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Committee on Assessment of the Use and Care of Dogs in Biomedical Research Funded by or Conducted at the U.S. Department of Veterans Affairs Institute for Laboratory Animal Research Division on Earth and Life Studies Board on Health Sciences Policy Health and Medicine Division A Consensus Study Report of
THE NATIONAL ACADEMIES PRESS â 500 Fifth Street, NW â Washington, DC 20001 This activity was supported by Contract No. 36C24E18C0058 with the U.S. Department of Veterans Affairs. 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: 978-0-309-67641-0 International Standard Book Number-10: 0-309-67641-X Digital Object Identifier: https://doi.org/10.17226/25772 Additional copies of this publication are available 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. Copyright 2020 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. 2020. Necessity, use, and care of laboratory dogs at the U.S. Department of Veterans Affairs. Washington, DC: The National Academies Press. https://doi.org/10.17226/25772.
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Consensus Study Reports publishedÂ by the National Academies of Sciences, Engineering, and MedicineÂ document the evidence-based consensusÂ on the studyâs statement of task by an author- ing committee of experts.Â Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committeeâs deliberations. Each report has been subjected to a rigorous and independent peer-review process, and it representsÂ theÂ posi- tionÂ ofÂ the National Academies on the statement of task. ProceedingsÂ publishedÂ by the National Academies of Sciences, Engineering, and MedicineÂ chronicle the presentations and discussions at a workshop, symposium, or otherÂ eventÂ convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. For information about other products and activities of the National Academies, please visitÂ www. nationalacademies.org/about/whatwedo.
COMMITTEE ON ASSESSMENT OF THE USE AND CARE OF DOGS IN BIOMEDICAL RESEARCH FUNDED BY OR CONDUCTED AT THE U.S. DEPARTMENT OF VETERANS AFFAIRS RHONDA CORNUM (Chair), TechWerks, Paris, KY W. RON DeHAVEN (Vice Chair), DeHaven Veterinary Solutions, LLC, El Dorado Hills, CA DONNA K. ARNETT, University of Kentucky, Lexington WARREN CASEY, National Institute of Environmental Health Sciences, Durham, NC CHRIS GREEN, Harvard University, Cambridge, MA JOAN C. HENDRICKS, University of Pennsylvania, Philadelphia (Emerita) KATHRIN HERRMANN, Johns Hopkins University, Baltimore, MD (until June 2019) JONATHAN KIMMELMAN, McGill University, Montreal, QC LEWIS B. KINTER, GLP Scientific Consulting, Kennett Square, PA SARAH L. LATHROP, University of New Mexico, Albuquerque NANCY FIGLER MARKS, The University of Iowa, Iowa City CHRISTIAN E. NEWCOMER, Independent Consultant, Brookeville, MD WILLIAM Z. POTTER, Independent Consultant, Philadelphia, PA DAVID M. POWELL, Saint Louis Zoo, Saint Louis, MO MARGARET (MIMI) FOSTER RILEY, University of Virginia, Charlottesville RODNEY A. WHITE, Long Beach MemorialCare Heart & Vascular Institute, Long Beach, CA Staff REBECCA A. ENGLISH, Study Director, Board on Health Sciences Policy (from June 2019) LIDA ANESTIDOU, Study Director, Institute for Laboratory Animal Research (until May 2019) CAMILLA YANDOC ABLES, Senior Program Officer, Board on Agriculture and Natural Resources JENNA BRISCOE, Research Associate, Board on Agriculture and Natural Resources ALEX REPACE, Senior Program Assistant, Board on Health Sciences Policy (from November 2019) KEIONA JONES, Senior Program Assistant, Institute for Laboratory Animal Research (until August 2019) Science Writer and Editor CAROL BERKOWER ROBERT POOL v
Reviewers T his Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We thank the following individuals for their review of this report: BONNIE BEAVER, Texas A&M University-College Station MATTHEW BREEN, North Carolina State University KATHLEEN CONLEE, The Humane Society of the United States LINDA C. CORK, NAM,1 Stanford Medicine CANDACE L. FLOYD, The University of Utah DAVID K. JOHNSON, Diplomate of the American College of Laboratory Animal Medicine JEFFREY KAHN, NAM, Johns Hopkins University MARGARET LANDI, GSK Pharmaceuticals PAUL LOCKE, Johns Hopkins Bloomberg School of Public Health DANIEL MYERS, University of Michigan JEFF SEBO, New York University JENNIFER SMITH, Henry Ford Health System NORMAN STOCKBRIDGE, U.S. Food and Drug Administration CHARLES H. VITE, University of Pennsylvania School of Veterinary Medicine PAUL WALDAU, Canisius College 1 National Academy of Medicine. vii
viii REVIEWERS Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by STEVE BARTHOLD, NAM, University of California, Davis, and ELI ADASHI, NAM, Brown University. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.
Preface T his Consensus Study Report represents the culmination of almost 2 years of hard work and dedication of an exceptionally diverse committee of professionals, including industry and academic scientists, physicians, veterinarians, lawyers, and bioethicists. Initially we thought it would be fairly straightforward to answer the primary question, âwhether dogs are or will continue to be necessary for any type of biomedical research directly related to the VAâs [U.S. Department of Veterans Affairsâ] mission.â We heard from panels of experts and individual experts, conducted independent data analysis, and were addressed by the senior leadership of the VAâs research program. Committee subgroups also visited two VA research facilities. Based on those collective experiences, we initially believed that it would be possible to reach conclusions and make recommendations that all members of the committee could support. What we all learned is that while facts are always facts, the emphasis that each individual places on each fact and the interpretation of a collection of facts leading to conclusions were widely disparate within this group. The differences seemed dependent on the discipline, each committee memberâs personal and professional experiences and values, the prevailing attitude of the memberâs usual constituency, and other, undefined factors. Despite sincere efforts by all to reach consensus, it was not possible. We believe the readers of this report will recognize the intellectual and professional honesty that went into both the majority and the minority conclusions and recommendations. We want to thank all of the committee members and the experts who generously gave their time and expertise. Additionally, we wish to thank the entire staff at the National Academies of Sciences, Engineering, and Medicine for their tireless efforts to forge a path for us, their outstand- ing research ability, and their timeliness. Special recognition goes to our study director, Rebecca English, for her calming influence and leadership. Camilla Yandoc Ables and Jenna Briscoe were similarly indispensable in facilitating our requests and requirements for more and more data min- ix
x PREFACE ing. Keiona Jones and Alex Repace were masters of getting everyone where they needed to be, every time, with all of the support that was needed. The National Academies Research Center also provided invaluable research support, with special thanks to Jorge Mendoza-Torres. Sincerely, Rhonda Cornum, Chair W. Ron DeHaven, Vice Chair Committee on Assessment of the Use and Care of Dogs in Biomedical Research Funded by or Conducted at the U.S. Department of Veterans Affairs
Contents SUMMARY 1 1 INTRODUCTION 13 Origin of This Study, 14 Recent Legislation Concerning the Use of Laboratory Dogs at the VA, 16 Study Process, 17 The Committeeâs Interpretation of Its Task, 19 Terminology Used in This Report, 19 Organization of the Report, 19 References, 20 2 LEGAL, SOCIAL, AND ETHICAL CONSIDERATIONS 23 Historical Overview of Research Using Dogs, 23 Legal Context for Using Laboratory Dogs in Biomedical Research, 25 Standards for the Use and Welfare of Dogs in Biomedical Research, 29 Social and Ethical Considerations, 29 Ethical Considerations on the Use of Dogs in VA Research, 30 References, 35 3 DETERMINING THE NECESSITY OF LABORATORY DOGS IN BIOMEDICAL RESEARCH FUNDED BY OR CONDUCTED AT THE U.S. DEPARTMENT OF VETERANS AFFAIRS 39 Trends in Dog Use in U.S. Research Facilities, 40 Laboratory Dog Use in Biomedical Research at the VA, 41 Next Steps for the Use of Laboratory Dogs in Biomedical Research Related to the VAâs Mission, 59 The VAâs Biomedical Research Review Process, 61 xi
xii CONTENTS Operationalizing âNecessaryâ Areas of Agreement and Disagreement Within the Committee, 64 Opportunities to Improve Biomedical Research Protocols and Review Processes at the VA, 70 References, 72 4 ALTERNATIVES TO THE USE OF LABORATORY DOGS 89 Current Status of Alternatives Development, 89 Companion Dogs, 90 Other Animal Models, 94 Non-Animal Models: New Approach Methodologies, 102 Human Clinical Trials, 109 References, 110 5 CARE AND WELFARE OF LABORATORY DOGS USED IN BIOMEDICAL RESEARCH FUNDED BY OR CONDUCTED AT THE U.S. DEPARTMENT OF VETERANS AFFAIRS 121 Current Knowledge in the Science of Animal Welfare: A Brief Overview, 121 Additional Considerations for Enhancement of the Welfare of Laboratory Dogs, 124 Assessment of Current VA Practices: Do They Meet Current Standards, Requirements, and Recommendations with Regard to the Care and Welfare of Dogs?, 127 Considerations for Enhancement at the VA, 129 References, 130 APPENDIXES A METHODS 135 B U.S. DEPARTMENT OF AGRICULTURE STATISTICS ON THE USE OF DOGS AND OTHER ANIMALS IN RESEARCH 143 C BIOGRAPHICAL SKETCHES OF COMMITTEE MEMBERS 149
Boxes, Figures, and Table BOXES S-1 Statement of Task, 2 1-1 Statement of Task, 15 1-2 Terminology Related to Weighing the Risk of Harm Against Potential Benefit, 20 3-1 Other Research Areas Previously Investigated by the U.S. Department of Veterans Affairs (VA) Using Laboratory Dogs, 59 FIGURES 3-1 Annual dog usage in the United States from 1973 to 2018, based on data collected by the U.S. Department of Agriculture, 40 3-2 The U.S. Department of Veterans Affairsâ (VAâs) intramural canine research review process, 62 B-1 Annual dog, non-human primate (NHP), and pig usage 1973â2018 in the United States, based on data collected by the U.S. Department of Agriculture, 144 TABLE B-1 Usage of Dogs, Non-Human Primates (NHPs), and Pigs Reported to the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service in 2017, 146 xiii