INTTERNAATIONNAL GUIDINNG PRINCIIPLESSFORBIOMEDIICAL RESEAR
RCH INVVOLVINNG ANIMALS
DECEM
MBER 2012

COUNCIL FOR INTERNNATIONAL ORGANIZATIION OF MED
DICAL SCIEN
NCESandERNATIONAL COUNCIL FOR LABORRATORY AN
NIMAL SCIENNCETHE INTEINTERRNATIONAL GUIDING P RINCIPLESSFOOR BIOMEDDICAL RESE
EARCH INVVOLVING ANIMALS
PREAM
MBLE

The International Guiding Prin
nciples for Bio
omedical Reseearch Involving
g Animals has been theamework for the developme
ent of laws, policies, and guidelines for ove
er 25 years. When thefra
Guiding Princip
ples were writtten in 1985, the professionn of laboratoryy animal mediicine andcience was still establishing best practicess and standarrds of care. O ver the years,, many ofscthhese practices and standards have becom
me ingrained inn the oversightt structure of numerous
ountries. Since the public
cation of the original Guidin
ing Principles,, the scope of animal
coesearch has ex
xpanded signiificantly, numeerous technolo
ogical advanceements have occurred,
rend societal atttention to the welfare of reseearch animalss has increase
ed. This evolu
ution has
anprrompted an update and expansion of the focus of the Guiding Principles to address
ontemporary isssues facing scientists whenn animals are used for reseearch and educcation.
coThe revised Inte
ernational Guiding
iPrinciples
s for Biomediccal Research In
nvolving Animmals is theesult of a parrtnership betw
ween the Cou
uncil for Interrnational Orgaanizations forr MedicalreMS) and the International Council for L aboratory Animal Science (ICLAS)
Science (CIOM
ormed to upda
ate the Guidingg Principles. These internattional organiza
ations have a common
fomission of advancing interrnational collaaboration in biomedical sciences. Thee revisedocument is the outcome off an internatio
onal collaborattion of scientissts, veterinarians, anddo
ons were gatthered from more than 10 different
otther experts whose ideas and suggestio
meetings held in conjunction
n with several scientific co nferences aro
ound the world over ape
eriod of more than 3 years. Discussions were based onn the Statemen
nts of Principle
es for thenal societies, organizations, and countrie
es. TheUse of Animals from over 30 profession
working group had an intern
national and in
nterdisciplinary
ry membershipp representing
g severalons.
piivotal stakeholder professional organizatio
The revised In
nternational Guiding Princip
ples for Biom
medical Reseaarch Involving Animals
eflect congruen
nce with the more specific guidance offere
ed by other national and inte
ernational
regencies.
Th
hese Guiding Principles will be a touch
hstone for countries with emerging
ag
esearch and teeaching progra
ams that use animals in deve
eloping a frammework of resp
ponsibility
rend oversight to ensure the appropriate
e use of animmals. They may also servve as anannternational beenchmark for countries with well-develope
ed animal-base
ed research programs.
inAs noted in 198
85, there are vaarying approaches in differe
ent countries too the use of an
nimals foresearch, testinng and teaching purposes. By applying thee these Guidinng Principles and otherreocuments withh more specificc standards off care, each coountry can devvelop a detailed systemdo
hat is commen
nsurate with na
ational custom
ms and social practices.
off guidelines orr regulations th
The use of animals in resea
arch, educatioon and testingg is an essen
ntial component of thedvancement of our understtanding about human and a nimal functio
on. This know
wledge isad
mportant for ad
dvancing hum
man and anima
al health and welfare through disease prrevention
imnd cures, neww treatments, and drug andd device devellopment. Thee scientific community,
annderstanding that using aniimals is a priv
vilege entruste
ed by society, remains com
mmitted tounnsuring the heealth and welffare of animalls as an integ
gral considerattion when animals areen
sed for these purposes.
usDeceember 2012

INTERRNATIONAL GUIDING P RINCIPLESSFOOR BIOMEDDICAL RESE
EARCH INVVOLVING ANIMALSThe follow
wing principles should be use
ed by the interrnational scien
ntific community to guide thee responsible use
ate animals in scientific and//or educationa
al activities.
of vertebra

I.

The advancement of scientific knowledge is important fo
or improveme
ent of human and animal heealthnd welfare, coonservation off the environm
ment, and the g ood of socieety. Animals play a vital rolle inanhese scientific activities andd good animal welfare is inttegral to achie
eving scientificc and educatio
onalthoals. Decisio
ons regarding
g the welfare, care, and usse of animals should be gu
uided by scien
ntificgonowledge and professional judgment, reflect ethical annd societal values, and conssider the poten
ntial
knenefits and thee impact on th
he well-being of the animals involved.
beII.

mals for scien
ntific and/or ed
ducational purposes is a pri vilege that caarries with it moral
The use of anim
bligations and responsibilitie
es for institutions and individuals to ensuree the welfare of these animals toob
he greatest ex
xtent possible
e. This is besst achieved inn an institutio
on with a culture of care andth
onscience in which individua
als working with animals wil lingly, delibera
ately, and con
nsistently act inn ancoe and complia
ant way. Instittutions and ind
dividuals usingg animals havve an obligatio
on toetthical, humaneemonstrate reespect for animmals, to be ressponsible andd accountable for their decissions and actions
deertaining to animal welfare, care and us
se, and to enssure that the highest standdards of scien
ntificpein
ntegrity prevail.

III.

Animals shouldd be used only
y when necessary and onlyy when their use is scientificcally and ethiccallyju
ustified. The principles of the Three Rs – Replaceme
ent, Reductionn and Refinem
ment – shouldd bencorporated intto the design and conduct off scientific and/or educationa
al activities tha
at involve animmals.
inound results and avoidance of unnecessa
ary duplicationn of animal-ba
ased activities are
Scientifically sochieved throug
gh study and understanding
g of the scienti fic literature and proper exp
perimental dessign.
acWhen no alternnative methodss, such as ma
athematical moodels, computter simulation, in vitro biolog
gicalystems, or oth
her non-animaal (adjunct) app
proaches, aree available to r eplace the usse of live animmals,sy
he minimum nu
umber of animmals should bee used to achieve the scientific or educattional goals. Costthnd convenienc
ce must not ta
ake precedencce over these p rinciples.
anIV.

Animals selecte
ed for the activ
vity should be suitable for the purpose andd of an approp
priate species andenetic backgro
ound to ensurre scientific va
alidity and rep
producibility. The nutritional, microbiological,gean
nd general heealth status ass well as the physiological a nd behaviora
al characteristiics of the animmalshould be appropriate to the planned use as determinedd by scientific and veterinaryy medical exp
perts
shnd/or the scien
ntific literaturee.
anV.

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

The welfare, ca
are, and use of animals sho
ould be under the supervisio
on of a veterinnarian or scienntist
ained and ex
xperienced in the health, welfare, prope
er handling, and use of th
he species beeingtramaintained or studied. The inndividual or team responsible for animal welfare, care and use shouldd benvolved in the developmentt and mainten
nance of all a spects of thee program. Animal health andinwelfare should be continuous
sly monitored and assessedd with measures to ensure that indicatorrs ofpootential suffering are prompttly detected annd managed. A ppropriate ve
eterinary care should alwayss bevailable and provided as necessary by a veterinarian.
avDeceember 2012

INTERRNATIONAL GUIDING P RINCIPLESSFOOR BIOMEDDICAL RESE
EARCH INVVOLVING ANIMALS
VII.

Innvestigators shhould assume that procedurees that would c ause pain or distress in hum
man beings ca
ause
ain or distress in animals, unnless there is evidence to th
he contrary. Thus, there is a moral impera
ativepao prevent or minimize streess, distress, discomfort, a nd pain in animals, consistent with sooundtocientific or vetterinary medic
cal practice. Taking into a ccount the reesearch and educational gooals,scmore than mom
mentary or minimal pain and//or distress in a nimals should be managed
d and mitigatedd byefinement of experimental techniques and/or app
propriate seda
ation, analge
esia, anestheesia,reon-pharmacological interven
ntions, and/or other palliativve measures developed in consultation wiith anoualified veterinnarian or scien
ntist. Surgica
al or other paiinful procedure
es should not be performedd onqunanesthetizedd animals.
unVIII.

Endpoints and timely interven
ntions should be established
d for both hummane and expe
erimental reasoons.
Humane endpo
oints and/or interventions shhould be estab
blished before
e animal use begins, shouldd bessessed throu
ughout the cou
urse of the study, and shoul d be applied a s early as po
ossible to prevvent,asmeliorate, or minimize unneecessary and//or unintended
d pain and/or distress. An
nimals that woouldamhronic pain, disstress, or disco
omfort that ca
annot be relievved and is not partottherwise suffer severe or ch
ental design, should be rem
moved from thee study and/orr euthanized using a proced
dure
off the experime
ppropriate for the species and condition of the animal.
apIX.

It is the respons
sibility of the innstitution to en
nsure that perrsonnel respon
nsible for the welfare, care, andse of animals
s are appropriately qualified
d and compettent through training and experience for theus
ey perform. Adequate opp
portunities sho
ould be proviided for on-gooing training andprrocedures theducation in thee humane andd responsible treatment of a nimals. Instittutions also are responsiblee foredupervision of personnel to ensure proficiency and the use of appropriiate procedure
es.
suX.

While implementation of theese Principles may vary fro
om country too country accoording to cultu
ural,conomic, religious, and social factors, a system of anim
mal use oversiight that verifie
es commitmen
nt toecthhe Principles should be impllemented in ea
ach country. T his system should include
e a mechanism
m foruthorization (ssuch as licensing or registerring of institutions, scientist,, and/or projeccts) and overssightauwhich may be assessed at th
he institutionall, regional, andd/or national level. The ove
ersight framew
work
hould encomp
pass both ethical review off animal use a s well as coonsiderations related to aniimal
shwelfare and care. It should promote a harm-benefit analysis for anim
mal use, balanncing the bene
efits
erived from thee research or educational acctivity with the potential for pain and/or disttress experien
nced
dey the animal. Accurate reccords should be maintained to documen
nt a system of sound program
bymanagement, research overs
sight, 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
ce
Laborattory Animal Scienc
Dr Cecilia Ca
arbone, Argentine National Memberr and former Secre
etary of the Interna
ational Council forr Laboratory Animaal Science
MEMBERS:Dr Kathryn Bayne, Associationn for Assessment and Accreditation of Laboratory Animal Association ofmal Care Internatiional, Internationa
es of Laboratory Animal Medicine, Innstitute for Laborattory Animal Reseaarch
CollegeDr Marianne Geiser, Presidentt of the Ethics Com
mmittee for Animal Experiments of thhe Swiss Academmies of Arts and Scciences
Dr Noriyuki Kasai, Vice-presideent & Secretary General of the Asian Federation of La
aboratory Animal Science Associations
Dr Gemma Perretta, former Prresident of Federa
ation of European Laboratory Animaal Science Associaations, National Re
esearch Council of Italy
Dr Margaret Rose, Australian National 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 Demmers, former President of the Interna
ational Council forr Laboratory Animaal ScienceDeceember 2012