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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

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

images

THE NATIONAL ACADEMIES PRESS

Washington, DC

www.nap.edu

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

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.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

images

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Ralph J. Cicerone is president.

The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. C. D. Mote, Jr., is president.

The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president.

The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine.

Learn more about the National Academies of Sciences, Engineering, and Medicine at www.national-academies.org.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

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

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

ROUNDTABLE ON SCIENCE AND WELFARE IN
LABORATORY ANIMAL USE
1

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.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

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

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

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

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

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.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
×

Acronyms and Abbreviations

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
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Page xiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2015. Design, Implementation, Monitoring, and Sharing of Performance Standards for Laboratory Animal Use: Summary of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/21820.
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In order to better understand the critical issues pertaining to the concept of performance standards for laboratory animal use, the Institute for Laboratory Animal Research Roundtable on Science and Welfare in Laboratory Animal Use held a public workshop on April 20-21, 2015. The purpose of the workshop was to promote the appropriate and responsible care of animals in research, to provide a balanced and civil forum for discussion and collaboration, and to help build transparency and trust among stakeholders. Participants addressed the challenges of defining, developing, implementing, assessing, and validating performance standards to ensure "optimal practices, management, and operations." This report summarizes the presentations and discussions from the workshop.

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