Design, Implementation,
Monitoring, and Sharing of
Performance Standards for
Laboratory Animal Use
SUMMARY OF A WORKSHOP
Joe Alper and Lida Anestidou, Rapporteurs
Roundtable on Science and Welfare
in Laboratory Animal Use
Institute for Laboratory Animal Research
Division on Earth and Life Studies
THE NATIONAL ACADEMIES PRESS
Washington, DC
THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001
This activity was supported by the American College of Laboratory Animal Medicine; American Veterinary Medical Association; Covance Laboratories, Inc.; Genentech; GlaxoSmithKline; Massachusetts General Hospital; National Primate Research Centers; Novartis; Pfizer, Inc.; Stanford University School of Medicine; University of California, Davis; University of Illinois; University of Michigan; University of North Dakota; University of Pittsburgh; and University of Washington. Funding for this conference was made possible, in part, by the Food and Drug Administration through grant 5 R13 FD 005298 - 02, views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.
International Standard Book Number-13: 978-0-309-37924-3
International Standard Book Number-10: 0-309-37924-5
DOI: 10.17226/21820
Additional copies of this workshop summary are available for sale from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu/.
Cover credit: Zebrafish in containers in laboratory. Available at http://www.genome.gov/dmd/img.cfm?node=Photos/Animals/Zebrafish&id=4164. Photo credit: Maggie Bartlett, NHGRI.
Two sheep in pen, technician examines one. Available at: http://www.understandinganimalresearch.org.uk/resources/imagelibrary/?cat=sheep. Credit: © Understanding Animal Research
Copyright 2015 by the National Academy of Sciences. All rights reserved.
Printed in the United States of America.
Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use (A Workshop Summary). Washington, DC: The National Academies Press.
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PLANNING COMMITTEE ON DESIGN, IMPLEMENTATION,
MONITORING AND SHARING OF PERFORMANCE
STANDARDS FOR LABORATORY ANIMAL USE: A WORKSHOP
Members
David M. Kurtz (Co-Chair), Veterinary Staff Scientist, National Institute of Environmental Health Sciences
Patricia V. Turner (Co-Chair), Professor and Program Leader, Laboratory Animal Science, Ontario Veterinary College, University of Guelph
David M. Anderson, Executive Director, Health Sciences Administration, University of Washington
Janet C. Garber, Consultant, Garber Consulting, LLC
Andrew W. Grady, Director, Laboratory Animal Facilities, University of Mississippi Medical Center
Donna Matthews Jarrell, Attending Veterinarian and Director, Center for Comparative Medicine, Massachusetts General Hospital
Guy B. Mulder, Executive Director, Veterinary and Professional Services, Research Models and Services, Charles River Laboratories
Randall J. Nelson, Associate Vice Chancellor for Research and Professor of Anatomy and Neurobiology, Institutional Official for Animal Care and Use, The University of Tennessee Health Science Center
Mary Ann Vasbinder, Head, Corporate Responsibility for 3Rs and Training Strategy for Animals, Office of Animal Welfare Ethics and Strategy, RD Platform Technology & Science, GlaxoSmithKline
ROUNDTABLE ON SCIENCE AND WELFARE IN
LABORATORY ANIMAL USE1
Co-Chairs
Lynn C. Anderson (Co-Chair), Vice President, Global Animal Welfare and Comparative Medicine, Covance Laboratories, Inc.
Steven Niemi (Co-Chair), Liaison to the American College of Laboratory Animal Medicine, Director, Office of Animal Resources, Harvard University Faculty of Arts and Sciences
Members
Paul A. Locke, (Liaison to ILAR Council), Associate Professor, Department of Environmental Health Sciences, Johns Hopkins School of Public Health
David M. Anderson, Executive Director, Health Sciences Administration, University of Washington
Bonnie V. Beaver, Professor, Department of Small Animal Clinical Sciences, College of Veterinary Medicine, Texas A&M University
Saverio “Buddy” Capuano III, Attending Veterinarian and Associate Director, Animal Services, Wisconsin National Primate Research Center, University of Wisconsin, Madison
Pamela Chamberlain, Veterinary Medical Officer and Institutional Official for the WOAP, Office of Counterterrorism and Emerging Threats, Food and Drug Administration
Carol Clarke, Research Specialist Staff Officer, US Department of Agriculture, APHIS Animal Care
Robert C. Dysko, Professor and Director, Unit for Laboratory Animal Medicine, University of Michigan Medical School
Gloria J. Gaito, Executive Director, Global Animal Welfare and Compliance, Comparative Medicine, Pfizer Worldwide Research and Development
Dianne Garnes, Pharmaceutical Division, Novartis Corporation
Gail C. Golab, Director, Animal Welfare Division, American Veterinary Medical Association
Sherril L. Green, Professor and Chair, Department of Comparative Medicine, Stanford University School of Medicine
_________________________
1 The National Academies of Sciences, Engineering and Medicine forums and roundtables do not issue, review, or approve individual documents. The responsibility for the published workshop summary rests with the workshop rapporteurs and the Institution.
Donna Matthews Jarrell, Attending Veterinarian, Director, Center for Comparative Medicine, Massachusetts General Hospital
Bruce W. Kennedy, Compliance Associate, Office of Research, California State Polytechnic University
Malak Kotb, Chair, Department of Basic Sciences, University of North Dakota
David M. Kurtz, Veterinary Staff Scientist, NIEHS – National Institutes of Health
Margaret S. Landi, Chief of Animal Welfare, Ethics and Strategy, GlaxoSmithKline
Kent K.C. Llloyd, Professor and Head, Mouse Biology Program, University of California, Davis
Anne Maglia, Program Director, Division of Biological Infrastructure, National Science Foundation
Joseph T. Newsome, Clinical Director, Division of Laboratory Animal Resources and Associate Professor, Pathology, University of Pittsburgh
Lawrence Schook, Vice President for Research, Edward William and Jane Marr Gutgsell Professor, University of Illinois
Susan Brust Silk, Director, Division of Policy and Education, Office of Laboratory Animal Welfare, National Institutes of Health
Rhonda J. Wiler, Senior Director, Transgenic Technology, Genentech
Robert H. Wurtz, NIH Distinguished Investigator, Laboratory of Sensorimotor Research, National Eye Institute, National Institutes of Health
Staff
Lida Anestidou, Director, Roundtable on Science and Welfare in Laboratory Animal Use
Angela Kolesnikova, Administrative Assistant, Institute for Laboratory Animal Research
Jenna Ogilvie, Senior Program Assistant, Board on Life Sciences
Consultant
Joe Alper, Writer
INSTITUTE FOR LABORATORY ANIMAL RESEARCH
Council Co-Chairs
Michael D. Lairmore (Co-Chair), Professor and Dean, School of Veterinary Medicine, University of California, Davis
Margaret S. Landi (Co-Chair), Chief of Animal Welfare, Ethics and Strategy, GlaxoSmithKline
Council Members
Karin Blumer, Scientific Affairs, Novartis International AG
Cory Brayton, Associate Professor of Molecular and Comparative Pathobiology, Johns Hopkins University
Joseph J. DeGeorge, Global Head of Safety Assessment and Laboratory Animal Resources, Merck Research Laboratories
Lewis B. Kinter, Consultant
Malak Kotb, Chair, Department of Basic Sciences, University of North Dakota, School of Medicine and Health Sciences
Paul A. Locke, Associate Professor, Department of Environmental Health Sciences, Johns Hopkins School of Public Health
Daniel S. Marsman, Head, Safety and Regulatory Affairs, Procter and Gamble Health Care
Melinda A. Novak, Professor of Psychology, Department of Psychology, University of Massachusetts
James A. Roth, Clarence Hartley Covault Distinguished Professor, Director, Center for Food Security and Public Health, College of Veterinary Medicine, Iowa State University
Lawrence B. Schook, Vice President for Research, Edward William and Jane Marr Gutgsell Professor, University of Illinois
Robert S. Sikes, Professor of Biology, University of Arkansas at Little Rock
Sheldon Sloan, Internal Medicine Portfolio Leader Established Products, Janssen Research and Development, LLC
Patricia Turner, Program Leader, Laboratory Animal Science and Professor, Department of Pathobiology, Ontario Veterinary College, University of Guelph
Staff
Frances E. Sharples, Acting Director
Lida Anestidou, Senior Program Officer
Bethelhem Mekasha, Financial Associate
Angela Kolesnikova, Administrative Assistant
Acknowledgments
This workshop summary has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Academies of Sciences, Engineering and Medicine Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published workshop summary as sound as possible and to ensure that the workshop summary meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the process.
We wish to thank the following individuals for their review of this workshop summary:
Bonnie V. Beaver, Texas A&M University
F. Claire Hankenson, Michigan State University
Richard B. Huneke, Drexel University College of Medicine
Neil S. Lipman, Memorial Sloan-Kettering Cancer Center and the Weill Medical College of Cornell University
Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the workshop summary before its release. The review of this workshop summary was overseen by Stephen W. Barthold, University of California-Davis. Appointed by the National Academies of Sciences, Engineering and Medicine, he was responsible for making certain that an independent examination of this workshop summary was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this workshop summary rests entirely with the rapporteur and the institution.
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Contents
Overview of Performance Standards for the Humane Care and Use of Laboratory Animals
Regulatory and Advisory Perspectives
The United Kingdom and European Perspective
The Perspective of U.S. Academia
The Pharmaceutical Industry Perspective
The Public Interest Perspective
An Accrediting Organization’s Perspective
Summary of the Afternoon Sessions
Detailed Steps in the Development and Implementation of Performance Standards
Reports from the Breakout Sessions
Performance Standard for Personnel Training in Animal Handling and Procedures
Developing the Performance Standard for Personnel Training in Animal Handling and Procedures
Performance Standard for Workplace Safety
Developing the Performance Standard on Workplace Safety
Performance Standard for Scientific Flexibility or Study Drift in Animal Use Protocols
Performance Standard for Perioeprative Surgical Management
Developing the Performance Standard for Perioperative Surgical Management
Comparing and Contrasting the Working Groups’ Performance Standard Development Process
Sharing Acceptable Performance Standards
Appendix B: Biographical Sketches of Workshop Speakers and Organizing Committee Members
3-1 Canada’s animal welfare guideline development process
4-1 Immediate post-clipping observations
4-2 Additional data from post-clipping observations
5-1 Charles River Laboratory’s behavioral assessment scoring for fighting and aggression
5-2 Charles River Laboratory’s behavioral assessment scoring for barbering
5-3 Charles River Laboratory’s behavioral assessment scoring for stereotypic behaviors
5-4 The smallest and largest mouse cages
5-5 The smallest and largest rat cages
6-1 Post-approval monitoring program checklist
7-2 Success rates, by career stage of investigator, for securing NIH RO-1 equivalent grants
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| APHIS | USDA Animal and Plant Health Inspection Service |
| AVMA | American Veterinary Medical Association |
| AWA | Animal Welfare Act |
| AWR | Animal Welfare Regulations |
| Ag Guide | Guide for the Care and Use of Agricultural Animals in Research and Teaching |
| CCAC | Canadian Council on Animal Care |
| CCMP | Center of Comparative Medicine and Pathology |
| CRL | Charles River Laboratories |
| EU | European Union |
| FAQ | Frequently Asked Questions |
| GSK | GlaxoSmithKline |
| Guide | Guide for the Care and Use of Laboratory Animals |
| IACUC | Institutional Animal Care and Use Committee |
| ILAR | Institute for Laboratory Animal Research |
| IO | Institutional Official |
| NIH | National Institutes of Health |
| NRC | National Research Council |
| NSF | National Science Foundation |
| OLAW | NIH Office of Laboratory Animal Welfare |
| PAM | Post-approval monitoring |
| PHS | Public Health Service |
| PPE | Personal protective equipment |
| SCAW | Scientists Center for Animal Welfare |
| SCWDS | Southeastern Cooperative Wildlife Disease Study |
| USDA | U.S. Department of Agriculture |
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