WhatInvestigatorsNeedtoKnow
AbouttheUseofAnimals
“Proper use of animals, including the avoidance or minimization of discomfort,
distress, and pain when consistent with sound scientific practices, is imperative.”
U.S. Government Principle IV, 1985
PrincipalInvestigatorsareresponsibleforthescientiϐicandtechnicalaspectsofagrantawardand
mustensurecompliancewithPublicHealthService(PHS)PolicyonHumaneCareandUseof
LaboratoryAnimals(Policy)whenusinglivevertebrateanimals.PHSPolicyincorporatesthe U.S.
GovernmentPrinciplesfortheUtilizationandCareofVertebrateAnimalsUsedinTesting,Research,
andTraining,theGuidefortheCareandUseofLaboratoryAnimals,andtheAmericanVeterinary
MedicalAssociation(AVMA)GuidelinesfortheEuthanasiaofAnimals.Vertebrate animalsinclude
traditionallaboratoryanimals,farmanimals,wildlife,andaquaticanimals.Animaluseencompasses
research,teaching,ortesting.Generationofcustomantibodies isconsideredanactivityinvolving
vertebrate animals.
WhoMustComplyWiththePHS
Policy?
InvestigatorResponsibilities
Investigatorsareaccountablefortheprotectionofthe
ThePHSPolicyappliestoextramuralandintramural researchanimalsintheircarefromtheearlieststages
activitiessupportedbyanyPHSagency,includingthe ofplanninguntila study iscompleted,including:
NationalInstitutesofHealth(NIH),theFoodandDrug  Describingproposeduseofanimalsingrant
applications;
Administration,theCentersforDiseaseControland

ObtainingIACUCapprovalpriortousinganimals
Prevention,andtheDepartmentofHealthandHuman
andpriortoimplementingsigniϐicantchanges;
Services.Allfundingmechanisms,includingresearch
 Ensuringresearchisconductedaccordingtothe
andtraininggrants,cooperativeagreements,and
protocol;
contracts,conductedatdomesticandforeign
 Complyingwithinstitutionalpoliciesand
institutions,arecoveredby thePolicy.Additionally,
procedures;
activitiesconductedorsupportedbytheDepartment
 Addressingsigniϐicantchangestotheuseof
ofVeteransAffairs,theNationalAeronauticsand
animalsinprogressreports;and
SpaceAdministration,andtheNationalScience
 Addressingchangesintheuseofanimalsthatmay
FoundationarecoveredbythePolicyunder
bea potentialchangeinscope,includingchanges
memorandaofunderstandingbytheseagencieswith
inperformancesite.
NIH.
Good animal care and good science
go hand in hand.
ApplyingforFunding
Theproposedinvolvementofvertebrate animalsis
evaluatedaspartofthepeerreviewprocess.
Applicantsmustprovidethefollowingingrant
WhatisanIACUC?
applications:
InstitutionalAnimalCareandUseCommittees
1. Concisedescriptionoftheproposedprocedures
(IACUCs)arelocal institutionalcommitteeswith
tobeusedthatinvolvevertebrate animals,
federallymandatedoversightresponsibilities,
includingspecies,strains,ages,sex,andtotal
including:
numberof animalsbyspeciestobeused.
 Reviewinganimal‐useprotocols;
2. Justiϐicationthatthespeciesareappropriatefor
theproposedresearchandexplanationwhy
 Reviewingsigniϐicantchangestoprotocols;
researchgoalscan’tbeaccomplishedusingan
 EvaluatinginstitutionalcompliancewithPHS
alternativemodel.
Policy,U.S.DepartmentofAgriculture(USDA)
3. Descriptionoftheinterventionsincluding
AnimalWelfareActandRegulations,and
analgesia,anesthesia,sedation,palliativecare
institutionalpolicies;
andhumaneendpointstominimizediscomfort,
 Monitoringinstitutionalanimalcareanduse
distress,painandinjury.
programs,includinginspectinganimalfacilities;
 Reviewingconcernsaboutanimalcareoruse;and 4. Indicationiftheeuthanasiamethodisconsistent
withAVMAGuidelinesanda descriptionofthe
 Reportingnoncomplianceandsuspensionstothe
methodandscientiϐicjustiϐicationifitisnot.
NIHOfϐiceofLaboratoryAnimalWelfare(OLAW).
ObtainingIACUCApproval
PostAward
IACUCapprovalisrequiredpriortoawardexceptinrare
circumstances.YourIACUCwillrequireyoutosubmit
informationaboutthecareanduseofanimalsona
protocolform.Mostanimal‐useprotocolsrequirea
descriptionofthefollowing elements:
IACUCreviewisrequiredatleastevery3years(annuallyif
coveredbyUSDAregulations).Signiϐicantchangesin
animalcareandusearetobeapprovedbytheIACUCprior
toimplementation.CheckwithyourIACUC todetermine
whatconstitutesasigniϐicantchange.
 Researchproject;
GranteesmustalsoobtainpriorapprovalfromNIHfor
 Rationaleforanimal useandconsiderationof
changesinscope,direction,or otherareasthatconstitutea
alternatives;
signiϐicantchangefromtheaims,objectives,orpurposes
 Justiϐicationforthechoice ofspeciesandnumberof
oftheapprovedproject.Thegranteemustmaketheinitial
animals;
determinationofthesigniϐicanceofthechangeandshould
 Researchproceduresinvolvinganimals;
consultwithaGrantsManagementOfϐicerasnecessary.
 Procedurestominimizepainanddistress;
 Animallivingconditionsandveterinarycare;
ConductingresearchintheabsenceofIACUCapprovalor
 Namesandqualiϐicationsofpersonnelwhowill
implementing asigniϐicantchangewithoutIACUC
performworkwithanimals;
approvalconstitutesnoncompliance.
 Methodofeuthanasia;and
 Endpointcriteria.
Chargestograntawardstoconductanimalactivitiesare
Theuseofanimalsasdescribedintheprotocolapproved notpermittedwithoutanapprovedAssuranceorIACUC
bytheIACUCmustbecongruentwiththedescriptionina approval(includingfailuretoobtainIACUCapprovalor
grantapplication.AnymodiϐicationrequiredbytheIACUC whenaprotocolisexpiredorsuspendedbytheIACUC).
thatsigniϐicantlychangestheanimalactivitymustbe
Investigatorsalsomustbeawareofandcomplywith
submittedtothefundingagencyalongwiththeIACUC
additionalinstitutionalpoliciesthatmaybemore
approvaldate.
restrictive.
“Investigators and other personnel shall be
appropriately qualified and experienced for
conducting procedures on living animals…”
U.S. Government Principle VIII, 1985
Resources:
NIH Office of Laboratory Animal Welfare
http://grants.nih.gov/grants/olaw/olaw.htm
ReceivinganAward
Toreceiveanawardthegranteeinstitutionandevery
performancesitewhereanimalworkwillbeperformed
musthaveanAnimalWelfareAssuranceapprovedby
OLAW.OLAWwillcontactaninstitutionwithspeciϐic
instructionswhenanAssuranceisrequired.An
InterinstitutionalAssuranceisnegotiatedwhenthe
granteedoesnothaveitsownanimalfacilitiesorIACUC
andtheanimalworkwillbeperformedataninstitution
withanAssurance.TheForeignAssuranceisrequiredfor
institutionsoutsidetheU.S.
SBIR/STTRinvestigatorsshouldbeawareofthe
requirementsinordertoaddresstheminatimelyfashion
sothatthenecessaryAssurancesareinplaceandgrants
canbeawarded.
ThedateofIACUCapprovalisessentialinordertoreceive
anawardandwillberequestedifnotpreviouslyprovided.
How to Write an Application Involving Research Animals http://www.niaid.nih.gov/researchfunding/sci/animal/
pages/anitutorial.aspx
Guide for the Care and Use of Laboratory
Animals: Eighth Edition http://www.nap.edu/catalog.php?record_id=12910
NIH Grants Policy Statement
http://grants.nih.gov/policy/nihgps/index.htm
PHS 398 Grant Application
http://grants.nih.gov/grants/funding/phs398/phs398.html
SF424 (R&R) Application and Electronic Submission Information
http://grants.nih.gov/grants/how-to-apply-applicationguide.htm
Vertebrate Animals Section Worksheet
http://grants.nih.gov/grants/olaw/VASchecklist.pdf
OFFICE OF LABORATORY ANIMAL WELFARE NATIONAL INSTITUTES OF HEALTH U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES NIH Publication No. 16-6009
Revised April 2016