Post-Approval Monitoring (PAM) Program

Transcription

1 Animal Care Committee Guideline Number: 23 Effective date: April 8, 2011 Post-Approval Monitoring (PAM) Program Background The Post-Approval Monitoring (PAM) Program at the University of Guelph is established to ensure that procedures described in the Animal Utilization Protocol (AUP) are undertaken in practice as they are approved in principle by the Animal Care Committee (ACC). Roles, responsibilities and lines of communication of the members of the animal care and use program are outlined in the University of Guelph Animal Care and Use Policy and Procedures, in the Terms of Reference of the Animal Care Committee (ACC) and subcommittees and in SOPs relevant to animal care and facility management. Guideline The post-approval monitoring program includes: A. AUP Specific Monitoring by ACC Members B. Annual Renewal of AUPs C. ACC Site Visits D. Animals for Research Act Inspections E. Veterinary Site Visits and Program Assessments F. Animal Incident Reports G. Animal Procurement H. Environmental Health and Safety Department I. Animal Care Staff J. Regional Campus and Research Station Post Approval Monitoring Programs A. AUP Specific Monitoring by ACC Members 1. If procedures in an AUP are of concern, the ACC assigns ACC members to monitor the conduct of these procedures. The monitors make arrangements with the PI to be present for the procedure/s. At the end of the session, any concerns or questions are discussed with the PI and the research team present; and monitor(s) take notes as required. A written report is then forwarded to the ACC. Effective Date: April 8, 2011 Page 1 of 5

2 The monitoring process by ACC members is described in SOP.ACC.101.Monitoring of AUP Procedures by ACC with Appendix ACC 101a. Protocol Monitoring Form. B. Annual Renewal of AUPs 1. Procedures for Annual Renewal of an AUP are outlined in the Terms of Reference for the Animal Care Committee. 2. The Annual Renewal includes a review of the following documents: Concerns related to the project reported in the last year Animal Incident Reports and follow-up Amendments to the project including revisions to the Assessment Score Sheet Provisos from past approval/s to ensure compliance Changes in regulatory/guidance documents since the last approval that may necessitate amendments or updates to the protocol 3. If during the review, a concern arises, the ACC makes recommendations to the Principal Investigator (PI) regarding recommended changes and refinements to the AUP. Recommendations are sent via to the PI prior to approval being granted, with a request that an updated Renewal/Amendment (RA) Form be submitted for final review and approval by ACC. 4. Concerns from the ACC may also bring about proviso/s to approval of the Annual Renewal. Provisos for approval are sent in the approval letter. The PI is expected to communicate in writing to Animal Care Services (ACS) on actions taken to comply with the proviso/s. Compliance with provisos is reviewed at the time of the next annual renewal. C. ACC Site Visits 1. ACC site visits are undertaken to assess facilities used for housing and holding animals for the purposes of research, teaching, production, and display purposes. 2. Site visits also give opportunities for the ACC site visit members to observe any research or teaching activities being undertaken at the time of the visit. 3. If there are noted changes in procedures, additional procedures being performed, concerns or suggestions for refinements or improvements at the time of the site visit, these are communicated to the individuals present at the facility during the site visit. 4. The project PI is contacted via with any suggestions, and is asked to amend the AUP accordingly. 5. The suggestions from ACC site visit members are also incorporated into the site visit report, distributed to PIs, animal facility manager, designated veterinarian, department chair, and VP Research. 6. communications requesting changes to an AUP are filed with the AUP documentation and are checked for compliance at the time of the next annual renewal. D. Animals for Research Act Inspections 1. Annual inspections by the provincial Veterinary Inspector are carried out under the Ontario Animals for Research Act and are administered by the Ontario Ministry of Agriculture, Food and Rural Affairs (OMAFRA). 2. A staff member of Animal Care Services accompanies the Inspector at all times. Effective Date: April 8, 2011 Page 2 of 5

3 3. Requirements and changes raised by the Veterinary Inspector, i.e. noted non-compliance or unapproved changes in AUP procedures, concerns, or suggestions for refinements or improvements, are communicated by the Veterinary Inspector directly to the animal facility manager, the Animal Care Services staff member, the facility veterinarian, PI (if available), and others present at the time of the inspection. 4. If the Veterinary Inspector s concerns relate to a specific AUP, the PI is contacted by ACS with the suggestion or requirement to amend the AUP. Selected portions of the OMAFRA Provincial Veterinary Inspector s Report, when available, are forwarded to the PI. 5. Following resolution of any issues requiring immediate attention, the communication or report requesting the changes is filed with the AUP and is checked for compliance at the time of the next renewal or amendment. E. Veterinary Site Visits and Program Assessments 1. A veterinarian, designated by the University, oversees the veterinary care program to ensure health and wellbeing of animals, and that the facility is providing adequate animal care and oversight of animal health. This veterinarian conducts regular facility veterinary site visits to all animal facilities and/or receives facility veterinary site visit reports from other approved veterinary designees. 2. If there are noted significant changes in a protocol, additional procedures being performed, concerns or suggestions for refinements or improvements at the time of the veterinary site visit, these are incorporated into the veterinary site visit report, and the PI is contacted with the suggestions. The PI is also requested to amend the AUP accordingly. 3. The communication or report requesting such changes is filed with the AUP and is checked for compliance at the time of the next renewal or amendment. F. Animal Incident Reports 1. Animal Incident Reports are filed for events involving unexpected morbidity, death, injury, a hazardous situation, or a near miss situation involving an animal or animal equipment. 2. Animal Incident Reports are submitted to the Animal Care Committee via ACS and copied to the Veterinary Director, Animal Facilities Management (AFM). 3. The Veterinary Director, AFM or their designee is responsible for communicating to facility manager, PI s, facility veterinarian, and/or other facility staff of any implications the incident may have for the care and use of animals at the facility. 4. The Veterinary Director, AFM or their designee follows-up on the incident report, i.e. compiles additional test results, including post-mortem reports, earlier incidents reported, etc. 5. All Animal Incident Reports are placed on the subsequent ACC meeting agenda with the Veterinary Director, AFM or their designee reporting follow-up information to the ACC members. 6. The ACC may suggest corrective actions, such as refinement of procedures on AUPs or adjustment of standard operating procedures. 7. The requirements are documented in the ACC minutes. The appropriate PI or facility manager is contacted via to request the updated documentation. The is filed with the AUP. 8. The updated documentation is reviewed and approved as per the Animal Care and Use Policy and Procedures. Effective Date: April 8, 2011 Page 3 of 5

4 G. Animal Procurement 1. All animal purchases must be approved through the purchasing approval process. 2. Purchase orders are prepared by the Central Animal Facility administrative staff and submitted to the purchasing department. 3. The order is forwarded to the AUP Coordinator, Animal Care Services, for review and approval. Once received, reviewed and approved by the ACC, the order will be returned to the department to proceed. 4. If the numbers of animals requested are available on the AUP, the order is approved and returned to the purchasing department for filling. 5. If insufficient numbers of animals are available on the AUP, the order is held and an amendment is requested of the PI to add additional animals to their AUP. Once the documentation is received and approved, the order is approved and returned to the department. 6. Animal orders are processed in Animal Care Services according to the SOP ACS.105 Animal Order Processing. H. Environmental Health and Safety Program The ACC sends copies of Section 13 of AUPs involving hazards of any kind, e.g. field work, biohazard use, radioactive material use, chemical agents, etc., to the Biosafety Officer in the Environmental Health and Safety department. Approvals of AUPs are withheld until all required related documentation, e.g. permits, biohazard certificates, radioisotope permits, etc. are in place. I. Animal Care Staff The animal care staff who are involved in the care of the animals or in the supervision of other staff who are care takers may, from time to time, observe changes in procedures, additional procedures being performed or concerns in conduct of those procedures. Such situations must be reported to the Facility Manager, the Director, ACS, Chair Animal Care Committee or the Veterinary Director, AFM. See the Animal Care and Use Policy and Procures Section 1, subsection 10 and Section 11, subsection 8.0. J. Regional Campus and Research Station Post Approval Monitoring Programs At each of the regional campuses and the New Liskeard Agricultural Research Station, a Post Approval Monitoring subcommittee has been struck. The membership and functioning for each location-specific subcommittee are outlined in the Standard Operating Procedure for the location. Each subcommittee meets at minimum annually with the Principal Investigator of each AUP. In these meetings, the AUP is reviewed to ensure the AUP accurately reflects the work being done, and the animals and/or procedures being performed are observed, if possible. Any identified requirements for changing/updating the AUP to reflect the actual activities is recorded and the report sent to the Animal Care Committee. At the time of the next Renewal/Amendment or replacement AUP, ACC ensures that these noted requirements have been met, and if they have not, this information is requested by ACS from the Principal Investigator. Effective Date: April 8, 2011 Page 4 of 5

5 References University of Guelph Animal Care Policy and Procedures (rev. 2012) Terms of Reference of the Animal Care Committee, CCAC policy statement (rev. 2006) Link to terms of reference: Guideline approved by the University of Guelph Animal Care Committee on: April 8, 2011 Effective Date: April 8, 2011 Page 5 of 5