研究合规
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协议提交和批准流程概述
All research and teaching activities involving animals 使用 must be reviewed and approved by the JSU Institutional Animal Care and Use Committee (IACUC) before any investigator obtains animals or initiates research involving animals. The IACUC may approve, require modification of, or withhold approval from a project. Animal 使用 in the absence of IACUC approval is a serious violation of University policy and a violation of federal law. 看到 该指南 道德原则, 在研究中使用动物的实践和护理标准, 教学与测试.
协议提交和批准流程概述
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IACUC提交和审查
1. The Principal Investigator (PI) must submit a completed electronic copy of the 协议 并附上适当的签名寄给IACUC办公室. PIs and all laboratory personnel including those having frequent contact with animals must complete the 动物使用者健康调查 把它放到网上 花旗生物医学负责任的研究行为 研究项目开始前的培训课程.
2. A primary reviewer performs a preliminary review of each 协议 as assigned by the IACUC Chairperson. 如果有必要的话, the primary reviewer will contact the PI for any significant questions or concerns before sharing with the other members.
3. The primary reviewer provides the 协议 to members of the IACUC followed by comments from the Veterinarian and the full committee OR designate member review (DMR). 看到 小灵通的动物人道关怀和使用政策 委员会审查详情.
4. Once significant concerns are addressed a meeting is called to discuss the 协议.
5. 在IACUC审查后,成员可以投票:
a)批准书面协议. IACUC主席或指定人员将在原始表格上签名, and the Office of 研究合规 (ORC) will assign a 协议 number.
b)要求微小的澄清/修改(以获得批准). This process is continued until members are satisfied with the required clarifications, 修改和回应.
c)推迟协议. The PI must address major clarifications/revisions and resubmit the 协议 for review by the IACUC at the next regularly scheduled meeting.
d)不赞成协议. The IACUC Chair/Administrator will provide written communication to the PI regarding the committee’s action on his/her 协议.
一项协议的批准期限最长为三年,每年进行一次审查. Continuation of the project beyond three years requires submission of a new animal subjects form for review by the IACUC.
职业健康和安全计划(OHSP)
The Occupational Health and 安全 Program are managed by the 有害物质 Officer. 所需的免疫接种由校园健康中心管理. Immunization requirements are determined by the identified risk factors and determined medical need. All employees who work with laboratory animals will complete a risk assessment questionnaire to access and address occupational risk.
动物护理和使用培训
作为IACUC动物使用协议批准程序的一部分, principal investigators must document the training and experience of their personnel. JSU has a mandatory training program based on federal regulations that requires training for all animal 使用rs. Specialized and hands on training is provided by the Institutional Veterinarian. 此外, 花旗计划 online courses meet USDA and OLAW requirements for training in the care and 使用 of animal in research.
生物安全合规
完成 生物安全议定书 每个IACUC协议都需要提交. Use of select toxins and agents and genetically modified animals (transgenic, 等) or inducing genetic changes in animals require review and approval by the 院校生物安全委员会 (IBC),然后IACUC批准.
该委员会每年召开两次会议,并根据需要召开会议.
要记住的礼仪技巧
· The IACUC has to be able to review the scientific merits of your proposal; 协议s shall have a review for scientific merit, 道德的使用, 以及人道关怀 & 使用.
· Provide adequate justification for number of vertebrate animals to be 使用d.
·疼痛和痛苦的分类不合适.
·遵循 JSU啮齿动物安乐死指南 如果你要对动物实施安乐死
· Provide reference of a literature search to ensure that your 协议s are not recurring or redundant
· Assurance that staff is adequately trained; When working with animals, all animal 使用r personnel must complete an Animal Care and Use workshop sponsored by the Institutional Veterinarian or online training program tailored to the species to be 使用d. 机构兽医和IACUC提供持续的培训
· Approved 协议s will be assigned a number which must accompany all animal orders.
· Animals must be purchased by from an approved list of suppliers to avoid introducing infections into the facility.
院校覆核委员会
The role of the 院校覆核委员会 is to review all the proposed research involving human subjects and to ensure that subjects are treated ethically and that their rights and welfare are adequately protected.
IRB过程是通过研究合规单位管理的. Investigators and student researchers are not allowed to solicit human subject participation or begin data collection prior to receiving IRB approval in writing
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研究合规
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