Continuing Protocol Review
A program of Continuing Protocol Review (CPR) was established by the IACUC to maintain the highest standards of animal care and use in the research programs at the University of Kentucky. This review process is intended to help investigators stay compliant with federal guidelines.
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 Office of the Attending Veterinarian (OAV) 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:
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: All pain category E; USDA covered species in pain category D; other species in pain category D that include multiple major survival surgeries or major survival surgeries in investigator’s laboratories; and prolonged restraint.
- 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 all other facilities.
- Average priority: Pain categories C and B; or those not included in the other two groups.
Exceptions will be made for protocols chosen through the random number generator that: i) have no animals in house, or ii) those protocols for which a third year re-write has been submitted to the IACUC but the re-write has not yet been approved.
- The PI will receive an informational e-mail 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 e-mail.
- The PI will receive a follow up e-mail to schedule the CPR visit and/or 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.
- List of Key Questions (pdf, 1pg)
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.
- CPR Checklist (pdf, 2pgs)
- 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 of noncompliance will be submitted to the IACUC noncompliance subcommittee for review.
- A monthly report of scheduled, ongoing, and completed CPR's will be presented to the IACUC.
Housing Room Checks
For those investigators that have animals housed on University of Kentucky property, but outside of the Division of Laboratory Animal Resources or College of Agriculture facilities for greater than 24 hours additional random room checks will be performed as part of this program. The Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) has recommended that these areas receive more oversight than the twice yearly site inspections that have occurred in the past. As part of the IACUC’s Continuing Protocol Review program, random checks of non-DLAR and non-College Of Agriculture maintained housing areas will be performed to meet the AAALAC expectation. These areas would include all of the permanent housing areas where rooms have been set up and maintained by the Investigators as well as the areas where the housing of animals for more than 24 hours will be intermittent. Random checks will include checking the animals, cages, food, and water and/or verifying that the daily check off sheet and post op records are up-to-date.