PROGRAM DESCRIPTION 计划描述 - AAALAC.docx

Program DescriptionAnimal Care and Use Program计划描述实验动物饲养和使用计划Program Unit Name计划单位名称Parent Organization上级机构Address地址ForAAALAC International国际AAALAC Date of Submission递交时间2/11Table of Contents 目录Section 1.Introduction7章节 1.介绍Section 2.Description11章节 2.描述I.Animal Care and Use Program11 动物饲养管理和使用计划A.Program Management11 计划管理1.Program Management Responsibility11 计划管理职责a.The Institutional Official11 机构负责人b.The Attending Veterinarian11 主治兽医师c.Collaborations12 机构间的合作2.Personnel Management12 人员管理a.Training and Education12 培训和教育i.Veterinary and Other Professional Staff12 兽医和其他专业人员ii.Animal Care Personnel13 动物饲养管理人员iii.The Research Team13 研究小组b.Occupational Health and Safety of Personnel14 员工职业保健和安全i.Hazard Identification and Risk Assessment14 危害识别和风险评估ii.Facilities, Equipment and Monitoring15 设施、设备和监测iii.Personnel Training16 员工培训iv.Personal Hygiene16 个人卫生v.Animal Experimentation Involving Hazards17 涉及有害因子的动物实验vi.Personal Protection19 个人保护vii.Medical Evaluation and Preventive Medicine for Personnel20 员工的医学鉴定和预防医学c.Investigating and Reporting Animal Welfare Concerns20 调查和汇报动物福利相关事件 B.Program Oversight21 计划的监督1.The Role of the IACUC/OB21 IAUCC/OB的职责a.IACUC/OB Composition and Function21 IACUC/OB的组成和功能b.Protocol Review21 实验方案审核c.Special Considerations for IACUC/OB Review22 IACUC/OB审核中的特殊考虑i.Experimental and Humane Endpoints22 实验和人道终点ii.Unexpected Outcomes that Affect Animal Well-being22 影响动物福利的非预期的结果iii.Physical Restraint23 动物保定iv.Multiple Survival Surgical Procedures23 多项活体手术操作v.Food and Fluid Regulation24 饮食和饮水的限制vi.Use of Non-Pharmaceutical-Grade Drugs and Other Substances24 非医用级别化学药品和物质的使用vii.Field Investigations25 现场调查研究viii.Agricultural Animals25 农畜ix.Animal Reuse25 动物的重复使用2.Post-Approval Monitoring25 动物使用方案批准后监督II.Animal Environment, Housing and Management26 动物的环境，饲养和管理A.Animal Environment26 动物的环境1.Temperature and Humidity27 温度和湿度2.Ventilation and Air Quality27 通风措施和空气质量3.Life Support Systems for Aquatic Species28 水生动物的生命维持系统4.Noise and Vibration28 噪声与振动B.Animal Housing (All terrestrial, flighted, and aquatic species)28 动物饲养（所用动物包括陆生、飞禽和水生动物）1.Primary Enclosures28 初级包围圈2.Environmental Enrichment, Social and Behavioral Management29 环境丰富、群体和行为管理a.Enrichment29 环境丰富b.Social Environment30 群体管理c.Procedural Habituation and Training of Animals30 动物的程序化适应和驯d.Enrichment, Social and Behavioral Management Program Review30 环境丰富、群体和行为管理计划检查e.Sheltered or Outdoor Housing31 遮蔽或户外关养f.Naturalistic Environments31 自然环境C.Animal Facility Management32 动物设施管理1.Husbandry32 饲养管理a.Food32 饲料b.Drinking Water33 饮水c.Bedding and Nesting Materials33 垫料和筑巢料d.Miscellaneous Animal Care and Use Equipment34 多种多样的动物饲养管理和使用设备e.Sanitation34 卫生措施f.Waste Disposal36 废物处理g.Pest Control36 虫害防治h.Emergency, Weekend and Holiday Care37 应急、周末和假日的饲养管理2.Population Management37 群体管理a.Identification37 识别b.Record Keeping37 记录保存c.Breeding, Genetics and Nomenclature38 繁育、遗传学和命名法III.Veterinary Care38 兽医保健A.Animal Procurement and Transportation38 动物的采购和运输1.Animal Procurement38 动物采购2.Transportation of Animals39 动物运输 B.Preventive Medicine39 预防医学1.Animal Biosecurity39 动物的生物安全2.Quarantine and Stabilization39 隔离检疫和安定3.Separation by Health Status and Species40 根据健康状况和物种进行的隔离4.Surveillance, Diagnosis, Treatment and Control of Disease40 疾病的监视、诊断、治疗和控制C.Clinical Care and Management41 临床保健和管理1.Emergency Care41 紧急护理2.Clinical Record keeping42 临床记录保存3.Diagnostic Resources42 诊断资源4.Drug Storage and Control42 药物存放和控制D.Surgery43 外科手术1.Pre-Surgical Planning43 术前计划2.Surgical Facilities43 手术设施3.Surgical Procedures44 外科操作4.Aseptic Technique44 无菌技术5.Intraoperative Monitoring45 术中监控6.Postoperative Care45 术后护理E.Pain and Distress45 疼痛和痛苦F.Anesthesia and Analgesia45 麻醉和镇痛G.Euthanasia46 安乐死术IV.Physical Plant47 动物房及物理布局A.Location and Construction Guidelines47 地点和建造指南B.Functional Areas and Operations48 功能区域及其运营管理1.Heating, Ventilation, and Air-Conditioning (HVAC)48 供暖、通风和空调设备2.Power and Lighting49 电力和照明3.System Malfunctions50 系统故障4.Storage Areas50 储藏区域5.Facilities for Sanitizing Materials50 设施消毒材料C.Special Facilities50 特殊设施1.Specialized Types of Animal Housing51 特殊类型的动物饲养设施2.Surgery51 手术设施3.Other Specialized Animal Use Facilities51 其它特定动物使用的设施4.Other Animal Support Facilities51 其它的动物饲养支持设施D.Security and Access Control52 安全保障和进出控制设施Appendices1. Organizational Chart(s) 组织机构图2. Animal Usage Form A or B 动物使用表A或B3. Summary of Animal Housing and Support Sites 动物饲养和支持场所统计4. Line Drawings 绘图5. Medical Evaluation Form 医学鉴定表6. IACUC/OB Membership Roster IACUC/OB成员名单7. Blank IACUC/OB Protocol Form IACUC/OB研究方案空白表8. IACUC/OB Minutes IACUC/OB会议记录9. IACUC/OB Periodic Report IACUC/OB IACUC/OB定期报告10. Heating, Ventilation and Air Conditioning (HVAC) System Summary 采暖通风与空调系统数据总结11. Aquatic Systems Summary 水生系统数据总结12. Primary Enclosures and Animal Space Provisions 初级包围圈和动物空间供应13. Cleaning and Disinfection of the Micro- and Macro-Environment 小环境和大环境的清洁和消毒Program Description计划描述Link to Instructions for Completing and Submitting the Program Description for the Institutional Animal Care and Use Program链接： 完成和递交机构动物饲养管理和使用计划描述的指导说明 Section 1. Introduction章节 1.介绍A. State the name of the program unit and, if applicable, its parent organization. List all organizations (schools, centers, etc.) included within the program unit.介绍计划单位名称，如果可能，提供上级机构名称。列出计划单位包含的所有机构名称（学校、中心等）。B. Give a brief overview of the institution, its purpose and how the animal care and use program relates to the mission of the institution.提供关于机构的总体介绍，成立机构的目的以及动物饲养和管理计划与机构使命之间的关系。 C.Note that AAALAC Internationals three primary standards are the Guide for the Care and Use of Laboratory Animals (Guide), NRC, 2011; the Guide for the Care and Use of Agricultural Animals in Research and Teaching (Ag Guide), FASS 2010, and the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes, Council of Europe (ETS 123). Other regulations and guidelines used (U.S. Department of Agriculture (USDA), Public Health Service (PHS) Policy, Good Laboratory Practice (GLP), Canadian Council on Animal Care (CCAC), etc.) may also apply. Describe which of the three primary standards and other regulations and guidelines are used as standards for the institutional animal care and use program and how they are applied. For example, an academic institution in the United States with an Office of Laboratory Animal Welfare (OLAW) Assurance may use the standards of the Guide and PHS Policy for all animals, the Animal Welfare Act regulations for covered species, and the Ag Guide for agricultural animals used in agricultural research and teaching. In the European Union, the standards applied might be the Guide, ETS 123, Directive 2010/63, and any country-specific regulations. AAALAC国际的三大主要标准是实验动物饲养管理和使用指南指南，（NRC，2011）；研究和教学中农畜的饲养管理和使用指南农畜 指南（ FASS，2010）以及欧洲实验用和其他科学研究用脊椎动物保护条约，欧洲委员会（ETS，123）。同时也参照其他相关规章和指导方针。介绍本机构动物饲养管理和使用计划所参照的标准、规章和指导方针，以及他们的实际运用。例如：美国的一所院校设立了确保实验动物福理办公室，该办公室对于所有动物的饲养管理和使用可能参照指南和PHS政策，对于动物福利法案中规定的几种动物的管理和使用参照该动物福利法案相关规定，对于用于研究和教学的农业动物的管理参照农畜 指南。在欧盟一些国家，一般都参照指南（ETS，123，Directive，2010/63）以及任何国家特定的法律。D.Describe the organization and include an organizational chart or charts (as an Appendix/Appendices) detailing the lines of authority from the Institutional Official to the Attending Veterinarian, the Institutional Animal Care and Use Committee/Oversight Body (IACUC/OB), and the personnel providing animal care. Please include the title, name (Note: For individuals whose information is publically available, provide the titles and names; for individuals whose information is not publically available, you may provide titles only.), and degree (if applicable) of each individual at the level of supervisor or above. Names of animal care staff below the title of supervisor need not be included, but the titles and number of animal care personnel under each supervisor should be included. If animal care responsibility is administratively decentralized, the organizational chart or charts must include all animal care programs, indicating the relationship between each administrative unit and personnel, the Attending Veterinarian, and the Institutional Official. 介绍机构组织架构，附上机构组织结构图或能阐述机构负责人、主治兽医师、机构动物饲养管理和使用伦理委员会或监督团体（IACUC或OB）和动物饲养管理员工的上级汇报领导及其权威性的结构图，并附上其姓名和职位（注：相关人员中如某些人员的信息已被公开发布，请提供职位和姓名；如个人信息未被公开发布，仅提供职位）。如可能，请提供管理层或更高层员工的学历。同时提供每位管理层的下属数目以及下属的职位。对于管理层以下的动物饲养管理人员的姓名则不需要提供。如动物饲养管理的职责在管理上比较分散，提供的组织机构图 必需包含整个动物饲养管理计划，指出每个行政管理单位和个人、主治兽医师以及机构负责人之间的关系E.Identify the key institutional representatives (including, but not limited to, the Institutional Official; IACUC/OB Chairperson; Attending Veterinarian; animal program manager; individual(s) providing biosafety, chemical hazard, and radiation safety oversight; etc.); and individuals anticipated to participate in the site visit. 指定机构主要代表（包括但不仅限于机构负责人、IACUC/OB主席、主治兽医师、动物计划负责人、提供生物安全、化学危害以及辐射安全监督人员等）和参与现场检查的人员F.Briefly describe the major types of research, testing, and teaching programs involving animals and note the approximate number of principal investigators and protocols involving the use of animals. As mentioned in the instructions, please complete one of the animal use forms included with this outline or provide the information requested in a similar format as an appendix. 简单描述涉及到动物使用的研究、试验和教学的主要项目类型并注明大致的课题负责人数和涉及动物使用的项目方案数目。根据指导说明，完成此概要中包含的动物使用表格或提供附录中要求的类似信息G.Note the source(s) of research funding (grants, contracts, etc.) involving the use of animals. 注明动物使用研究的资金来源（专用拨款、合同等）H.List other units (divisions, institutes, areas, departments, colleges, etc.) of your organization that house and use animals that are not included in this Description. If any of these are contiguous, physically or operationally (e.g., same IACUC/OB, same animal care staff), with the applicant unit, describe the association. Explain why such units are not part of this program application. 列出本机构内饲养和使用动物且其动物的使用未包含在本描述内的其他单位（分部、学院、区域、部门或大学等）。如这些单位与申请机构在物理位置上邻近或行政运作上相关（如：使用同一个IACUC/OB，相同的动物饲养管理人员），请描述彼此间的关系并解释为何这些单位不包含在计划中I.Contract Facilities: If the institution contracts for animal care facilities or services for animals owned by the institution, the contractor and its AAALAC International accreditation status must be identified. If a contractors animal care and use program is not accredited by AAALAC International, a brief description, following this Program Description outline, of the relevant contractors programs and facilities must be provided. In addition, the species and approximate average number of animals housed in the contract facilities and the approximate distance between the institutions animal facility and the contract facility must be noted. Incorporation of the contractor program into the site visit schedule will be discussed with institutional representatives. If the institution does not contract for animal care facilities or services, so note. 合同设施：如机构的动物饲养管理设施或属于本机构的动物的相关服务属于合同外包性质，则 应注明合同承包方及其AAALAC国际认证状态。如合同承包方的动物饲养管理和使用计划未接受过AAALAC国际认证，则需根据此计划描述的大纲，提供一份关于该承包方的计划和设施情况的简单介绍。此外，还需注明承包方动物设施内饲养的动物品种、动物数量，设施与本机构动物设施之间的距离。AAALAC国际将与机构代表讨论是否需对承包方的动物设施进行现场检查。如机构的动物设施或动物服务未委托外包，则在此注明。J.Note other relevant background that will assist reviewers of this report. 提供有助于此次审核的其他背景信息532/11Section 2.Description章节 2.描述I.Animal Care and Use Program 动物饲养管理和使用计划A.Program Management 计划管理1.Program Management Responsibility Guide, pp. 13-15 计划管理职责 指南（本计划描述中提及的均为英文版）第13-15页a. The Institutional Official Guide p. 13-14机构负责人 指南第13-14页Describe how program needs are clearly and regularly communicated to the Institutional Official by the Attending Veterinarian, IACUC/OB, and others associated with the program.描述主治兽医师、IACUC/OB以及计划的其他相关人员是如何将计划的需要清晰且定期的与机构负责人进行沟通的b. The Attending Veterinarian Guide, p. 14主治兽医师 指南第14页i.Describe the institutional arrangement for providing adequate veterinary care. For each veterinarian associated with the program (including private practitioners), provide the veterinarians name(s), list responsibilities, and how the veterinarian is involved in monitoring the care and use of laboratory animals. If employed fulltime by the institution, note the percentage of time devoted to supporting the animal care and use program of the institution. If employed part-time or as a consultant, note the frequency and duration of visits. 描述机构如何提供适当的兽医保健。提供参与计划的兽医人员（包括个体执业兽医师）的姓名、职责以及这些兽医如何参与到监督实验动物饲养管理和使用中的信息。对于机构的全职兽医，请注明其对动物饲养管理和使用计划提供兽医保健支持的时间比率。对于兼职兽医或顾问，注明其来访频率和持续时间。ii.List others (e.g., Principal Investigators, veterinarians serving as Principal Investigators, veterinary faculty/staff, technical staff, farm managers) who have a direct role in the provision of veterinary care and describe their responsibilities. An organizational chart depicting the reporting relationship between these individuals and the Attending Veterinarian should be included as an appendix. 列出其他直接参与提供兽医保健的人员（如：课题负责人、身为课题负责人的兽医师、兽医从业人员、技术员、饲养场负责人），描述其职责。并附上一份能描述其之间以及与主治兽医师之间汇报关系的组织结构图c. Collaborations Guide, p. 15机构间的合作 指南第15页Describe processes for assigning animal care and use responsibility, animal ownership and IACUC/OB oversight responsibilities at off-site locations (i.e., collaborations). 描述对于机构外动物的饲养管理和使用（如：合作），机构指定动物饲养管理和使用计划的职责的程序、动物的所有权以及IACUC/OB的监督职责。2.Personnel Management 人员管理a. Training and Education培训和教育Describe how the IACUC/OB provides oversight and evaluates the effectiveness of training programs. Describe how training is documented.描述IACUC/OB如何对培训计划的有效性进行监督和评估以及培训是如何被记录的i. Veterinary and Other Professional Staff Guide, pp. 15-16 兽医和其他专业人员 指南第1516页Provide name and credentials of veterinary and other professional staff, including the veterinary personnel listed above, and describe their qualifications, training, and continuing education. Please do not provide curriculum vitae of personnel.提供兽医和其他专业人员（包括之前列出的兽医人员）的姓名及其资格证书，并描述其资格、所接受的培训和继续教育。不需提供人员的履历ii. Animal Care Personnel Guide, p. 16 动物饲养管理人员 指南第16页Indicate the number of animal care personnel. _动物饲养人员数目 _Summarize their training, certification level and type, experience, and continuing education opportunities provided. 概述其获得的培训、证书级别和类型、经验和继续教育机会 iii. The Research Team Guide, pp. 16-17; 115-116; 122; 124 研究小组 指南第1617；115116； 122；124页1) Describe the general mechanisms, by which the institution or IACUC/OB ensures that research personnel have the necessary knowledge and expertise in the animal procedures proposed and the species used. 描述机构或IACUC/OB如何确保研究人员获得动物操作和动物物种的必备知识和专业经验a) Briefly describe the content of any required training. 简单介绍要求培训的内容b) Describe the timing of training requirements relative to the commencement of work. 描述员工在相对于开始工作前需要获得培训的时间c) Describe continuing education opportunities offered. 描述机构提供的继续教育的机会2) Describe the process(es) to ensure surgical and related procedures are performed by qualified and trained personnel. Who determines that personnel are qualified and trained for surgical procedures? What role does the Attending Veterinarian and IACUC/OB have