SHARING PUBLICATION-RELATED DATA AND MATERIALS

RESPONSIBILITIES OF AUTHORSHIP IN THE LIFE SCIENCES

Committee on Responsibilities of Authorship in the Biological Sciences

Board on Life Sciences

Division on Earth and Life Studies

NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.www.nap.edu



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Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences SHARING PUBLICATION-RELATED DATA AND MATERIALS RESPONSIBILITIES OF AUTHORSHIP IN THE LIFE SCIENCES Committee on Responsibilities of Authorship in the Biological Sciences Board on Life Sciences Division on Earth and Life Studies NATIONAL RESEARCH COUNCIL OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C.www.nap.edu

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Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, D.C. 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 Contract no. N01-OD-4–2139, Task Order #88 between the National Academy of Sciences and the Department of Health and Human Services/ the National Institutes of Health; Grant No. DBI-0127703 between the National Academy of Sciences and the National Science Foundation; Agreement No. B2001–47 between the National Academy of Sciences and the Sloan Foundation; and the National Research Council Fund. 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 0-309-08859-3 Additional copies of this report are available from the Board on Life Sciences, 500 Fifth Street, N.W., Washington, D.C. 20001; (202) 334–2236, or the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, D.C. 20055; (800) 624–6242 or (202) 334–3313 (in the Washington metropolitan area); Internet, http://www.nap.edu Cover: Details from the library ceiling of the National Academy of Sciences building (Lee Lawrie, sculptor) Front cover: Recording of discovery Back cover: Reading of the record Copyright 2003 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences 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. 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. Wm. 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. 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. Bruce M.Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences COMMITTEE ON RESPONSIBILITIES OF AUTHORSHIP IN THE BIOLOGICAL SCIENCES THOMAS R.CECH (Chair), Howard Hughes Medical Institute, Chevy Chase, Maryland SEAN R.EDDY, Howard Hughes Medical Institute; Washington University, St. Louis, Missouri DAVID EISENBERG, Howard Hughes Medical Institute; University of California, Los Angeles KAREN HERSEY, Massachusetts Institute of Technology, Cambridge STEVEN H.HOLTZMAN, Infinity Pharmaceuticals, Inc., Boston, Massachusetts GEORGE H.POSTE, Health Technology Networks, Gilbertsville, Pennsylvania NATASHA V.RAIKHEL, University of California, Riverside RICHARD H.SCHELLER, Genentech, Inc., South San Francisco, California DAVID B.SINGER, GeneSoft, Inc., South San Francisco, California MARY C.WALTHAM, Independent Publishing Consultant, Princeton, New Jersey Project Staff ROBIN A.SCHOEN, Study Director BRIDGET K.B.AVILA, Senior Project Assistant ELIA BEN-ARI, Science Writer NORMAN GROSSBLATT, Editor

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Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences BOARD ON LIFE SCIENCES COREY S.GOODMAN (Chair) University of California, Berkeley, California R.ALTA CHARO, University of Wisconsin, Madison, Wisconsin JOANNE CHORY, The Salk Institute for Biological Studies, La Jolla, California DAVID J.GALAS, Keck Graduate Institute of Applied Life Science, Claremont, California BARBARA GASTEL, Texas A&M University, College Station, Texas JAMES M.GENTILE, Hope College, Holland, Michigan LINDA GREER, Natural Resources Defense Council, Washington, District of Columbia ED HARLOW, Harvard Medical School, Cambridge, Massachusetts ELLIOT M.MEYEROWITZ, California Institute of Technology, Pasadena, California ROBERT T.PAINE, University of Washington, Seattle, Washington GREGORY A.PETSKO, Brandeis University, Waltham, Massachusetts STUART L.PIMM, Columbia University, New York, New York JOAN B.ROSE, University of South Florida, St. Petersburg, Florida GERALD M.RUBIN, Howard Hughes Medical Institute, Chevy Chase, Maryland BARBARA A.SCHAAL, Washington University, St. Louis, Missouri RAYMOND L.WHITE, DNA Sciences, Inc., Fremont, California Senior Staff FRANCES SHARPLES, Director

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Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences Preface I agreed to chair the National Research Council’s Committee on Responsibilities of Authorship in the Biological Sciences because I thought the topic is central to the proper conduct of research. And it is an important topic to revisit now because genome databases and other large datasets have greatly ramped up the value of “published materials” while the increasing entanglement of academic and commercial research has complicated the landscape on which science is pursued. I also thought it would be a relatively easy task: after all, isn’t there a consensus that publication-related data and materials need to be freely shared? Now, more than a year later, it is clear to me and the committee that there is in fact a general consensus about sharing published data and materials, but also wide variation in how this implicit contract to share is implemented and in whether individual scientists, companies, or editors exempt themselves in particular circumstances. One hears academic scientists explain, “We always send out our transgenic mice after we publish…but of course we expect to be coauthors on any publications that result.” One hears company scientists proclaim adherence to the same principle of sharing, “but of course you first need to sign an agreement granting us an exclusive license to commercialize any discovery made with our database or materials.” Thus, as in many human activities, the devil is in the details. As a result, the committee ended up

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Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences not simply recording the community standards as they are practiced, but gleaning from them principles and recommendations that we think are worth adopting generally. The process the committee traversed in its deliberations is prescribed by the National Research Council to maximize fairness. There was even a meeting in which the Committee was asked whether it had broad enough representation; we decided we did not, and additional industrial representatives were recruited. A public meeting held at the National Academy of Sciences drew a large and diverse audience whose opinions were taken into account. As drafts of the report were written, the committee’s deliberations intensified. I had anticipated that there would sometimes be differences of opinion between academic and industrial members; to my surprise, there was no such divide: everyone on the committee felt strongly that once they publish, academic and company scientists take on the same responsibilities to share and should enjoy the same benefits of receiving published materials, data, and software. Finally, detailed anonymous critiques from a diverse group of reviewers led to useful modifications and inclusion of more examples in the report. The question the committee heard over and over again was, “Shouldn’t there be exceptions to the general responsibility to share?” We therefore devote an entire chapter to analysis of such questions. While there are some obvious justifications for exceptions—for example, if it is illegal for a scientist from a particular country to send out a particular type of material—in general, the committee held to a uniform principle for sharing integral data and materials expeditiously, or UPSIDE. The upside of UPSIDE is two-fold: it keeps science honest, and it fosters the progress of science. Both are worth nurturing and protecting. Thomas R.Cech Chairman

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Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences Acknowledgment of Reviewers This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the NRC’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution 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 deliberative process. We wish to thank the following individuals for their review of this report: Paul Evans, Ohio State University, Columbus, Ohio; Journal of Money, Credit, and Banking, Columbus, Ohio Philip Campbell, Nature, London, England, United Kingdom Kevin Davies, Bio-IT World, Framingham, Massachusetts Maria Friere, The Global Alliance for Tuberculosis Drug Development, New York, New York W.R. “Reg” Gomes, Division of Agriculture and Natural Resources, University of California, Oakland, California Donald Kennedy, Stanford University, Stanford, California; Science Magazine, Washington, D.C. David Korn, Association of American Medical Colleges, Washington, D.C.

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Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences Tom E.Lovejoy, H.John Heinz III Center for Science, Economics, and the Environment, Washington, D.C. Andrew Neighbour, University of California, Los Angeles, California Peter H.Raven, Missouri Botanical Garden, St. Louis, Missouri Joseph V.Smith, The University of Chicago, Chicago, Illinois Oliver Smithies, University of North Carolina, Chapel Hill, North Carolina Philip P.Green, University of Washington School of Medicine, Seattle, Washington Randy Scott, Genomic Health, Inc., Redwood City, California Lincoln Stein, Cold Spring Harbor Laboratory, Long Island, New York Although the reviewers listed above have provided 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 Gilbert S. Omenn of the University of Michigan and C.H. “Herb” Ward of Rice University. Appointed by the National Research Council, they were 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.

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Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences Acknowledgments This report is the product of many individuals. In particular, we would like to thank all those who attended our workshop, Community Standards for Publication-Related Data and Materials, on February 25, 2002. Without the input of each of these participants, this report would not have been possible. Mark Adams, Celera Genomics Wendy Baldwin, National Institutes of Health Catherine Ball, National Science Foundation Jules Berman, National Cancer Institute Helen Berman, Rutgers University Steven Briggs, Torrey Mesa Research Institute Eric Campbell, Harvard University Phil Campbell, Nature Michelle Cimbala, Sterne, Kessler, Goldstein, and Fox, PLLC Barbara Cohen, The Journal of Clinical Investigation Francis Collins, National Human Genome Research Institute Katie Cottingham, Science Magazine Nicholas Cozzarelli, University of California-Berkeley, Proceedings of the National Academy of Sciences Jeffrey Drazen, The New England Journal of Medicine Anita Eisenstadt, National Science Foundation Lila Feisee, Biotechnology Industry Organization Maria Freire, The Global Alliance for Tuberculosis Drug Development

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Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences Elisabeth Gantt, University of Maryland Barbara Gastel, Texas A&M University Michael Gazzaniga, Dartmouth College Corey Goodman, Renovis, Inc. Laurie Goodman, Genome Research Robert Haselkorn, The University of Chicago Michael Hayden, University of British Columbia Kathy Hudson, National Human Genome Research Institute Barbara Jasny, Science Magazine Elke Jordan, National Human Genome Research Institute Donald Kennedy, Stanford University, Science Magazine Carter Kimsey, National Science Foundation Marc Kirschner, Harvard Medical School Stephen Koslow, National Institute of Mental Health Enno Krebbers, DuPont, University of Delaware David Kulp, Affymetrix Eric Lander, Whitehead Institute, MIT Robert Last, Cereon Genomics Eaton Lattman, Johns Hopkins University Craig Liddell, Paradigm Genetics Ann Link, American Association of Immunologists Karin Lohman, Committee on Science, United States House of Representatives Pal Maliga, Waksman Institute, Rutgers University Cheryl Marks, National Cancer Institute Victoria McGovern, Burroughs Wellcome Fund Ira Mellman, Yale University School of Medicine Joachim Messing, Waksman Institute, Rutgers University Kate Murashige, Morrison & Foerster, LLP Elizabeth Neufeld, University of California-Los Angeles, School of Medicine Ari Patrinos, U.S. Department of Energy Jerome Reichman, Duke University Law School

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Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences Ellis Rubenstein, Science Magazine James Siedow, Duke University Vivian Siegel, Cell Jane Silverthorn, National Science Foundation Fintan Steele, Molecular Therapy Diane Sullenberger, Proceedings of the National Academy of Sciences Herbert Tabor, National Institute of Diabetes & Digestive & Kidney Diseases Heidi Wagner, Genentech, Inc. Bob Waterston, Washington University School of Medicine Jim Wells, Sunesis Pharmaceutical, Inc. Sandra Wolman, Universities Associated for Research and Education in Pathology

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Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences Contents     EXECUTIVE SUMMARY   1 1   STUDY OVERVIEW AND BACKGROUND   17 2   THE PURPOSE OF PUBLICATION AND RESPONSIBILITIES FOR SHARING   27 3   SHARING DATA AND SOFTWARE   35 4   SHARING MATERIALS INTEGRAL TO PUBLISHED FINDINGS   51 5   DIFFERENT INTERPRETATIONS OF EXISTING STANDARDS   61 6   ENCOURAGING COMPLIANCE WITH AND CONTINUING THE DEVELOPMENT OF STANDARDS   69     REFERENCES   79     APPENDIXES:     A   COMMITTEE BIOGRAPHIES   81 B   WORKSHOP AGENDA AND SITUATIONS   89

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