Post Approval Monitoring Program

1. Post Approval Monitoring Program Presented by Carolyn Malinowski Manager, Quality Assurance and Training

2. Discussion Areas • What is Post Approval Monitoring • Why should we do this • Who will be involved • Logistics • Implementation • Questions

3. Post-Approval Monitoring (PAM) • PAM is a program through which ACUC/CCM can ensure and document program integrity, compliance with regulations and guidelines, and adherence to protocol. • PAM can serve as a facilitator or conduit for information exchange between researchers, and between researchers and ACUC/CCM • PAM can serve as the eyes and ears of the ACUC

4. PAM can provide assurance to regulatory agencies and Northwestern University that animal experiments are monitored for compliance with approved ACUC protocols

5. Goals • Ensure animal well being • Protect the Institution • Resource for the research community • Facilitate science • Ensure regulatory compliance

6. What PAM is NOT • NOT Animal Cops • NOT a replacement for the ACUC • NOT required by the USDA or PHS • NOT a “must” of AAALAC • NOT new ground or a new regulation

7. Regulatory Basis • USDA: 2.31 IACUC Functions • Public Health Service (PHS) • The ‘Guide for the Care and Use of Laboratory Animals’ • U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training

8. USDA: 2.31 IACUC Functions • Review, at least once every 6 months, the research facility’s program for the humane care and use of animals… • Inspect, at least once every 6 months, all of the research facilities, including animal study areas…

9. 3. …The IACUC may determine the best means of conducting evaluations of the research facility’s programs and facilities… 4. …Investigate concerns involving the care and use of animals at the research facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees…

10. Public Health Service 1. … Review at least once every 6 months the institution’s program for humane care and use of animals… 2. … The IACUC shall confirm that the research project will be conducted in accordancewith the Animal Welfare Act insofar as it applies to the research project, and that the research project is consistent with the Guide unless acceptable justification for a departure is present. Further the IACUC shall determine that the research project conforms with the institution's Assurance…

11. 3. The IACUC shall conduct continuing review of activities covered by this Policy at appropriate intervals as determined by the IACUC… 4. The IACUC may suspend an activity that is previously approved if it determines that the activity is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the Guide, the institution’s Assurance…

12. 1. …IACUC, also referred to as “the committee,” to oversee and evaluate the institution’s animal program, procedures, and facilities to ensure that they are consistent with the recommendations in this Guide… 2. Its (the IACUC) functions includeinspection of facilities; evaluation of programs and animal-activity areas; submission of reports to responsible institutional officials; review of proposed uses of animals in research, testing, or education (i.e., protocols); and establishment of a mechanism forreceipt and review of concerns involving the care and use of animals at the institution. The ‘Guide’

13. 3. Performance standards define an outcome in detail and provide criteria for assessing that outcome, but do not limit the methods by which to achieve that outcome. This performance approach requires professional input and judgment to achieve outcome goals. 4. ...the IACUC should pay particular attention to animal well-being through continuing evaluation of outcomes.

14. 5. Assessment of animal space needs should be a continuing process. 6. A continuing and thorough assessment of surgical outcomes should be performed to ensure appropriate procedures are followed… In the event of modification, assessment of outcomes should be even more intense and might have to incorporate criteria other than the obvious clinical morbidity and mortality.

15. U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training VIII. Investigators and other personnel shall be appropriately qualified and experienced for conducting procedures on living animals. Adequate arrangements shall be made for their in-service training…

16. Who will be involved? • Quality Assurance and Training Staff • ACUC Staff/Committee • Animal Health Technicians/Veterinarians • PI’s and Lab/Research Staff • Note: all CCM staff will report directly to the ACUC for all matters concerning PAM

17. Who will be selected? • All active protocols • Random selection • At the discretion of the ACUC and veterinary staff • Complimentary to ACUC semi-annual inspections • Initial Goal: one inspection per week

18. Upon Selection… • Know the lab and the protocols • Labs will be contacted and visits scheduled • Compliance Liaison (CL) team visit • Document findings • Discuss findings with PI and research staff

19. Examples of Areas that will be Reviewed • Protocol and Personnel • Study Procedures • Anesthesia • Surgery • Post-Surgical Care • Euthanasia • Record Keeping • Laboratory

20. After CL Team visit • Written draft of visit to PI/research personnel • Final report: PI, research personnel, ACUC, Attending Veterinarian • Files of reports maintained by CLA • Follow up and support: • - Training • - Protocol modifications if needed

21. Implementation • Tentative plan to begin PAM program in January 2006 • Initial plan to visit one lab per week • Much of it will be established as the program progresses • Changes will be made as necessary

22. Questions or Comments