1、实验动物福利伦理审查北京市实验动物福利伦理审查指南Guide for the Care and Use of Laboratory animals目录第四条从事实验动物相关工作的单位，应成立由管理人员、科技人员、实验动物专业人员和本单位以外人士参加的实验动物福利伦理审查委员会具体负责本单位有关实验动物的福利伦理审查和监督管理工作北京市实验动物福利伦理审查指南北京市实验动物福利伦理审查指南 第五条 伦理委员会至少由5 人组成，设主席一名，副主席、委员 主席应由实验动物专业（最好是兽医专业人员）人员担任 每届任期3 或4 年，由单位负责聘任、岗前培训、解聘，并及时补充成员 伦理委员会应制定章程、审
2、查程序、监督制度、例会制度、报告制度、工作纪律、专业培训计划等北京市实验动物福利伦理审查指南北京市实验动物福利伦理审查指南 第六条 伦理委员会应独立开展工作，履行以下职责：审查和监督本单位开展的有关实验动物的研究、繁育、饲养、生产、经营、运输，以及各类动物实验的设计、实施过程是否符合动物福利和伦理原则 伦理委员会应依据实验动物福利伦理审查的基本原则，兼顾动物福利和动物实验者利益，在综合评估动物所受的伤害和使用动物的必要性基础上进行科学评审，并出具伦理审查报告北京市实验动物福利伦理审查指南北京市实验动物福利伦理审查指南第七条 各类实验动物的饲养和动物实验都应获得伦理委员会的批准方可开始，并接受日
3、常的监督检查北京市实验动物福利伦理审查指南北京市实验动物福利伦理审查指南 第八条 申请福利伦理审查，应向伦理委员会提交正式申请书。申请书应包括以下内容：实验动物或动物实验项目名称及概述 项目负责人、执行人的姓名、专业背景简历、实验动物或动物实验岗位证书编号，环境设施许可证号 项目的意义、必要性、项目中有关实验动物的用途、饲养管理或实验处置方法、预期出现的对动物的伤害、处死动物的方法、项目进行中涉及动物福利和伦理问题的详细描述 遵守实验动物福利伦理原则的声明 伦理委员会要求补充的其它文件北京市实验动物福利伦理审查指南北京市实验动物福利伦理审查指南 第九条 伦理委员会审查依据的基本原则：动物保护原
4、则 动物福利原则 伦理原则 综合性科学评估原则北京市实验动物福利伦理审查指南北京市实验动物福利伦理审查指南 第十条 伦理委员会审查程序 在接到有关实验动物项目的申请文件后，由伦理委员会主席指定委员进行初审 常规项目首次评审后，可由主席或授权 的副主席直接签发 新开项目和有争议的项目，应聘请有关专家，5 个工作日内提出书面意见，交伦理委员会审议 参加审议的委员不得少于半数。申请者可以申请现场答疑，并可以提请对项目保密或评审公正性不利的委员回避 伦理委员会应尽量采用协商一致的方法做出决议，如无法协商一致，应根据少数服从多数的原则，在 10 个工作日内做出福利伦理审查决议，由主席或授权副主席签发后，
5、3 个工作日内送达北京市实验动物福利伦理审查指南北京市实验动物福利伦理审查指南第十四条 伦理委员会应有专人负责文件的收发和档案管理工作，所有文件在项目结束后应至少保留3 年 国家另有规定的，按照规定办理北京市实验动物福利伦理审查指南北京市实验动物福利伦理审查指南 AAALAC International relies on Three Primary Standards used by the Council to evaluate programsGuide for the Care and Use of Laboratory Animals Guide for the Care and U
6、se of Laboratory Animals(the Guide,NRC 2011)Guide for the Care and Use of Agricultural Animals in Research and Teaching(the Ag Guide,FASS 2010)European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes,Council of Europe(ETS 123)The IACUC(or insti
7、tutional equivalent)is responsible for assessment and oversight of the institutions Program components and facilities The responsibility of the IACUC is to oversee and routinely evaluate the ProgramThe Institutional Animal Care and Use Committee（IACUC）IACUC Constitution and Function Committee member
8、ship includes the following:a Doctor of Veterinary Medicine either certified(e.g.,by ACLAM,ECLAM,JCLAM,KCLAM)or with training and experience in laboratory animal science and medicine or in the use of the species at the institution at least one practicing scientist experienced in research involving a
9、nimals at least one member from a nonscientific background,drawn from inside or outside the institution at least one public member to represent general community interests in the proper care and use of animalsIACUC Constitution and Function The following topics should be considered in the preparatio
10、n of the protocol by the researcher and its review by the IACUC:rationale and purpose of the proposed use of animals a clear and concise sequential description of the procedures involving the use of animals that is easily understood by all members of the committee availability or appropriateness of
11、the use of less invasive procedures,other species,isolated organ preparation,cell or tissue culture,or computer simulation justification of the species and number of animals proposed;whenever possible,the number of animals and experimental group sizes should be statistically justifiedProtocol Review
12、 unnecessary duplication of experiments nonstandard housing and husbandry requirements impact of the proposed procedures on the animals well-being appropriate sedation,analgesia,and anesthesia(indices of pain or invasiveness might aid in the preparation and review of rotocols;see Appendix A,Anesthes
13、ia,Pain,and Surgery)conduct of surgical procedures,including multiple operative procedures postprocedural care and observation(e.g.,inclusion of post-treatment or postsurgical animal assessment forms)Protocol Review description and rationale for anticipated or selected endpoints criteria and process
14、 for timely intervention,removal of animals from a study,or euthanasia if painful or stressful outcomes are anticipated method of euthanasia or disposition of animals,including planning for care of long-lived species after study completion adequacy of training and experience of personnel in the proc
15、edures used,and roles and responsibilities of the personnel involved use of hazardous materials and provision of a safe working environmentProtocol Review While the responsibility for scientific merit review normally lies outside the IACUC,the committee members should evaluate scientific elements of
16、 the protocol as they relate to the welfare and use of the animals For example,hypothesis testing,sample size,group numbers,and adequacy of controls can relate directly to the prevention of unnecessary animal use or duplication of experimentsProtocol Review For some IACUC questions,input from outsid
17、e experts may be advisable or necessary In the absence of evidence of a formal scientific merit review,the IACUC may consider conducting or requesting such a review(Mann and Prentice 2004)IACUC members named in protocols or who have other conflicts must recuse themselves from decisions concerning these protocolsProtocol Review谢谢！
