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Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
×

ANIMAL RESEARCH
IN A GLOBAL
ENVIRONMENT

MEETING THE CHALLENGES

Proceedings of the November 2008
International Workshop

Institute for Laboratory Animal Research

Division on Earth and Life Studies

NATIONAL RESEARCH COUNCIL
                        OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

www.nap.edu

Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
×

THE NATIONAL ACADEMIES PRESS     500 Fifth Street, NW     Washington, DC 20001

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.

This workshop was supported by Contract No. N01-OD-4-2139, TO 205, between the National Academy of Sciences and the National Institutes of Health. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the views of the agency that provided support for the project.

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Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine

The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.

The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering.

The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.

The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
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Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
×

STEERING COMMITTEE FOR THE INTERNATIONAL WORKSHOP ON ANIMAL RESEARCH IN A GLOBAL ENVIRONMENT: MEETING THE CHALLENGES

Members

Coenraad F.M. Hendriksen, Chair, Netherlands Vaccine Institute, Bilthoven, The Netherlands

Stephen W. Barthold (IOM), Center for Comparative Medicine, University of California, Davis

Kathryn A. Bayne, Association for Assessment and Accreditation of Laboratory Animal Care International, Frederick, Maryland

Jeffrey Everitt, GlaxoSmithKline Research & Development, Research Triangle Park, North Carolina

James G. Fox (IOM), Division of Comparative Medicine, Massachusetts Institute of Technology

Joseph W. Kemnitz, Institute for Clinical and Translational Research, University of Wisconsin, Madison

Hilton J. Klein (formerly with Merck Research Laboratories), Lansdale, Pennsylvania

Judy A. MacArthur Clark (formerly with Pfizer), Animals Scientific Procedures Inspectorate, Home Office, London, United Kingdom

Staff

Joanne Zurlo, Director (until April 2010)

Frances E. Sharples, Acting Director

Lida Anestidou, Senior Program Officer

Kathleen Beil, Administrative Coordinator (until April 2011)

Cameron H. Fletcher, Senior Editor

Rhonda Haycraft, Senior Project Assistant (until January 2011)

Jason Worthy, Program Assistant

Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
×

INSTITUTE FOR LABORATORY ANIMAL RESEARCH COUNCIL: 2008 MEMBERSHIP

Stephen W. Barthold (IOM), Chair, Center for Comparative Medicine, University of California, Davis

Kathryn A. Bayne, Association for Assessment and Accreditation of Laboratory Animal Care International, Waikoloa, Hawaii

Myrtle A. Davis, Toxicology, Drug Disposition, and Pharmacokinetics, Lilly Research Laboratories, Greenfield, Indiana

Jeffrey Everitt, Comparative Medicine and Investigator Support, GlaxoSmithKline Research and Development, Research Triangle Park, North Carolina

James G. Fox (IOM), Divisions of Comparative Medicine and of Biological Engineering, Massachusetts Institute of Technology, Cambridge

Nelson L. Garnett, Consultant, Laboratory Animal Care and Use Programs, Dickerson, Maryland

Estelle B. Gauda, Division of Neonatology, Johns Hopkins University School of Medicine, Baltimore, Maryland

Joseph W. Kemnitz, National Primate Research Center, University of Wisconsin, Madison

Judy A. MacArthur Clark, Animals Scientific Procedures Inspectorate, London, United Kingdom

Martha K. McClintock (IOM), Institute for Mind and Biology, The University of Chicago

Leticia V. Medina, Animal Welfare and Compliance, Abbott Laboratories, Abbott Park, Illinois

Timo Olavi Nevalainen, National Laboratory Animal Center, University of Kuopio, Finland

Bernard E. Rollin, Department of Animal Sciences, Colorado State University, Fort Collins

Abigail Smith, School of Veterinary Medicine, University of Pennsylvania, Philadelphia

Stephen A. Smith, Department of Biomedical Sciences and Pathobiology, VA-MD Regional College of Veterinary Medicine, Virginia Polytechnic Institute and State University, Blacksburg

James E. Womack, Department of Veterinary Pathobiology, Texas A&M University, College Station

Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
×

INSTITUTE FOR LABORATORY ANIMAL RESEARCH COUNCIL: 2011 MEMBERSHIP

Members

Floyd E. Bloom (IOM), Chair, Molecular and Integrative Neuroscience Department (emeritus), Scripps Research Institute, La Jolla, California

Kathryn A. Bayne, Association for Assessment and Accreditation of Laboratory Animal Care International, Frederick, Maryland

Myrtle A. Davis, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Bethesda, Maryland

Nelson L. Garnett, Consultant, Laboratory Animal Care and Use Programs, Dickerson, Maryland

Judy A. MacArthur Clark, Animals Scientific Procedures Inspectorate, London, United Kingdom

Daniel S. Marsman, Personal Health/Feminine Care Safety, Procter & Gamble, Mason, Ohio

Garry Neil, Corporate Office of Science and Technology, Johnson & Johnson, New Brunswick, New Jersey

Timo O. Nevalainen, Professor Emeritus, University of Eastern Finland, Kuopio

Steven M. Niemi, Center for Comparative Medicine, Massachusetts General Hospital, Charlestown

Melinda A. Novak, Department of Psychology, University of Massachusetts, Amherst

Menelas Pangalos, Innovative Medicine Units, AstraZeneca, Alderley Park, United Kingdom

Bernard E. Rollin, Departments of Philosophy, Behavorial Sciences, and Animal Sciences, Colorado State University, Fort Collins

James A. Roth, Center for Food Security and Public Health, College of Veterinary Medicine, Iowa State University, Ames

Staff

Frances E. Sharples, Acting Director

Lida Anestidou, Senior Program Officer

Cameron H. Fletcher, Managing Editor, ILAR Journal

Jason Worthy, Program Assistant

Page viii Cite
Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
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Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
×

Preface

THE GLOBALIZATION OF ANIMAL RESEARCH: SCIENCE AND ETHICS AS A FOUNDATION FOR STANDARDS

Impacts of Globalization

International economist Jagdish Bhagwati has called globalization the “most powerful force for social good in the world today” (Bhagwati 2004, ix). Yet, in the wake of highly publicized news stories about counterfeit pharmaceuticals, the 2007 pet food recall, and tainted heparin supplies, other voices loudly criticize the loss of jobs in America and of quality assurance for products associated with international outsourcing.

In addition, pressures on both the health care industry—which relies heavily on animal models for biomedical research and preclinical trials—and science in general continue to build. A variety of sources provide data showing that demands for new and better medications and for research on health and quality of life will grow, in large part due to the expanding global population.

• In 2006 the United Nations noted that in just 12 years the world population was expected to climb from 6.7 billion to 7.6 billion (UN 2006b).

• The American Veterinary Medical Association has described the health risks to this increasing population: “The convergence of people, animals, and our environment has created a new dynamic in which the health of each group is inextricably interconnected. The challenges associated with this dynamic are demanding, profound, and unprecedented” (AVMA 2008, 3).

• The World Health Report states that “the global health economy is growing faster than gross domestic product (GDP)…. In absolute terms, adjusted for inflation, this represents a 35% growth in the world’s expenditure on health over a five-year period” (WHO 2008, xii).

• And three of the UN Millennium Development Goals (www.un.org/millenniumgoals) specifically address health: child health (Goal 4), maternal health (Goal 5), and the prevention and treatment of HIV/AIDS, malaria, and other diseases (Goal 6).

Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
×

Animal research will play an essential role in efforts to meet these increasing demands for global health care. Yet the animal research community faces the challenge of overcoming negative impressions that industry and academia engage in international collaborations in order to conduct work in parts of the world where animal welfare standards are less stringent. Thus the importance of ensuring the international harmonization of the principles and standards of animal care and use cannot be overstated. A number of national and international groups are actively working toward this goal.

The Role of the Institute for Laboratory Animal Research

The Institute for Laboratory Animal Research (ILAR), a program unit of the US National Research Council, is committed to promoting both the welfare of animals used in research and the quality of the resulting science. To that end, it convenes those involved in such research and related activities—investigators, attending veterinarians and animal care technicians, policymakers and oversight committee members, and educators, from academia, industry, professional societies, and government—to participate in workshops that address both broad and particular challenges in the increasing globalization of animal research.

In 2003 ILAR hosted an international workshop to examine the Development of Science-Based Guidelines for Laboratory Animal Care (NRC 2004). Participants discussed the available knowledge that could positively influence a framework of standards of laboratory animal care and identified gaps in critical information. A common thread in the discussions was the subject of harmonization of animal care standards, specifically its merits and challenges. While scientific evidence was certainly identified as critical to decisions regarding animal care, participants also recognized cultural context as an intrinsic factor in such decisions. Many speakers and participants observed that, despite much progress in the establishment of standards for the objective evaluation of animal care and housing practices, a great deal of work remained to be done.

In 2007 ILAR convened an international meeting of laboratory animal medicine specialists to review the regulatory and guidance documents of several countries; the group analyzed descriptions in these documents of the role of the veterinarian in this type of work and also determined whether training in areas specific to laboratory animal species is required or recommended. This review (Zurlo et al. 2009) revealed both commonalities (e.g., in the provision of clinical care) and significant differences (e.g., in the designation of who at the institution has decision-making authority regarding euthanasia).

In 2008, to follow up on the 2003 event, ILAR convened a workshop to define more precisely the types of information still needed and to identify the data necessary to enable prioritization of research and funding support for related initiatives. This workshop, on Animal Research in a Global Environment: Meeting the Challenges, brought together 200 participants from 17 countries with a diversity of perspectives. The speakers and participants noted that the

Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
×

landscape of animal-based research had changed in some significant ways since the 2003 workshop. Globalization of biomedical research was well under way. Outsourcing of research, sometimes to countries with widely divergent regulatory systems of oversight, had become an important element of the biomedical research enterprise, and academic collaborations across country borders were commonplace. Yet air transportation of animals was becoming more restricted. And there was increasing public concern about the quality of products and services from certain regions of the world. Calls for improvement in laboratory animal welfare and data quality became more prominent and the need for globally accepted approaches to the responsible and ethical conduct of animal research more pressing.

Organization and Content of the Workshop

Fully cognizant of the demands and cautions related to the globalization of animal research, ILAR appointed a Workshop Steering Committee, composed of US and foreign individuals from academia, industry, and the nonprofit sector, to design the program for the 2008 workshop such that session speakers might identify and promote better understanding of important challenges in the conduct of animal research across country boundaries. These challenges appear in the sourcing of animals; the quality of veterinary care; appropriately qualified and competent staff; the provision of a suitable environment (including nutritious food and potable water) for animals, both during transport and at the institution; ethical review of the proposed work and ongoing oversight of the animal program; suitable facilities and equipment in which to conduct the work; appropriate policies and procedures; and protection of the personnel involved in the animal program.

General topics that framed the first day of discussions were challenges and opportunities for harmonization, with representatives from seven organizations providing a variety of international perspectives; operational challenges of working across differing global standards, with representatives from the pharmaceutical industry, contract research organizations (CROs), and academia describing their experiences; and the training and educational challenges of working across different global standards, with colleagues from various regions of the world illustrating how training programs can overcome those challenges.

On the second day speakers examined in more detail specific issues that require attention. They discussed the varying standards and state of veterinary care for research animals around the world as well as potential steps toward harmonizing veterinary education in laboratory animal medicine and standards for laboratory animal care. Presenters also described international principles and approaches to pain, distress, euthanasia, and humane endpoints.

The third day opened with a session concerning efforts to coordinate international rodent resources, for example by facilitating transportation, enhancing databases, and addressing repository issues. The afternoon presentations

Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
×

were devoted to nonhuman primate resources, reviewing the scope of the need for primates in research, the concept of an International Primate Plan to investigate and report on supply and demand, the need for harmonized care standards, and transportation concerns.

Impacts of the Workshop

The impact of this 2008 workshop has extended beyond the oral presentations conveyed in these proceedings. It has been a vital bridge for diverse colleagues and organizations around the world to advance initiatives designed to fill gaps in standards, professional qualifications, and coordination of animal use.

The World Organization for Animal Health (the OIE), with the involvement of speakers from the 2008 ILAR workshop, has published standards on the use of animals in research as part of its Terrestrial Animal Code, which includes a specific chapter regarding the care and use of research animals. Thanks to the OIE’s status as a reference organization for the World Trade Organization (WTO), the Code serves as a standards template for the 178 member countries and territories of the OIE and thus applies to numerous economies and cultures.

In addition, ILAR, the OIE, and the International Association of Colleges of Laboratory Animal Medicine (IACLAM) convened focus groups to assess the laboratory animal veterinary community’s perspective on harmonizing global veterinary qualifications and training in laboratory animal medicine. These groups met in 2010 at three pivotal laboratory animal science meetings held in Europe, the United States, and Asia: the June meeting of the Federation of Laboratory Animal Science Associations (FELASA) in Helsinki; the September meeting of the Association for Laboratory Animal Science (AALAS) in Atlanta; and the November meeting of the Asian Federation of Laboratory Animal Science (AFLAS) Associations in Taipei. More than 100 individuals representing 27 countries participated in the three meetings, the results of which will be published in the online ILAR Journal.

Finally, development of an International Primate Plan (IPP) continues to gain momentum. In 2009 ILAR hosted an international meeting in Irvine, California, to determine the outline and approach to the plan. The participants represented key stakeholders such as researchers, veterinarians, and suppliers. Focused meetings were held in association with the 2010 AFLAS congress, and the IPP has been discussed with the National Institutes of Health (NIH), EUPRIMNET (the European Primate Network), and the Interagency Research Advisory Committee (IRAC) of the US federal government. Substantial progress has been made toward the launch of the plan.

The papers in these proceedings describe important topics facing the biomedical research enterprise. Time has not stood still since the workshop and there has been progress in some areas, yet much work remains to be done—

Page xiii Cite
Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
×

requiring additional attention and resources—to address many of the issues described in the following papers.

A Note about the Transcripts

The transcripts in these proceedings are those approved by the speakers; presentations shown on the agenda but without a corresponding transcript are those for which the speaker did not provide permission for publication. The transcripts have been only lightly edited, largely for clarity, the addition of sources, and, when appropriate and possible, updating to incorporate the outcome of reports issued or events held since 2008. The report and speakers’ slides are posted on the ILAR website.

Acknowledgments

ILAR thanks the US National Institutes of Health, which sponsored this workshop, and the members of the Workshop Steering Committee.

Kathryn A. Bayne
Global Director, AAALAC International

References

AVMA [American Veterinary Medical Association]. 2008. One Health: A New Professional Initiative. Available online (www.avma.org/onehealth/onehealth_final.pdf), accessed on April 14, 2011.

Bhagwati J. 2004. In Defense of Globalization. New York: Oxford University Press.

NRC [National Research Council]. 2004. Development of Science-Based Guidelines for Laboratory Animal Care: Proceedings of the November 2003 International Workshop. Washington: National Academies Press.

OIE [World Organization for Animal Health]. 2010. Use of Animals in Research: Terrestrial Animal Health Code. Available online (www.oie.int/index.php?id=169&L=0&htmfile=chapitre_1.7.8.htm), accessed on April 14, 2011.

UN [United Nations]. 2006a. The Millennium Development Goals Report 2006. Available online (http://mdgs.un.org/unsd/mdg/Resources/Static/Products/Progress2006/MDGReport2006.pdf), accessed on April 14, 2011.

UN. 2006b. World Population Prospects: The 2006 Revision. Available online (www.un.org/esa/population/publications/wpp2006/WPP2006_Highlights_rev.pdf), accessed on April 14, 2011.

WHO [World Health Organization]. 2008. The World Health Report 2008: Primary Health Care Now More Than Ever. Available online (www.who.int/whr/2008/whr08_en.pdf), accessed on April 14, 2011.

Zurlo J, Bayne K, MacArthur Clark J. 2009. Adequate veterinary care for animals in research: A comparison of guidelines from around the world. ILAR J 50:85-88.

Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
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Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
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Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
×

ANIMAL RESEARCH
IN A GLOBAL
ENVIRONMENT

MEETING THE CHALLENGES

Proceedings of the November 2008
International Workshop

Suggested Citation:"Front Matter." National Research Council. 2011. Animal Research in a Global Environment: Meeting the Challenges: Proceedings of the November 2008 International Workshop. Washington, DC: The National Academies Press. doi: 10.17226/13175.
×

 

 

 

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Animal research will play an essential role in efforts to meet increasing demands for global health care. Yet the animal research community faces the challenge of overcoming negative impressions that industry and academia engage in international collaborations in order to conduct work in parts of the world where animal welfare standards are less stringent. Thus, the importance of ensuring the international harmonization of the principles and standards of animal care and use cannot be overstated. A number of national and international groups are actively working toward this goal.

The Institute for Laboratory Animal Research (ILAR), a program unit of the US National Research Council, is committed to promoting both the welfare of animals used in research and the quality of the resulting science. In 2008, to follow up on the 2003 event, ILAR convened a workshop which brought together 200 participants from 17 countries. Their mission was to identify and promote better understanding of important challenges in the conduct of animal research across country boundaries. These challenges include: the sourcing of animals; the quality of veterinary care; competent staff; the provision of a suitable environment (including nutritious food and potable water) for animals; and ongoing oversight of the animal program; among others.

Animal Research in a Global Environment summarizes the proceedings of the 2008 workshop. The impact of this 2008 workshop has extended beyond the oral presentations conveyed in these proceedings. It has been a vital bridge for diverse colleagues and organizations around the world to advance initiatives designed to fill gaps in standards, professional qualifications, and coordination of animal use.

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