INTTERNAATIONNAL GUIDINNG PRINCIIPLES
SFORFBIOMEDIIICAL RESEAR
RCH INVVOLVINNG ANIMALS
DECEM
MBER 201 2

COUNCIL FORF
INTERNNATIONAL ORGANIZATIOION OF MED
DICAL SCIEN
NCESandTHE INTEERNATIONAL COUNCIL FOR LABORRATORY AN
NIMAL SCIENNCEINTERRNATIONAL GUIDING P RINCIPLESSFOOR BIOMEDDICAL RESE
EARCH INVVOLVING AN
NIMALSPREAM
MBLE

The International Guiding Prin
nciples for Bio
omedical Reseearch Involving
g Animals has been theamework for the developme
ent of laws, policies, and gui delines for oveWhen thefra
er 25 years. WGuiding
GPrincip
ples were writtten in 1985, thet professionn of laboratoryy animal mediicine andsccience was still establishing best practicess and standarrds of care. OOver the years,, many ofthhese practices and standards have becom
me ingrained inn the oversightt structure of nnumerouscoountries. Since the public
cation of the originaloGuidining Principles,, the scope oof animal
reesearch has ex
xpanded signiificantly, numeerous technolo
ogical advanceements have ooccurred,annd societal atttention to the welfare
wof reseearch animalss has increase
ed. This evolu
ution hasprrompted an updateuand expansion
eof the focus of the Guiding Principles to addresscoontemporary isssues facing scientists
swhen
n animals are used for reseearch and educcation.
ernational Guiiding Principles
s for Biomediccal Research In
nvolving Animmals is theThe revised Inte
esult of a parrtnership betw
ween the Cou
uncil for Interrnational Orgaanizations forr MedicalreScience (CIOMMS) and the International Council
Cfor L
Laboratory An imal Science (ICLAS)
ormed to upda
ate the Guidingg Principles. TheseTinternattional organiza
ations have a common
fomissionmof advancing interrnational collaaboration in biomedical s ciences. Thee revised
doocument is the outcome off an internatio
onal collaborattion of scientissts, veterinarians, andotther experts whosew
ideas and suggestio
ons were gatthered from m
more than 10 different
meetingsmheld in conjunction
n with several scientific co nferences aro
ound the world over ape
eriod of more thant
3 years. Discussions werew
based onn the Statemennts of Principle
es for theUse of Animals from over 30
3 profession
nal societies, organizations, and countrie
es. Theworking
wgroup had an intern
national and in
nterdisciplinary
ry membershipp representing
g severalpiivotal stakeholder professional organizatio
ons.
nternational Guiding
GPrincip
ples for Biom
medical Reseaarch Involving Animals
The revised In
eflect congruen
nce with the moremspecific guidance offere
ed by other national and inte
ernational
reaggencies.
Th
hese Guiding Principles will be a touch
hstone for countries with eemerging
reesearch and teeaching progra
ams that use animals
ain deve
eloping a frammework of resp
ponsibility
annd oversight to ensure the appropriate
e use of animmals. They m
may also servve as aninnternational beenchmark for countries
cwith well-develope
ed animal-base
ed research pprograms.
As noted in 198
85, there are vaarying approaches in differe
ent countries too the use of an
nimals forreesearch, testinng and teaching purposes. By
B applying thee these Guidinng Principles aand otherdoocuments withh more specificc standards off care, each coountry can devvelop a detailed system
off guidelines orr regulations th
hat is commen
nsurate with na
ational custom
ms and social ppractices.
The use of animals in resea
arch, educatioon and testingg is an essen
ntial component of theaddvancement ofo our understtanding about human and aanimal functio
on. This know
wledge isim
mportant for ad
dvancing hum
man and anima
al health and welfare through disease prrevention
annd cures, neww treatments, and drug andd device devellopment. Thee scientific community,
unnderstanding that using aniimals is a privvilege entruste
ed by society, remains com
mmitted toen
nsuring the heealth and welffare of animalls as an integ
gral considerattion when animals areus
sed for these purposes.
pDeceember 2012

INTERRNATIONAL GUIDING P RINCIPLESSFOOR BIOMEDDICAL RESE
EARCH INVVOLVING ANNIMALS

wing principles should be use
ed by the interrnational scien
ntific community to guide thee responsible use
The followof vertebra
ate animals in scientific and//or educationa
al activities.

I.

The advancement of scientific knowledge is important fo
or improveme
ent of human aand animal heealthannd welfare, coonservation off the environm
ment, and the ggood of socieety. Animals p
play a vital rolle inth
hese scientific activities andd good animal welfare is inttegral to achie
eving scientificc and educatio
onal
gooals. Decisio
ons regarding
g the welfare, care, and usse of animals should be gu
uided by scien
ntifickn
nowledge and professional judgment, reflect ethical annd societal values, and conssider the poten
ntialbeenefits and thee impact on th
he well-being ofo the animals involved.

II.

mals for scien
ntific and/or ed
ducational pur poses is a pri vilege that caarries with it m
moral
The use of anim
bligations and responsibilitie
es for institutions and individ uals to ensuree the welfare oof these animals toobth
he greatest ex
xtent possible
e. This is bes
st achieved inn an institutio
on with a culture of care andcoonscience in whichw
individua
als working with animals wil lingly, delibera
ately, and con
nsistently act inn anetthical, humanee and complia
ant way. Instittutions and ind
dividuals usingg animals havve an obligatio
on todeemonstrate reespect for animmals, to be res
sponsible andd accountable for their decissions and actions
peertaining to animal welfare, care and us
se, and to enssure that the highest standdards of scien
ntificinntegrity prevail.

III.

Animals shouldd be used only
y when necessary and onlyy when their use is scientificcally and ethiccallyju
ustified. The principles of thetThree Rs – Replaceme
ent, Reductionn and Refinem
ment – shouldd bein
ncorporated intto the design anda conduct off scientific and /or educationa
al activities tha
at involve animmals.
Scientifically soound results and avoidance of unnecessa
ary duplicationn of animal-ba
ased activities arechieved throug
gh study and understandingug of the scienti fic literature a nd proper exp
perimental dessign.
acWhenW
no alternnative methodss, such as ma
athematical moodels, computter simulation, in vitro biolog
gicalsyystems, or oth
her non-animaal (adjunct) app
proaches, aree available to rreplace the usse of live animmals,thhe minimum nu
umber of animmals should bee used to achi eve the scientific or educattional goals. CCost
annd convenienc
ce must not ta
ake precedenc
ce over these pprinciples.

IV.

Animals selecte
ed for the activ
vity should be suitable for th e purpose andd of an approp
priate species andge
enetic backgro
ound to ensurre scientific va
alidity and rep
producibility. T
The nutritional, microbiological,
annd general heealth status ass well as the physiologicalpaand behaviora
al characteristiics of the animmalsshhould be appropriate to the planned use asa determinedd by scientific and veterinaryy medical exp
perts
annd/or the scien
ntific literaturee.

V.

d welfare of animalsashould be primaryy consideratio
ons in decisio
ons regarding theThe health andcal care to inc
clude animal aacquisition andd/or productioon, transportattion,
prrogram of veterinary medichuusbandry and management, housing, resttraint, and fina
al disposition oof animals, whhether euthanaasia,
reehoming, or release. Mea
asures should be taken to ensure that the animals’ environment andmals’ well-being.
management
mare appropriate
e for the specie
es and contrib
bute to the animVI.

ntist
are, and use ofo animals sho
ould be under the supervisio
on of a veterinnarian or scien
The welfare, ca
ained and ex
xperienced in the health, welfare,w
prope
er handling, aand use of th
he species beeingtramaintained
mor studied.
sThe inndividual or team responsib le for animal w
welfare, care aand use shouldd beinnvolved in the developmentt and mainten
nance of all a
aspects of thee program. AAnimal health andwelfarew
should be continuous
sly monitored and assessedd with measures to ensure that indicatorrs ofpootential suffering are prompttly detected annd managed. A
Appropriate ve
eterinary care should alwayss beavvailable and provided as necessary by a veterinarian.
v

Deceember 2012

INTERRNATIONAL GUIDING P RINCIPLESSFOOR BIOMEDDICAL RESE
EARCH INVVOLVING AN
NIMALSVII.

In
nvestigators shhould assume that procedurees that would ccause pain or distress in humman beings caausepaain or distress in animals, unnless there is evidence
eto thhe contrary. Thus, there is a moral impera
ativetoo prevent or minimize streess, distress, discomfort, aand pain in animals, consistent with sooundsccientific or vetterinary medic
cal practice. Taking into a
account the reesearch and e
educational gooals,
morem
than mommentary or minimal pain and//or distress in aanimals shoul d be managed
d and mitigatedd byreefinement of experimental techniques and/or app
propriate seda
ation, analge
esia, anestheesia,
noon-pharmacological interven
ntions, and/or other palliativve measures ddeveloped in cconsultation wiith aquualified veterinnarian or scien
ntist. Surgica
al or other paiinful procedure
es should not be performedd onunnanesthetizedd animals.

VIII.

t
intervenntions should beb established
d for both hummane and expe
erimental reaso
ons.
Endpoints and timely
Humane endpo
oints and/or interventions shhould be estab
blished before
e animal use b
begins, shouldd beasssessed throu
ughout the cou
urse of the study, and shoul d be applied aas early as po
ossible to prevvent,ammeliorate, or minimize
munne
ecessary and//or unintended
d pain and/or distress. An
nimals that woould
ottherwise suffer severe or chhronic pain, disstress, or disco
omfort that ca
annot be relievved and is not partoff the experime
ental design, should
sbe rem
moved from thee study and/orr euthanized uusing a proced
dure
ap
ppropriate for the species and condition ofo the animal.

IX.

sibility of the innstitution to en
nsure that perrsonnel respon
nsible for the w
welfare, care, andIt is the respons
se of animals
s are appropriately qualified
d and compettent through training and experience for theus
prrocedures theey perform. AdequateA
opp
portunities sho
ould be proviided for on-gooing training anded
ducation in thee humane andd responsible treatment of aanimals. Instittutions also are responsible
e forsu
upervision of personnel
pto ensureeproficiency and the u se of appropriiate procedurees.

X.

WhileW
implementation of theese Principles may vary fro
om country too country accoording to cultuural,ec
conomic, religious, and social factors, a system
sof anim
mal use oversiight that verifie
es commitmen
nt tothhe Principles shouldsbe impllemented in ea
ach country. TThis system sshould include
e a mechanism
m for
auuthorization (ssuch as licensing or registerring of instituti ons, scientist,, and/or projeccts) and overssightwhichw
may be assessed
aat thhe institutionall, regional, andd/or national level. The ove
ersight framew
workshhould encomp
pass both ethical review off animal use aonsiderations related to aniimalas well as cowelfarewand care. It should promote a harm-benefit an alysis for anim
mal use, balanncing the beneefitsdeerived from thee research or educationaleac
ctivity with the potential for p
pain and/or disttress experienncedbyy the animal. Accurate reccords should be maintaine d to documen
nt a system oof sound program
management,mresearchr
overssight, and adequate veterina
ary medical caare.

AD HOC COM
MMITTEE TO REVISE
E THE INTERNATIONNAL GUIDING PRINC
CIPLES
CO-CHAIRS:
ood, International Union of Basic and Clinical Pharma
acology and Goverrning Board membber of the International Council for
Dr JR Haywo
Laborattory Animal Scienc
ceDr Cecilia Ca
arbone, Argentine National Memberr and former Secre
etary of the Interna
ational Council forr Laboratory Animaal Science
MEMBERS:Dr Kathryn Bayne,
BAssociationn for Assessment anda Accreditation of Laboratory Animal Association ofmal Care Internatiional, Internationa
Collegees of Laboratory Animal Medicine, In
nstitute for Laborattory Animal Reseaarch
Dr Marianne Geiser, Presidentt of the Ethics Com
mmittee for Animal Experiments of thhe Swiss Academmies of Arts and ScciencesDr Noriyuki Kasai,K
Vice-presideent & Secretary General of the Asian Federation of La
aboratory Animal S
Science Associations
Dr Gemma Perretta,P
former Prresident of Federa
ation of European Laboratory
LAnimaal Science Associaations, National Re
esearch Council oof Italy
Dr Margaret Rose, Australian National
N
Health an
nd Medical Research Council
Dr Peter Suteer, former Presideent of the Swiss Ac
cademy of Medica
al Science
EDITOR-IN-CH
HIEF:
Ms Molly Gre
eene, IACUC 101
EX OFFICIO:Dr Gilles Dem
mers, former President of the Interna
ational Council forr Laboratory Animaal ScienceDeceember 2012