Post Approval Monitoring

 

Purpose

The Institutional Animal Care and Use Committee IACUC) 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 IACUC protocols. The PAM program at UConn Health will operate under the acronym PAWS: Post-Approval Animal Welfare Support.

Action

1. All PAM will be under the supervision of the IACUC and will be performed by a designated Compliance Liaison Officer (CLO) accompanied by one voting member of the animal Care Committee.  A minimum of 12 reviews will be performed per year.

2. 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 restrictions

3. A summary of the findings of PAM reviews during a given month will be reported to the IACUC at its monthly meeting.

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 IACUC approved protocol. If any inconsistencies are identified,  the CLO will immediately ask the PI to address these either by discontinuing the procedure or, within 28 days, submitting a modification of the protocol to the IACUC office.  At this time, the PI can also ask questions of the CLO and seek clarification of any issues that might be 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. Issues that pose a significant threat to animal welfare will be referred immediately to the attending veterinarian for resolution and also to the IACUC for further investigation.

7. An oral report of the monitoring results, including suggested corrective actions, will be presented to the IACUC chair or designee.

8. The PI will have 28 calendar days from the date of the initial PAM review to respond to any identified deficiencies and recommended corrective actions. Investigators who disagree with PAM review results, recommendations, or corrective actions can appeal their concerns to the IACUC.

9. The IACUC chair (or designee) will review and approve the PI’s responses. If the PI’s responses are not acceptable, the IACUC chair (or designee) will seek further revisions and the PI will have 14 additional days to respond.

10. An oral report of the PAM review results will be presented to the IACUC at the monthly meeting.

11. If the PI does not respond to the inspection findings of the CLO within the appropriate time frame as outlined above, the ACC will then decide on how to proceed.

Effective Dates:    December 6, 2018 thru December 31, 2021