INTTERNA ATION NAL GUIDIN NG PRINCIIPLES S FOR F
BIOMEDI I ICAL RESEAR RCH INV VOLVIN NG ANIMALS DECEM MBER 201 2
COUNCIL FOR F INTERN NATIONAL ORGANIZATI O ION OF MED DICAL SCIEN NCES and THE INTE ERNATIONAL COUNCIL FOR LABOR RATORY AN NIMAL SCIEN NCE
INTER RNATIONAL GUIDING P RINCIPLES S BIOMED DICAL RESE EARCH INV VOLVING AN NIMALS PREAM MBLE
The International Guiding Prin nciples for Bio omedical Rese earch Involving g Animals has been the amework for the developme ent of laws, policies, and gui delines for ove When the fra er 25 years. W Guiding G Princip ples were writtten in 1985, the t profession n of laboratoryy animal mediicine and sc cience was still establishing best practices s and standarrds of care. O Over the years,, many of th hese practices and standards have becom me ingrained in n the oversightt structure of n numerous co ountries. Since the public cation of the original o Guidin ing Principles,, the scope o of animal re esearch has ex xpanded signiificantly, nume erous technolo ogical advance ements have o occurred, an nd societal atttention to the welfare w of rese earch animalss has increase ed. This evolu ution has prrompted an update u and expansion e of the focus of the Guiding Principles to address co ontemporary is ssues facing scientists s when n animals are used for rese earch and educcation. ernational Guiiding Principles s for Biomediccal Research In nvolving Anim mals is the The revised Inte esult of a parrtnership betw ween the Cou uncil for Interrnational Orga anizations forr Medical re Science (CIOM MS) and the International Council C for L Laboratory An imal Science (ICLAS) ormed to upda ate the Guiding g Principles. These T internattional organiza ations have a common fo mission m of advancing interrnational colla aboration in biomedical s ciences. The e revised do ocument is the outcome off an internatio onal collaborattion of scientissts, veterinarians, and otther experts whose w ideas and suggestio ons were gatthered from m more than 10 different meetings m held in conjunction n with several scientific co nferences aro ound the world over a pe eriod of more than t 3 years. Discussions were w based on n the Statemen nts of Principle es for the Use of Animals from over 30 3 profession nal societies, organizations, and countrie es. The working w group had an intern national and in nterdisciplinary ry membership p representing g several piivotal stakeholder professional organizatio ons. nternational Guiding G Princip ples for Biom medical Resea arch Involving Animals The revised In eflect congruen nce with the more m specific guidance offere ed by other national and inte ernational re ag gencies. Th hese Guiding Principles will be a touch hstone for countries with e emerging re esearch and te eaching progra ams that use animals a in deve eloping a fram mework of resp ponsibility an nd oversight to ensure the appropriate e use of anim mals. They m may also servve as an in nternational be enchmark for countries c with well-develope ed animal-base ed research p programs. As noted in 198 85, there are va arying approaches in differe ent countries to o the use of an nimals for re esearch, testin ng and teaching purposes. By B applying the e these Guidin ng Principles a and other do ocuments with h more specific c standards off care, each co ountry can devvelop a detailed system off guidelines orr regulations th hat is commen nsurate with na ational custom ms and social p practices. The use of animals in resea arch, educatio on and testing g is an essen ntial component of the ad dvancement of o our understtanding about human and a animal functio on. This know wledge is im mportant for ad dvancing hum man and anima al health and welfare through disease prrevention an nd cures, new w treatments, and drug and d device devellopment. The e scientific community, un nderstanding that using aniimals is a priv vilege entruste ed by society, remains com mmitted to en nsuring the he ealth and welffare of animalls as an integ gral considerattion when animals are us sed for these purposes. p
Dece ember 2012
INTER RNATIONAL GUIDING P RINCIPLES S BIOMED DICAL RESE EARCH INV VOLVING AN NIMALS
wing principles should be use ed by the interrnational scien ntific community to guide the e responsible use The follow of vertebra ate animals in scientific and//or educationa al activities.
The advancement of scientific knowledge is important fo or improveme ent of human a and animal he ealth an nd welfare, co onservation off the environm ment, and the g good of socie ety. Animals p play a vital rolle in th hese scientific activities and d good animal welfare is inttegral to achie eving scientificc and educatio onal go oals. Decisio ons regarding g the welfare, care, and usse of animals should be gu uided by scien ntific kn nowledge and professional judgment, reflect ethical an nd societal values, and conssider the poten ntial be enefits and the e impact on th he well-being of o the animals involved.
mals for scien ntific and/or ed ducational pur poses is a pri vilege that ca arries with it m moral The use of anim bligations and responsibilitie es for institutions and individ uals to ensure e the welfare o of these animals to ob th he greatest ex xtent possible e. This is bes st achieved in n an institutio on with a culture of care and co onscience in which w individua als working with animals wil lingly, delibera ately, and con nsistently act in n an etthical, humane e and complia ant way. Instittutions and ind dividuals using g animals havve an obligatio on to de emonstrate re espect for anim mals, to be res sponsible and d accountable for their decissions and actions pe ertaining to animal welfare, care and us se, and to enssure that the highest stand dards of scien ntific in ntegrity prevail.
Animals should d be used only y when necessary and onlyy when their use is scientificcally and ethiccally ju ustified. The principles of the t Three Rs – Replaceme ent, Reduction n and Refinem ment – should d be in ncorporated intto the design and a conduct off scientific and /or educationa al activities tha at involve anim mals. Scientifically so ound results and avoidance of unnecessa ary duplication n of animal-ba ased activities are chieved throug gh study and understanding u g of the scienti fic literature a nd proper exp perimental dessign. ac When W no altern native methods s, such as ma athematical mo odels, computter simulation, in vitro biolog gical sy ystems, or oth her non-anima al (adjunct) app proaches, are e available to rreplace the usse of live anim mals, th he minimum nu umber of anim mals should be e used to achi eve the scientific or educattional goals. C Cost an nd convenienc ce must not ta ake precedenc ce over these p principles.
Animals selecte ed for the activ vity should be suitable for th e purpose and d of an approp priate species and ge enetic backgro ound to ensurre scientific va alidity and rep producibility. T The nutritional, microbiological, an nd general he ealth status as s well as the physiological p a and behaviora al characteristiics of the anim mals sh hould be appropriate to the planned use as a determined d by scientific and veterinaryy medical exp perts an nd/or the scien ntific literature e.
d welfare of animals a should be primaryy consideratio ons in decisio ons regarding the The health and cal care to inc clude animal a acquisition and d/or productio on, transportattion, prrogram of veterinary medic hu usbandry and management, housing, resttraint, and fina al disposition o of animals, wh hether euthana asia, re ehoming, or release. Mea asures should be taken to ensure that the animals’ environment and mals’ well-being. management m are appropriate e for the specie es and contrib bute to the anim
ntist are, and use of o animals sho ould be under the supervisio on of a veterin narian or scien The welfare, ca ained and ex xperienced in the health, welfare, w prope er handling, a and use of th he species be eing tra maintained m or studied. s The in ndividual or team responsib le for animal w welfare, care a and use should d be in nvolved in the developmentt and mainten nance of all a aspects of the e program. A Animal health and welfare w should be continuous sly monitored and assessed d with measures to ensure that indicatorrs of po otential suffering are prompttly detected an nd managed. A Appropriate ve eterinary care should alwayss be av vailable and provided as necessary by a veterinarian. v
Dece ember 2012
INTER RNATIONAL GUIDING P RINCIPLES S BIOMED DICAL RESE EARCH INV VOLVING AN NIMALS
In nvestigators sh hould assume that procedure es that would ccause pain or distress in hum man beings ca ause pa ain or distress in animals, un nless there is evidence e to th he contrary. Thus, there is a moral impera ative to o prevent or minimize stre ess, distress, discomfort, a and pain in animals, consistent with so ound sc cientific or vetterinary medic cal practice. Taking into a account the re esearch and e educational go oals, more m than mom mentary or minimal pain and//or distress in a animals shoul d be managed d and mitigated d by re efinement of experimental techniques and/or app propriate seda ation, analge esia, anesthe esia, no on-pharmacological interven ntions, and/or other palliativve measures d developed in cconsultation wiith a qu ualified veterin narian or scien ntist. Surgica al or other paiinful procedure es should not be performed d on un nanesthetized d animals.
t interven ntions should be b established d for both hum mane and expe erimental reaso ons. Endpoints and timely Humane endpo oints and/or interventions sh hould be estab blished before e animal use b begins, should d be as ssessed throu ughout the cou urse of the study, and shoul d be applied a as early as po ossible to prevvent, am meliorate, or minimize m unne ecessary and//or unintended d pain and/or distress. An nimals that wo ould ottherwise suffer severe or ch hronic pain, dis stress, or disco omfort that ca annot be relievved and is not part off the experime ental design, should s be rem moved from the e study and/orr euthanized u using a proced dure ap ppropriate for the species and condition of o the animal.
sibility of the in nstitution to en nsure that perrsonnel respon nsible for the w welfare, care, and It is the respons se of animals s are appropriately qualified d and compettent through training and experience for the us prrocedures the ey perform. Adequate A opp portunities sho ould be proviided for on-go oing training and ed ducation in the e humane and d responsible treatment of a animals. Instittutions also are responsible e for su upervision of personnel p to ensure e proficiency and the u se of appropriiate procedure es.
While W implementation of the ese Principles may vary fro om country to o country acco ording to cultu ural, ec conomic, religious, and social factors, a system s of anim mal use oversiight that verifie es commitmen nt to th he Principles should s be impllemented in ea ach country. T This system sshould include e a mechanism m for au uthorization (s such as licensing or registerring of instituti ons, scientist,, and/or projeccts) and overssight which w may be assessed a at th he institutionall, regional, and d/or national level. The ove ersight framew work sh hould encomp pass both ethical review off animal use a onsiderations related to aniimal as well as co welfare w and care. It should promote a harm-benefit an alysis for anim mal use, balan ncing the bene efits de erived from the e research or educational e ac ctivity with the potential for p pain and/or disttress experien nced by y the animal. Accurate rec cords should be maintaine d to documen nt a system o of sound program management, m research r overs sight, and adequate veterina ary medical ca are.
AD HOC COM MMITTEE TO REVISE E THE INTERNATION NAL GUIDING PRINC CIPLES CO-CHAIRS: ood, International Union of Basic and Clinical Pharma acology and Goverrning Board memb ber of the International Council for Dr JR Haywo Laborattory Animal Scienc ce Dr Cecilia Ca arbone, Argentine National Memberr and former Secre etary of the Interna ational Council forr Laboratory Anima al Science MEMBERS: Dr Kathryn Bayne, B Association n for Assessment and a Accreditation of Laboratory Anim al Association of mal Care Internatiional, Internationa College es of Laboratory Animal Medicine, In nstitute for Laborattory Animal Resea arch Dr Marianne Geiser, Presidentt of the Ethics Com mmittee for Animal Experiments of th he Swiss Academ mies of Arts and Scciences Dr Noriyuki Kasai, K Vice-preside ent & 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 L Anima al Science Associa ations, National Re esearch Council o of Italy Dr Margaret Rose, Australian National N Health an nd Medical Research Council Dr Peter Sute er, former Preside ent 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 Anima al Science
Dece ember 2012
Published on May 22, 2014
The 1985 International Guiding Principles for Biomedical Research Involving Animals have been revised by an ad hoc committee appointed by th...