AAALAC International leads the way in global accreditation for ...

Association for Assessment and Accreditation of Laboratory Animal Care InternationalaaalacupdateGlobalaccreditationfor animalresearchWhere science and responsible animal care connect. Summer 2006AAALAC International leads the wayin global accreditation for laboratoryanimal care and researchScience has always been an international endeavor. Inter-country collaborations andworldwide dissemination of research have been common practice for many, many years.For scientists all over the world who are engaged in biomedical research, the use of animals continuesto play a critical role in their discoveries. But it has onlybeen in the last decade or so that research institutionshave started to pay serious attention to the need for highinternational standards for animal research. This desire tofind some mechanism for “harmonizing” animal care andresearch standards from country to country has receivedmuch attention.cover pg. three pg. four pg. sixAAALACoffers “preaccreditation”assessmentsAAALAC International is gaining recognition as a viablemeans of providing this international standard. AAALACInternational accreditation is a performance-based,peer review program that encourages consistent,high-quality animal care and use—withoutimposing rigid engineering standards, andwhile respecting the laws and regulationsthat already exist in the country.AAALAC International is the onlyinternational program for animalresearch that is awardingaccreditation based on a globalstandard. For this reason, thereare now more than 700 researchinstitutions in 28 countries thathave earned AAALAC Internationalaccreditation. Many of these institutionsnote that the international nature of theAAALAC accreditation credential is atremendous asset, especially when collaborating withinstitutions in other countries.“Because science has no borders, AAALAC International accreditationmakes tremendous sense, especially for research institutions hoping toWhat is theAAALACstandard?Ad hocConsultantsadd expertiseto site visitsPacificRimIssue!continued next page ...

Summer 2006collaborate with scientists in other countries,” says John G.Miller, D.V.M., Executive Director of AAALAC International.“Earning AAALAC accreditation provides an assurancethat certain quality standards are being met from institutionto institution, and from country to country.”More information on applying for AAALAC Internationalaccreditation can be found online at www.aaalac.org.•Pacific Rim countries/localeswith accredited programsThis list includes the year in which an organization in eachcountry first earned AAALAC International accreditation …Philippines 1995Indonesia 1996Korea 1998Thailand 1999Taiwan, R.O.C. 2000Hong Kong 2005Japan 2005Peoples Republic of China 2006Institutions currently accreditedby AAALAC International include:Development Center for BiotechnologyXizhi City, Taipei CountyTAIWAN/R.O.C.INA Research Inc.INA Research Inc., Testing FacilityNagano, JAPANINA Research PhilippinesINARP-LTI, Biñan, LagunaPHILIPPINESINA Research PhilippinesPrimate Quality Control Center, Biñan, LagunaPHILIPPINESKorea Food and Drug AdministrationSeoul, KOREAKorea Institute of ToxicologyDaejeon, KOREANaval Medical Research CenterU.S. Naval Medical Research Unit No. 2 (NAMRU-2)Jakarta, INDONESIANext Century IncorporatedNanjing/Jiangsu, P.R. CHINASamsung Medical CenterSamsung Biomedical Research InstituteSeoul, KOREASICONBREC, Inc.Makati City, PHILIPPINESSungkyunkwan UniversitySungkyunkwan University School of MedicineSuwon, KOREA“AAALAC accreditation has not onlyprovided international measuresto evaluate our animal care anduse program, but also a channel ofinformation and opportunity whichmade us improve in our field in aninternationally acceptable manner.”Takashi Hayashi, President & Chief Operating OfficerINA RESEARCH PHILIPPINES, INC.The University of Hong KongLaboratory Animal UnitHong Kong, CHINAWalter Reed Army Institute of ResearchU.S. Army Medical Component-Armed ForcesResearch Institute of Medical SciencesBangkok, THAILANDYonsei UniversityCollege of MedicineSeoul, KOREA

AAALAC International’s “Program Status Evaluation”provides pre-accreditation assessmentsThe AAALACInternational ProgramStatus Evaluation (PSE)is a completely confidentialpeer review that helpsassess the quality of allaspects of your animalresearch, teaching or testingprogram, including animalhusbandry, veterinarycare, institutional policies,and the facilities whereanimals are housed andused. This review serviceis available to institutionsprior to participating inthe AAALAC Internationalaccreditation program.In recent years, researchinstitutions in China, Japanand Singapore haveparticipated in ProgramStatus Evaluations.AAALAC International offersProgram Status Evaluations tonon-accredited institutions thatwant a “pre-accreditation” sitevisit.aaalac updateThe PSE not only promotesthe well-being of laboratoryanimals, it helps validatethe results of research usinganimals. Of note, it canalso serve as the first step toward achieving AAALACInternational accreditation.AAALAC International offers Program Status Evaluations tonon-accredited institutions that want a “pre-accreditation”site visit. These institutions are sometimes less familiar withthe accreditation process and want to find out how theirprograms compare to AAALAC International standardsbefore engaging in the formal accreditation program,and the results of the PSE are not shared with AAALAC’sCouncil on Accreditation. Indeed, the conduct of a PSE iskept completely confidential.The PSE service assists institutions in determining if theiranimal care and use programs meet AAALAC Internationalstandards by identifying weaknesses and suggestingways to improve or correct them. It also helps familiarizeinstitutions with the AAALAC International accreditationprocess and encourages them to participate.AAALAC International’s PSE service is available tocompanies, universities, hospitals, and other researchfacilities around the world who are not accredited. ThePSE includes a comprehensive, on-site evaluationby AAALAC International professionals. A detailedwritten report with recommendations is provided afterthe on-site evaluation.A PSE determines where your program stands interms of meeting AAALAC International standards.Although a PSE does not guarantee accreditationfollowing any future accreditation site visit, it willgive you a sound understanding of the AAALACInternational peer-review process and what anaccreditation site visit team will expect. It willalso identify areas that future site visit teamsand the Council on Accreditation are likely tonote as needing improvement prior to receivingaccreditation.More information is available on AAALACInternational’s web site, www.aaalac.org/programstatus/index.cfm, or by contacting Dr.Kathryn Bayne, Senior Director and Director ofPacific Rim Activities for AAALAC International, atkbayne@aaalac.org.•

Summer 2006What is the “AAALAC Standard,”and how is it applied around the world?by Kathryn Bayne, M.S., Ph.D., D.V.M.Senior Director and Director of Pacific Rim Activities for AAALAC InternationalSometimes people mistakenly believe that AAALACInternational creates its own set of standards forevaluating animal care and use programs. Instead,AAALAC applies a combination of existing, sciencebasedstandards and a peer-review process to create the“AAALAC Standard” which programs must meet in order toearn AAALAC International accreditation.The GuideThe Guide for the Care and Use of Laboratory Animals(Guide), NRC 1996, is the standard most widelyrecognized throughout the global laboratory animalscience community.The Guide is theprincipal standardused by AAALACInternational and theU.S. Public HealthService (PHS) inevaluating animalcare and use. Eachof the seven editionsof the Guide hasbenefited greatlyfrom the input ofscientists, with itsguidance based on“published data,scientific principles,expert opinion and experience with methods and practicesthat have proved to be consistent with high-quality, humaneanimal care and use.”This scientific support for the Guide’s recommendations—from peer-reviewed data to experiential evidence—hasundoubtedly contributed to its widespread acceptance bythe laboratory animal and general scientific communities.Its usefulness as an international standard is demonstratedby the fact that the Guide has been translated into ninelanguages.While the Guide is the principal resource used byAAALAC to evaluate animal care and use programs allover the world, AAALAC fully recognizes each country’sown laws and regulations, and in its reviews of animalcare and use programs, combines the principles of theGuide with the country’s legal standards.AAALAC uses avariety of existingstandards andguides when itassesses animal programs. And while the Guide is ourprincipal standard and we apply its provisions andprinciples world-wide, the Guide is intentionally written ingeneral terms to allow flexibility in its application. Giventhe Guide’s emphasis on performance as a measure ofsuccess, situations naturally occur in which professionaljudgments differ.AAALAC International’sReference ResourcesThe Guide hasbenefited greatly fromthe input of scientists ...To assist AAALAC International evaluators in thesesituations, we have developed a list of publications andother documents we call AAALAC’s “Reference Resources.”The full list is available at www.aaalac.org and includesreferences from Europe, Canada, and the United States.These resources are more specific than the Guide ina wide variety of areas, and in many cases provideexamples of appropriate outcomes. The Guide andAAALAC’s Reference Resources are all science based.Applying these standards internationallyNo program can become AAALAC accredited if it isin violation of local legal and regulatory requirements.AAALAC uses members of the Council on Accreditationand ad hoc Consultants who are familiar with thelocal requirements to ensure that those requirementsare being followed and applied. Once AAALAC issatisfied that these local baseline requirements are met,the Guide becomes the next standard to be applied.When local requirements are more stringent than Guiderecommendations, the former must be met in order toachieve accreditation.In some instances, the Guide includes provisions notaddressed in national or supranational animal welfarelegislation or regulations, e.g., in the area of occupationalhealth and safety. In such cases, two options areavailable. First, other local requirements may exist. Inthe absence of alternative local standards, the Guidestandards are used as the basis for evaluation in theseareas.

Peer review and professional judgmentFinally, the application of expert professional judgmentthrough the peer review process by the Council onAccreditation determines a program’s final accreditationstatus. To maintain consistency and uniformity of theAAALAC International Standard across diverse internationalsettings and standards, all principles of the Guide must bemet.But circumstances do occasionally arise for whichthere is no applicable published standard. In addition,professional judgments may differ regarding theacceptability of practices or procedures not specificallyaddressed in existing standards. In these circumstancesAAALAC looks to science for solutions. The Council looksfor published data in the area in question. When norelevant reports are located, scientific principles and expertopinion form the basis for resolution, with the final decisionoften informed by Council members’ experience withproven methods or practices.Thus, the AAALAC International Standard is not astatic document. In fact, it is not a single documentat all, but rather a compilation of many existingstandards, guidelines and policies that encompassall aspects of an animal care and use program. Themajority of these are science based—a fact thatnot only gives credence to those, like the AAALACInternational Council on Accreditation, who applythem within an accreditation program, but alsoleads to the greater likelihood of acceptance andimplementation by the scientists subject to theirprovisions.The AAALAC International Standard is, therefore, anevolutionary product, developing as internationallyrecognized standards are interpreted through thecollective professional judgment of animal care anduse experts, and applied through an in-depth, multilayeredscientific peer review process.•aaalac updateThe AAALAC InternationalStandard is, therefore, anevolutionary product,developing asinternationallyrecognized standardsare interpretedthrough thecollectiveprofessionaljudgmentof animalcare anduse experts,and appliedthrough anin-depth,multi-layeredscientific peerreview process.

Summer 2006Ad hoc Consultants from the Pacific Rim regionadd expertise to the site visit teamThe AAALAC International accreditation processinvolves a comprehensive review of an animal careand use program by a team of expert colleagues.Site visits are led by a member of AAALAC International’sCouncil on Accreditation. These evaluators areknowledgeable in the fields of laboratory animal scienceand medicine, and have a deep understanding of nationaland local legislation.Earning accreditation helps an institution demonstrateaccountability, provide an assurance of quality, showa commitment to continued improvement, and promoteanimal welfare and scientific validity. Today more than700 institutions in 28 countries (including eight Pacific Rimcountries/territories) have earned AAALAC Internationalaccreditation.Who are ad hoc Consultants?AAALAC International maintains a roster of more than 180“ad hoc Consultants and Specialists” who accompanyCouncil members on site visits and makerecommendations to the Council on Accreditation.Many of these Consultants have expertise intraditional laboratory animal medicine and science.Others have unique discipline competencies, such asapplied neuroscience, behavioral science, toxicology,pharmacology or physiology. These Specialists add depthto the site visit team, and understand the intricacies ofbalancing the research mission with animal well-being.Serving as an ad hoc Consultant is considered one of thebest continuing education and professional developmentopportunities available. In-person and online training areoffered to all new ad hoc Consultants prior to participatingin their first site visit.What are the responsibilitiesof an ad hoc Consultant?AAALAC International ad hoc Consultants assist withconducting site visits to institutions applying for or renewingtheir accreditation. The site visit includes meetings withkey personnel and a tour of their facilities. Site visitstypically last one or two days depending on the size of theinstitutional program.Ad hoc Consultants are responsible for readingbackground materials about the institution prior to the siteAAALAC Internationalis the only internationalprogram for animalresearch that is awardingaccreditation based on aglobal standard.

visit, then participating inall facets of the site visit. Adhoc Consultants may also beasked to assist in preparingthe written report, which issubmitted to the full Councilon Accreditation for review.Because the accreditationprocess is completelyconfidential, all ad hocConsultants must sign aconfidentiality agreement.How do I apply tobecome an AAALAC Internationalad hoc Consultant?To become an ad hoc Consultant, you must complete anapplication, which is available online at www.aaalac.org. New ad hoc Consultants are elected once a year,and applications should be submitted before 1 February.Completed applications should be e-mailed or faxed toDr. Kathryn Bayne at AAALAC International, kbayne@aaalac.org or fax +808.883.1155. If you would like toknow more about the accreditation process and the workinvolved, please contact Dr. Kathryn Bayne at kbayne@aaalac.org, or visit http://www.aaalac.org/about/adhoc_app.cfm.•“Benefits ofaccreditationby AAALACInternational”The following testimony was submitted by KenshiNakagawa of INA RESEARCH INC., Nagano, Japan...“INA Research Inc. [Japan] was fully accredited byAAALAC in February 2005. This provided us with twomajor benefits.First, awareness of animal welfare and occupationalhealth and safety has been raised in our company. Forexample, animal care and use programs are developedand managed by the Institutional Animal Care and UseCommittee (IACUC) of INA research Inc., and the studydirectors are now establishing study designs which morecarefully consider these programs.Second, the number of inquiries about our non-clinicalstudies from foreign pharmaceutical companies hasincreased by approximately 63% and the numberof contracts from these companies has increasedby approximately 120%. We have realized that fullaccreditation by AAALAC can be one of the key factorsfor foreign clients in selecting contract laboratories.For these reasons, we believe that AAALACaccreditation will greatly contribute to our business inthe future.”aaalac updateCurrent ad hoc Consultants for AAALAC International include …Jung Sik Cho, Ph.D.Director, Division of Laboratory Animal ResourcesNational Institute of Toxicological ResearchKorea Food and Drug AdministrationKOREAMontip Gettayacamin, D.V.M.Assistant ChiefResearch and Laboratory Animal MedicineUSAMC-AFRIMSTHAILANDJin Soo Han, D.V.M., Ph.D.Assistant ProfessorDepartment of Laboratory Animal MedicineCollege of Veterinary MedicineKonkuk UniversityKOREASang-Seop Han, Ph.D.PresidentKorea Institute of ToxicologyKOREANaoko Kagiyama, D.V.M., Ph.D.Research Fellow,RIKEN Center for Developmental BiologyAdvisor, Central Institute for Experimental AnimalsJAPANTsutomu Miki Kurosawa, D.V.M., Ph.D.Associate ProfessorThe Institute of Experimental Animal SciencesIEXAS Medical School, Osaka UniversityJAPANBryan E. Ogden, D.V.M.Head, Maccine Veterinary ServicesMaccine Pte. Ltd.SINGAPOREJeKyung Seong, M.S., Ph.D., D.V.M.Associate ProfessorCollege of Veterinary MedicineSeoul National UniversityKOREA

Association for Assessment and Accreditation of Laboratory Animal Care InternationalAAALAC supports PacificRim scientific meetingsAAALAC International is pleased to be an ongoingparticipant and supporter of scientific meetings throughoutPacific Rim countries. Here is a complete list of Pacific Rimmeetings in which AAALAC International has participated orwill participate in the months ahead …• Asian Federation of Laboratory Animal ScienceAssociations (AFLASA)• Australian and New Zealand Council for the Care ofAnimals in Research and Teaching (ANZCCART)• Chinese Association for Laboratory Animal Science(CALAS)• Japanese Association for Laboratory Animal Science(JALAS)•Korean Association for Laboratory Animal Science (KALAS)“The number of inquiries about ournon-clinical studies from foreignpharmaceutical companies hasincreased by approximately 63%and the number of contracts fromthese companies has increased byapproximately 120%. We haverealized that full accreditation byAAALAC International can be oneof the key factors for foreign clients inselecting contract laboratories.”—Kenshi NakagawaINA RESEARCH INC, Japan8Association for Assessmentand Accreditation ofLaboratory Animal CareInternationalEstablished in 1965, AAALAC International is a private, non-governmental organization that validates the quality ofanimal care and use programs and verifies that they meet or exceed national and international standards. AAALACInternational’s voluntary, confidential, peer-review accreditation process serves as a valuable adjunct to other qualityinitiatives and legislation, and is the only international accreditation for animal care and use programs.Institutions seeking AAALAC International accreditation receive a comprehensive review by an international team of expertevaluators who are knowledgeable in the fields of laboratory animal science and medicine, as well as national andlocal legislation. Institutions that meet or exceed applicable standards are awarded accreditation—a symbol of qualityassurance recognized around the world. More than 700 institutions in 28 countries,including eight Pacific Rim countries/territories, have earned AAALAC accreditation. Moreinformation is available on AAALAC International’s Web site at www.aaalac.org.Pacific Rim Office:68-3549 Makana Aloha PlaceWaikoloa, HI 96738+808.883.2186 tel+808.883.1155 faxEuropean Office:Avenue de Tervuren 4021150 Brussels, Belgium+32.2.761.6678 tel+32.2.761.6679 faxU.S. Office:11300 Rockville Pike, Suite 1211Rockville, Maryland 20852-3035+301.231.5353 tel+301.231.8282 faxaccredit@aaalac.org • www.aaalac.org