SubmissionDate Approval Date Protocol#
UNION COLLEGE
IACUCLaboratoryAnimalProtocol
1.Name ofPrincipalInvestigator:
Title:
Dept./Phone:
1a.Name ofCo-Investigator(s);
Title:
Dept./Phone:
Iftheindividualconductingthe activityisastudent,pleasenotethattheFaculty
SupervisoristhePrincipalInvestigator.ThestudentislistedunderCo-investigator.
2.Applicationisfor:
a.Initialapprovaltouselivevertebrateanimals.Pleasecomplete theattachedformincludingadetaileddescriptionof thestudy.
b.Amendment, revision,or renewal of an approvedprotocol:
Numberofprotocolbeingrevised or renewed:______. Pleaseprovidea complete descriptionof thechanges, if any.
c.Applicationisfor externalfundingsupport:
Submissiondeadline. Pleasecompletetheattachedpages andprovideaabstractofyourresearchproposal.
3.Typeof Project:
Research
Class (name/number):
Other
4.ProjectTitle:
5. / PeriodCoveredbythisProposal:Startingdate:
Completion date:
6. / SpeciesandTotalofanimalsforproject: Species / #
1.
2.
3.
4.
7.Checktheappropriateitems.Pleaseincludeexplanationfor all checkeditems innarrativeunderSection12.
FieldStudy
CaptiveObservations
Behavioralconditioningisrequired
Animalscollectedfromthewild
Tissuebiopsy(includingblood)
Drugadministration
Antibodyproduction(orotherimmunologicaltechnique)isrequired
(filloutsectionB)
Biologicalor radiologicalhazardousagentsarerequired(fillout
SectionB)
Tumorproductionrequired
Long-termrestraintisrequired
Survivalsurgeryisrequired(filloutsectionB)
Laboratoryexercise/classprojects
8.Thisprojectwillinvolveexperimentson animalsthatfallunder
Category. SeeAttachment1 for adescriptionof thecategoriesA-E.
Discomfortto animalsmustbelimitedto whatisunavoidableinscientifically valuablestudies.Appropriatedrugs inproperdoses mustbeused where indicatedtominimizediscomfortandpain.Drug doses (anesthetics, analgesics,tranquilizers,etc.)androuteof administrationmustbedescribed underSection12.
9.Wherewilltheanimalsbeobtained?
10.Willtheanimalsbe housed?NoYesWhere?
11.Dispositionof animalsupon completionofproject:
12.Pleaseattachanarrativedescriptionof theproposedstudy(you mayattachlab handout/protocol),includingbutnotlimitedtothefollowinginformation(see Attachment2 forFederalCriteriaforGrantingIACUCApproval):
a.Brieflyexplainthescientificmeritof theproposaltojustifytheuse of animalsto anyreasonableandwell-informedlayperson.Includethe rationaleforspecieschoice,gender(ifappropriate)andnumberof individuals.Investigatorsmustprovideassurancethattheminimal numberof animalsrequiredwillbeused.
b.Pleasedescribe,allproceduresandmanipulationstobeusedinyour projectthatinvolveanimals.Allitemscheckedinsection7 ofthe protocolmustbeincluded.
c.Methodof euthanasiamustbedescribed(when andbywhat agent/method).
d.Describethequalificationsof theinvestigator(s)and/ortechnician(s)to performanimalmanipulations.Includeanyanimalcareandtraining programyou havecompleted.
e.Describeanyhealthandsafetypracticesrequiredwhen performingthe proposed study(i.e.hand washingrequiredafterhandlingreptilesto reducerisk ofsalmonellainfections)andprovideassurancethat personnelhavebeen adequatelytrained.
13.PrincipalInvestigatorAssurance:
a.Theexperimentsdescribedinthisprotocoldo notnecessarily duplicatepreviousexperiments.
b.Personnelconductinganimalprocedureswillbeappropriately qualifiedandtrainedintheseprocedures.
c.Allalternativemethodsforperformingtheseprocedureshavebeen thoroughlyreviewed,
d.Iftheprocedures,etc.,hereinrequirerevision(changein procedure, species,numbers,etc.),Iwillsubmitaprotocolrevision tothechairoftheIACUC. Itistheresponsibilityof the investigatortosubmitaprotocolrevisioneachyeartoindicateif
theprojectwillbedonethatyear andtoindicateanychanges.
e.IherebyassurethatIshall conformto allinformationcontainedin thisproposalandfollowtheregulationssetforthbytheUSDA undertheprovisionsof theAnimalWelfareActandthepolicyon HumaneCareandUseofLaboratoryAnimalsas establishedbythe publicHealthServiceandthattheinformationprovidedaboveis accuratetothebestof myknowledge.
PrincipalInvestigatordateCo-Investigatordate
IACUC Chairdate
SectionB
A. SURGICALPROCEDURES:Thetechniqueforsurvivalrodentsurgeryrequires theuseof sterileinstruments,sterileglovesandtheappropriatepreparationofthe surgicalfield.Fullsteriletechniqueisrequiredfor allotherwarmbloodedmammals. Justificationisrequirediftheanimalisrequiredtoundergomorethanone survival surgery.
1.Indicatewheresurgerywillbeperformed,theperson(s)performingthe surgeryandthequalificationsandexperienceof thatindividualtoperform thetechniquesinvolved(aseptictechniquesmustbeusedduringsurgery).
2.Describethesurgeryprocedureincludingallsupport careandmonitoring duringtheprocedure.
3.Anesthesia
Species / Anesthetic / Dose / Route / Duration4.Pleasedescribemethodof measuring/monitoringdepthof anesthesia.
5.Describeanypre-operativeprocedures,includingfasting(food,water) and pre-anesthetics.
6.Ifsurvivalsurgery,describepostoperativesurvivaltime,care(andwho willgiveit),including:
Recovery:
Supportivecare:
Postoperativemonitoring:
Analgesia:
Antibiotics:
B. IMMUNIZATION/ANTIBODYPRODUCTION:
Species / Agent / Route / Site / Volume / # of doses / IntervalC.HAZARDOUS AGENTS
Agent(s):
Biosafety,RadiationSafetycontrolledsubstanceApproval(Liz Dobson-Davis, X-6340)
Yes
No
Pending
Describethemethod,route,placeofadministration,personnelinvolved, precautionstoprotectpeopleand animals,andcarcassdisposal.
CategoriesofBiomedicalExperimentsBasedonIncreasingEthicalConcernsforNon-humanSpecies
(LaboratoryAnimalScience.SpecialIssue:11-13,1987)
CategoryA
Experimentsinvolvingeither nolivingmaterialsor useofplants,bacteria,protozoa,orinvertebrateanimal
species.
Biochemical,botanical,bacteriological,microbiological,orinvertebrateanimalstudies,tissuecultures, studiesontissuesobtainedfromautopsyorfromslaughterhouse,studiesonembryonatedeggs.Invertebrate animalshave nervoussystemsandrespondto noxiousstimuli,andthereforemustalsobetreatedhumanely.
CategoryB
Experimentson vertebrateanimalspeciesthatareexpectedtoproducelittleor nodiscomfort.
Mereholdingofanimalscaptiveforexperimentalpurposes;simpleproceduressuchasinjectionsof relativelyharmlesssubstancesandbloodsampling;physicalexaminations;experimentsoncompletely anesthetizedanimalswhichdonotregainconsciousness;food/waterdeprivationfor shortperiods(afew hours);standardmethodsofeuthanasiathatinduce.rapidunconsciousness,suchasanestheticoverdoseor decapitationprecededbysedationorlightanesthesia.
CategoryC
Experimentsthatinvolvesomeminorstressorpain(short-durationpain)to vertebrateanimalspecies.
Exposureofbloodvesselsorimplantationofchroniccatheters withanesthesia;behavioralexperimentson awakeanimalsthatinvolveshort-termstressfulrestraint;immunizationemployingFreund'sadjuvant; noxiousstimulifromwhichescapeispossible;surgicalproceduresunderanesthesiathat mayresultin some minorpost-surgicaldiscomfort.CategoryCproceduresincuradditionalconcerninproportiontothe degreeanddurationof unavoidablestressordiscomfort.
CategoryD
Experimentsthatinvolvesignificantbut unavoidablestressorpainto vertebrateanimalspecies.
Deliberateinductionofbehavioralstressinordertotestitseffect;majorsurgicalproceduresunder anesthesiathatresultinsignificantpost-operativediscomfort;inductionofananatomicalorphysiological deficitthat willresultinpainordistress;applicationofnoxiousstimulifromwhichescapeisimpossible; prolongedperiods(upto severalhoursormore)ofphysicalrestraint;maternaldeprivationwithsubstitution ofpunitivesurrogates;inductionofaggressivebehaviorleadingto self-mutilationorintra-species aggression;proceduresthatproducepaininwhichanestheticsare notused,suchastoxicitytestingwith deathasanendpoint;productionofradiationsickness,certaininjections,andstressandshockresearchthat wouldresultinpainapproachingthepaintolerancethreshold,i.e.thepointatwhichintenseemotional reactionsoccur.CategoryDexperimentspresentanexplicitresponsibilityontheinvestigatortoexplore alternativedesignstoensurethatanimaldistressisminimizedoreliminated.
CategoryE
Proceduresthatinvolveinflictingseverepainnear,at,orabovethepaintolerancethresholdof
unanesthetized,consciousanimals.
Useof musclerelaxantsorparalyticdrugssuchassuccinylcholineorothercurariformdrugsusedalonefor surgicalrestraintwithouttheuseofanesthetics;severeburnortraumainflictiononunanesthetizedanimals; attemptstoinducepsychotic-likebehavior;killingbyuseof microwaveovensdesignedfor domestic kitchensor bystrychnine;inescapablyseverestressorterminalstress.CategoryE experimentsare consideredhighlyquestionableor unacceptableirrespectiveofthe significanceofanticipatedresults.Many oftheseproceduresare specificallyprohibitedin nationalpoliciesandtherefore mayresultinwithdrawalof federalfundsand/orinstitutionalUSDAregistration.
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Federal Criteria forGranting IACUCApproval
(From the ARENA/NIHIACUC Guidebook)
ActivitiesMustbein accordwith USDARegulations/PHS Policy.
Pain/DistressMustavoid/minimizediscomfort, distress, and/or pain.If pain/distress is caused, appropriate sedation, analgesia oranesthesia will be used. Attending veterinarian must be involved in planning. Useof paralytics without anesthesia is prohibited. Animals with chronic/severeunrelievable pain will be painlesslykilled.
SurgeryMustmeet requirementsforsterilesurgeryand pre/postoperativecare. Cannot useone animal for several major operativeprocedures from which it willrecover,withoutmeetingspecified conditions.
EuthanasiaEuthanasia method must be consistent with USDA Regulations/AVMArecommendations.
Housing/HealthAnimal livingconditions must be consistent with standards ofhousing, feedingandcaredirected by veterinarian or scientistwith appropriateexpertise.
AlternativesTheremustbe considered alternatives to painful procedures; also must document consideration of alternatives if animals experiencepain or suffering.
Rationale andMethodsMustprovide written narrativeof methods/sources.
DuplicationMustprovide assurancethat activities do not unnecessarilyduplicate previous efforts.
QualificationsPersonnel must be appropriatelyqualified.
Deviations fromRequirementsMustbejustifiedforscientific reasons, in writing.
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