresent.
X.
3.
IftheIACUCsuspendsanactivityinvolvinganimals,thePIwillbeinformedinwritingofthesuspension,itsconditions,andtheexpectationsoftheIACUCwhichneedtobemetbeforeadditionalactivitiesinvolvinganimalsresume.
X.
4.
IftheIACUCsuspendsanactivityinvolvinganimals,theInstitutionalOfficial,inconsultationwiththeIACUC,shallreviewthereasonsforthesuspension,takeappropriatecorrectiveaction,andreportthatactionwithafullexplanationtoUSDA/APHISandPHS/OLAW,AAALAC,andthefederaland/ormajoragencyfundingthatactivity.
X.
5.
IntheeventthatanIACUC-approvedprotocolexpires,orisclosedbythePI,orforanyreasonanimalswhichhadbeenmaintainedunderaformerlyapprovedprotocolremainwithinthefacilities,butarenotdescribedinanIACUC-approvedprotocol,theIACUCwillservewrittennotificationofnon-compliancetothePI,thatthesubjectanimalsareconsideredinComparativeMedicine"caretakerstatus"notavailableforresearchuseuntilresolutionofnon-compliance,andrequestthatthePIeithersubmitanewapplicationforanimaluse,identifytheIACUC-approvedprotocolwhichnowdescribestheuseoftheseanimals,orformallyrequestinwritingthattheclosedprotocolbereopenedandreviewed.
Absenceofawrittenresponsetothiswrittennotificationofnoncomplianceinexcessofthirtydayscanresultintheremoval,reassignment,oreuthanasiaofthesubjectanimals.
RequestsbythePIforadditionalanimalsand/orserviceswillnotbefilledbyComparativeMedicineuntilallanimalsaredescribedbyanIACUC-approvedprotocol.
ThePIofafederalgrant(e.
g.
,NIH,NSF,VA)supportedprotocolwithanimalsplacedin"caretakerstatus"mustprovideComparativeMedicinewithasourceoffundingotherthanthefederalgrantthatwillsupporttheanimalswhilein"caretakerstatus"untilresolutionofthenoncompliance.
X.
6.
ThePIisresponsibleforensuringthatadequatefiscalsupporthasbeenretained,andisavailablefortheprocurement,care,anduseofallanimalsregisteredundertheirIACUC-approvedprotocol(s)intheirname.
ThePImustensurethatallcostsinvoicedtoagrantaccountareallocabletothepurposeofthegrant.
Costallocabletooneprotocolmaynotbeshiftedtoanotherinordertomeetdeficienciescausedbyoverruns,orforotherreasonsofconvenience.
Rotationofchargesamongprotocolsbymonthwithoutestablishingthattherotationschedulecrediblyreflectstherelativebenefittoeachprotocolisunacceptable.
IntheeventthatinvoicesservedbyComparativeMedicinetothePIremainunpaidforlongerthan30daysafterthedateoftheinvoice,accountinginComparativeMedicinewillconsidersaidinvoicesaspastdue.
Intheabsenceofpayment,allprotocolsoftheinvolvedPIcanbeinterruptedbytheIACUC,andanimalscanbereassigned,removed,oreuthanatized.
Requestsforadditionalanimalsand/orserviceswillnotbefilledbyComparativeMedicineuntilfullpaymenthasbeenreceived.
X.
7.
SincethePIhasassuredtheIACUContheirRequestfortheFacilityOrientationandCertificationofNewResearchPersonnelUsingAnimalsthatthecertifiedpersonnelcontributingtotheirIACUC-approvedprotocolshasbeenprovidedadequatetraining,andhasadequateknowledgeandexperiencetoperformtheirduties,thePIisnotifiedwhenevertheperformanceoftheirstaffisnotinaccordancewiththeseIACUCPrinciplesandProcedures.
ThePImustensurethatanycorrectiveretrainingoractions,requiredofthemortheirstaffbytheIACUC,inresponsetodeficienciesinanimalcareoruse,areaccomplished.
X.
8.
Inadequateanimalcareoruse,inadequateclinicalanimaloversightortreatment,inadequateanticipationoralleviationofanimaldiscomfort,distress,orpain,inadequateanimalmedicalrecordkeeping,orconductingproceduresinvolvinganimalspriortotheirapprovalbytheIACUCcanresultinthesuspensionofanimaluseprivilegesofthesupervisingPIandinvolvedresearchoranimalcarestaff.
RICIACUCDC#002.
36Effective3/21Page16of31X.
9.
TheIACUCdeliberatesregardingreportsofallegeddeficienciesatitsnextregularlyscheduledmonthlymeeting,ortheIACUCChairpersoncancallanemergencyquorumtodiscusstheissueinadvanceofaregularmeetingifdeemednecessary.
TheIACUCChairpersoncanchoosetoinviteinvolvedpersonneltothemeetingtowhomquestionscanbedirected.
TheIACUCreportsthefindingsofitsdeliberationstothePIandtheInstitutionalOfficialX.
10.
Afteritsreviewofthereportedallegeddeficienciesinanimalcareoruse,theIACUCmayelecttorequireadditionaltrainingoftheinvolvedpersonnel,and/ormayelecttodemotethecertificationstatusoftheinvolvedpersonneland/ortheirPItoprobationarystatus,and/ormayelecttosuspendorrevoketheanimaluseprivilegesofthatindividualand/orPI.
Personnelwhosecertificationisplacedonprobationarystatusmayberequiredtoworkonlyinthepresenceofanothercertifiedstaffmember,mayneedtocompleteadditionaltraining,mayneedtoassistwithanauditofresearchandanimalmedicalrecords,and/ormayneedtoundergoanevaluationofresearchtechnique.
Allsuchconditionsofaprobationarycertificationwillbespecificastotheconsequencesoffurthernoncompliance,thelengthofprobationaryperiod,andtheconditionsthatmustbemetinordertoreturntofullcertificationstatus.
AllactionsmadebytheIACUCregardingthecertificationstatusofanindividualwillbereportedtotheminwriting,withacopytotheirsupervisingPI,andtheInstitutionalOfficial.
X.
11.
SubsequenttothedecisionbeingmadebytheIACUC,iftheinvestigatorhasnewinformationwhichwasnotpartoftheoriginalinvestigationorthereisanissueregardingdueprocess,theinvestigatormayappealthedecisionoftheIACUCasfollows:SubmitinwritingtotheIACUCofficetheissueofconcernandpositionwithsupportingdocumentswithinthirtydaysofreceiptofthesuspensionletterfromtheIACUC.
TheIACUCofficewillacknowledgereceiptoftheletterinwritingandforwardtheletterandsupportingdocumentstothefullIACUCcommittee.
TheIACUCwilldiscusstheinvestigator'sappealataconvenedmeetingwithaquorumpresent.
TheinvestigatormayrequestanappearancebeforetheIACUCtopresentargumentsforthereversalofadecision.
Awrittenrecordofthediscussionandthemeetingwillbemade.
FollowingthediscussionattheIACUCmeeting,theinvestigatorwillbeinformedoftheoutcome.
AsummaryoftheIACUC'sre-evaluation/appealdecisionwillbesenttotheinvestigatorandtotheInstitutionalOfficial.
TheIACUCofficewillinformanyotherinstitutionalorregulatoryofficesorofficials,asappropriate.
AdecisionbytheIACUCmayonlybeoverturnedbytheIACUC;thereisnofurtherappealprocessXI.
Transportation,Relocation,orReassignmentofAnimalsXI.
1.
Alltransportationofanimals,includingintra-institutionaltransportation,shouldoccuronlywhenessentialsinceanytransittimeintroducesrisksofexposuretoenvironmentalextremes,crowding,infectiousagents,andpossiblezoonosis,whichcanaffectanimalandpublicwelfare,andtheconsistencyofresults.
(RefertoSOP#007Transportation,Relocation,orReassignmentofAnimals).
Transportationofrodentsinprivatevehiclesisdiscouragedbecauseofpotentialbiosecurity,zoonotic,allergenic,safety,health,andliabilityrisks.
IACUCapprovedprotocolsthatdescribeinitem6.
1.
2and6.
3.
1thatrodentswillbetransportedinaprivatevehiclefromavivariumtoabasiclaboratory,mustalsostatethat(1)deliverywillbedirectsoastominimizetransittime,(2)rodentswillbecontainedineitheradisposablerodentshippingcontainer,arodentmicroisolator,oranindividually-ventilatedrodentcage,(3)containersorcageswithbecoveredwithadisposabledrapeorgownandsecuredduringtransit(e.
g.
,bungeecord),(4)rodentswillbeprotectedagainstenvironmentalextremes(e.
g.
,directsunlight),(5)onlypersonnelIACUCapprovedontheprotocolwillbeintheprivatevehicleduringrodenttransport,(6)personnelsmoking,eating,ordrinkingwillnotoccurwhenanimalsareintheprivatevehicle,(7)theprivatevehiclewillbesanitizedusingadisinfectantaftereveryrodenttransport,andthat(8)theprivatevehicleowneracknowledgesandacceptsresponsibilityforanydamagetotheirvehicleduringrodenttransport.
XI.
2.
Transportingofanimalstoresearchlaboratories,procedural,ortestingareasoutsideofananimalfacilitymayjeopardizetheintegrityofresearchdata,impairsregulatoryoversight,andabrogatestheimplementationofuniformstandardsofanimalcareandusewithinthoseareas,andrequiresstrongwrittenscientificorlogisticaljustificationtheIACUCapplication.
RICIACUCDC#002.
36Effective3/21Page17of31XI.
3.
Movementofanimalswithinanimalhousingroomsisdiscouraged.
Movementofanimalsbetweenanimalhousingroomsofasinglefacility,orbetweenseparatefacilitiesisdiscouraged,andpermittedonlywhenrequestedinwritingusingaRequesttoRelocateResearchAnimalsand/orRequesttoReassignResearchAnimalsform,andapprovedbytheAssistantDirectorofComparativeMedicine.
XI.
4.
TransferofanimalsfromoneIACUC-approvedresearchuse(excludingmurineproductionasdescribedinanIACUC-approvedmurinecolonyonlyapplication,andexcludingmurineimagingreferencedintheoriginatingprotocolanddescribedintheSmallAnimalModelandImagingCoreprotocol)toanotherispermittedonlywhenrequestedinwritingusingaRequesttoReassignResearchAnimalsform,thereassignmentisjustifiedinwriting,andapprovedbyboththeoriginatingandreassignedPIs,andtheProgramCoordinator.
AnapprovedreassignmentofanimalsfromoneIACUC-approvedresearchprotocoltoanewIACUCprotocolbecomeseffectiveonthedateofthetransfer,andallanimalperdiem,identifyingcards,andinventoriesarechangedtoreflectthisreassignment.
ReassignmentofnavemiceoriginatingfromanIACUC-approvedmurinecolonyonlyprotocoltoanIACUC-approvedresearchprotocolisaccomplishedbynotifyingthefacilitymanager,whocompletesaRequesttoReassignLocallyProducedMicetoaResearchProtocolform,whoadjustsallanimalperdiem,identifyingcards,andinventoriestoreflectthisreassignment,whichbecomeseffectiveonthedateofthetransfer,andwhosecurespriorapprovalfromtheAssistantDirectorofComparativeMedicineifthereassignmentnecessitatesaphysicalrelocationofmice.
Requestsforreassignmentofnon-naverodentswithrespecttomajormedical,surgical,researchorteachingproceduresfromanapprovedresearchprotocoltoamurinecolonyonlyprotocolrequiresIACUCreviewandapproval.
XI.
5.
ShipmentofanimalstoorfromotherinstitutionsmustberequestedinwritingusingaRequesttoShipAnimalsToAnotherInstitution,oraRequesttoReceiveAnimalsFromAnotherInstitutionform,approvedbytheDirectorofComparativeMedicineordesignee,andarrangedandaccomplishedbyComparativeMedicine,incompliancewithAWA,andthelatestInternationalAirTransportAssociationLiveAnimalRegulations.
XI.
6.
Rodentsfromunapprovedsourcesarequarantinedforfiveweeks,beforetheirhealthstatusandeligibilityforreleasefromquarantineisdetermined.
(RefertoSOP#411RodentQuarantine).
XII.
AvoidanceandAlleviationofResearchAnimalPainandDiscomfortXII.
1.
TheIACUCaffirmsthatthestudyanduseofanimalscontributestotheadvancementofknowledge,andthatanypotentialforresearchanimalpain,discomfort,ordistressmustbeminimized.
XII.
2.
Painisaperceptionofsufferingoragonythatresultsfrommechanical,thermal,orchemicalstimuliactingonnociceptors,whichinturngenerateimpulsesvianeuralpathways,mediatingspinalreflexesandcentralsensoryprocessingbythereticularformation,thalamus,andcerebralcortex.
Discomfortordistressisconsideredtorefertothoseconditionsthatarenotinthemselvespainful,butwhicharedisagreeable,andwhichtheanimalwouldnormallychoosetoavoid.
XII.
3.
Althoughanimalsthatareinpainmaynotbehavelikehumans,(e.
g.
,paininanimalsmaybeaccompaniedbyimmobilityandsilence,incontrasttothegroansandcriesofhumanpatients),itisassumedthatproceduresthatcausepaininhumanscausepaininanimals.
XII.
4.
Thepresenceofpaininanimalscanberecognizedbyalterationsinanimalbehavior(e.
g.
,reducedactivity,reducedgrooming,hunched-upposture,alteredgait,changesintemperament,vocalizations,reducedfoodandwaterintake,reducedurinaryandfecaloutput),andinphysiologicalvariables,(e.
g.
,reduceddepthofrespiration,increasedheartrate,andreducedhydrationstatus).
XII.
5.
Animalpainanddiscomfortcanproducearangeofundesirablephysiologicalchanges,whichmayradicallyaltermeasuredresponsestoexperimentalstimuli,aswellastherateofrecoveryfromsurgicalprocedures,hence,itsavoidanceandalleviationareinthebestinterestofboththeanimalandresearcher.
XII.
6.
Reducingpost-procedural/post-operativepainanddiscomfortisaccomplishedbygoodnursingcare,(e.
g.
,keepingtheanimalwarm,clean,dryandwellpadded),andbytheadministrationofanalgesicdrugs.
XII.
7.
Preemptiveand/orpost-operative/post-proceduralanalgesiamustbeadministeredforanappropriateintervalandrecordedonformsprovidedbyComparativeMedicinewheneverproceduresareidentifiedthatareassumedtoproducemorethanmomentaryorslightpainanddiscomfort,unlesstheprotocolprecludessuchpractice(ResearchPainCategoryC),theinvestigatorhasjustifiedsuchinwriting,andtheIACUChasapprovedsuchpractices.
RICIACUCDC#002.
36Effective3/21Page18of31XII.
8.
Inadditiontotheavoidanceandalleviationofpainanddiscomfort,adequatepost-procedural/post-operativeanimalcarealsoincludeseffortstopreventand/ortreatpost-anestheticcomplications,(e.
g.
,aspiration,hypostaticpneumonia,cardiovascularandrespiratorydepression,dehydration,andinfection).
XII.
9.
ComparativeMedicinemaintainsaninventoryofanimaluseregardingthepotentialforpainordiscomfort.
Vertebrateanimalsusedinresearch,teachingortestingmustbeassignedtooneofthreepaincategoriesofresearch.
ResearchPainCategoryA(USDAC)involvesprocedureswhichproducenopainordistress,ornomorethanmomentaryorslightpainordistress,andinvolvenouseofpain-relievingdrugs(e.
g.
,unrestrainedobservation,briefrestraintforphysicalexamination,phlebotomy,injectionofnon-noxiousmaterial,tagging/punchingoftheperipheralearpinnaofmice,andeuthanasiausingspecies-andage-appropriatemethodsdescribedinIACUCPrinciplesandProceduresXXfollowedbytissuederivation).
ResearchPainCategoryB(USDAD)involvesprocedures,whichproducemorethanmomentaryorslightpain,discomfortordistress,whichisalleviatedbytheuseofappropriateanesthetics/analgesicsand/ortranquilizerdrugs,orothermethodsforrelievingpainordistress(e.
g.
,surgicalorinvasiveproceduresconductedwhilethepatientanimalismaintainedatasurgicalplaneofgeneralanesthesia).
ResearchPainCategoryC(USDAE)involvesprocedures,whichproducepaindiscomfort,ordistress,whichcannotorisnotalleviatedbytheadministrationofappropriateanestheticsand/oranalgesicsorothermethodsofrelievingpainordistress.
(e.
g.
,tumorstudiesthatcanbelocallyinvasiveordistantlymetastatic,certainbehavioralstudies,injectionofimmunogenicemulsionscontainingcompleteFreund'sadjuvant,monoclonalantibodyascitesproduction,survivalanalysis).
XII.
10.
WhenproposingResearchPainCategoryCactivitiesinvolvinganimalswherepainfulorstressfuloutcomesareanticipatedorpossible,thePImustdefineinwritingtheclinicalcriteriawhichwillbeusedtoensuretimelyinterventionandtreatment,orremovaloftheanimalsfromthestudy,eitherinadvanceof,orimmediatelyafterrecognitionofthediscomfort,orthespecificclinicalendpointatwhicheuthanasiaoftheanimalswillbeaccomplished.
Theearliestpossibleclinicalendpointthatwillcontributetotheresolutionofthehypothesismustbeseparatelyidentifiedandutilizedforeachvertebratespeciesrequestedintheapplication.
Ifavoidanceoralleviationofanimalpainordiscomfortadverselyaffectstheprotocol,thePImustprovideadetailedjustificationofwhytreatmentscannotbeinitiated.
WhenidentifyingtheearliestclinicalendpointinapplicationstotheIACUC,thePIshouldconsiderproposingbothearlynotificationcriteria(e.
g.
,tumordiameter)whichwhenmetcausesstafftoalertthePItoconsiderwhetherstudyobjectiveshavebeenmet,andalsolaterexclusioncriteria(e.
g.
,largertumordiameter,and/orcomplicationsreferabletothetumor)whichwhenmetrequirestheeuthanasiaoftheanimal.
Whenidentifyingtheearliestclinicalendpoint,thePIshouldrefertosectionC.
2.
c.
oftheARENA/OLAWGuidebookentitled"HumaneEndpoints"viewableathttp://grants1.
nih.
gov/grants/olaw/GuideBook.
pdf.
XII.
11.
ThePIandassociatedresearchstaffmustmaintainwrittenrecordsofactivitieswheneverproceduresareassumedtoproducemorethanmomentaryorslightpainanddiscomfortrequiringtheadministrationofanalgesia.
RecordsmustbekeptwithintheanimalfacilityonformsprovidedbyComparativeMedicine(e.
g.
,ProgressNotesform,orSurgicalRecordform,orRecordofGeneralAnesthesiaform,orRodentSurgical/ProceduralRecordform),withentriesthatdescribewhenthepainfulorstressfuloutcomeisfirstrecognized,whattreatmentsareinstituted,andwhenthediscomfortisresolved,orwhentheanimaliseuthanatized.
XII.
12.
ThewrittenjustificationfortheuseofanimalsinvolvedinResearchPainCategoryCproceduresmustseparatelyidentifyandutilizeforeachvertebratespeciesrequestedintheapplicationtheearliestpossibleclinicalendpointthatwillcontributetotheresolutionofthehypothesis.
Ifdeathisdeterminedtobetheearliestpossibleendpointthatwillcontributetothespecificaimsoftheresearch,thenawrittenjustificationofwhyanearlierclinicalendpointisinadequateforresolvingtheproposedhypothesismustbeincludedintheIACUCapplication.
Whendeterminingtheearliestpossibleclinicalendpointforaproposedresearchactivity,theapplicantPIshouldrefertotheguidelinesreviewedin"HumaneEndpointsforAnimalsUsedinBiomedicalResearchandTesting",vol.
41(2),2000,publishedbytheInstituteforLaboratoryAnimalResearch,NationalResearchCouncilandviewableathttp://grants.
nih.
gov/grants/olaw/GuideBook.
pdf.
XII.
13.
Investigatorsmustconsidertheneedsandwell-beingofanimalsinvolvedinprotocolsthathaveapotentialtocauseanimaldiscomfort,pain,ordistresswhichmaynotbereliablyanticipatedorcontrolled.
Suchprotocolsincludethoseofnewand/oruniquephenotypesoftransgenic,knock-out,knock-in,orgenetically-engineeredrodents.
Investigatorsmustprovidewrittenassuranceofadequateclinicaloversight,alongwithadescriptionofinterventioncriteriatopreventanimaldiscomfort,orajustificationofwhyinterventionconflictswiththeproposedinvestigation.
Whenproposingresearchinvolvinggeneticallyengineeredmice,theapplicantPImayfindhelpfulthearticles"WelfareIssuesofGeneticallyModifiedAnimals"publishedbytheInstituteforLaboratoryAnimalResearch,NationalResearchCouncilinVol.
43(2),2002,and"HumaneEndpointsforGeneticallyEngineeredAnimalModels"ILARVol.
41(2),2000,eachviewableathttp://ilarjournal.
oxfordjournals.
org/content/41/2/94.
full.
XII.
14ApplicantPIsassuretheIACUCintheirmurinecolonyonlyprotocolthatprogenymicewillberegularlymonitored,thatmorbidityandmortalityrecordswillbereviewedtoidentifyunanticipatedhealthproblems,andthattheIACUCwillbeinformedimmediatelywheneverrecurringhealthproblemsdevelopincolonymice.
RICIACUCDC#002.
36Effective3/21Page19of31XII.
15.
If,inthecourseofgeneratingandcharacterizinggeneticallyengineeredmice,theemergentphenotypeincludesunanticipated,butrecurringhealthproblems,thentheoriginalIACUC-approvedprotocolmustbeamendedbydirectmodificationoftheapprovedIACUCprotocol.
Therequesttoamendtheexistingprotocolmustdescribethenewhealthcondition(s)thathaveemerged,mustdescribethetreatmentsthatwillbeusedtoalleviateanypotentialdiscomfortorjustifywhytreatmentsinterferewiththeproductionandcharacterizationofthecolony,andmustdeterminetheearliestpossibleclinicalendpointthatwillresultintheexclusionoftheaffectedanimalanditseuthanasia.
XII.
16.
Whendevelopingamurinecolonyonlyapplicationoramendingit,thePImustutilizetheearliestpossibleclinicalendpoint(s)thatwillcontributetothephenotypiccharacterizationofthemurinelineorgenotype(e.
g.
,theonsetofdisease,orthepresenceofapalpabletumormustbeusedastheendpoint,notadvanceddiseaseprogression,orthedevelopmentofaparticulartumorsizeorvolume).
ExperimentaluseofanimalsproducedunderanIACUC-approvedmurinecolonyprotocolmustfirstbeproposedto,andapprovedbytheIACUCinaresearchapplication.
Forexample,characterizingtheprogressionofastrain/line/genotype-specificpathologyorcondition,orevaluatingwhetheritisamendabletoexperimentaltherapeuticregimes,orevaluatingitsinfluenceontheincidenceofmortalitymustfirstbeproposedto,andapprovedbytheIACUCinaseparateresearchapplication,distinctfromthemurinecolonyonlyprotocol.
XII.
17.
Investigatorsmustcontinuouslyrefinemethodssoastoavoid,alleviateand/orminimizeanyanimalpainordiscomfortassociatedwithexperimentalprotocols,andsearchforalternatives,whichreduceanimalpain,discomfortanduse.
XII.
18.
Investigatorsandtheirstaffmustconductclinicalandpostmorteminvestigationswheneveranimalsexperiencemorbidityormortalitynotanticipatedintheprotocol.
Investigatorsandtheirstaffmustmakeentriestononrodentmammalianmedicalrecords,whichsummarizetheclinicaldiagnosticandnecropsyfindingsofanunanticipatedanimalmorbidityormortality,whichoccursunrelatedtotheprotocol,sothatresearchmethodscanberefined.
XII.
19Physicalrestraintisdefinedastheuseofmanualormechanicalmeanstolimitsomeorallofananimal'smovementforthepurposeofexamination,samplecollection,drugadministration,therapy,orexperimentalmanipulation.
Insomecases,personnelsafetymayalsonecessitatethephysicalrestraintofananimal.
Prolongedrestraintisdefinedasphysicalrestraintofaconsciousanimallasting>30minutes.
Prolongedrestraint,includingchairingofnon‐humanprimates,shouldbeavoidedunlessitisjustifiedinwriting,essentialforachievingresearchobjectives,andapprovedbytheIACUC.
Chairingofnon‐humanprimatesisconsideredprolongedrestraintregardlessofduration.
Whenproposingprolongedrestraint,theIACUCapplicationmustinclude(1)ascientificjustificationfortheuseofprolongedrestraint,(2)adescriptionoftherestraintdevice,(3)adescriptionofacclimationprocedurestoconditiontheanimaltoprolongedrestraint,(4)themaximumamountoftimetheanimalmayberestrained,(5)adescriptionofhowtheanimalwillbeobservedandmonitoredduringrestraint,(6)whenthedurationofprolongedrestraintis≥6hours,adescriptionofwhenfoodandwaterwillbegiven,howbodyweightwillbemonitored,andhowhydrationstatuswillbemonitored.
Physicalrestraintthatis4daysofage,orduringmajorsurgicalprocedures.
XIII.
5.
Coolingectothermicspecies(e.
g.
,frogs)to4°Cwilldecreasetheirmetabolismandfacilitatetheirhandling,butthereisnoevidencethatwholebodycoolingreducespainorisclinicallyefficaciousasananesthetic.
XIV.
ControlledSubstancesXIV.
1.
UniversityPrinciplesandProceduresregardingprocurement,distribution,use,security,andrecordkeepingofcontrolledsubstancesregulatedbytheDrugEnforcementAdministration(DEA)areguidedbytheregulationsdetailedin21CFR1300-1308viewableathttp://www.
ecfr.
gov/cgi-bin/text-idxgp=&SID=8d2adf78008465d28a17634af7abdce9&mc=true&tpl=/ecfrbrowse/Title21/21chapterII.
tpl.