Animal Care Committee
Approved ACC Policy
Post Approval Monitoring
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Animal Care Committee Approved ACC Policy |
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The Animal Care Committee (ACC) recognizes that ensuring compliance with approved animal care and use protocols is an important aspect of a laboratory animal program. The purpose of a post approval monitoring (PAM) program is to work with investigators to facilitate their animal research and to be proactive in identifying potential problems in their compliance with active ACC protocols. The PAM program at the University of Connecticut Health Center will operate under the acronym PAWS: Post-Approval Animal Welfare Support.
1. All PAM will be under the supervision of the ACC and will be performed by a designated Compliance Liason Officer (CLO) accompanied by one member of the animal Care Committee.
2. Review of approved protocols will be conducted at a rate of up to four per month.
3. All active animal care and use protocols are eligible for PAM review. Criteria which may increase the frequency of PAM protocol review include:
● Animal use in pain categories D or E
● Significant personnel changes
● Significant increases in protocol activity
● The use of biohazards and/or carcinogens
● The use of physical restraint
● The use of food and/or water restriction
4. The procedure for the performance of a PAM review will be as follows:
● The CLO will notify a PI that his or her protocol has been selected for review at least one month before the review will occur. At this time, the PI will receive the "PAWS checklist" for the review of items that will be addressed during the PAM review (different checklists will be devised with core elements to be addressed during all reviews and broad categories with special activities such as survival surgery).
● All visits will be scheduled at the convenience of the PI and the senior research staff of the laboratory.
● During the PAM review, the CLO will ask the PI and the laboratory staff that are present to describe their animal procedures verbally. These verbal reports will then be checked against the approved procedures in the protocol that is being reviewed. Specific attention will be paid to drugs administered, procedures performed, and all surgeries (survival and non-survival).
● During the PAM review, the CLO will identify any inconsistencies between the verbal record of what the laboratory is actually doing with animals and the procedures that are described in the ACC approved protocol. If the CLO determines that the laboratory is performing an unapproved procedure, or discovers that an inconsistency exists between the details of an approved procedure and the way it is currently being performed, the CLO will instruct the PI to discontinue that procedure immediately. If warranted, the PI must submit an application to modify the protocol to the ACC office. It is only after the modification is approved by the ACC that the procedure may be re-instated by the laboratory. The PI should ask questions of the CLO/ACC committee member and seek clarification of any issues that have been raised during the PAM review.
5. The PI and the senior research staff for the reviewed protocol are required to be present during a PAM review to facilitate the review.
6. After the PAM review, a written report of the monitoring results will be presented to the ACC. These written reports will be kept on file. Issues that pose a significant threat to animal welfare will be referred immediately to the attending veterinarian for resolution and to the ACC for further action.
7. A summary of the findings of PAM reviews during a given month will be reported to the ACC at its monthly meeting.
8. The PI will have 28 calendar days from the date of the initial PAM review to respond to any identified deficiencies and/or recommended corrective actions. Investigators who disagree with PAM review results, recommendations, or corrective actions can appeal their concerns to the ACC. Procedures not approved by the ACC cannot be performed until ACC approval has been obtained
9. The ACC chair (or designee) will review the response of the PI. If the response is deemed acceptable, no further action will be taken. Should the response be deemed unacceptable, the ACC chair (or designee) will seek further revisions and the PI will have 14 additional days to respond.
10. If the PI does not respond to the inspection findings of the CLO within the appropriate time frame as outlined above, then ACC will then decided on how to proceed.
Effective Dates: October 25, 2007 thru October 24, 2010
This policy has been approved by a majority vote of the Animal Care Committee
Members
Joseph Lorenzo, M.D., Chair, Animal Care Committee