In order for the IACUC to maintain accurate and up-to-date records for NEOUCOM/COP-based animal use activities, all protocol paperwork must be processed in a timely manner.  This will facilitate the smooth flow of uninterrupted research activities and allow the IACUC to remain in compliance with all regulatory agencies.

Part A – Annual Protocol Updates

Annual protocol renewals are typically forwarded to the PI 30 days prior to the anniversary of the IACUC approval date.  The IACUC requires that PIs respond within 2 weeks of receiving this information.  Failure to return the annual review form by the review date may lead to suspension of research activities involving animals. 

Part B – Protocol Resubmissions

According to OLAW and AAALAC regulations, protocols cannot be approved for more than 3 years.  For longer studies, the investigator must submit a new protocol to continue the project.  The IACUC requires that the new protocol be fully approved prior to the 3-year expiration date if the PI wishes to avoid an interruption in his/her work.  Failure to obtain approval will result in suspension of research activities until IACUC approval has been granted.  Notification that a protocol is nearing its 3-year expiration will be forwarded to the PI 120 days prior to its expiration date.  To allow adequate processing time, the IACUC recommends that new protocol, and related paperwork, be submitted 60 days prior to the protocol expiration date.  The review process takes at least two to three weeks to complete from the time a protocol is received in the CMU office but could take longer if a full IACUC review at a convened meeting is required.

Part C – Response to Primary Reviewer Comments

Due to the extensive record keeping associated with animal use protocol review, the IACUC requires that responses to primary reviewer comments on all protocol paperwork (i.e., primary reviewer comments for newly submitted protocols, addenda, etc.) be submitted within 30 days of receiving this information.  Failure to do so will result in the voiding of the submitted protocol paperwork and will require resubmission, including responses to the reviewer comments, at a future date.

It is the PIs responsibility to seek the approval of the IACUC Chairperson if the response times, as listed in Part A, B, and C above, can not be met due to special or unforeseen circumstances.

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