IACUC协议申请和审查过程

  1. The Principal Investigator (PI) should establish the need for an IACUC protocol by reviewing relevant policies and guidelines (see IACUC指南和政策声明) and then obtain any required federal or state permits. PIs using animals on campus must consult with the Animal Care Facility Specialist regarding available facilities and procedures 之前 提交申请. Animals cannot be used or procured for a project until the protocol has been approved by the IACUC. PIs who are proposing animal work that also involves potential biohazards or zoonotic diseases, 受控物质, radiation or radioactive isotopes should consult with the appropriate safety officer 之前 completing their application and if necessary, 提交一个 小马IACUC 请求.
  2. All individuals (PIs/staff/students) who handle or directly assist with the care of vertebrate animals must be screened for potential health risks associated with working with animals. PI必须完成工作职责部分 医疗转介PDF文件 在新窗口中打开 and then email a copy of the form to all individuals who will handle animals. Each worker will then complete the first page of the form and then email it to EHS (mandronic@chathams.net). EHS will email the form to our contracted medical provider (Kaiser), who will then contact each worker to assess potential risks and if necessary, 安排健康检查. In addition, all workers must complete an online CITI training course on using animals in research. All personnel must provide evidence of CITI training and be medically cleared to handle animals 之前 a protocol can be approved. 因为这个过程可能需要几个星期, PIs must ensure that worker begin training and submit the Medical Referral form immediately after the protocol application is submitted, 以避免开始工作的延误.
  3. 开始协议申请过程, the PI should log on to the 小马IACUC online application system and gather the necessary information. Staff or students involved in a project must be listed in the Personnel section. 确保所有的部分都完成了, 所有的文献综述, 搜索的数据库, 关键词使用, the date the search was done and dates covered by the search are all provided. PIs are urged to use the Excel template provided for the initial submission or for the continuation submission to construct the table describing the number of animals to be used.  此外, it is the responsibility of the PI to ensure that all personnel receive appropriate protocol-specific training and to maintain documentation of that training in their research laboratories.  All individuals planning to work in the CSUF vivarium rooms must be trained by the Animal Facility Specialist 之前 entering those facilities.
  4. PIs are strongly encouraged to contact the IACUC chair for pre-review of their completed Draft application 之前 通过卡尤塞提交. The chair will provide feedback to the PI and suggest changes 之前 it is submitted for formal IACUC review. After the PI has modified the application in response to the chair’s comments, the PI will digitally sign the assurance in Cayuse and submit the application.
  5. The coordinator will distribute the application to the IACUC for review. IACUC review and approval normally takes about 6 weeks. If approval is needed sooner, the PI should notify the IACUC chair at the time of pre-review.
  6. 根据审查结果, the chair will inform the PI of the changes that are needed for the application to be approved. The PI must address the committee’s comments in Cayuse by re-submitting the application with changes that address these comments. The PI’s response and changes will then be re-routed to IACUC, which must approve of all the changes 之前 the protocol can be approved.
  7. Once the application is approved and all certifications received, an automated email notification will be sent to the PI. The PI’s department chair will also be notified by the IACUC office.
  8. 批准有效期为三年, but protocols must be reviewed annually by submitting a Continuing Review 请求 through Cayuse. 三年之后, work that is ongoing must be renewed by submitting a De Novo protocol application through Cayuse. When all work on a project is completed, PIs must close the protocol in Cayuse.
  9. 当协议需要修改时, the proposed changes must be submitted as an Amendment 请求 in Cayuse. Amendment 请求s must be reviewed and approved by the IACUC 之前 beginning work. The PI must describe the Reason for the Change in detail in the online application. 一些小的改变.e., that are not considered significant as defined by NIH-OLAW and USDA, 比如人事变动, 可以由IACUC主席单独批准吗, 但仍然必须通过小马IACUC提交.