Continued Protocol Review

While semiannual inspections will continue to be used by the IACUC to monitor overall animal care at the university, a system of continuing protocol review (CPR) will be used as a more focused tool to oversee the protocols approved by the IACUC. The IACUC has selected an ORI staff member to serve as the primary liaison for CPR but the DLAR veterinarians and IACUC members will be part of the process and will be available for consultations and assistance in the inspections. The process entails four steps:

1) Protocol Selection:

All “for cause” protocols will receive highest priority and will be subject to CPR. The “for cause” protocols are those for which there is a report of abuse/violation, a prior un-corrected deficiency, a continuing protocol deviation, or a failure to attend semiannual inspections.

For all other protocols, a randomized sample will be selected for CPR. Within a review period, protocols will be randomly selected for CPR such that the majority will come from a high priority group, the remaining from medium and average priority groups. The protocols will be assigned to these groups as follows:

• High priority: Pain category E; pain category D; multiple major survival surgeries; or major survival surgeries in investigator’s laboratories.
• Medium priority: USDA covered species in pain categories B or C; minor survival or major non-survival surgeries in investigator’s laboratories; or major survival surgeries in DLAR facilities.
• Average priority: Pain categories C and B; or those not included in the other two groups.

2) Pre-Visit Preparation:

• The PI will receive an informational letter indicating that their protocol has been selected; key questions to consider about the protocol and the logic for the selection will be included in this letter.
• The PI will receive a follow up phone call to discuss the protocol and research being conducted (this will include a discussion of what is working, not working, and what changes have been made during the course of the study due to unforeseen problems).
• The CPR liaison will be available to help with amendments as necessary.
• A meeting will be scheduled by the CPR liaison to observe procedures.
• The PI will have input as to what format the visit will take in order to be least intrusive to the ongoing research.
• Download the list of Key Questions, pdf, 12 kb.

3) The Monitoring Visit:

• The CPR liaison will watch the procedures in the format as determined through mutual agreement with PI and CPR personnel.
• A time will be scheduled for questions or comments after the procedures have been completed to ensure accurate observations by the CPR liaison.
• The PI, or a designated lab member, will be notified of any protocol deviations or necessary updates to procedures; the CPR liaison is available to help with amendments.
• Download the CPR Checklist, pdf, 43 kb

4) Reports:

• The PI will receive a report of findings that includes a list of any necessary follow up actions.
• The PI will receive a phone call to set a date and time to help with follow up actions if necessary.
• All findings will be compiled and submitted to the IACUC in a monthly report.