Guidance for the Description of
Animal Research in Scientific Publications

Institute for Laboratory Animal Research

Division on Earth and Life Studies

NATIONAL RESEARCH COUNCIL              

                                 OF THE NATIONAL ACADEMIES                     









THE NATIONAL ACADEMIES PRESS
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Guidance for the Description of Animal Research in Scientific Publications Institute for Laboratory Animal Research Division on Earth and Life Studies THE NATIONAL ACADEMIES PRESS Washington DC www.nap.edu

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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 study was supported by core funding for the Institute for Laboratory Animal Research from the National Science Foundation under contract DBI-0838150; the US Department of the Army under contract W81XWH-09-1-0664; the US Department of the Navy under contract N00014- 05-G-0288, Task Order #21; and the Department of Health and Human Services/National Institutes of Health under contract N01-OD-4-2139, Task Order #221. 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 organizations or agencies that provided support for the project. International Standard Book Number-13: 978-0-309-21951-8 International Standard Book Number-10: 0-309-21951-5 Additional copies of this report are available from the National Academies Press, 500 Fifth Street NW, Lockbox 285, Washington DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu Copyright 2011 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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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

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COMMITTEE ON GUIDELINES FOR SCIENTIFIC PUBLICATIONS INVOLVING ANIMAL STUDIES Jeffrey Everitt, Chair, GlaxoSmithKline Research and Development, Research Triangle Park, North Carolina Stephen W. Barthold (IOM), Center for Comparative Medicine, University of California, Davis Timo Nevalainen, Professor Emeritus, University of Eastern Finland, Kuopio Stephen A. Smith, Department of Biomedical Sciences and Pathobiology, Virginia Polytechnic Institute and State University, Blacksburg Mary Waltham, Publishing Consultant, Princeton, New Jersey Staff Cameron H. Fletcher, Program Officer (from April 2010) Joanne Zurlo, ILAR Director (until April 2010) v

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INSTITUTE FOR LABORATORY ANIMAL RESEARCH COUNCIL Floyd E. Bloom (IOM), Chair, Molecular and Integrative Neuroscience Department (emeritus), Scripps Research Institute 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 in 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, Behavioral 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 vi

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REVIEWERS The draft of this report was reviewed by individuals chosen for their diverse perspectives and expertise, in accordance with procedures approved by the Report Review Committee of the National Research Council. The purpose of this independent review is to provide candid and critical comments that will assist the committee in making its published report as sound as possible, and to ensure that the report 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 deliberation process. The committee thanks the following individuals for their review of the draft report: Floyd Bloom, Scripps Research Institute Cory Brayton, Johns Hopkins University Patricia A. Brown, National Institutes of Health Hershel Raff, Medical College of Wisconsin Randy W. Schekman, University of California, Berkeley Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by John Vandenbergh, North Carolina State University. Appointed by the National Research Council, he was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution. vii

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CONTENTS 1 Overview 1 1.1 The Need for Guidance, 2 1.2 Related Guidelines, 3 1.3 Organization and Content of This Report, 3 2 Defining an Optimal Description of an Animal Study 4 2.1 How Much Detail Is Necessary?, 4 2.2 A Values-Based Approach, 5 3 The Research Animal 5 3.1 General, 5 3.2 Source, 6 3.3 Genetics, 6 3.4 Microbial/Pathogen Status, 7 3.5 Preparation and Assignment of the Research Animal to Study, 8 4 The Research Animal Environment (Study Conditions) 8 4.1 Diet, 9 4.2 Water, 9 4.3 Housing, 9 4.4 Macroenvironment, 10 5 Basic Animal Methodology 11 5.1 Description of the Research Animal during the Study, 11 5.2 Administration of Anesthetics, Analgesics, and Other Substances, 11 5.3 Use of Infectious Agents, 12 5.4 Tissue and Fluid Sample Acquisition, 12 5.5 Euthanasia, 12 6 Aquatic Systems 12 6.1 Water Quality, 12 6.2 Diet, 13 6.3 Housing, 13 6.4 Animal Numbers, 14 7 Summary and Conclusions 14 References 15 Appendix 27 ix

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