STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES

Committee on Cost of and Payment for Animal Research

Institute for Laboratory Animal Research

National Research Council

NATIONAL ACADEMY PRESS
Washington, D.C.



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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES Committee on Cost of and Payment for Animal Research Institute for Laboratory Animal Research National Research Council NATIONAL ACADEMY PRESS Washington, D.C.

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES NATIONAL ACADEMY PRESS 2101 Constitution Avenue, NWWashington, DC20218 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 Grant No. NO–0D–4–2139 between the National Academies and the National Institutes of Health of the U.S. Department of Health and Human Services. 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 0-309-07261-1 Library of Congress Catalog Card Number 00-110818 Additional copies of this report are available from the National Academy Press 2101 Constitution Avenue, N.W., Lockbox 285, Washington, D.C.20055; (800) 624-6242or (202) 334-3313(in the Washington metropolitan area); Internet: http://www.nap.edu Copyright 2000 by the National Academy of Sciences. All rights reserved. Printed in the United States of America.

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES THE NATIONAL ACADEMIES National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council 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. Bruce M. Alberts 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. William A. Wulf 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. Kenneth I. Shine 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. Bruce M. Alberts and Dr. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES COMMITTEE ON COST OF AND PAYMENT FOR ANIMAL RESEARCH CHRISTIAN E. NEWCOMER (Chair), Division of Laboratory Animal Medicine, The University of North Carolina, Chapel Hill, North Carolina FREDERICK W. ALT, Howard Hughes Medical Institute, Children's Hospital, Boston, Massachusetts RANSOM L. BALDWIN, Department of Animal Science, University of California, Davis, California JOHN C. DONOVAN, Laboratory Animal Science and Welfare, Aventis Pharmaceuticals, Inc., Collegeville, Pennsylvania JANET L. GREGER, Department of Nutritional Sciences, University of Wisconsin, Madison, Wisconsin JOSEPH HEZIR, EOP Group, Inc., Washington, D.C. CHARLES McPHERSON, American College of Laboratory Animal Medicine, Cary, North Carolina JOSH STEVEN MEYER, GPR Planners Collaborative, Inc., Purchase, New York ROBERT B. PRICE, University of Texas Health Center, San Antonio, Texas DANIEL H. RINGLER, Unit for Laboratory Animal Medicine, University of Michigan Medical School, Ann Arbor, Michigan JAMES R. SWEARENGEN, Veterinary Medicine Division, U.S. Army Medical Research, Institute of Infectious Diseases, Fort Detrick, Maryland JOHN G. VANDENBERGH, Department of Zoology, North Carolina State University, Raleigh, North Carolina Staff Ralph B. Dell, Director Kathleen A. Beil, Administrative Assistant Norman Grossblatt, Editor Susan S. Vaupel, Editor Marsha K. Williams, Project Assistant

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES INSTITUTE FOR LABORATORY ANIMAL RESEARCH COUNCIL JOHN L. VANDEBERG, Chair 1998-1999, Southwest Foundation for Biomedical Research, San Antonio, Texas PETER A. WARD, Chair 1999-2000, Department of Pathology, University of Michigan Medical School, Ann Arbor, Michigan CHRISTIAN R. ABEE, Department of Comparative Medicine, University of South Alabama, Mobile, Alabama MURIEL T. DAVISSON, The Jackson Laboratory, Bar Harbor, Maine BENNETT DYKE, Southwest Foundation for Biomedical Research, San Antonio, Texas ROSEMARY W. ELLIOTT, Department of Molecular and Cellular Biology, Roswell Park Cancer Institute, Buffalo, New York GERALD F. GEBHART, Department of Pharmacology, College of Medicine, University of Iowa, Iowa City, Iowa JAMES W. GLOSSER, Massillon, Ohio GAIL E. HERMAN, Wexner Research Facility, Children's Hospital, Columbus, Ohio HILTON J. KLEIN, Department of Laboratory Animal Resources, Merck Research Laboratories, West Point, Pennsylvania MARGARET LANDI, Department of Laboratory Animal Science, SmithKline Beecham Pharmaceuticals, King of Prussia, Pennsylvania CHARLES R. MCCARTHY, Kennedy Institute of Ethics, Washington, D.C. WILLIAM MORTON, Regional Primate Research Center, University of Washington, Seattle, Washington RANDALL J. NELSON, Department of Anatomy and Neurobiology, University of Tennessee, Memphis, Tennessee THOMAS D. POLLARD, The Salk Institute, La Jolla, California ROBERT J. RUSSELL, Harlan Sprague Dawley, Inc., Indianapolis, Indiana WILLIAM S. STOKES, Environmental Toxicology Program, National Institute of Environmental Health Sciences, Research Triangle Park, North Carolina MICHAEL K. STOSKOPF, Department of Companion Animal and Special Species Medicine, North Carolina State University, Raleigh, North Carolina RICHARD C. VAN SLUYTERS, School of Optometry, University of California, Berkeley, California JOHN G. VANDENBERGH, Department of Zoology, North Carolina State University, Raleigh, North Carolina THOMAS WOLFLE, Annapolis, Maryland

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES JOANNE ZURLO, Center for Alternatives to Animal Testing, Johns Hopkins School of Hygiene and Public Health, Baltimore, Maryland Staff Ralph B. Dell, Director Kathleen A. Beil, Administrative Assistant Susan S. Vaupel, Editor Marsha K. Williams, Project Assistant

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES COMMISSION ON LIFE SCIENCES MICHAEL T. CLEGG (Chair), College of Natural and Agricultural Sciences, University of California, Riverside, California PAUL BERG (Vice Chair), Stanford University School of Medicine, Stanford, California FREDERICK R. ANDERSON, Cadwalader, Wickersham & Taft, Washington, DC JOANNA BURGER, Division of Life Sciences, Environmental and Occupational Health Sciences Institute, Rutgers University, Piscataway, New Jersey JAMES E. CLEAVER, University of California Cancer Center, San Francisco, California DAVID EISENBERG, University of California, Los Angeles, California JOHN L. EMMERSON, Eli Lilly and Co. (ret.), Indianapolis, Indiana NEAL L. FIRST, Department of Animal Science, University of Wisconsin, Madison, Wisconsin DAVID J. GALAS, Chiroscience R&D, Inc., Bothell, Washington DAVID V. GOEDDEL, Tularik, Inc., South San Francisco, California ARTURO GOMEZ–POMPA, Department of Botany and Plant Sciences, University of California, Riverside, California COREY S. GOODMAN, Department of Molecular and Cell Biology, University of California, Berkeley, California JON W. GORDON, Department of Obstetrics and Gynecology, Mount Sinai School of Medicine, New York, New York DAVID G. HOEL, Department of Biometry and Epidemiology, Medical University of South Carolina, Charleston, South Carolina BARBARA S. HULKA, Department of Epidemiology, University of North Carolina, Chapel Hill, North Carolina CYNTHIA J. KENYON, Department of Biochemistry, University of California, San Francisco, California BRUCE R. LEVIN, Department of Biology, Emory University, Atlanta, Georgia DAVID M. LIVINGSTON, Dana-Farber Cancer Institute, Boston, Massachusetts DONALD R. MATTISON, March of Dimes, White Plains, New York ELLIOT M. MEYEROWITZ, Division of Biology, California Institute of Technology, Pasadena, California ROBERT T. PAINE, Department of Zoology, University of Washington, Seattle, Washington RONALD R. SEDEROFF, Department of Forestry, North Carolina State University, Raleigh, North Carolina

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES ROBERT R. SOKAL, Department of Ecology and Evolution, State University of New York at Stony Brook, New York CHARLES F. STEVENS, MD, The Salk Institute for Biological Studies, La Jolla, California SHIRLEY M. TILGHMAN, Department of Molecular Biology, Princeton University, Princeton, New Jersey RAYMOND L. WHITE, Department of Oncological Sciences, University of Utah, Salt Lake City, Utah Staff Warren Muir, Executive Director

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES Preface Care and use of animals in research are expensive, prompting efforts to contain or reduce costs. Components of those costs are personnel, regulatory compliance, veterinary medical care, and laboratory animal management, equipment, and procedures. Many efforts have been made to control and reduce personnel costs, the largest contributing factor to cost, through better facility and equipment design, more efficient use of personnel, and automation of many routine operations. However, there has been no comprehensive, recent analysis of the various cost components or examination of the strategies that have been proven or are purported to decrease the cost of animal facility operation. The National Research Council appointed the Committee on Cost of and Payment for Animal Research (Cost Committee) in January 1998 to examine the current interpretation of governmental policy (Office of Management and Budget Circular A–21) concerning institutional reimbursement for overhead costs of an animal research facility and to describe methods for economically operating an animal research facility. The study was conducted under the auspices of the Institute for Laboratory Animal Research (ILAR) of the Commission on Life Sciences. The committee produced its first report titled Approaches to Cost Recovery for Animal Research: Implications for Science, Animals, Research Competitiveness, and Regulatory Compliance in May 1998. The principal conclusion of that report was that animal research facilities are used extensively for the conduct of research and support an environment and animal health profile that are integral to the validity of the experimental animal model. Hence, the facilities and

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES administrative (F&A) costs should be eligible for inclusion in an institution's indirect cost category. The Office of Grants and Acquisition Management of the Department of Health and Human Services ultimately accepted most of this recommendation and extended its applicability to institutions governed by Circulars A–21 and A–122 (see Appendix A). This action also catalyzed an NIH committee's final revisions of the NIH Cost Accounting and Rate Setting Manual for Laboratory Animal Facilities. The Cost Committee then considered cost containment methods for animal research facilities and wrote the present report. This report is intended primarily for directors and managers of animal research facilities. The literature available to the Cost Committee that specifically addresses cost containment methods was relatively sparse. However, two other sources of information were available: The Ohio State University Committee on Institutional Cooperation Study (CIC) of 12 institutions (see Appendix B) and the Yale University 1999 Animal Resources Survey (1999 ARS) of 63 institutions (see Appendix C). The present report is based upon the experience of the committee members, most of whom have been directors of laboratory animal facilities, researchers relying on animal models or professionals overseeing research resources for many years (see biographical sketches, Appendix D), information in the literature, and the two surveys. This report has been reviewed by persons chosen for their diverse perspectives and technical expertise in accordance with procedures approved by the National Research Council's Report Review Committee. The purposes of the independent review are to provide candid and critical comments that will assist the authors and the National Research Council in making the published report as sound as possible and to ensure that the report meets institutional standards of objectivity, evidence, and responsiveness to the study charge. The contents of the review comments and the manuscript draft remain confidential to protect the integrity of the deliberative process. We thank the following persons for their participation in the review of this report: Michael Adams, DVM, Professor of Pathology/Comparative Medicine, Wake Forest University School of Medicine, Winston–Salem, NC; Ronald A. Banks, DVM, Director, Laboratory Animal Resource, School of Medicine, University of Colorado Health Sciences Center, Denver; B. Taylor Bennett, DVM, PhD, Associate Vice Chancellor for Research, University of Illinois, Chicago; Linda Cork, DVM, PhD, Chair, Comparative Medicine, Stanford University School of Medicine, CA; Ron DePinho, MD, Dana-Farber Cancer Institute, Boston, MA;

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES Robert E. Faith, DVM, PhD, Director, Center for Comparative Medicine, Baylor College of Medicine, Houston, TX; James G. Fox, DVM, Director, Comparative Medicine, Massachusetts Institute of Technology, Cambridge; Warren W. Frost, DVM, MS, Director, Animal Resources Center, Montana State University, Bozeman; Lauretta W. Gerrity, DVM, Director, Animal Resources Program, University of Alabama, Birmingham; Cynthia S. Gillett, DVM, Director, Research Animal Resources, University of Minnesota, Minneapolis; Michael J. Huerkamp, DVM, Assistant Director, Division of Animal Resources, Emory University, Atlanta, GA; Robert O. Jacoby, DVM, PhD, Chairman, Section of Comparative Medicine, Yale University School of Medicine, New Haven, CT; Timothy Kern, PhD, Professor of Medicine and Ophthalmology, Director, Center for Diabetes Research, Case Western Reserve University, Cleveland, OH; Dennis F. Kohn, DVM, PhD, Director, Institute of Comparative Medicine, Columbia University, New York, NY; C. Max Lang, DVM, Chair, Department of Comparative Medicine, Hershey Medical Center, Pennsylvania State University, Hershey; Neil S. Lipman, VMD, Director, Research Animal Resource Center, Memorial Sloan–Kettering Institute, New York, NY; Richard J. Rahija, DVM, PhD, Director, Laboratory Animal Resources, Duke University Medical Center, Durham, NC; Irving Weissman, MD, Professor, Department of Pathology, Stanford University School of Medicine, CA; David York, Associate Executive Director for Basic Science, Boyd Professor, Pennington Biomedical Research Center, Baton Rouge, LA; and, William P. Yonushonis, DVM, Director, Laboratory Animal Resources, Ohio State University, Columbus. The list shows the diversity and background of the reviewers, again attesting to the rigor of the process of producing this report. Although the persons listed have provided many constructive comments and suggestions, responsibility for the final content of this report rests solely with the authoring committee and the National Research Council. I am very thankful to the committee members, reviewers, and ILAR staff. Members of the committee demonstrated their expertise, dedication, and perseverance and donated their precious time and energy to focus on this project throughout their tenure on the committee. The

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES reviewers provided invaluable insights that helped to make the final report more relevant, informative, and robust. The committee wishes to thank Robert Jacoby of the Section of Comparative Medicine of Yale University School of Medicine, for making available the data from the 1999 ARS, and Rajasekhar Ramakrishnan and Steven Holleran of the Division of Biomathematics and Biostatistics, Department of Pediatrics, College of Physicians and Surgeons, Columbia University, for summarizing and analyzing the data. Ralph Dell was an extraordinary liaison with the groups on the Cost Committee's behalf, playing a pivotal role during our critique and refinement of the survey instrument and the analysis of survey data. The committee deeply appreciated his deft management of the review process and concluding efforts toward publication of the final report. The committee is further indebted to Kathleen Beil and Marsha Williams, of ILAR staff, for their cheerful support of committee functions, manuscript preparation, and producing all the tables (Appendix C) summarizing the 1999 ARS. Christian E. Newcomer (Chair) Director, Division of Laboratory Animal Medicine The University of North Carolina

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES Contents     EXECUTIVE SUMMARY   1     INTRODUCTION   6  1   PERSONNEL   10      Administrative Personnel,   11      Animal Care Staff,   12      Personnel Training,   13      Team Management: A Case Study,   14      Salaries, Benefits and Incentives,   16      Outsourcing Animal Care Services,   17      Summary,   18  2   LABORATORY ANIMAL MANAGEMENT PRACTICES   19      Administrative Practices,   19      Animal Husbandry,   24      Summary,   31  3   VETERINARY MEDICAL CARE   33      Veterinary Staffing,   34      Technicians,   35      Diagnostic Laboratory Support,   35      Health Surveillance,   36      Summary,   37

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STRATEGIES THAT INFLUENCE COST CONTAINMENT IN ANIMAL RESEARCH FACILITIES  4   INTEGRATION OF DESIGN, EQUIPMENT, OPERATION, AND STAFFING: A CONTEMPORARY CASE STUDY   39      Ventilated Racks,   40      Ventilated-Rack Supply and Exhaust,   41      Automatic Watering,   41      Universal Room Design,   42      Animal Transfer Stations,   43      Robotics,   44      Vacuum Bedding System,   45      Expandable–Contractible Barriers,   45      Interstitial Space,   45      Wall Materials and Finishes,   46      Summary,   47  5   REGULATORY CONCERNS   48      Summary,   52  6   FUTURE DIRECTIONS IN RESEARCH ANIMAL USE: INFRASTRUCTURE, COST, AND PRODUCTIVITY   53      Overview,   53      Factors Contributing to Increased Mouse Use,   54      Potential Strategies to Dampen the Explosion in Mouse Use,   56      Summary of Mouse Projections,   57      Potential for Use of Other Transgenic Species,   58      Summary,   59     REFERENCES   60  APPENDIX A   Office of Grants and Acquisition Management Memorandum   63  APPENDIX B   Summary of Findings from the Ohio State University - Committee on Institutional Cooperation Study (CIC)   65  APPENDIX C   Animal Research Survey-1999 and Survey Tables   67  APPENDIX D   Biographical Sketches of Committee Members   145