Research Compliance
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Protocol Submission And Approval Process Overview
所有涉及动物使用的研究和教学活动必须经过JSU机构动物护理和使用委员会(IACUC)的审查和批准,然后研究者才能获得动物或启动涉及动物的研究. IACUC可以批准、要求修改或拒绝批准一个项目. 在未经IACUC批准的情况下使用动物是严重违反大学政策和联邦法律的行为. See The Guide for ethical principles, practices and care standards for use of animals in research, teaching and testing.
Protocol Submission and Approval Process Overview
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IACUC Submission and Review
1. 首席研究员(PI)必须提交一份完整的电子副本 protocol with the appropriate signatures to the IACUC Office. pi和所有实验室人员,包括经常与动物接触的人员必须完成 Animal User Health Survey and taken the online CITI Biomedical Responsible Conduct of Research training course prior to start of the research project.
2. 主要审稿人根据IACUC主席的指派对每个方案进行初步审查. If necessary, 在与其他成员分享之前,主要审稿人将与PI联系任何重大问题或担忧.
3. 主要审稿人向IACUC成员提供方案,然后由兽医和全体委员会或指定成员审查(DMR)提出意见。. See the PHS Policy for the Humane Care and Use of Animals for committee review details.
4. 一旦重大问题得到解决,就召开会议讨论协议.
5. After IACUC review members may vote to:
a) Approve the protocol as written. The IACUC Chair or designee will sign the original form, 研究合规办公室(ORC)将分配一个协议编号.
b) Require minor clarifications/revisions (to secure approval). 这一过程将继续进行,直到成员对所要求的澄清感到满意为止, modifications and responses.
c) Defer the protocol. PI必须处理重大澄清/修订,并在下次定期会议上重新提交议定书供IACUC审查.
d) Disapprove the protocol. IACUC主席/管理员将就委员会对其协议采取的行动向PI提供书面沟通.
A protocol can be approved for up to three years with annual reviews. 项目持续三年以上需要提交一份新的动物实验表供IACUC审查.
Occupational Health and Safety Program (OHSP)
职业健康和安全计划由有害物质管理官员管理. Required immunizations are administered by the Campus Health Center. 免疫需求取决于确定的风险因素和确定的医疗需求. 所有与实验动物打交道的员工都要完成一份风险评估问卷,以获取和处理职业风险.
Animal Care and Use Training
As part of the IACUC Animal Use Protocol approval process, 主要调查人员必须记录其人员的培训和经验. JSU有一个基于联邦法规的强制性培训计划,要求对所有动物使用者进行培训. 专业和实践培训由机构兽医提供. Additionally, CITI Program 在线课程符合美国农业部和OLAW对研究中动物护理和使用培训的要求.
Biosafety Compliance
Completion of a Biosafety protocol is required for submission with each IACUC protocol. 使用选定的毒素和制剂和转基因动物(转基因), (等)或者诱导动物基因变化,需要经国家卫生行政部门审查批准 Institutional Biosafety Committee (IBC) before IACUC approval is granted.
The IACUC meets twice a year and as needed.
Protocol Tips to Keep in Mind
· The IACUC has to be able to review the scientific merits of your proposal; protocols shall have a review for scientific merit, ethical use, and humane care & use.
·为使用的脊椎动物数量提供充分的理由.
· Pain and distress categories are not appropriate.
· Follow the JSU Guidelines for Rodent Euthanasia if you have to euthanize an animal
·提供文献检索参考,以确保您的协议不重复或冗余
· Assurance that staff is adequately trained; When working with animals, 所有动物使用人员必须完成由机构兽医主办的动物护理和使用研讨会或针对所使用物种量身定制的在线培训计划. The Institutional Veterinarian and IACUC provides ongoing training
·批准的协议将被分配一个号码,该号码必须随所有动物订单一起发放.
·动物必须由经批准的供应商购买,以避免将感染引入设施.
Institutional Review Board (IRB)
机构审查委员会(IRB)的作用是审查所有涉及人类受试者的拟议研究,并确保受试者得到道德对待,并确保他们的权利和福利得到充分保护.
The IRB process is administered through the Research Compliance Unit. 在收到IRB书面批准之前,调查人员和学生研究人员不得征求人类受试者参与或开始数据收集
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Research Compliance
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