AAALAC International: The Accreditor s Viewpoint. Kathryn Bayne, M.S., Ph.D., D.V.M., DACLAM, DACAW, CAAB Global Director

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1 AAALAC International: The Accreditor s Viewpoint Kathryn Bayne, M.S., Ph.D., D.V.M., DACLAM, DACAW, CAAB Global Director

2 AAALAC s Role In the face of increasing connectivity of animal-based research across institutions and countries, harmonization of animal care and use standards and practices becomes essential. Improved animal welfare Refined animal model More reliable data

3 The Challenge for All Assurance that standards of animal care and use are comparable Dealing with potentially significant cultural, communication, and philosophical differences Potential impact on care of animals, numbers of animals used, research methodologies, etc.

4 Science as the Common Language If the standards proposed for laboratory animal care in one country or group of countries are not scientifically based, their global acceptance will be more limited. Science is objective, verifiable, based on facts

5 AAALAC 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.

6 Founding Member Organizations American Association of Dental Schools American College of Physicians American College of Surgeons American Dental Association American Heart Association American Medical Association American Veterinary Medical Association Association of American Medical Colleges Association of American Veterinary Medical Colleges Federation of American Societies for Experimental Biology National Association of State Universities and Land Grant Colleges National Society for Medical Research Pharmaceutical Manufacturers Association

7 AAALAC Founders Recognized that consistent, high level of research animal care would benefit science Recognized as well that input from scientists was needed

8 Animal Care Panel 1964 Report As part of the scientific community, the Animal Care Panel has been working to define the conditions of animal care which promote sound and proper animal experimentation. The Animal Care Panel cannot and will not proceed with this program [accreditation] without the consent and support of the scientific community.

9 ILAR Newsletter October 1965 The AAALAC has been organized to promote a program for the accreditation of laboratory animal care facilities which will encourage, promote and facilitate scientific research which includes the use of experimental animals.

10 AAALAC: Founded in Science, Guided by Science Board of Trustees Member Organizations More than half represent scientific organizations Toxicology, agriculture, neuroscience, transgenic technology, etc. Others represent veterinary medical, patient advocacy, science advocacy and industry/academic interest groups Approximately one-third of the Council on Accreditation hold a Ph.D.

11 Who Are the AAALAC BOT Members? 69 Organizations Approximately 40 represent research disciplines 17 Represent veterinary or animal sciences specialty groups Patient advocacy, science advocacy and industry/academic interest groups comprise the balance Many international organizations (e.g., AFLAS, FELASA, KCLAM, ICLAS, ANZCCART)

12 AAALAC International Member Organizations Academy of Surgical Research American Association for Laboratory Animal Science American Association for the Advancement of Science American Association of Colleges of Pharmacy American Association of Corporate and Public Practice American Association of Immunologists American College of Laboratory Animal Medicine American College of Neuropsychopharmacology, Inc. American College of Surgeons American College of Toxicology American College of Veterinary Pathologists American Dairy Science Association American Dental Education Association American Diabetes Association American Heart Association American Hospital Association American Physiological Society American Psychological Association American Society for Nutrition American Society for Pharmacology and Experimental American Society of Animal Science American Society of Laboratory Animal Practitioners American Society of Mammalogists American Society of Primatologists American Veterinary Medical Association Americans for Medical Progress Asian Federation of Laboratory Animal Science Association for Behavior Analysis International Association for Gnotobiotics Association for Psychological Science Association of American Medical Colleges Association of American Veterinary Medical Colleges Association of Independent Research Institutes Association of Minority Health Professions Schools, Inc.

13 AAALAC International Member Organizations Association of Primate Veterinarians Association of Public and Land-Grant Universities Australian and New Zealand Council for the Care of Animals in Research and Teaching - New Zealand College on Problems of Drug Dependence, Inc. European Federation of Pharmaceutical Industries and Associations European Society of Laboratory Animal Veterinarians Federation of American Societies for Experimental Biology Federation of Animal Science Societies Federation of European Laboratory Animal Science Associations Institute of Animal Technology International Association for Gnotobiology International Behavioral Neuroscience Society International Council for Laboratory Animal Science International Society for Applied Ethology International Society for Developmental Psychobiology International Society for Transgenic Technologies Interpharma Korean College of Laboratory Animal Medicine Laboratory Animal Management Association National Association for Biomedical Research Neurobehavioral Teratology Society Pennsylvania Society for Biomedical Research Poultry Science Association Public Responsibility in Medicine and Research Safety Pharmacology Society Scientists Center for Animal Welfare Shock Society Sleep Research Society Society for Neuroscience Society for Pediatric Research Society of Toxicology Teratology Society The Association for Research in Vision and The Ornithological Council

14 Core Values Animal Welfare Science Voluntary High Quality Programs Peer Review Collegial Accuracy Confidential

15 The Assessment Process Evaluation or Inspection? the accreditation process is a communication-intensive program of evaluation and support, stressing application of performance standards and professional judgment rather than inspection and enforcement of engineering standards.

16 The four major components of the animal care and use program assessed by AAALAC International: institutional policies and responsibilities animal environment, housing and management veterinary medical care and physical plant

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19 Lack of Reproducibility in Preclinical Research Many of these failures [in reproducibility] have simple and practical explanations: different animal strains, different lab environments or subtle changes in protocol. Francis S. Collins, Director, NIH and Lawrence A. Tabak, Principal Deputy Director, NIH Nature, Vol 505, January 2014

20 Harmonization of animal care Efforts of: and use standards and expectations ICLAS IACLAM AAALAC International OIE (World Organisation for Animal Health) CIOMS

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24 Proper care and use of laboratory animals (from breeding to end of experiments) Better quality of science No repetition of experiments Internat l. recognition Efficiency Reduction nº animals Papers, funding Reduced research costs, Faster development

25 Benefits of Accreditation Concentrates on promoting continuous improvement to a global benchmark Performance based (focuses on outcome measures to determine performance) Represents a level of quality consistent with global standards Recognized by funding sources and research partners AAALAC is the ONLY animal care and use accrediting body that is worldwide

26 Benefits of Accreditation Promotes scientific validity for publication in international high-impact journals Minimizes experimental variability Promotes reproducible quality data Fosters inter-instutional collaboration Keeps institutions knowledgeable and in step with global best practices Promotes high standards and helps to raise the global benchmark for animal well-being in science Provides the public and other stakeholders with a positive image

27 Incidence of Immediate Success in Accreditation (No Mandatory Findings) 100% P E R C E N T A G E 90% 80% 70% 60% 50% 40% 30% 20% 10% 0%

28 What are outcomes of accreditation? Global nature of science International collaboration or outsourcing International meetings Peer-reviewed journals Scientific imperative for: Reproducibility of results Transferability of results Statistical validity of data Animal care = scientific variable Demonstrates highest tier institution

29 QUESTIONS?