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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.
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.
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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.
This study was supported by Contract/Grant No. N01-0D-4-2139 between the National Academy of Sciences and the Department of Health and Human Services and 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 organizations or agencies that provided support for the project.
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COMMISSION ON LIFE SCIENCES
Thomas D. Pollard
The Salk Institute for Biological Studies, La Jolla, California
Frederick R. Anderson,
Cadwalader, Wickersham & Taft, Washington, DC
John C. Bailar, III,
University of Chicago, Illinois
Stanford University, Stanford, California
Rutgers University, Piscataway, New Jersey
Sharon L. Dunwoody,
University of Wisconsin, Madison
John L. Emmerson,
Eli Lilly and Co. (Ret.), Indianapolis, Indiana
Neal L. First,
University of Wisconsin, Madison, Wisconsin
Ursula W. Goodenough,
Washington University, St. Louis, Missouri
Henry W. Heikkinen,
University of Northern Colorado, Greeley, Colorado
Hans J. Kende,
Michigan State University, East Lansing, Michigan
Cynthia J. Kenyon,
University of California, San Francisco, California
David M. Livingston,
Dana-Farber Cancer Institute, Boston, Massachusetts
Thomas E. Lovejoy,
Smithsonian Institution, Washington, DC
Donald R. Mattison,
University of Pittsburgh, Pennsylvania
Joseph E. Murray,
Harvard University, Wellesley Hills, Massachusetts
Edward E. Penhoet,
Chiron Corporation, Emeryville, California
Malcolm C. Pike,
Norris/USC Comprehensive Cancer Center, Los Angeles, California
Jonathan M. Samet,
The Johns Hopkins University, Baltimore, Maryland
Charles F. Stevens,
The Salk Institute for Biological Studies, La Jolla, California
John L. VandeBerg,
Southwest Foundation for Biomedical Research, San Antonio, Texas
Accounting for the costs of an animal research facility has been a source of confusion and inconsistency causing friction among researchers, animal care providers and administrators. The principal issue in the debate is which of the costs of an animal research facility are direct costs that are to be charged to the investigator and which are indirect costs (facilities and administrative, or F&A costs) that are to be charged to the indirect cost pool.
Principles for determining the allocation are set forth in an Office of Management and Budget (OMB) policy, Circular A-21. Federal agencies have interpreted this policy to mean that all costs associated with an animal research facility must be recovered as direct costs through animal per diem charges. However, if a researcher keeps animals in the laboratory, the F&A costs are recoverable from the indirect cost pool and often the researcher can avoid paying the institution's animal per diem charges. That interpretation of Circular A-21 encourages investigators to house animals in research laboratories - a practice that impedes institutional oversight, leads to inefficient and sub-optimal care and compromises research results. Good science depends upon good animal care, which can be delivered most efficiently and economically in centralized animal research facilities. Thus, some observers believe that the current interpretation of Circular A-21 is contrary to good science. The National Center for Research Resources, National Institute of Health asked the National Research Council (NRC) to appoint a committee to study this issue.
The members of the Committee on Cost of and Payment for Animal Research were chosen by the National Research Council to represent a wide range of views on the interpretation of Circular A-21. The Committee 's charges were to develop recommendations to enable federal auditors and research institutions to allocate research animal facility costs congruently to the direct or F&A cost categories and to project the anticipated financial and scientific ramifications of implementing these recommendations at PHS funded institutions. Some members had worked for OMB or the Department of Health and Human Services and, in the past, may have supported the federal government's interpretation of Circular A-21; others, from industry or the Department of Defense, felt that the level of accounting detail required by the current interpretation of federal auditors was excessive and counter productive; university researchers endorsed efforts to promote high quality science while minimizing per diem charges; and animal research facility managers favored a Circular A-21 interpretation that fostered the support and development of centralized animal facility resources to provide efficient, flexible and inexpensive animal care in an environment conducive to high quality research. These views were sufficiently divergent that at the outset there was a serious question as to whether it could reach the goal of consensus. However, this report does represent such a consensus, lending considerable weight to the conclusions drawn and the recommendation made.
This report has been reviewed by persons chosen for their diverse perspectives and technical expertise in accordance with procedures approved by the Research Council's Report Review Committee. The purposes of this independent review are to provide candid and critical comments that will assist the authors and the 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 content of the review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following persons for their participation in the review of this report:
Linda C. Cork, Stanford University School of Medicine, Stanford, CA
Delbert Glanz, Salk Institute for Biological Studies, La Jolla, CA
Milton Goldberg, Council on Government Relations, Washington, DC
Joseph R. Haywood, University of Texas Health Science Center, San Antonio, TX
Robert O. Jacoby, Yale University School of Medicine, New Haven, CT
David Korn, Association of American Medical College, Washington, DC
Judith Lave, University of Pittsburgh, Pittsburgh, PA
Cathy Liss, Animal Welfare Institute, Washington, DC
John J. Lordan, Johns Hopkins University, Baltimore, MD
Bruce S. McEwen, The Rockefeller University, New York, NY
Norinne E. Noonan, Florida Institute of Technology, Melbourne, FL
Charles Paoletti, Office of Naval Research, Arlington, VA
John H. Richards, California Institute of Technology, Pasadena, CA
Norman R. Scott, Cornell University, Ithaca, NY
Frank A. Sloan, Duke University, Durham, NC
Seeing this list after the report was accepted by Research Council, I was struck by the diversity of the backgrounds of the reviewers, again attesting to the rigor of the process of producing this report. Although the persons listed above have provided many constructive comments and suggestions, responsibility for the final content of this report rests solely with the author committee and the National Research Council.
To the committee members, reviewers, and staff, I extend my deepest appreciation. Members of the committee devoted precious weekends, evenings and work hours, and endless energy to meet short deadlines. The reviewers also worked under short deadlines, and their efforts greatly improved the logic, coherence and comprehensibility of our report.
I appreciate the guidance and support provided by the Institute for Laboratory Animal Research staff throughout. Kathleen Beil provided timely and important communications to the committee in arranging travel and lodging and in production of this report. Ralph Dell' s focus on the topic and his management of the review and publication were of inestimable value. Norman Grossblatt's editing made the report eminently more readable - a feature that will be appreciated by readers.
Christian E. Newcomer, Chair
Committee on Cost of and Payment for Animal Research