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1、實驗動物的使用實驗動物的使用及及動物實驗管理小組介紹動物實驗管理小組介紹國家實驗動物中心張維正1Why do we need animal experiments?23nAnimal Rights is a philosophical view that animals have rights similar or the same as humans. nThere is no rational basis for saying that a human being has special rights. A rat is a pig is a dog is a boy. Theyre al
2、l mammals.nAnimal rights supporters reject all animal use, no matter how humane .nIngrid Newkirk, founder of People for the Ethical Treatment of Animals Animal rights 4Animal welfare n. a human responsibility that encompasses all aspects of animal well-being, including proper housing, management, nu
3、trition, disease prevention and treatment, responsible care, humane handling, and, when necessary, humane euthanasia.nThe American Veterinary Medical Association5What is laboratory animal?6What is laboratory animal?AWA: The term animal means live dogs, cats, monkeys (nonhuman primate mammals), guine
4、a pigs, hamsters, and rabbits.Guide: Laboratory animals include any vertebrate animal (e.g., traditional laboratory animals, farm animals, wildlife, and aquatic animals) used in research, teaching, or testing.7動動 物物 保保 護護 法法第一章總則n第三條 本法用詞定義如下： 一、動物：指犬、貓及其他人為飼養或管領之脊椎動物，包括經濟動物、實驗動物、寵物及其他動物。二、經濟動物：指為皮毛
5、、肉用、乳用、役用或其他經濟目的而飼養或管領之動物。三、實驗動物：指為科學應用目的而飼養或管領之動物。四、科學應用：指為教學訓練、科學試驗、製造生物製劑、試驗商品、藥物、毒物及移植器官等目的所進行之應用行為。 8Animal Protection Law第三章動物科學之應用 第十五條 使用動物進行科學應用，應儘量減少數目，並以使動 物產生最少痛苦及傷害之方式為之。 中央主管機關得依動物之種類訂定實驗動物之來源、 適用範圍及管理方法。 第十六條 進行動物科學應用之機構應組成動物實驗管理小組， 以督導該機構進行實驗動物之科學應用。 中央主管機關應設置實驗動物倫理委員會，以監督並 管理動物之科學應用
6、。 前項委員會至少應含獸醫師及民間動物保護團體代表 各一名。 動物實驗管理小組之組成、任務暨管理辦法與實驗動 物倫理委員會之設置辦法，由中央主管機關定之。9Animal Protection Law第十七條 科學應用後，應立即檢視實驗動物之狀況，如其已失 去部分肢體器官或仍持續承受痛苦，而足以影響其生 存品質者，應立即以產生最少痛苦之方式宰殺之。 實驗動物經科學應用後，除有科學應用上之需要，應 待其完全恢復生理功能後，始得再進行科學應用。 第十八條 國民中學以下學校不得進行主管教育行政機關所定課 程標準以外，足以使動物受傷害或死亡之教學訓練。10Animal Protection Law第五章
7、行政監督第二十三條 直轄市、縣(市)主管機關應置動物保護檢查人員，並得甄選義務動物保護員，協助動物保護檢查工作。 動物保護檢查人員得出入動物比賽、宰殺、繁殖、買賣、寄養、訓練、動物科學應用等場所，稽查、取締違反本法規定之有關事項。 對於前項稽查、取締，不得規避、拒絕或妨礙。動物保護檢查人員於執行職務時，應出示身分證明文件，必要時得請警察人員協助。 11動物實驗動物實驗管理小組設置辦法 (92.01.30修正) 第一條 本辦法依動物保護法（以下簡稱本法）第十六條第四項規定訂定之。 第二條 進行動物科學應用之機構，應組成動物實驗管理小組(以下簡稱管理小組)；由相關人員三至十五人組成，其中應包括獸醫
8、師或經中央主管機關指定動物實驗管理訓練合格專業人員。進行動物科學應用之機構應於管理小組組成後三十日內，將成員名冊報中央主管機關備查，異動時亦同。12動物實驗管理小組設置辦法 第三條 管理小組之任務如下：一、 審核該機構進行實驗動物之科學應用。 二、 提供該機構有關動物實驗設計之科學應用諮詢意見。 三、 提供該機構有關實驗動物飼養設施改善之建議。 四、 監督該機構實驗動物之取得、飼養、管理及應用等行為。 五、 提供該機構年度執行實驗動物科學應用之監督報告。 前項年度執行報告應於年度結束後三個月內報中央主管機關備查。 13動物實驗管理小組設置辦法 第四條 利用動物進行科學實驗者，其需採用之實驗動物
9、種類、 品種、數量及實驗設計應先申請，經管理小組審議核可， 始得進行。 第五條 本管理小組發現該機構進行實驗動物之科學應用，違反 本辦法相關規定時，經限期改善，逾期仍未改善者，得 終止其實驗動物之使用。 第六條 本辦法相關書表格式由中央主管機關定之。 第七條 本辦法發布後利用動物進行科學應用之機構，應於本辦 法施行後一年內，依本辦法之規定組成管理小組，逾期 未辦理者，依本法第二十九條處罰。 第八條 本辦法自發布日施行。14動物實驗管理小組設置辦法依據：動物實驗管理小組設置辦法第六條，訂定動物實驗申請表、年度動物實驗管理小組監督報告格式，如附件 ( )。 15動物科學應用機構查核輔導要點一、行政
10、院農業委員會(以下簡稱本會)為監督及管理動物之科學應用，並俾利動物科學應用機構之查核輔導，特訂定本要點。二、本要點之查核方式分內部查核及外部查核二種，內部查核由動物科學應用機構之動物實驗管理小組（以下簡稱管理小組）依據動物科學應用機構內部查核表（如附表一）所定項目每半年查核一次，查核結果如有缺失自行改進，並保存紀錄三年以上，該查核表應列為管理小組年度監督報告之附件。 外部查核由本會實驗動物倫理委員會委員以任務編組方式組成，並會同該轄區之直轄市或縣(市)政府動物保護檢查員、實驗動物相關專家及該機構目的事業主管機關代表，依據動物科學應用機構外部查核表（如附表二）實地查核輔導，以每年二十至四十場為辦
11、理原則。16動物科學應用機構查核輔導要點三、外部查核時，該科學應用機構之管理小組應備妥之相關文件如下：（一）管理小組成立、異動、作業流程與標準及會議等相關文件與規章。（二）歷年動物實驗申請表。（三）動物飼養管理標準作業程序相關文件。（四）歷年管理小組年度監督報告。（五）歷年本要點所附內部及外部查核表。171819202122How to treat animal well?nGoal of the Guide To promote the humane care of animals used in biomedical and behavioral research, teaching, a
12、nd testing.nObjective of the Guide enhance animal well-being, the quality of biomedical research, and the advancement of biologic knowledge that is relevant to humans or animals.2324Institutional Animal Care and Use Committee GuidebooknA. The IACUC A.1. Timeline, Background and HistoryA.2. Authority
13、, Composition and FunctionsA.3. Operation and AdministrationA.4. Training for MembersA.5. Legal Concerns25Institutional Animal Care and Use Committee GuidebookA.1. Timeline1950 Formal establishment of Animal Care Panel.1963 First edition of the Guide for the Care and Use of Laboratory Animals (Guide
14、) developed by the Animal Care Panel.1965 Incorporation of the American Association for the Accreditation of Laboratory Animal Care (AAALAC).1966 Congress passed the Laboratory Animal Welfare Act (PL 89-544) and the USDA was named the responsible agency.1967 Animal Care Panel changed its name to the
15、 American Association for Laboratory Animal Science (AALAS).1971 NIH Policy on Humane Care and Use of Laboratory Animals for PHS Supported Institutions.1973 First Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals.1979 PHS Policy required each animal-using grantee instit
16、ution to have a PHS Assurance and a committee to maintain oversight of its animal care program.1985 Health Research Extension Act (P.L.99-158) passed by Congress.26Institutional Animal Care and Use Committee GuidebookA.1. Timeline (conti.)1985 Animal Welfare Act Amendments passed by Congress.1990 Th
17、e structure of the Office for Protection from Research Risks (OPRR) was changed to establish a Division of Animal Welfare.1992 First Institutional Animal Care and Use Committee Guidebook was developed ARENA and OPRR.1996 7th Edition of the Guide for the Care and Use of Laboratory Animals revised by
18、an ILAR committee and published by the NRC.1996 AAALAC became the Association for the Assessment and Accreditation of Laboratory Animal Care International.2000 OPRR Division of Animal Welfare was separated from OPRR and became the Office of Laboratory Animal Welfare (OLAW), NIH.2002 ARENA/OLAW Insti
19、tutional Animal Care and Use Committee Guidebook. Second edition.2728Program of Education and Training for New IACUC MembersObjectives1. To introduce members to the role of the IACUC and its evolution2. To provide the basic information necessary for IACUC members to discharge their responsibilities3
20、. To provide a forum for response to, and discussion of, members concerns and questions29Program of Education and Training for New IACUC MembersnSyllabusThe IACUC Genesis and chronologyU.S. Government PrinciplesCriteria for membershipAuthority of the IACUCProposal (protocol) submission and reviewIAC
21、UC review criteriaMonitoring of approved protocols30Program of Education and Training for New IACUC MembersProtocol changes (amendments)RecordsSemiannual reviewsHandling animal welfare concernsInstitutional Official (IO)Community31Program of Education and Training for IACUC MembersObjectives1. To in
22、crease members knowledge, understanding and awareness2. To keep members current on:Laws (federal, state, local)Regulations (proposed, promulgated/issued)GuidelinesDevelopments and trendsInstitutional policies3. To address issues, concerns and questions raised by IACUC members,institutional staff, an
23、d the community.32Program of Education and Training for IACUC MembersnSyllabusQuestions and concerns brought to the attention of the IACUCOfficial directivesPublicationsNotices of, and reports from, conferences, seminars, etc.Animal facility staff and/or veterinarians observations and recommendation
24、sFacility inspections and program evaluationsProblem situations33Institutional Animal Care and Use Committee GuidebooknB. Oversight of the Animal Care and Use ProgramB.1. Program and Facility ReviewB.2. Animal Environment, Housing and ManagementB.2.a. GeneralB.2.b. Animal EnvironmentB.2.c. Husbandry
25、B.2.d. Facility MaintenanceB.2.e. Emergency, Weekend and Holiday Care34Facility ReviewAll animal housing facilities must be inspected in the semiannual review.35Facility ReviewnCategories to be Inspected sanitation, food and water provisions, animal identification, waste disposal, animal health reco
26、rds, controlled and/or expired drugs, environmental control, occupational health and safety concerns, staff training, knowledge of applicable rules and regulations, and security.36B.2. Animal Environment, Housing and ManagementThe Guide states: Proper housing and management of animal facilities are
27、essential to animal well-being, to the quality of research data and teaching or testing programs in which animals are used, and to the health and safety of personnel. A good management program provides the environment, housing, and care that permit animals to grow, mature, reproduce, and maintain go
28、od health; provides for their well-being; and minimizes variations that can affect research results. Specific operating practices depend on many factors that are peculiar to individual institutions and situations. Welltrained and motivated personnel can often ensure high quality animal care, even in
29、 institutions with less than optimal physical plants or equipment.37Institutional Animal Care and Use Committee GuidebookB.2.f. Behavioral Management for Laboratory AnimalsB.3. Role of the VeterinarianB.4. Occupational Health and SafetyB.5. Personnel Training and EducationB.6. Emergency Preparedness
30、B.6.a. Security and Crisis ManagementB.6.b. Disaster Planning38B.3. Role of the Veterinariannimmunization against infectious pathogens;nsurveillance of colonies for specific infectious microbial agents;ndisease prophylaxis utilizing pharmaceutical agents;nisolation and quarantine of incoming animals
31、; andnseparate housing of animals according to species, source or different background microbial floras.39B.3. Role of the VeterinariannSpecific areas requiring the veterinarians attention and guidance are:the selection and utilization of suitable anesthetic and analgesic agents and methods of eutha
32、nasia;appropriate selection of species for research projects; andproper performance of surgical procedures and adequate preoperative, surgical, and post-operative care.40Occupational Health and Safety ProgramnTraining should include information about:zoonoses,chemical safety,microbiologic and physic
33、al hazards (e.g., allergens, radiation),hazards associated with experimental procedures,handling of waste materials, andpersonal hygiene.41424344Institutional Animal Care and Use Committee GuidebooknC. Review of Proposals C.1. Fundamental IssuesC.2. Protocol Review CriteriaC.2.a. Alternatives Replac
34、ement, Reduction and RefinementC.2.b. EuthanasiaC.2.c. Humane EndpointsC.2.d. Minimization of Pain and DistressC.2.e. Personnel QualificationsC.2.f. Veterinary Review and Consultation45The “3 Rs”nAlternatives are framed within the context of the “3 Rs” articulated originallyby Russell and Burch in 1
35、959; they include:1. Replacement, or utilizing non-animal models;2. Reduction of numbers of animals used; and3. Refinement, or elimination or reduction of unnecessary pain and distress in animals.46The following topics should be considered in the preparation and review of animal care and use protoco
36、ls:Rationale and purpose of the proposed use of animals. Justification of the species and number of animals requested. Whenever possible, the number of animals requested should be justified statistically. Availability or appropriateness of the use of less-invasive procedures, other species, isolated
37、 organ preparation, cell or tissue culture, or computer simulation (see Appendix A, Alternatives). Adequacy of training and experience of personnel in the procedures used. Unusual housing and husbandry requirements. Appropriate sedation, analgesia, and anesthesia. (Scales of pain or invasiveness mig
38、ht aid in the preparation and review of protocols; see Appendix A, Anesthesia, Pain and Surgery.) Unnecessary duplication of experiments. Conduct of multiple major operative procedures. Criteria and process for timely intervention, removal of animals from a study, or euthanasia if painful or stressf
39、ul outcomes are anticipated. Postprocedure care. Method of euthanasia or disposition of animal. Safety of working environment for personnel. 47Review of ProposalsnProposal Review Procedures Full committee review Designated member reviewnCategories of IACUC Actions Approval Modifications required to
40、secure approval Withhold approval Defer or table review4849Pain management50Do animals experience pain?nNo direct evidencenSubtle behavioural responsesComplex learning to avoid noxious stimuliSelf-administration of analgesics in chronic pain conditionsResponse to analgesicsnAssessment central51Why t
41、reat pain?nLegal and ethical reasonnBeneficial for the animalnBeneficial for reserachRapid return to normal functionA higher survival rateCounteract physiological changes Thoracic and abdominal pain affect ventilationReduction in food and water consumption52Pain managementnPrevention: preemptive app
42、roachnRecognition of painnChoice of substancenDrug dose and duration53Recognition of painnSigns to look forGeneral appearance and conditionAttitude, posture and movementsInteractions with cage matesReactions to manipulationFood and water consumptionProduction of faeces and urine Species-typical sign
43、s of pain and distressProcedure-specific signs5455Postoperative painnPeripheral sensitizationnCentral sensitizationAmplification of pain sensationnSurgeryInflammatory painNeuropathic painnPrevention by preemptive analgesia56Management of postoperative painnPreemptive analgesianGood surgical techniqu
44、e nSterile techniquenSupportive therapy Soft foodLong drinking nipplesSoft beddingWarm environmentnAvoid social isolation57nMinor proceduressingle dose of an opioid or NSAID sufficient (preoperatively when possible)nMore invasive surgeryContinue treatment for up to 24-36h nAfter major surgeryContinu
45、e analgesic administration for 36-72 hoursCombination therapyOpioidNSAIDLocal analgesia Management of postoperative pain cont. 58USDA classifications for pain-associated project59USDA classifications for pain-associated projectnClassification A: This category is no longer in use. nClassification B:n
46、Classification C:nClassification D:nClassification E:60USDA classifications for pain-associated projectnClassification B:Animals being bred, conditioned, or held for use in teaching, testing, experiments, research, or surgery, but not yet used for such purposes.61USDA classifications for pain-associ
47、ated projectnExamples:Breeding colonies of any animal species that are held in legal sized caging and handled in accordance with the Guide and other applicable regulations. Breeding colony includes parents and offspring. Newly acquired animals that are held in proper caging and handled in accordance
48、 with applicable regulations. Animals held under proper conditions or wild animals that are being observed.62USDA classifications for pain-associated projectnClassification C:Animal upon which testing, research, experiments, or tests will be conducted involving no pain, distress, or use of pain-reli
49、eving drugs.63USDA classifications for pain-associated projectnExamples:Procedures performed correctly by trained personal such as administration of electrolytes/fluids, administration of oral medication, blood collection from a common peripheral vein per standard veterinary practice or catherizatio
50、n of same, standard radiography, parenteral injections of non-irritating substances. Euthanasia performed in accordance with the recommendations of the most recent AVMA Panel on Euthanasia, utilizing procedures that produce rapid unconsciousness and subsequent humane death. 64USDA classifications fo
51、r pain-associated projectnClassification D:Animals upon which experiments, teaching, research, surgery, or tests will be conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drug will be used.65USDA classificati
52、ons for pain-associated projectnExamples:Surgical procedures conducted by trained personnel in accordance with standard veterinary practice such as biopsies, gonadectomy, exposure of blood vessels, chronic catheter implantation, laparotomy or laparoscopy. Blood collection by more invasive routes suc
53、h as intracardiac or periorbital collection from species without a true orbital sinus such as rats and guinea pigs. Administration of drugs, chemicals, toxins, or organisms that would be expected to produce pain or distress but which will be alleviated by analgesics. 66USDA classifications for pain-
54、associated projectnClassification E:Animals upon which teaching, experiments, research, surgery, or tests will be conducted involving accompanying pain or distress to the animals and for which the use of appropriate anesthetic, analgesic, or tranquilizing drugs will adversely affect the procedures,
55、results, or interpretation of the teaching, research, experiments, surgery, or tests.67Institutional Animal Care and Use Committee GuidebookC.3. Other Protocol Review ConsiderationsC.3.a. Agricultural ResearchC.3.b. Antibody ProductionC.3.c. Breeding ColoniesC.3.d. Field StudiesC.3.e. Hazardous Mate
56、rialsC.3.f. Instructional Use of Animals C.3.g. Surgery C.3.h. Transgenic AnimalsC.4. Monitoring of Approved Protocols68Institutional Animal Care and Use Committee GuidebooknD. Evaluation of Animal Care and Use ConcernsnE. Recordkeeping and CommunicationsE.1. Recordkeeping and ReportingE.2. Communic
57、ations697071Institutional Animal Care and Use Committee GuidebooknAppendicesAppendix A. ResourcesAppendix B. Office of Laboratory Animal Welfare Organizational ChartAppendix C. Mandatory IACUC Issues Identified During AAALAC International Site VisitsAppendix D. Recommendations of the 2000 AVMA Panel on Euthanasia Appendix E. Federal and State Permits Required for Field StudiesAppendix F. U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training72THE END73
