2008 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.
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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, The Greenwall Foundation, and the Howard Hughes Medical Institute. Any opinions, findings, conclusions, or recom- mendations 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: 978-0-309-12220-7 International Standard Book Number-10: 0-309-12220-1 Suggested Citation: National Research Council and Institute of Medicine. 2008. 2008 Amend- ments 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 neurodevelop- mental 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, NW, Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. Copyright 2008 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 (Cochair), University of Wisconsin, Madison, WI RICHARD O. HYNES (Cochair), 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, Arthritis Foundation, 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, 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 AMANDA P. CLINE, Senior Program Assistant, Board on Life Sciences NORMAN GROSSBLATT, Senior Editor, Division on Earth and Life Studies iv

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BOARD ON LIFE SCIENCES KEITH YAMAMOTO (Chair), University of California, San Francisco, CA ANN M. ARVIN, Stanford University School of Medicine, Stanford, CA RUTH BERKELMAN, Emory University, Atlanta, GA DEBORAH BLUM, University of Wisconsin, Madison, WI VICKI CHANDLER, University of Arizona, Tucson, AZ JEFFERY L. DANGL, University of North Carolina, Chapel Hill, NC PAUL R. EHRLICH, Stanford University, Stanford, CA MARK D. FITZSIMMONS, John D. and Catherine T. MacArthur Foundation, Chicago, IL JO HANDELSMAN, University of Wisconsin, Madison, WI KENNETH H. KELLER, Johns Hopkins University School of Advanced and International Studies, Bologna, Italy JONATHAN D. MORENO, University of Pennsylvania, Philadelphia, PA RANDALL MURCH, Virginia Polytechnic Institute and State University, Alexandria, VA MURIEL E. POSTON, Skidmore College, Saratoga Springs, NY JAMES REICHMAN, University of California, Santa Barbara, CA (retired) BRUCE W. STILLMAN, Cold Spring Harbor Laboratory, Cold Spring Harbor, NY MARC T. TESSIER-LAVIGNE, Genentech, Inc., South San Francisco, CA JAMES TIEDJE, Michigan State University, East Lansing, MI CYNTHIA WOLBERGER, Johns Hopkins University School of Medicine, Baltimore, MD Staff FRANCES E. SHARPLES, Director JO L. HUSBANDS, Scholar/Senior Project Director ADAM P. FAGEN, Senior Program Officer ANN H. REID, Senior Program Officer MARILEE K. SHELTON-DAVENPORT, Senior Program Officer ANNA FARRAR, Financial Associate AMANDA P. CLINE, Senior Program Assistant REBECCA L. WALTER, Senior Program Assistant v

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BOARD ON HEALTH SCIENCES POLICY FRED GAGE (Chair), Salk Institute for Biological Studies, La Jolla, CA DONALD S. BURKE, University of Pittsburgh, Pittsburgh, PA C. THOMAS CASKEY, University of Texas, Houston Health Science Center, Houston, TX GAIL H. CASSELL, Eli Lilly and Company, Indianapolis, IN JAMES F. CHILDRESS, University of Virginia, Charlottesville, VA DENNIS CHOI, Emory University, Atlanta, GA LINDA GIUDICE, University of California, San Francisco, CA LYNN R. GOLDMAN, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD LAWRENCE O. GOSTIN, Georgetown University Law Center, Washington, DC MARTHA N. HILL, Johns Hopkins University School of Nursing, Baltimore, MD PAUL E. JARRIS, Association of State and Territorial Health Officials, Arlington, VA DAVID KORN, Association of American Medical Colleges, Washington, DC RICHARD C. LARSON, Massachusetts Institute of Technology, Cambridge, MA ALAN LESHNER, American Association for the Advancement of Science, Washington, DC LINDA B. MILLER, Volunteer Trustees Foundation, Washington, DC E. ALBERT REECE, University of Maryland, Baltimore, MD LINDA ROSENSTOCK, University of California, Los Angeles, CA KEITH A. WAILOO, Rutgers, The State University of New Jersey, New Brunswick, NJ MICHAEL J. WELCH, Washington University School of Medicine, St. Louis, MO OWEN N. WITTE, University of California, Los Angeles, CA Staff ANDREW M. POPE, Director AMY HAAS, 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, Children’s Hospital Boston and Harvard Medical School Norman Fost, University of Wisconsin–Madison Henry T. Greely, Stanford Law School Geoffrey Lomax, California Institute for Regenerative Medicine Gail R. Martin, University of California, San Francisco P. Pearl O’Rourke, Partners HealthCare System James Thomson, University of Wisconsin–Madison Laurie Zoloth, Northwestern University Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions vii

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Acknowledgments viii or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Janet Rowley, University of Chicago Medical Center, and Floyd Bloom, Scripps Research Institute (retired). Appointed by the National Research Council, they were respon- sible 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 Applicability of the Guidelines to Non-Embryonic Human Pluripotent Stem Cells 4 From Section 1 6 From Section 3 7 From Section 4 9 From Section 5 10 Section 7 10 Clarification of the Meaning of “Proper Notification” 13 1.3(a) hES Cell Research Permissible after Currently Mandated Reviews 14 Sections 6.1 and 6.2 15 Public Openness and ESCRO Committee Audits 15 2.0 Establishment of an Institutional Embryonic Stem Cell Research Oversight Committee 16 Clarification of Policy Regarding Reimbursement for Oocyte Donors 17 Section 3.4(b) 19 References 20 ix

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Contents x Appendixes A National Academies’ Guidelines for Human Embryonic Stem Cell Research, Amended as of September 2008 21 B Glossary 39 C Committee Biographical Sketches 47