2. This lecture will be available on the AAALAC International Web site at: http://www.aaalac.org/resources/available.cfm http://www.aaalac.org/resources/available.cfm Scroll to the bottom and look under Power Point Presentations

3. External Influences on Animal Research The publics expectations for science are high Public demands for good practices Public and research demands for best practices Research costs with animals is increasingly a big business investment for science. Animal rights groups want to stop animal use

4. Animal-based research requires institutional commitment: That a system of ensuring high quality research is in place That criticism of animal research is met with strong push-back from the administration; high quality research is defensible

5. Mechanisms of Animal Research Oversight Internal Ethical review committees External Federal regulations and inspections Third party, peer review National audit; may not have international acceptance AAALAC International is the only global accrediting program

6. But the oversight mechanism should satisfy both national and international stakeholders.

7. Animal science is about new discovery and knowledge, but it is also about the international adoption and transfer of that knowledge to all aspects of human and animal life… John P. Hearn Chair, Committee on International Activities ILAR (1995)

8. Harmonizing Procedures and Practices… Optimizes the quality of science; Addresses the need for similar standards to govern the care and use of animals in international research protocols, thereby bringing a degree of equivalency to the data or information generated;

9. Harmonizing Procedures and Practices… Facilitates the movement and exchange of research animals and animal products; Addresses the need for efficiency in costs of research

10. AAALAC International Mission AAALAC International is a voluntary accrediting organization that enhances the quality of research, teaching, and testing by promoting humane, responsible animal care and use. It provides advice and independent assessments to participating institutions and accredits those that meet or exceed applicable standards.

11. AAALAC International Accreditation Program The concept of a truly international accreditation program, one that is science-based and sensitive to cultural and legal differences, is logical and consistent within the framework of the international scientific community.

12. AAALAC has a Long History of Accrediting Internationally First non-U.S. site accredited by AAALAC in 1981 (Canada) First European site accredited by AAALAC in 1986 (England) First Pacific Rim site accredited by AAALAC in 1995 (Philippines) Institutions now accredited in 28 countries/territories around the world

13. The International Face of AAALAC International ad hoc Consultants International Council on Accreditation International Board of Trustees Globally regional offices Hawaii - Pacific Rim Office Belgium - European Office

14. Countries/ Regions with Accredited Units Austria Belgium Canada China Denmark Egypt England France Germany Hungary India Indonesia Italy Japan Korea Netherlands Norway Peru Philippines Russia Scotland South Africa Spain Sweden Switzerland Taiwan Thailand USA

15. Why is There Such International Interest in AAALAC? Global nature of science international meetings International peer-reviewed journals Scientific imperative for reproducibility of results statistical validity of data Animal care = scientific variable Can be controlled to a large extent through use of an international standard Public accountability

16. Accreditation Promotes Quality Assurance and Provides Research Defense A defensible standard - science Flexibility of performance standards Sensitivity to legal, cultural issues Cross fertilization through site visits Highlighting of best practices International benchmarking of quality

17. International Quality Assurance and Defense of… High animal welfare standards Appropriate animal care and use practices

18. Quality Assurance- The proof is in the practice Different national standards may result in inconsistent animal care and thus variable data Collaborators and contractors need assurances of quality and consistency Science and animals benefit

19. Accreditation internationally Each countrys own national requirements as baseline No national requirementsGuide provisions applied AAALAC Reference Resources as applicable Expert, professional judgment Peer review process * ALL PRINCIPLES OF GUIDE MUST BE MET

20. The Accreditation Program Application of Basic Principles A performance approach Professional judgment The 3 Rs

21. A Performance Approach "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."

22. Professional Judgment… The judgment of the profession, not simply the judgment of an individual professional.

23. The Three Rs: A Symbol of Animal Welfare Reduction Replacement Refinement

24. Consequences of a flawed system Public trust in research is diminished Frustration in the research enterprise Animal protections questioned, which can lead to restrictions on research

25. What Are The Risks? Public relations problems Increased regulatory burden with no benefit to science or the animals Increased cost/loss of innovation Erosion of public and community trust

26. Emerging Issues and Future Concerns - The Challenges U.S.Global Rising Costs of Research Defining the Gaps in the Scientific Literature Regarding Animal Welfare Standards Social and Political Pressures Defining the Optimal Animal Welfare and Scientific Standards Application of Sound Professional Judgment Creating a Vibrant, Dynamic System That is Persuasive for Flexibility, Accountability and Responsibility

27. The Globalization of Animal Research and the Need to Protect It The scientific principles of reproducibility and statistical validity of results will move researchers and their institutions inevitably toward consistency in animal care and use practices.

28. How AAALAC International Accreditation Benefits Science Elimination/minimization of variables Reproducibility of experimental results Statistical significance of experimental data Comparability of studies

29. How AAALAC International Accreditation Benefits Animals Fresh, unbiased perspective separate from the lines of authority at the institution Reviewers who can benchmark the program against peer institutions The animals are the focus of the evaluation

30. How AAALAC International Accreditation Benefits the People Ensuring a high level of occupational health and safety Encourages institutional team work; this involves all stakeholders Pride in the workplace

31. AAALAC International Pacific Rim Office 68-3549 Makana Aloha Place Waikoloa, HI 96738 808.883.2186 phone 808.883.1155 fax kbayne@aaalac.org www.aaalac.org Where science and responsible animal care connect. For more information...