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IACUC/CTRB Guidelines of 14 Last Modified: 8/7/17

GuidelinetoAssistinCompletingtheInstitutionalAnimalCareandUse

Committee(IACUC)ProtocolforaUCDavisVMTHClinicalTrial

Purpose:ThepurposeofthisdocumentistohelpyoucompletetheIACUCprotocolforaUCDavisVeterinaryMedicalTeachingHospital(VMTH)clinicaltrial.PleasenotethatthespecificdetailsthatyouneedtoincludeinyourIACUCprotocolforeachclinicaltrialisvariable,sonotallpointsmadeinthisdocumentmaybeapplicabletoyourprotocol.IfyouhaveanyquestionswhilecompletingyourownIACUCprotocol,pleasecontacttheIACUC(530)[email protected])ortheVeterinaryCenterforClinicalTrials([email protected]).Contents:

• GeneralInformationabouttheIACUCProtocol• GettingStarted• RequiredTrainingforApprovalonaProtocol• NavigatingtheIACUCHomepage• NavigatingtheIACUC/InvestigatorMenu• InitiatingaNewIACUCProtocolfromanAlreadyActiveProtocol• InitiatingtheIACUCProtocol(fromscratch)• CompletingtheIACUCProtocol• OwnerInformedConsentDocumentAssistance

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GeneralInformationabouttheIACUCProtocolTheInstitutionalAnimalCareandUseCommittee(IACUC)isaninstitution’sregulatoryofficeforanimalresearch.Thisgroupensuresthatallresearchdoneusinganimals(eitheruniversity-orclient-ownedanimals)isdoneasmandatedbytheHealthResearchExtensionAct(HREA)andtheAnimalWelfareAct.AnIACUCprotocolmustbesubmittedtodescribetheprocedurestobedonetoanimalsinaresearchstudyhereatUCDavis.Althoughotherindividualscanhelpwriteoreditaprotocol,thePrincipalInvestigator(PI)musthaveacareerstaffposition.).IACUCprotocolsmustberenewedannuallywithadenovoreviewevery3years.AnIACUCprotocolmustbeapprovedBEFOREstartingthestudy.Itcantakeseveralweeks(generally6-8weeks)togetaprotocolapproved,soplanahead!

GettingStartedThefirststepistogototheUCDavisIACUC’shomepage.There,youwillfindthelinktotheonlineprotocolsystemaswellastomanyotherimportantand/orhelpfulresources.

VETERINARY MEDICINEVeterinary Center for Clinical Trials


RequiredTrainingforApprovalonaProtocolACU101,anonlinetrainingcourse,isrequiredforanyonethatisgoingtoworkwithvertebrateanimalsonaprotocol.Ittakesapproximatelyanhourtocomplete.ParticipationintheOccupationalHealthSurveillanceprogramisrequiredsothattheuniversitycanmonitoryourhealthwhileyouareworkingwithanimalsand/orhazardousagents.YoumusthavesignedupandcompletedtheprogrambeforebeingaddedtoanIACUCprotocol.Renewalcanvaryfrom1-5yearsdependingonindividualrisks.Togettotheapplication,clickon“Application–OccupationalHealthandAnimals(OHSS)”.Additionalinformationabouttheprogramcanbefoundifyouclickonthe“HelpwiththeOccupationalHealthProgram”link.PleasenotethatyoursupervisororPIistheonetocreatetheRiskAssessment(RA)foryou(theparticipant).You(theparticipant)willthencompletetheHealthQuestionnaire.

NavigatingtheIACUChomepageByclickingonthe“AccesstotheAmendments&ProtocolOnlineSystem”link,youwillbeabletoaccesstheIACUConlinesystemandgetstartedonanIACUCprotocol(youwillneedaUCDavisKerberosloginandpasswordtoenterthissystem).Althoughyoumustsubmittheprotocolonlineforittobereviewed,ablankWorddocumentformoftheprotocolcanbefoundasareferenceifyouclickon“ProtocolTemplateForm(doc,docx)”.Ifyouaresubmittingaclinicaltrial,youarerequiredtosubmitanOwnerInformedConsentdocument.Thisdocumentcanbefoundifyouclickon“VMTHClinicalTrials”andthen“OwnerInformedConsentform”.CommitteePolicies&Guidelines–Althoughclinicaltrialsdonotuseresearchanimals,yourprotocolandresearchmuststillfollowmanyoftheIACUCpoliciesandguidelines.Forexample,youmayneedguidelines/policieson(notanall-inclusivelist):

• BloodVolumes,MaximumBloodDraws,andBloodCollectionSitesinSmallMammals,BirdsandFish

• ExpiredDrugsandMedicalMaterials• GuidelinesforChangesintheUseofTherapeuticDrugsonProtocols• Non-PharmaceuticalGradeSodiumPentobarbital• NumbersRationaleforAnimalsinProtocols• TrainingRequirementsforPersonnelExposedtoLive,VertebrateAnimals• TrainingResponsibilitiesbyPrincipalInvestigators• TrialsinNon-UniversityOwnedAnimals• UseofNon-Pharmaceutical-GradeCompoundsinAnimals


NavigatingtheIACUC/InvestigatorMenuOnthispage,youwillfindlinksto:Viewamendmentsandprotocolsthatarependingsubmissionoraresubmitted,Initiateandsubmitnewprotocols,Amendactiveprotocolsorrosters,and;Viewtherosterofallactiveprotocols.

InitiatingaNewIACUCProtocolfromanAlreadyActiveProtocolIfyouarethePIonanactiveprotocol,youcanstartanIACUCprotocolfromanalreadyactiveone.IntheIACUC/InvestigatorMenu,selectwhichactiveprotocolyouwouldliketouseasatemplatefromthedropdownmenuprovided.

OntheIACUCProtocolFormscreen,clickonthe“StartaNewProtocolUsingThisActiveProtocolasaTemplate”linkinthetopleft-handcorner.

Thiswillbringyoutoaneditedversionofthealreadyactiveprotocol.Pleasenotethatattachments(e.g.,informedconsentdocument)donottransferover,sodonotforgettoaddthosebackinbeforesubmitting.


InitiatingaNewIACUCProtocol(fromscratch)OnceyouareontheIACUC/InvestigatorMenu,clickon“SubmitNewProtocol”inthefirstcolumnofthetableunder“Protocols”.Section1–PrimaryContacts

1. YouareautomaticallyenteredasthePrincipalInvestigator(PI),sothefirstrealstepistonominateanAlternateContact.ThisindividualcanhelpwithdecisionsregardingtheprotocolandwillbetheindividualtostepinifthePrincipalInvestigator(PI)isunabletodoso(e.g.,intheeventofanemergency,deathofthePI).IncludinganAlternateContactisrequiredtogoontofillingouttherestoftheprotocol.

a. ToaddanAlternateContact,enterthelastnameoftheindividualyouarelookingforintothetextboxprovidedatthebottomofthescreen.

b. Thesystemwillprovideyouwithalistofindividualswiththatlastname.Selecttheradiobuttonoftheindividualyouarelookingforandthenclickon“Select”.

c. Informationforthatindividualwillpopup.Addtheafter-hoursphonenumberandedittheremaininginformationifneeded.Whenfinished,click“AddAlternateContact”.

2. ToedittheinformationforthePIorthatoftheAlternateContactatanytimeduringthecompletionofyourprotocol,click“edit”(locatednextto“PrincipalInvestigator”or“AlternateContact”).Don’tforgettoaddtheafter-hoursphonenumberforthePI.

3. YoucanswitchthePIandAlternateContactorevenmakethemthesameindividual.ItishighlyrecommendedtohaveanAlternateContactincaseofananimalwelfareconcernandthePIcannotbecontacted.So,ifyouchoosetomakethemthesameindividual,youwillneedtodesignatesomeonetolookaftertheanimalsintheeventthatthePIisunabletodoso.

o NOTE:Ifyouarearesidentorstudentfillingoutaprotocolforsubmission,pleasenotethatthePIshouldbeswitchedtoafacultymemberpriortosubmission.Ifyouarewritingtheprotocolonbehalfofsomeoneelse(likethefacultymember)orarecompletingtheprotocolforyourownproject,pleasemakesuretotalkwiththefacultymemberthatyouareputtingasPIfirst.Rememberthatyouarefillingouttheprotocolintheirname,sotheyshouldbeawareofwhatiswrittenandsubmitted,asthereisnowaytoedittheprotocolonceithasbeensubmitted.Theonlytimethisinformationcanbeeditedisafterithasgonethroughthepre-reviewprocess.

4. Selecttheradiobuttonassociatedwiththeroleforwhowillbetheprimarycontactforsickanimals.

Section2–ProjectTitle

1. Whenyouaresearchingforaprotocoltoamend(ifneeded)ortoduplicate,youwillonlybegiventhetitleoftheprojecttochoosefrom,somakesureyouwillknowwhichprojectiswhichbycreatingadetailedtitle.Thetitleshouldbeconsistentbetweentheprotocolandinformedconsentdocument.

2. Includeacleartitleforyourproject.Thetitleshouldincludethe“Phase”ofthetrial(definitionsmodifiedfromtheNationalCancerInstitute[NCI]):


o Phase0=Exploratorytrialswithnotherapeuticordiagnosticintent(e.g.,screeningstudies,microdosestudies)

o Phase1=Includesinitialstudiestodeterminethemetabolismandpharmacologicactionsofdrugsinhumansandthesideeffectsassociatedwithincreasingdose,mayincludehealthyparticipantsand/orpatients

o Phase1/2=CombinationofPhase1and2trialso Phase2=Includescontrolledclinicalstudiesconductedtoevaluatethe

effectivenessofthedrugforaparticularindicationorindicationsinpatientswiththediseaseorconditionunderstudyandtodeterminethecommonshort-termsideeffectsandrisks

o Phase2/3=CombinationofPhase2and3trialso Phase3=Includesexpandedcontrolledanduncontrolledtrialsafterpreliminary

evidencesuggestingeffectivenessofthedrughasbeenobtained.Thesetrialsareintendedtogatheradditionalinformationtoevaluatetheoverallbenefit-riskrelationshipofthedrugandprovideadequatebasisforlabeling

o Phase4=StudiesofFDA-approveddrugstodelineateadditionalinformationincludingthedrug’srisks,benefits,andoptimaluse

3. Example:PhaseIItrialtoexaminetheeffectivenessofDrugAindogswithXXdisease.Section3–ProtocolType

1. Forveterinaryclinicaltrials,select“VMTHClinicalTrial”2. Click“SubmitandInitializeIACUCProtocol”

Atthispoint,ascreenwithverybasicinstructionswillappear.Click“ContinuetoProtocolForm”tocompletetherestoftheprotocol.

CompletingtheIACUCProtocolGeneralInformationWheneveryouwanttoaddsomethingtoasection,clickonthe“Add/Save”buttonineachsection.Otherwise,youworkwillnotbesaved!


Section3–ProtocolTypeAttachtheOwnerInformedConsentdocument.Instructionshavebeenincluded(inred)ontheactualWorddocument.Additionalinstructionsareincludedattheendofthisdocument.Section4–Species

1. ToaddoreditSpeciesInformation,clickonthe“addoreditSpeciesInformation”link.2. Enter/Select:

a. Thecommonname(e.g.,dog)b. Speciesdetails(ifneeded)c. Maximumnumberrequiredforthetriald. The“source”oftheanimals(forveterinaryclinicaltrials,enter“client-owned

animals”)3. Click“AddSpeciestoList”

Section5–BriefSummaryofProcedures

1. Includeoneortwosentencesabouttheproject,includingabriefsummaryoftheproceduresdonetotheanimals.

2. Whenfinished,click“Add/SaveProcedurestoProtocol”.Section6–AnimalLocation(s)

1. StudyArea/Laboratory–a. Ifanimalswillbegoingtoyourlaboratoryorstudyareaoutsidethehospital,

includetheroomnumberandbuilding.b. Iftheanimalswillalwaysbeinsidethehospital,thenselect“None/AnimalsWill

NotLeaveAnimalFacility”.2. OvernightHousing(vivaria)–

a. NOTE:ThissectionislinkedtotheIACUC’sinspectionsystem,soeveniftheanimalsarenotstayingovernight,theIACUCmusthaveawaytodeterminewhereanimalsarebeingkeptand/orusedsothattheycaninspectthoseareas.Regardlessofwhetheryouranimalsarestayingovernight,pleasecompletethissubsection.

i. Clickon“addVivaria”ii. Selecttheappropriateoptionfromthedrop-downmenu.iii. Click“AddVivariumtoList”

3. Animalswillbemaintainedby–Thisquestionisdependentonthespecificexperimentalproceduresinvolvedwiththeproject.Mostofthetimeforclinicaltrials,youjustneedtoselecttheradiobuttonfor“Vivarium”ifhospitalstaffwilltakecareoftheanimalsastheynormallywouldiftheywerehospitalpatientsnotenrolledinaclinicaltrial.However,ifyou(theInvestigator)aretheoneresponsibleforgivingyourpatientaspecificdiet(forexample)thatnooneelsecangivethem,youwillneedtoselect“Vivarium&Investigator”.

4. Click“Add/Save‘MaintainedBy’InformationtoProtocolSection7–SpecialHusbandryRequirements

1. Forthemajorityofclinicaltrials,typein“NotApplicable”astheanimalwilllikelybehousedasisstandardforthatspeciesintheVMTH.


2. PerSection6:IfanimalswillNOTstayovernight(despitewhatwasselectedinSection6),pleaseindicatethatanimalsparticipatinginthisstudywillnotstayovernightandthattheywillgohomewiththeirowneraftereachvisit.

3. Ifthereissomethingnotstandardaboutthehusbandry,includetheinformationinthissection.

4. Click“Add/SaveSpecialHusbandryRequirementstoProtocol”.Section8–HazardousMaterials

1. SelectYesorNoasapplicable.2. Click“Add/SaveHazardousMaterialsInformationtoProtocol”.

a. Ifyouclicked“Yes”,atablewillappearforyoutofillout.b. Click“addHazardousMaterialsInformation”c. Enterthematerialtype,whatthematerialisandthelocationwhereyouwillbe

usingthematerialin.d. Click“AddMaterialtoList”

3. Additionally,youwillneedtoprovideadditionalinformation(additionofAppendixA–RoomLabSafetySheet)inSection19.

4. Dependingontheactualmaterial,youmayalsoneedapprovalfromothercommitteesandofficestousethesematerials,includingtheBiosafetySafetyOffice,RadiationSafetyProgram,orStemCellResearchOffice(SCRO).ApplicationsyoumayneedtofillouttogainapprovalcouldincludeaBiohazardousUseApplication(BUA),RadiationUseAuthorization(RUA),StemCellResearchOffice(SCRO)application(humanstemcelluse)and/orlaseruseapplication.Informationregardinghowtohandlethesematerials(eitherbyownersorstaff)shouldbeclarifiedinSection14.Ifyouhavequestionsaboutcertaindrugs(e.g.,thoseusedforchemo),pleasecontacttheEnvironmentalHealth&Safety(EH&S)’[email protected].

Section9–SpecialProceduresand/orActivities

1. Thissection’sselectionsdependontheproject.2. Iftheinvestigationalaspectofyourprotocolrevolvesaroundusingmaterials(e.g.,

anesthesia)ordoingproceduresnormallydoneinthehospital(e.g.,surgery),youstillhavetochecktheboxforthoseproceduresinthissection.

a. Forexample,ifyouaredoinganyproceduresusinganesthesia,select“Anesthetics/Tranquilizers/Sedatives”.Youwillneedtoprovidedetailsregardingthedrugs,dosages,routes,etc.usedinSection14b.

3. Click“SaveChanges”.4. AdditionalboxesinSection14willappearifyouselect

“Anesthetics/Tranquilizers/Sedatives”,“SurvivalSurgicalProcedures”,and/or“TerminalSurgicalProcedures”.

5. Atextboxtoprovidejustificationwillappearifyouselectanyproceduresunderneathoftheheading“Ifanyofthefollowingproceduresoractivitiesarechecked…”.

Section10–FundingSource(s)

1. Click“addoreditFundingInformation”2. Selectthemostappropriateoptions.3. Ifyouselect“Other/NoneListed”,provideadditionaldetailsinthetextboxthatappears.4. Click“AddSourcetoList”.


Section11–VeterinaryCare1. Selectthemostappropriateoptionforwhichservicewillbeoverseeingtheanimals.2. Click“Add/SaveVeterinaryServicesInformationtoProtocol”.

Section12–ObjectivesandSignificance

1. Thissectionshouldbewritteninlayman’sterms(8thgradelevel).a. Objectives–Outlinethegoalsofyourstudy

i. NOTE:Thissectionwillbeimportantifyoueverneedtodoanamendmentontheoriginalprotocol.Amendmentsmustfallwithintheoriginalprotocolobjectivesotherwiseanewprotocolwouldbeappropriate.

b. Significance–Summarizewhyyouaredoingthisproject.Whowillitbenefit?Whyisitnecessary?

2. Click“Add/SaveStudyObjectives&SignificancetoProtocol”.Section13–The3R’s–Refinement,Replacement,andReduction

1. DatabaseSearchforAlternatives(Section13a)a. DoesthisprojectinvolveUSDAcoveredspecies?

i. Select“No”ifyouareinvolvingclient-ownedanimalsreceivingclinicalcareorparticipatinginclinicalstudies.

ii. Select“Yes”ifyouareinvolvingclient-ownedanimalsreceivingclinicalcareorparticipatinginclinicalstudieswithnopossiblebenefittotheanimal.Ifthisisselected,itisrecommendedthatyoucontacttheIACUCstaffortheCTRBChairpriortomovingforward.

b. Ifyouselect“Yes”totheUSDAquestion,thefollowingquestionwillappear:Doesthisprotocolinvolveproceduresthatmaycauseorhavethepotentialtocausemorethanmomentarypainordistress?

i. Select"No"ifyourprojectisnon-invasiveorislimitedtoeuthanasiaorprocedureslikelyonlytoresultinmomentarypain(injections,bloodcollections,imaging),etc.

ii. Select"Yes"forproceduresthatwouldincludesurgery,ocularordermaltoxicitytesting,inflammatorydiseasemodels,useofnoxiousstimuli,etc.

1. Ifyouselect“Yes”,youwillneedtodoandthendocumentyourliteraturesearch.

LiteraturesearchesforAlternativeProcedures:

a. Ifyouselected“Yes”tobothquestionsforSection13a,theIACUC/CTRBwantstoknowwhetherthereareanyalternativestoproceduresthatcouldcausetheanimalgreaterthanmomentary/slightpainordistress.

b. Youneedtodoaliteraturesearchusingproject-specifictermsthatarelikelytocausepainanddistressintheanimal.Examplesofpainfulproceduresinclude(butarenotlimitedto)surgeries,biopsies,andtumorgrowthstudies.So,ifyouarelookingtodoabiopsy,youwillneedtodoaliteraturesearchonwhetherthereareanylesspainfulordistressingproceduresthatcangetyouthesameorsimilarresults.

c. Donotdoaliteraturesearchthatshowsthatnooneelseisdoingthescienceportionorthatyouneedtouseanimalsbecauseinvitroworkisnotsufficient.Sections13canddcoverthosequestionsandanswers.


d. AdditionalassistancecanbefoundattheUCDavisCenterforAnimalAlternativesInformation

2. Refinement(Section13b)a. Inthissection,youwillneedtodescribewhatyoufoundduringyourliterature

search.b. Listanyproceduresthatmaycausepotentialpainanddistressandifthereareany

alternativestothoseprocedures.Ifnot,statethatnoalternativeswerefoundandthereasonwhyyoucan’tuseanyoftheonesyoudidfindduringthatliteraturesearch.

c. Iftherearenoalternativestoapainfulordistressingprocedure,describehowyouwillminimizethatpainanddistress.

i. Example:“Throughtheuseofappropriateanesthetics,analgesicsandproperhandling,wewillminimizeanypotentialpainanddistressintheanimals”

d. Click“Add/SaveResultsofLiteratureSearchtoProtocol”.3. Hasthisstudybeenpreviouslyconducted?(Section13c)

a. Formost,theansweris“No”.b. Indicate“Yes”ifyouarereplicatingastudyandprovideanexplanationastowhy

youneedtoredothestudy.c. Click“Add/SavePreviouslyConductedStudyInformationtoProtocol”

4. Replacement(SpeciesRationale)(Section13d)a. Describewhyyouneedtouseanimals(comparedtousinginvitromethodsor

computersimulations).b. Indicatewhythespecificspeciesisnecessarytouse(i.e.,whycan’tyoulookat

rabbitsinsteadofdogs?)c. Clarifywhyclientanimalsneedtobeusedandifthereisanybenefittothese

animals.d. Click“Add/SaveSpeciesRationaleInformationtoProtocol”.

5. Reduction(AnimalNumbersJustification)(Section13e)a. Ifyouclick“(more)”,additionalinformationforwhattheIACUCislookingforwill

appear.b. Animalnumbersshouldbeaminimumtoreachvalidresults.Justifyhowyoucame

upwiththenumberofgroupsandnumberofanimalspergroup.c. Justificationshouldbebasedonstatisticalreasoning(e.g.,poweranalysis)if

possible,clinicalpopulationnumbers,mortalitypercentages,etc.d. PilotstudynumbersshouldbeVERYsmall(e.g.,under10animals).Youwillstill

needtojustifywhyyouneedeventhatnumberofanimalsthough.e. Click“Add/SaveAnimalNumbersJustificationtoProtocol”.f. Additionalinformationcanbefoundinthe“RationaleforNumbersandSpeciesin

Protocols”guideline.6. StudyGroupsandNumbersTable(Section13f)

a. Click“addoreditStudyGroup(s)/Numbersb. GroupName/Identifier:Usuallyanumberor“Treatment”c. Species:AutomaticallyinsertedbasedonwhatyouincludedinSection4d. Maximumnumberofanimalsthatyouwanttoenrollpergroup.Youcansay“a

maximumofXX”or“uptoXX”,butdonotincludearange(NOTE:ThemaximumnumberofanimalsfortheprojectcomesfromwhatyouputinSection4).


e. FortheProcedures/treatmentssection,indicatetheprocedures/treatmentsthatthegroupwillundergo(alistofthemisfine).

f. Click“AddStudyGrouptoList”Section14–ProcedureDetails

1. Describetheuseofanimalsinyourproject(Section14a)a. Clearlydescribeallprocedurestobedonetotheanimals,includingscreening

processesandinclusion/exclusioncriteria.Ifyourprojectincludeshospitalproceduresthatwouldhappenregardlessofwhetherornottheanimalwasintheclinicaltrial,makesuretoindicatethatinformationVERYclearly.

i. Recommended:Makeeachprocedure(e.g.,howtobiopsy,contrastenhancedvidefluorscopy,cystocentesis,surgery)it’sownparagraph.Doingthismakesiteasierforthereviewertoknowwhatisgoingon.

b. Wheneverpossible,indicatethatyouwilldothingsaseptically(e.g.,catheterplacement).

i. Example:Treatmentswillbeadministeredintravenouslythroughanaseptically-placedbutterflycatheter.

c. Ifyouarecollectinganything(tissue,blood,urine,etc.),indicatethemethodofcollectionandthereasonforcollectingthosesamples.Forbloodortissuecollectedforstemcells,indicatethevolumetobecollected.Volumeisnotrequiredforfreecatchurineortissueremovedfromatumor.

i. Example:Wewillasepticallycollectbloodviaperipheralveinfromthedogover24hours(at2,4,8,12and24hourtimepoints)inordertoanalyzethepharmacokineticsofthedrug(levelsintheblood)overtime.BloodwillbecollectedpertheIACUC’s“BloodVolumes,MaximumBloodDraws,andBloodCollectionSitesinSmallMammals,BirdsandFish”guideline.

ii. Example:Forbloodcollection,nomorethan1%oftheanimal’sbodyweightwillbecollectedwithina14dayperiodperpolicy:http://safetyservices.ucdavis.edu/ps/a/IACUC/po/bloodVolumes

iii. Example:Urineviaafreecatchorcystocentesiswillbecollectedandanalyzed(e.g.,urinalysis).Ifacystocentesisisneeded,itwillbedoneasepticallyandinthestandardmethoddoneattheVMTH(placinganeedleintotheurinarybladdertocollecttheurine).Sedationissometimesneeded.

d. Don’tforgettoincludeatimelineofevents(thisishelpfulforthosereadingitwhoarenotasfamiliarwithyourstudyand/ordonothavea(oryour)scientificbackground).

i. Example:Week1–physicalexamination,bloodcollection(CBC,chempanel),urinecollection(urinalysis),MRI+anesthesia.Week2–injectionofdrugduringcraniotomyprocedure.

e. Ifsomethingexperimentalisneededfromastandardprocedure(e.g.,abiopsyiscollectedduringasurgery)oryouaredoingsomethingexperimentalduringtheprocedure(e.g.,injectionofstemcells),youmustthoroughlydescribethestandardprocedureandtheexperimentalportion.

f. Avoidgettingsuperspecific(e.g.,specificneedlesize,suturetypeandsize)because,ifsomethinggoesunexpectedlyandyoudon’tendupusingthatneedlesizeorsuturetype,itistechnicallyadeviationfromtheprotocol.Usemoregeneraltermslike“Suitablysizedneedle”.Insteadofgivinganexactdose,giveamaximum


orarangetogiveyousomewiggleroomincaseyouendupneedtogiveahigherdosethanoriginallyexpected.

g. ForproceduresinvolvinganesthesiabeingdonebytheVMTHAnesthesiaServiceandgenerallyispartoftheroutineclinicalcareoftheanimalsandnotdirectlypartofthestudy,pleaseincludethefollowingstatement:"AnesthesiawillbeprovidedandmonitoredbytheVMTHAnesthesiaServiceandoverseenbyaveterinaryanesthesiologist.Theanesthesiaserviceandtheanesthesiologistinchargewilldeterminethemostappropriatedrugs,dosesandroutestobeused."

h. TheIACUCneedstoensurethatanyhumans(e.g.,faculty,staff,owners)oranimalscomingintocontactwithhazardouschemicalsordrug,youmustindicatehowyouwillminimizeexposure.Forexample,indicateifyourVMTHservicegivestheownerinformationaboutthedrugbeinggivenand/orhowtohandleitwhentheyarereadytobringtheirdoghome(e.g.,doyoutellindividualsthatpregnantwomenshouldnothandlethechemicalorcomeintocontactwiththedog’surinefollowingadministration?)

i. Example:WehaveextensiveSOPswrittentominimizestaffexposuretochemotherapyagents.Ownersareinstructedhowtohandleitwhentheytakeithomeandaregivenglovestominimizeriskofexposure.

i. Clearlystatetheprojectendpoint(s).i. Example:ThestudyendsafterthedoghasreceivedtheappointmentinWeek24.Afterthestudyhasended,thedogwillgohomewiththeowner.

j. Click“Add/SaveSummaryofProcedurestoProtocol”2. Alldrugsandcompoundstobeadministeredtotheanimals(Section14b):

a. Thisincludesexperimentalcompounds,saline,localanesthesia,etc.!b. Click“addDrugInformation”c. Foranesthetics:

i. IfdonebyVMTHAnesthesiaService,includethefollowing:1. Includecommonnameofspecies2. Put“various”fordruganddose3. Forroute,leavewiththedefault(“-=SelectOne=-“)orjustchoose

anyroute4. For“Whenandhowoftenwillitbegiven?”,put"Thedrugrouteswill

bevarious.AnesthesiatobeperformedbytheVMTHAnesthesiaService"

5. ForcertainprojectstheIACUCmayaskforadditionalinformationrelatingtotheanesthesia,howeverthiswillbeonacasebycasebasissojustincludethetemplatelanguageontheinitialsubmission.

d. ForexperimentalcompoundsandanesthesianotdonebyVMTHAnesthesiaService,completetherequiredfieldsasthoroughlyaspossible.

e. Click“AddDrugtoList”OPTIONS:Ifyouchose“Anesthetics/Tranquilizers/Sedatives”inSection9–SpecialProceduresand/orActivities,thefollowingsectionswillappear:

3. AnesthesiaMonitoring(Section14c)a. IfanesthesiawillbeprovidedandmonitoredbytheVMTHAnesthesiaService

overseenbyaveterinaryanesthesiologist,indicatethisinthissection.b. Example:Routinemonitoringofheartrate,respiratoryrate,andbloodpressure

willbeperformedbythetechnicianperforminganesthesia.Theseparameterswill


betakenintoconsiderationaswellaspatientmovementtodetermineadequacyofpaincontrolanddepthofanesthesia.Allspecificclinicaldecisionsregardinganestheticmonitoringwillbemadeonanindividualcase-by-casebasisnotbytheprimaryinvestigator.TheywillbemadeaccordingtotherecommendationsoftheUCDavisVMTHAnesthesiaservice.

c. Click“Add/SaveAnesthesiaMonitoringtoProtocol”4. Post-AnestheticMonitoring(Section14d)

a. Example:Thefollowingparameterswillbeusedtomonitorthepatientduringtherecoveryperiod:temperature,heartrate,respiratoryrateandpattern,mucousmembranecolorandcapillaryrefilltime.Theanesthesiatechnicianwillremainwiththepatientuntilswallowreflexisobservedandthepatientisextubated.Monitoringwillcontinueuntilthepatientisambulatory.Allspecificclinicaldecisionsregardingpost-anestheticmonitoringwillbemadeonanindividualcase-by-casebasisnotbytheprimaryinvestigator,butratheraccordingtotherecommendationsoftheserviceclinicianassumingprimarycaseresponsibilityforthepatient.

b. Click“Add/SavePost-AnesthesiaMonitoringtoProtocol”OPTIONS:Ifyouchose“SurvivalSurgicalProcedures”inSection9–SpecialProceduresand/orActivities,thefollowingsectionswillappearinadditiontotheAnesthesiaandPost-AnesthesiaMonitoringsections:

5. Surgery(Section14e)a. SurgeryLocation(s)andSurgeon(s)(Section14.e.i)

i. Click“addSurgeryInformation”ii. SelecttheappropriateSurgeryLocationandRoomnumberiii. Includethename(s)ofeachsurgeoninvolved.iv. Click“AddtoSurgeryLocationList”

b. Post-SurgicalMonitoring(Section14.e.ii)i. Thissectionisgoingtobedependentonthesurgerysobeasclearandthoroughaspossible,butshouldclarifywhensuturesareremovedandthattheincisionsiteshouldbecheckeddailyuntilthesuturesareremoved(minimumof7days).

c. Click“Add/SavePost-SurgicalMonitoringInformationtoProtocol”Section15–AdverseEffects

1. Clearlydescribeallsignificantadverseeventsfromtheproceduresoutlinedinyourproject(eveniftheyarerare),howyouwillmonitorforthoseeventsandhowyouwilltakecareofthemifyouobserveanyoftheeffects.ThisinformationshouldbeconsistentwithwhatisdescribedintheConsentForm.

2. Criteriaforeuthanasia(Section15d)a. Euthanasiaisgenerallynotusedinclinicaltrials;howeversomethingneedstobe

writtenperfederalregulationsthatbindtheIACUC.b. Example:Wedonotexpectanyanimalstodieorrequireeuthanasiaaspartofthis

study.However,sincethisisaclinicalstudywithprivatelyownedanimals,thedecisionofeuthanasiaremainssolelyatthediscretionoftheowner.

c. Click“Add/SaveAdverseEffectsInformationtoProtocol”Section16–Euthanasia


1. Eventhougheuthanasiaisnotexpected,youstillneedtoincludeinformationshouldacatastrophiceventoccurthatrequireseuthanasiatobeperformed.

2. Putwhateverisdoneforthatspecies.a. Example:

i. Species:Dogii. Method:Overdoseiii. Drug:Pentobarbitaliv. Dose:≥100mg/kgv. Route:Intravenous(IV)

3. Click“AddMethodtoList”

Section17–Disposition1. Click“Add/SaveDispositionofAnimalstoProtocol”2. Outlineendpoints(i.e.,whatwillhappentotheanimalsattheendofthestudy).

a. Example:Thepatientsenrolledinthisstudyareclient-ownedanimalsandthereforeremainthepropertyoftheirownersandfamilies.Animalswillbedischargedtotheircareaftereachvisitandoncethestudyiscompleted.

3. Click“Add/SaveDispositionofAnimalstoProtocol”Section18–Roster

1. Youwillneedtoaddinallmajorpersonnel(e.g.,faculty,residents,students)thatwillcomeincontactwiththeseanimalsintheroster(excludetechnicians,andstaff).

2. Click“AddtooreditProjectRoster”3. EntertheLastNameofwhomeveryouaretryingtoaddandselecttheappropriateoption

thatcomesoutofthesearch.4. Makesurethebasicinformation(email,department,contactinformation)isuptodate.5. FortheQualifications/Experiencesection:TheIACUCislookingforspecies-specificand

procedure-specificinformation.Theyknowyouareanexcellentvet,butanyoneelsewhoreadstheprotocol(e.g.,theUSDA)maynotknowthat.

a. Example:“Dr.Doehas15numberofyearsexperienceworkingwithdogs(specifyexperiencerelatedtothespeciesinyourprotocol)andinperforminggastropexysurgeries.

b. Pleasebesurethatforanyoneconductingsurgery,theprotocolspecifictypeofsurgeryandqualificationsarestated.So,ratherthanstating"....experienceinallareasofthisprotocolincludingsurgery..."specificallystateexperienceinperformingthetypeofsurgerydescribedintheprotocol.

c. Exampleofsomeonewhowillbetrainedduringthestudy:Ms.Vethaslimitedexperience(<1year)andwillbeproperlytrainedbythePItohandlecats,prepareandmaintainimplantsinasterilemanner,andrecordactivityincats.Thistrainingwillbedocumented.

6. Indicatewhetherornotyouwantthemtoviewtheprotocol.7. Click“AddPersonneltoRoster”8. TheOccupationalHealthParticipationDateandACU101Trainingdatewillbe

automaticallyincludedIFtheyhavealreadytakenthosetrainings.Section19–AppendicesThissectionwillonlybeavailableifthereareanyappendicesthatneedtobeadded,suchasifhazardsareusedinthestudy.


AssurancesfortheHumaneCareandUseofVertebrateAnimalsCheckthe“Ihavereadandagreewiththeabovestatement”box.InformedConsent

1. Alinktotheconsentformtemplatecanbefoundhere.2. ThisdocumentMUSTbeattachedtoyourIACUCprotocolwhenyousubmiteverything.

Otherwise,yourprotocolwillbesentbacksoyoucanattachit,whichwilldelayapprovaltime.

3. Instructionsareincludedincommentbubbles,sodeletethemwhenyouaredone.4. Provideanswerstoeachquestionasthoroughlyandclearlyaspossible.Don’tforgetthat

thisdocumentwillbegiventothegeneralpublic,sopleasewritetheanswersinlayman’sterms(8thgradereadinglevel).

5. Withintheboldquestions,thereareafewinstancesthathave“[PLEASESPECIFY]”,“[DISEASE/CONDITIONOFINTEREST]”,etc.appears.Replacethosewordswiththeappropriateterminology.Forexample,replace“[DISEASE/CONDITIONOFINTEREST]”withthediseaseorconditionyouareassessinginthisclinicaltrial.

6. Thisdocumentisgoingtoindividualsthataregoingto(hopefully)puttheirpetinyourcare,soyouwanttoPROOFREADBEFORESUBMITTINGtotheIACUC.Keeptheformatting,fonttypeandsizeconsistentthroughoutthedocument.Makesuretocheckspellingandgrammar.Dependingonyourfacultymember,youmaywanttoaskyourattendingfacultymemberorevensomeonenotinyourservicetoreadthroughtheconsentformbeforesubmittingtomakesureeverythinglooksandsoundsappropriate.Makesuretocompleteallofthesections.

7. TheprotocolnumbershouldbeaddedtotheheaderportionoftheConsentForm.

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