FormNotes:Beforecompletingthisform,pleasereadthefollowing:

AdobeReadermustbeusedtocompletethisform.

If you have saved this form to your computer, please confirm revision date with current webform before proceeding.

PROTOCOLFORMFORUSEOFVERTEBRATEANIMALS INRESEARCHANDEDUCATION

UNIVERSITYOFMARYLANDCENTERFORENVIRONMENTALSCIENCE

UMCEShasonfilewiththePublicHealthService(PHS)awrittenAssurancewhichcommitsthe Centerto followingthestandardsandregulationsestablishedbytheAnimalWelfareAct. UMCEShasestablishedanInstitutionalAnimalCareandUseCommittee(IACUC)toensure that allactivitiesare incompliancewith theAct,otherapplicablefederaland statelaw, and PHS and institutionalpolicy. The IACUCis responsiblefor reviewand approvalof all animal researchand educationprotocols.The IACUC is responsiblefor the welfareof “any live vertebrateanimalusedorintendedforuseinresearch,experimentation, teaching,training,or relatedpurposes....”iftheseanimalsaremaintainedatanUMCESfacilityorareusedunder fundsadministeredby UMCES.

Note:Aseparateformmustbefiledforeach differentprojectorprotocol.

DateofSubmission:

Applicant:

Telephone: Fax:

Email:

Checkoneboxperline: InitialSubmission DeNovoSubmission Modification

FacultyResearch ThesisResearch Other:

If FacultyResearch: / PrincipalInvestigator:
UMCESLaboratory:
ResearchSponsor:
IfThesisResearch: / FacultyAdvisor:
UMCESLaboratory:
Programor Dept.:

Degree-GrantingInstitution:

DegreeSought:

NOTE:AppendixBmaybeusedtoprovideanyadditionaloroverflowinformation,wherefieldspaceislimited.

ProjectTitle:

GrantTitle(ifdifferentfromProjectTitle):

AnticipatedStartingDate: AnticipatedEndingDate:

LocationWhereAnimalsWillbeHoused:

A.JUSTIFICATIONS

The U.S. Government'sPrinciples for the Utilization and Care of VertebrateAnimals Used in Testing, Research,andTrainingincludes: "Procedures involvinganimalsshouldbedesignedandperformedwithdue consideration oftheirrelevancetohumanoranimalhealth,theadvancement ofknowledge,orthegoodof society."

1.ResearchGoals:

a. Whatarethescientificissuesaddressedbytheresearch? Specifically,howwillthisresearch improvehumanoranimalhealthoradvanceknowledge?

b.Whatarethespecificgoalsoftheanimalstudiesdescribedinthisprotocol?

2. Explainwhyanimalstudiesarepreferredtonon-animalalternativesinachievingtheseresearch goals:

TheanimalWelfareActrequiresthat"...theprincipalinvestigatorhasprovidedwrittenassurancethatthe activitiesdonotunnecessarilyduplicatepreviousexperiments."

3.Doesthisresearchduplicatepreviousexperiments? YES NO

IF YES,pleaseexplainwhythisduplicationisnecessary.

4. Dotheanimalproceduresplanned forthisresearchinvolvesimplefieldobservationwithnoimpact oneithertheanimalsortheirenvironment?

YES NO

IF YES,it isnotnecessarytocompletetheinformationalsectionsofthisprotocolform.

INSTEAD:

a. UseAppendixBtodescribethestudy activities. Includealltheprecautionstaken toensurenoadverseimpactonthestudyanimalsandtheirenvironment.

b.Includecopiesofanyrequiredpermitsand/orlettersofpermissionorprovidedocumentation thatsuchpermitsarenotrequired.

c.SignthisformunderSectionH.Assuranceonpage11.

d.SubmitthispackagetotheChairoftheUMCESIACUC.

IF NO,theremainderofthisformmustbecompleted.Proceedtothenextsection.

NOTE: UMCESinstitutionalpolicyprohibitslaboratoryandmanipulative experimental fieldstudieswithall vertebratesexceptfinfish,amphibians,andreptiles. ConsultSectionVII-2of theUMCESPoliciesand ProceduresManualforinformation onhowresearchonothervertebrateanimalspeciesmaybeundertaken withinthelimitsofthispolicy.

U.S.GovernmentPrinciplesfortheUtilizationandCareofVertebrateAnimals UsedinTesting, Research,and Trainingstates,"Theanimalsselectedforaprocedureshouldbeofanappropriatespeciesandqualityand the minimumnumberrequiredtoobtainvalidresults."

1. ResearchSpecies:

Strain:

Whyisthisthemostappropriatespecies/straintouseinthesestudies?

2. Howmanyanimalsdoyouplantouseforthisprotocol? Completethefollowingtablebelowtodefine

thenumber(s)ofanimal(s)tobeusedineachcategory.Usethefollowinganimalwelfarecategories:

CATEGORY: 0: Nopain.

1: Littleormomentarypainordiscomfort.

2: Potentialdiscomfortorpainwhichisrelievedbytheappropriateanestheticor analgesic.

3: Discomfortorpainwhichisnotrelieved.

ExperimentalGroupsorAnimalSpecies
Category
0
1
2
3

You mustprovideabreakdownofthe animalsintoexperimentalgroupsifsubstantiallydifferentprocedureswill beusedbetweengroupsorifdifferentspecieswillbeused (identifyeachexperimentalgroupand thenumbers ofanimalsineachgroup)andyoumustprovideajustificationforthenumbersofanimals. Itwouldbe beneficialifyouincludeinyourjustification statisticalanalysiswhichwasusedtodeterminethattheanimal numbersaretheminimumrequiredforvalidresults. Youcanprovidethisinformationinyourdescriptionof theExperimentalProcedures,SectionB.

TheAnimalWelfareActstates: "Theprincipalinvestigatorhasconsideredalternativestoproceduresthatmay causemorethanmomentary orslightpainordistresstotheanimals,andhasprovidedawrittennarrative description ofthemethodsandsources(e.g.,theAnimalWelfareInformationCenter)usedtodeterminethat alternativeswerenotavailable. . ."

3. Ifyouhaveplacedanyanimalnumbersincategories2or3,youmustcompletethefollowing(use

AppendixB, if additionalspaceisnecessary):

a. Explainwhythepainordiscomfortcannotberelievedandwhatprocedureswillbeusedto minimizediscomfort.

b.Whatinformationalmethodsandresourcesdidyouusetodeterminethat(non-animalor non-painful)alternativeswerenotappropriateforthisresearch?

Databasessearched(includekeywordsused)1

Literaturecitations

Meetingswithknowledgeableindividuals(name,date)

Othermethods/resources

1SeeC.P.Smith,AWICTipsforSearchingforAlternativestoAnimalResearchandTesting. AnimalWelfareInformation

Center, USDA,National Agricultural Library,Beltsville, MD.

B.EXPERIMENTALPROCEDURES

1. GeneralProcedures:

Describe(onAppendixAofthisform)theanimalproceduresthataretobeperformedandthe necessityofconductingtheseexperimentalproceduresinfulfillingthegoalsoftheproject. Besure tobespecificaboutanyprocedureswhichmayimpactonthehealthandcomfortofthestudy animals(examples: frequencyofperformanceofanyprocedures,methodsofrestraint,blood samplevolumes,etc.). Asmentionedearlier,youmaywishtoincludetheexperimentalgroupsin thissection. Whendefiningyourexperimentalgroupsincludethenumbersofanimalswithineach group.Pleaseprovideajustificationfortheanimalnumbersused.

The Animal Welfare Act states that, "Procedures that may cause more than momentary or slight pain or distress totheanimals will:a)Beperformed with appropriate sedatives, analgesics, oranesthetics unless withholding such agents is justified for scientific reasons, in writing, by the principal investigator and will continue foronlythenecessary period oftime; b)Involve intheirplanning,

consultation withtheattending veterinarian...,c) Notincludetheuseofparalyticswithoutanesthesia...."

2. AnestheticsandAnalgesics:

Ifanestheticsoranalgesicsaretobeused,pleaseprovidethefollowinginformation(thissection

neednotbecompletediftherequestedinformationisprovidedintheanimaluseprocedures

describedabove):

PROCEDURE / ANESTHETIC / DOSEMETHODOFADMINISTRATION

TheAnimalWelfareActstates: "Activitiesthatinvolvesurgeryincludeappropriateprovisionforpre-operativeand post-operative care of the animals in accordance with established veterinary medical and nursing practices. Allsurvivalsurgerywillbeperformed usingasepticprocedures,includingsurgicalgloves,masks,sterileinstruments,andaseptictechniques."

3. SurgicalProcedures:

If surgeryistobeperformed:

a. Surgerylocation/room:

Isit aterminalprocedure?

Isit asurvivalprocedure?

YES NO

YES NO

b. On AppendixA,describethe surgicalprocedurestobeperformed.Be sure toinclude theprocedurestobefollowedtoensureasepsis. (Ifasepticproceduresarenotto be performed,usethisspacetojustifywhynotanddescribetheprocedureofchoice.)

c. Describethepost-operativecare(bothimmediateandlong-term).(If describedinAppendix

A, donotrepeathere.)

4. Euthanasia

PleaseconsultUMCESResearchProtocolGuidelinesforacceptableeuthanasiapractices. Willtheanimalsbeterminatedattheendoftheexperiment?

YES NO

IF YES,themethodofeuthanasiais:

TheAnimalWelfareActstates,"Personnelconductingproceduresonthespeciesbeingmaintainedorstudied willbeappropriatelyqualifiedandtrainedinthoseprocedures."

5. Pleasedescribebelowthetrainingandqualificationsofyourselfandotherindividuals whoareincluded inthisprotocol. Inparticular,pleasebeveryspecificaboutthehands-ontrainingofthoseindividuals performing procedures which may produce animal discomfort, i.e., restraint, injections, blood collection,surgery,euthanasia,etc.(UseAppendixB, if necessary.)

C.HUSBANDRYPRACTICES

1. Describethehusbandrypracticesthatwillbeused. [Iffishareraisedashatcheryorlaboratory aquariumstocks,youmayrefertoestablishedstandardoperatingproceduresfortheappropriate facility.Ifyouareraisingfishyourself,youmustcompletethissection.]

2. Describe procedure for disposition of dead animals, including whether or not necropsy will be performed.

D. WILL THE ANIMALS BE REMOVED FROM THE FACILITY IDENTIFIED ON PAGE 1 OF THIS PROTOCOLFORM?

YES NO

If YES: Forhowlong?

NOTE:If removalwillbegreaterthan24hoursavariancerequestmayberequired.

Towhere?

Willtheybereturnedtothefacility?

YES NO

If NO,whynot?

E.ENVIRONMENTALSAFETY

1.Areinfectiousagentstobeused?

YES NO

IF YES,theagentis

IF YES,istheagentinfectioustohumans?

YES NO

2.Arechemicalhazardstobeused?

YES NO

IF YES,thechemicalhazardis

3. Areradioisotopestobeused?

YES NO

IF YES,theradioisotopeis

4.Areotherbiohazardstobeused?

YES NO

IF YES,thebiohazardis

IfanyoftheabovequestionsareansweredYES,allproceduresmustcomplywithEnvironmentalSafety requirementsoftheappropriateUMCESLaboratory.

F. HAVEYOUCOMPLETEDTHEUMCESVERTEBRATEANIMALCAREANDUSETRAINING PROGRAM?

YES NO

If YES,givedateofprogramsession:

If NO,youmustcompletethisProgramwithin1calendaryearofthedateofapprovalofthisprotocoland submitcertificationthereoftotheChairoftheIACUC.Thisprogramcoversthecompositionandfunctionof theIACUC,historicalbackground,federallaws,PHSAssurance,protocolsubmissionandreviews, occupationalhealthandsafetyissuesandmuchmore.Failuretocompletethisprogramwithin1 calendaryearcouldresultin suspensionoftheprojectbytheIACUC.

In theinterim,it istheresponsibilityoftheemployeetomakethemselvesawareofanyhealthandsafety issuesrelatedtotheperformanceoftheirduties.Theyshouldseekassistanceandtrainingfromtheir immediatesupervisor,LaboratoryManagerorPrincipleInvestigator,toinsurethattheyfullyunderstandthe healthandsafetyissuesofworkingwiththeirspecificvertebratespecies.Newemployeeswhoplanto

workwithvertebratesmustprovidedocumentationthattheyhavehadatetanus/diphtheria vaccination/boosterwithinthepast10years.Atuberculinskintestisrequiredforemployeesworkingwith finfish.Theyshouldbetestedevery2years,aspositivetuberculinreactionsmaybeduetoinfectionwith Mycobacteriummarinum.Thoseworkingwithbatsorvertebratesknowntoharborrabiesarerequiredto havethepre-exposurerabiesvaccination.Theirserumshouldbetestedforrabiesantibodyevery2years and,if thetiterisinadequate,haveaboosterdose.It isimpossibletocovereveryzoonosesorhealthrisk here,asmanyarespeciesspecific.It istheemployee’sandimmediatesupervisor’sresponsibilitytomake surethattheyareinformedofanyhealthandsafetyrisksbeforebeginningworkwithaspecificvertebrate species.If thereareanyconcerns,theIACUCChairshouldbecontacted.

G. LISTALLNAMESANDTELEPHONENUMBERSOFPERSONNEL,INCLUDINGYOURSELF, ASSOCIATEDWITH THE PROJECTIDENTIFIEDIN THIS PROTOCOLWHO WILL WORK WITH ANIMALSORANIMALTISSUE. CHECKTHEAPPROPRIATEBOXTOINDICATEWHETHERORNOT EACHINDIVIDUAL HASCOMPLETEDTHEUMCESANIMALCAREANDUSETRAININGPROGRAM. ALSO,CHECKTHEAPPROPRIATEBOXTOINDICATEIFEACHINDIVIDUAL HASFULFILLED REQUIREMENTSFORVACCINATION/TESTING.

UMCESAnimal CareandUse Training / Vaccination/ Testing / Name / Phone / Email
YES / NO / YES / NO
YES / NO / YES / NO
YES / NO / YES / NO
YES / NO / YES / NO
YES / NO / YES / NO
YES / NO / YES / NO
YES / NO / YES / NO
YES / NO / YES / NO

H.ASSURANCE

Iattesttotheaccuracyandcompleteness oftheinformationprovided. Ipromisetoconductthisworkwith animalsinaccordancewiththeprotocolasapprovedbytheUMCESIACUCunderUMCESanimalcareand usepolicy. Iwillnotmake anysubstantivechangesintheaboveprotocolwithoutfirstobtainingtheapprovalof theUMCESIACUC,andI willnotuseanyprocedureswhicharenotincludedinthisform.

Applicant: date:

Iacknowledgeresponsibilityfortheconductoftheseprocedureswithanimalswhichwillbeperformedbythe individualidentifiedaboveundermydirection.

PrincipalInvestigator: date:

OR

Student’sThesisAdvisor: date:

IhavereviewedtheresearchprotocoloutlinedonthisformandherebytransmitittotheUMCESInstitutional

AnimalCareandUseCommitteeforreview.

LaboratoryDirector: date:

ACTIONBYUMCESIACUC: ProtocolNo.Assigned:

Approvedassubmitted

5HTXLUHVmodificationWR VHFXUH DSSURYDO

HoldfordiscussionbyCommittee

Disapprovedaspresented;mustresubmit

COMMENTSORINSTRUCTIONS:

FINALACTION:

IACUCChair: date:

STATEMENTONCONFIDENTIALINFORMATION

TheAnimalWelfareAct,Section27,statesthatitisunlawfulforanymemberofanInstitutionalAnimalCare

and Use Committeetoreleaseany confidentialinformationincludingthe following:processes,operations,style

ofwork,apparatus,buildingsused,confidentialstatisticaldata,etc. UMCESconsidersALLinformationon ProtocolFormsconfidential, andwillnotforwardtheseformstoanyinstitutionthatdoesnothonorthis confidentiality.

Appendix A

B.ExperimentalProceduresDescription(s),frompage6:

Describetheanimalprocedures thataretobeperformedandthenecessityofconducting theseexperimental proceduresinfulfillingthegoals oftheproject. Besuretobespecificabout anyprocedureswhichmayimpact onthehealthandcomfortofthestudyanimals(examples: frequencyofperformanceofanyprocedures, methodsofrestraint,bloodsamplevolumes, etc.). Asmentioned earlier,youmaywishtoincludethe experimental groupsinthissection. Whendefiningyourexperimentalgroupsincludethenumbersofanimals withineachgroup.Pleaseprovideajustificationfortheanimalnumbersused.

TheAnimalWelfareActstatesthat,"Proceduresthatmaycausemorethanmomentaryorslightpainor distresstotheanimalswill: a)Beperformedwithappropriatesedatives,analgesics,oranestheticsunless withholdingsuchagentsisjustifiedforscientificreasons,inwriting,bytheprincipalinvestigatorandwill continueforonlythenecessaryperiodoftime; b)Involveintheirplanning,consultation withtheattending veterinarian. . ., c)Notincludetheuseofparalyticswithoutanesthesia. .. ."

Rev.8/9/11 AppendixA, Page1

Rev.8/9/11 AppendixA, Page2

Rev.8/9/11 AppendixA, Page3

Rev.8/9/11 AppendixA, Page4

Appendix B

AdditionalInformation:Thispagemaybeusedtoincludeadditionaloroverflowinformationfromsections wheretheformfieldsspaceislimited.

Rev.8/9/11 AppendixB,Page1