FINAL REPORT OF THE NATIONAL ACADEMIES’ HUMAN EMBRYONIC STEM CELL RESEARCH ADVISORY COMMITTEE AND 2010 AMENDMENTS TO THE NATIONAL ACADEMIES’ GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH

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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

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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 The Ellison Medical Foundation. Any opinions, findings, con- clusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the organizations or agencies that provided support for the project. International Standard Book Number-13: 978-0-309-15600-4 International Standard Book Number-10: 0-309-15600-9 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, www.nap.edu. Suggested citation: National Research Council and Institute of Medicine. 2010. Final Report of the National Academies’ Human Embryonic Stem Cell Research Advisory Committee and 2010 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. 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 Uni- versity of Wisconsin’s Board of Regents. 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, www.nap.edu. Copyright 2010 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 distin- guished 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 au- tonomous 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 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 Engineer- ing 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 Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org

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HUMAN EMBRYONIC STEM CELL RESEARCH ADVISORY COMMITTEE R. ALTA CHARO (Co-chair), University of Wisconsin, Madison, WI1 RICHARD O. HYNES (Co-chair), Howard Hughes Medical Institute and Massachusetts Institute of Technology, Cambridge, MA ELI Y. ADASHI, Brown University, Providence, RI BRIGID L.M. HOGAN, Duke University Medical Center, Durham, NC MARCIA IMBRESCIA, Peartree Design, Lynnfield, MA TERRY MAGNUSON, University of North Carolina, Chapel Hill, NC LINDA B. MILLER, Volunteer Trustees Foundation, Washington, DC JONATHAN D. MORENO, University of Pennsylvania, Philadelphia, PA PILAR N. OSSORIO, University of Wisconsin, Madison, WI E. ALBERT REECE, University of Maryland, Baltimore, MD JOSHUA R. SANES, Harvard University, Cambridge, MA HAROLD T. SHAPIRO, Princeton University, Princeton, NJ JOHN E. WAGNER, Jr., University of Minnesota, Minneapolis, MN Staff ADAM P. FAGEN, Senior Program Officer, Board on Life Sciences BRUCE M. ALTEVOGT, Senior Program Officer, Board on Health Sciences Policy FRANCES E. SHARPLES, Director, Board on Life Sciences ANDREW M. POPE, Director, Board on Health Sciences Policy AMANDA P. CLINE, Senior Program Assistant, Board on Life Sciences 1 Professor Charo was appointed as a senior policy advisor in the Office of the Commis- sioner of the U.S. Food and Drug Administration (FDA) on August 31, 2009. None of her assigned tasks at FDA are related to the topics discussed in this report. iv

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BOARD ON LIFE SCIENCES KEITH YAMAMOTO (Chair), University of California, San Francisco, CA ANN M. ARVIN, Stanford University, Stanford, CA BONNIE L. BASSLER, Howard Hughes Medical Institute and Princeton University, Princeton, NJ VICKI L. CHANDLER, Gordon and Betty Moore Foundation, Palo Alto, CA SEAN EDDY, Janelia Farm Research Campus, Howard Hughes Medical Institute, Ashburn, VA MARK D. FITZSIMMONS, John D. and Catherine T. MacArthur Foundation, Chicago, IL DAVID R. FRANZ, Midwest Research Institute, Frederick, MD LOUIS J. GROSS, University of Tennessee, Knoxville, TN JO HANDELSMAN, Yale University, New Haven, CT CATO T. LAURENCIN, University of Connecticut Health Center, Farmington, CT JONATHAN D. MORENO, University of Pennsylvania, Philadelphia, PA ROBERT M. NEREM, Georgia Institute of Technology, Atlanta, GA CAMILLE PARMESAN, University of Texas, Austin, TX MURIEL E. POSTON, Skidmore College, Saratoga Springs, NY ALISON G. POWER, Cornell University, Ithaca, NY BRUCE W. STILLMAN, Cold Spring Harbor Laboratory, Cold Spring Harbor, NY CYNTHIA WOLBERGER, Howard Hughes Medical Institute and Johns Hopkins University School of Medicine, Baltimore, MD MARY WOOLLEY, Research!America, Alexandria, VA Staff FRANCES E. SHARPLES, Director JO L. HUSBANDS, Scholar/Senior Project Director KATHERINE BOWMAN, Senior Program Officer ADAM P. FAGEN, Senior Program Officer MARILEE K. SHELTON-DAVENPORT, Senior Program Officer INDIA HOOK-BARNARD, Program Officer ANNA FARRAR, Financial Associate CARL-GUSTAV ANDERSON, Senior Program Assistant AMANDA P. CLINE, Senior Program Assistant AMANDA MAZZAWI, Program Assistant v

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BOARD ON HEALTH SCIENCES POLICY JAMES F. CHILDRESS (Chair), University of Virginia, Charlottesville, VA ELI Y. ADASHI, Brown University, Providence, RI DONALD S. BURKE, University of Pittsburgh, Pittsburgh, PA C. THOMAS CASKEY, The University of Texas-Houston Health Science Center, Houston, TX DENNIS W. CHOI, Emory University, Atlanta, GA KATHLEEN A. DRACUP, University of California, San Francisco, CA FRED H. GAGE, Salk Institute for Biological Studies, La Jolla, CA LINDA C. GIUDICE, University of California, San Francisco LEWIS R. GOLDFRANK, New York University School of Medicine, New York, NY LAWRENCE O. GOSTIN, Georgetown University, Washington, DC PAUL E. JARRIS, Association of State and Territorial Health Officials, Arlington, VA RICHARD C. LARSON, Massachusetts Institute of Technology, Cambridge, MA ALAN I. LESHNER, American Association for the Advancement of Science, Washington, DC LINDA B. MILLER, Volunteer Trustees Foundation, Washington, DC STEVEN M. PAUL, Eli Lilly and Company, Indianapolis, IN REED V. TUCKSON, UnitedHealth Group, Minnetonka, MN RAJEEV VENKAYYA, Bill & Melinda Gates Foundation, Seattle, WA KEITH WAILOO, Rutgers, The State University of New Jersey, New Brunswick, NJ CLYDE W. YANCY, Baylor University Medical Center, Dallas, TX Staff ANDREW M. POPE, Director AMY K.H. PACKMAN, Administrative Assistant DONNA RANDALL, Financial Officer vi

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Acknowledgments The Committee acknowledges the input received from members of the stem cell research and oversight communities and the speakers and partici- pants in its meetings. This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with proce- dures approved by the National Research Council’s Report Review Commit- tee. 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: George Q. Daley, Howard Hughes Medical Institute, Children’s Hospital Boston, and Harvard Medical School Fred H. Gage, Salk Institute for Biological Studies Lawrence S.B. Goldstein, Howard Hughes Medical Institute and University of California, San Diego Bernard Lo, University of California, San Francisco Geoffrey Lomax, California Institute for Regenerative Medicine Gail R. Martin, University of California, San Francisco P. Pearl O’Rourke, Partners HealthCare System, Inc., and Harvard Medical School Steven Peckman, University of California, Los Angeles vii

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viii Acknowledgments Janet D. Rowley, University of Chicago Huda Y. Zoghbi, Howard Hughes Medical Institute and Baylor College of Medicine Although the reviewers listed above have provided many constructive com- ments 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. 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.

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Contents Introduction 1 The 2010 National Academies’ Guidelines 4 The Future Role of the National Academies in Stem Cell Research Oversight 5 2010 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research 7 APPENDIXES A National Institutes of Health Guidelines for Research Using Human Stem Cells 9 B Invited Participations at the August 7, 2009, Meeting of the Human Embryonic Stem Cell Research Advisory Committee 17 C National Academies’ Guidelines for Human Embryonic Stem Cell Research, Amended as of May 2010 19 D Committee Member and Staff Biographies 37 ix

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