2007 AMENDMENTS THE NATIONAL ACADEMIES’ GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH

Human Embryonic Stem Cell Research Advisory Committee

Board on Life Sciences

Division on Earth and Life Studies

Board on Health Sciences Policy

Institute of Medicine

NATIONAL RESEARCH COUNCIL AND INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.
www.nap.edu



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2007 Amendments The National Academies’ Guidelines for Human Embryonic Stem Cell Research 2007 AMENDMENTS THE NATIONAL ACADEMIES’ GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH Human Embryonic Stem Cell Research Advisory Committee Board on Life Sciences Division on Earth and Life Studies Board on Health Sciences Policy Institute of Medicine NATIONAL RESEARCH COUNCIL AND INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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2007 Amendments The National Academies’ Guidelines for Human Embryonic Stem Cell Research THE NATIONAL ACADEMIES PRESS 500 Fifth Street, N.W. 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 The Ellison Medical Foundation, The Greenwall Foundation, and the Howard Hughes Medical Institute. 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: 978-0-309-10559-0 International Standard Book Number-10: 0-309-10559-5 Suggested Citation: National Research Council (NRC) and Institute of Medicine (IOM). 2007. 2007 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. Cover: A cluster of motor neurons and neural fibers derived from human embryonic stem cells in the lab of University of Wisconsin-Madison stem cell researcher and neurodevelopmental biologist Su-Chan-Zhang. The motor neurons are shown in red, neural fibers appear green, and the blue specks indicate DNA in cell nuclei. These motor neurons were developed from one of James Thomson’s original human embryonic stem cell lines. Copyright for the photograph is held by the University of Wisconsin’s Board of Regents. Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. Copyright 2007 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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2007 Amendments The National Academies’ Guidelines for Human Embryonic Stem Cell Research 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. 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. Ralph J. Cicerone and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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2007 Amendments The National Academies’ Guidelines for Human Embryonic Stem Cell Research HUMAN EMBRYONIC STEM CELL RESEARCH ADVISORY COMMITTEE R. ALTA CHARO (Co-Chair), University of Wisconsin, Madison RICHARD O. HYNES (Co-Chair), Massachusetts Institute of Technology, Cambridge ELI Y. ADASHI, Brown University, Providence, Rhode Island BRIGID L.M. HOGAN, Duke University Medical Center, Durham, North Carolina MARCIA IMBRESCIA, Arthritis Foundation, Lynnfield, Massachusetts TERRY MAGNUSON, University of North Carolina, Chapel Hill LINDA B. MILLER, Volunteer Trustees Foundation, Washington, D.C. JONATHAN D. MORENO, University of Pennsylvania, Philadelphia STUART H. ORKIN,1 Harvard Medical School and Dana Farber Cancer Institute, Boston, Massachusetts PILAR N. OSSORIO, University of Wisconsin, Madison E. ALBERT REECE, University of Maryland, Baltimore JOSHUA R. SANES, Harvard University, Cambridge, Massachusetts HAROLD T. SHAPIRO, Princeton University, Princeton, New Jersey JOHN E. WAGNER, Jr., University of Minnesota, Minneapolis Staff ADAM P. FAGEN, Study Co-Director, Board on Life Sciences BRUCE M. ALTEVOGT, Study Co-Director, Board on Health Sciences Policy FRANCES E. SHARPLES, Director, Board on Life Sciences ANDREW M. POPE, Director, Board on Health Sciences Policy ANNE F. JURKOWSKI, Senior Program Assistant, Board on Life Sciences RIMA L. ADLER, Christine Mirzayan Science & Technology Policy Graduate Fellow, Board on Life Sciences SARAH L. HANSON, Research Associate, Board on Health Sciences Policy 1 Resigned from committee effective December 18, 2006.

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2007 Amendments The National Academies’ Guidelines for Human Embryonic Stem Cell Research BOARD ON LIFE SCIENCES KEITH YAMAMOTO (Chair), University of California, San Francisco ANN M. ARVIN, Stanford University School of Medicine, Stanford, California JEFFREY L. BENNETZEN, University of Georgia, Athens RUTH BERKELMAN, Emory University, Atlanta, Georgia DEBORAH BLUM, University of Wisconsin, Madison R. ALTA CHARO, University of Wisconsin, Madison JEFFREY L. DANGL, University of North Carolina, Chapel Hill PAUL R. EHRLICH, Stanford University, Stanford, California MARK D. FITZSIMMONS, John D. and Catherine T. MacArthur Foundation, Chicago, Illinois JO HANDELSMAN, University of Wisconsin, Madison ED HARLOW, Harvard Medical School, Boston, Massachusetts KENNETH H. KELLER, Johns Hopkins School of Advanced International Studies, Bologna, Italy RANDALL MURCH, Virginia Polytechnic Institute and State University, Alexandria GREGORY A. PETSKO, Brandeis University, Waltham, Massachusetts MURIEL E. POSTON, Skidmore College, Saratoga Springs, New York JAMES REICHMAN, University of California, Santa Barbara MARC T. TESSIER-LAVIGNE, Genentech, Inc., South San Francisco, California JAMES TIEDJE, Michigan State University, East Lansing TERRY L. YATES, University of New Mexico, Albuquerque Staff FRANCES E. SHARPLES, Director KERRY A. BRENNER, Senior Program Officer ANN H. REID, Senior Program Officer MARILEE K. SHELTON-DAVENPORT, Senior Program Officer EVONNE P.Y. TANG, Senior Program Officer ROBERT T. YUAN, Senior Program Officer ADAM P. FAGEN, Program Officer ANNA FARRAR, Financial Associate TOVA G. JACOBOVITS, Senior Program Assistant ANNE F. JURKOWSKI, Senior Program Assistant RIMA L. ADLER, Christine Mirzayan Science & Technology Policy Graduate Fellow

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2007 Amendments The National Academies’ Guidelines for Human Embryonic Stem Cell Research BOARD ON HEALTH SCIENCES POLICY FRED GAGE (Chair), The Salk Institute for Biological Studies, La Jolla, California GAIL H. CASSELL, Eli Lilly and Company, Indianapolis, Indiana JAMES F. CHILDRESS, University of Virginia, Charlottesville ELLEN WRIGHT CLAYTON, Vanderbilt University, Nashville, Tennessee DAVID COX, Stanford University School of Medicine, Stanford, California LYNN R. GOLDMAN, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland BERNARD GOLDSTEIN, University of Pittsburgh, Pittsburgh, Pennsylvania MARTHA N. HILL, Johns Hopkins University School of Nursing, Baltimore, Maryland ALAN LESHNER, American Association for the Advancement of Science, Washington, D.C. DANIEL MASYS, University of California, San Diego JONATHAN MORENO, University of Pennsylvania, Philadelphia E. ALBERT REECE, University of Maryland, Baltimore MYRL WEINBERG, National Health Council, Washington, D.C. MICHAEL J. WELCH, Washington University School of Medicine, St. Louis, Missouri OWEN N. WITTE, David Geffen School of Medicine at the University of California, Los Angeles MARY WOOLLEY, Research!America, Alexandria, Virginia Staff ANDREW M. POPE, Director AMY HAAS, Administrative Assistant

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2007 Amendments The National Academies’ Guidelines for Human Embryonic Stem Cell Research Acknowledgments The Committee would like to acknowledge the input received from members of the stem cell research and oversight communities as well as the speakers and participants in its meetings. 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 National Research Council’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: Robert Cook-Deegan, Duke University William H. Danforth, Washington University Norman Fost, University of Wisconsin–Madison Larry Goldstein, University of California, San Diego Henry T. Greely, Stanford Law School Bernard Lo, University of California, San Francisco

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2007 Amendments The National Academies’ Guidelines for Human Embryonic Stem Cell Research Gail Martin, University of California, San Francisco P. Pearl O’Rourke, Partners HealthCare System, Inc. Steven Peckman, University of California, Los Angeles Catherine Racowsky, Harvard Medical School Brock C. Reeve, Harvard Stem Cell Institute Susan L. Solomon, The New York Stem Cell Foundation Clive Svendsen, University of Wisconsin–Madison Although the reviewers listed above have 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 Floyd E. Bloom, The Scripps Research Institute, and Janet D. Rowley, University of Chicago. 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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2007 Amendments The National Academies’ Guidelines for Human Embryonic Stem Cell Research Contents     Introduction   1     Clarifying the Phrase “Provenance of the Cell Lines”   4      1.2(a)  hES Cell Research Permissible After Currently Mandated Reviews   5     Use of NIH-Approved hES Cell Lines   5      1.4  Use of NIH-Approved hES cell lines   6     Importation of hES Cell Lines into an Institution or Jurisdiction   7      1.5  Acceptability of Research Using hES Cell Lines Imported from Other Institutions or Jurisdictions   8     ESCRO Committees Serving Multiple Institutions   8      2.0  Establishment of an Institutional Embryonic Stem Cell Research Oversight Committee   10     Frozen IVF Blastocysts Derived from Anonymous Sperm Donors: Absence of Informed Consent   11

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2007 Amendments The National Academies’ Guidelines for Human Embryonic Stem Cell Research     Considering the Science in hES Cell Research Proposals: Advice for ESCRO Committees   12      Sample Questions for Reviewing hES Cell Research   13     Appendixes     A   National Academies’ Guidelines for Human Embryonic Stem Cell Research, Amended as of February 2007   15 B   Committee Biographical Sketches   29