GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH

Committee on Guidelines for Human Embryonic Stem Cell Research

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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Guidelines for Human Embryonic Stem Cell Research GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH Committee on Guidelines for Human Embryonic Stem Cell Research 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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Guidelines for Human Embryonic Stem Cell Research 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 material is based on work supported by the National Academies, the Ellison Medical Foundation, and the Greenwall Foundation. Library of Congress Cataloging-in-Publication Data Guidelines for human embryonic stem cell research / Board on Life Sciences, National Research Council, Board on Health Sciences Policy, Institute of Medicine. p. cm. Includes bibliographical references and index. ISBN 0-309-09653-7 (pbk.)—ISBN 0-309-55024-6 (pdf) 1. Embryonic stem cells—Research. 2. Human embryo—Research. I. National Research Council (U.S.). Board on Life Sciences. II. National Research Council (U.S.). Board on Health Sciences Policy. QH588.S83G85 2005 616′.02774—dc22 2005016338 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. 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-Chun 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. Copyright 2005 by the National Academy of Sciences. All rights reserved. Printed in the United States of America

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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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Guidelines for Human Embryonic Stem Cell Research COMMITTEE ON GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH RICHARD O. HYNES (Co-Chair), Massachusetts Institute of Technology, Cambridge, Massachusetts JONATHAN D. MORENO (Co-Chair), University of Virginia, Charlottesville, Virginia ELIZABETH PRICE FOLEY, Florida International University, Miami, Florida NORMAN FOST, University of Wisconsin, Madison, Wisconsin H. ROBERT HORVITZ, Massachusetts Institute of Technology, Cambridge, Massachusetts MARCIA IMBRESCIA, Arthritis Foundation, Lynnfield, Massachusetts TERRY MAGNUSON, University of North Carolina, Chapel Hill, North Carolina CHERYL MWARIA, Hofstra University, Hempstead, New York JANET ROSSANT, Mount Sinai Hospital, Toronto, Ontario, Canada JANET D. ROWLEY, University of Chicago, Chicago, Illinois Board on Life Sciences Liaison to the Committee R. ALTA CHARO, University of Wisconsin, Madison, Wisconsin Staff FRANCES SHARPLES, Study Director ROBIN SCHOEN, Senior Program Officer MATTHEW D. MCDONOUGH, Program Assistant KATHI E. HANNA, Science Writer NORMAN GROSSBLATT, Senior Editor

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Guidelines for Human Embryonic Stem Cell Research BOARD ON LIFE SCIENCES COREY S. GOODMAN (Chair), Renovis Inc., South San Francisco, California ANN M. ARVIN, Stanford University School of Medicine, Stanford, California JEFFREY L. BENNETZEN, University of Georgia, Athens, Georgia RUTH BERKELMAN, Emory University, Atlanta, Georgia R. ALTA CHARO, University of Wisconsin, Madison, Wisconsin DENNIS CHOI, Merck Research Laboratories, West Point, Pennsylvania JEFFREY L. DANGL, University of North Carolina, Chapel Hill, North Carolina PAUL R. EHRLICH, Stanford University, Palo Alto, California JAMES M. GENTILE, Research Corporation of America, Tucson, Arizona ED HARLOW, Harvard Medical School, Boston, Massachusetts DAVID HILLIS, University of Texas, Austin, Texas KENNETH F. KELLER, University of Minnesota, Minneapolis, Minnesota RANDALL MURCH, Virginia Polytechnic Institute and State University, Alexandria, Virginia GREGORY A. PETSKO, Brandeis University, Waltham, Massachusetts STUART L. PIMM, Duke University, Durham, North Carolina BARBARA A. SCHAAL, Washington University, St. Louis, Missouri JAMES TIEDJE, Michigan State University, East Lansing, Michigan KEITH YAMAMOTO, University of California, San Francisco, California Staff FRANCES E. SHARPLES, Director KERRY A. BRENNER, Senior Program Officer ROBIN SCHOEN, Senior Program Officer MARILEE K. SHELTON-DAVENPORT, Senior Program Officer ROBERT T. YUAN, Senior Program Officer ADAM P. FAGEN, Program Officer ANN REID, Program Officer EVONNE P. Y. TANG, Program Officer SETH STRONGIN, Senior Program Assistant MATTHEW D. MCDONOUGH, Program Assistant DENISE GROSSHANS, Financial Associate

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Guidelines for Human Embryonic Stem Cell Research BOARD ON HEALTH SCIENCES POLICY PHILIP PIZZO (Chair), Stanford University School of Medicine, Stanford, California LESLIE BENET, University of California, San Francisco, California DAVID BLUMENTHAL, Harvard Medical School & Massachusetts General Hospital, Boston, Massachusetts GAIL H. CASSELL, Eli Lilly and Company, Indianapolis, Indiana ELLEN WRIGHT CLAYTON, Vanderbilt University Law School, Nashville, Tennessee DAVID COX, Perlegen Sciences, Mountain View, California NANCY DUBLER, Montefiore Medical Center & The Albert Einstein College of Medicine, Bronx, New York ROBERT GIBBONS, University of Illinois at Chicago, Chicago, Illinois 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 DANIEL MASYS, Vanderbilt University Medical Center, Nashville, Tennessee JONATHAN D. MORENO, University of Virginia, Charlottesville, Virginia E. ALBERT REECE, University of Arkansas, Little Rock, Arkansas MYRL WEINBERG, National Health Council, Washington, DC MICHAEL J. WELCH, Washington University School of Medicine, St. Louis, Missouri MARY WOOLLEY, Research!America, Alexandria, Virginia Staff ANDREW M. POPE, Director AMY HAAS, Administrative Assistant

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Guidelines for Human Embryonic Stem Cell Research Preface We are pleased to offer our committee’s report on guidelines for human embryonic stem cell research. This report and its recommendations are the result of many hours of committee meetings as well as a public workshop. During those sessions we heard from many dedicated and talented people who represent a wide range of views. We have tried to take these diverse perspectives into account in a report that mirrors the seriousness with which we have reflected upon them. Our task was made more difficult and also more significant by events in the worlds of science and public affairs, which altered the terrain even as we explored it. All of us on the committee have appreciated the opportunity to be part of this important and timely effort. Great possibilities for improvements in human health are offered by research using human stem cells, both adult and embryonic. Like many scientific advances, these technologies raise questions about balancing the evident promise against the potential for inappropriate application. In the case of embryonic stem cell research, there are differing opinions within our society about the relative merits and risks of various approaches and there are philosophical differences about what is or is not appropriate. Some believe strongly that we should not turn away from the promise that embryonic stem cells will provide new therapeutic advances. Others believe that the derivation and application of human embryonic stem cells will undermine the dignity of human life. These disparate views are deeply and sincerely held and must be considered as we move forward in advancing this research. Some of the qualms arise from unfamiliarity and the “shock of the new,” but others arise from concerns about the nature of human life, about ethical treatment of reproductive

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Guidelines for Human Embryonic Stem Cell Research materials and about exploitation of donors of such materials. Those ethical concerns need to be balanced against the duty to provide the best medical care possible, enhancing the quality of life and alleviating suffering for many people. The challenge to our society is to achieve that balance. Scientific inquiry should not proceed unfettered, without consideration for the ethical and public policy imperatives of the society in which it operates. On the other hand, concerns about potential ethical complexities should be cause for judicious oversight and regulation, not necessarily for prohibition. Our democratic society should be capable of entertaining challenges to familiar beliefs and adapting to new conditions without yielding on its fundamental values. We believe that it is possible to do so, that human dignity will be enhanced, rather than diminished, by the great project of addressing the suffering that attends illness. Freedom of inquiry and a confident attitude toward the future are at the heart of America’s civic philosophy, in which the freedom to explore controversial ideas is celebrated rather than suppressed. That is one reason that our country’s scientific establishment is the envy of the world, a source of our inventive energy that was celebrated by Thomas Jefferson who wrote, “Liberty is the great parent of science and of virtue; and a nation will be great in both in proportion as it is free.” In that spirit we offer this report. Richard O. Hynes Jonathan D. Moreno Co-chairs, Committee on Guidelines for Human Embryonic Stem Cell Research

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Guidelines for Human Embryonic Stem Cell Research Acknowledgments Like all National Academies reports, this one is the result of the contributions of many people. First, we sincerely thank all the speakers who participated in our workshop, “Guidelines for Human Embryonic Stem Cell Research,” on October 12-13, 2004. A workshop agenda and a list of the workshop speakers with their biographies are included in Appendix C. Without their input, this report would not have been possible. Second, we would like to thank the Ellison Medical Foundation and the Greenwall Foundation for their financial support of this activity. This report has been reviewed in draft form by persons 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 of 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 for their review of this report: Alexander Capron, World Health Organization Mark Fishman, Novartis Linda Giudice, Stanford School of Medicine Virginia Hinshaw, University of California, Davis Brigid Hogan, Duke University Bernard Lo, University of California, San Francisco

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Guidelines for Human Embryonic Stem Cell Research Michael Manganiello, Christopher Reeve Foundation Doug Melton, Harvard University Catherine Racowsky, Brigham and Women’s Hospital Laura Robbins, Weill Cornell Medical College John Robertson, University of Texas Law School Harold Shapiro, Princeton University Harold Varmus, Memorial Sloan-Kettering Cancer Center LeRoy Walters, Georgetown University 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, Scripps Research Institute, and William H. Danforth, Washington 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. Finally, we wish to acknowledge Dr. Kathi Hanna, our superb science writer, and the National Research Council staff (Fran Sharples, Robin Schoen, Matt McDonough, and Norman Grossblatt) for their thorough, thoughtful, and efficient assistance with all aspects of the preparation of this report.

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Guidelines for Human Embryonic Stem Cell Research Contents     Summary   1 1   Introduction   15 2   Scientific Background of Human Embryonic Stem Cell Research   29 3   Addressing Ethical and Scientific Concerns Through Oversight   47 4   Current Regulation of Human Embryonic Stem Cell Research   63 5   Recruiting Donors and Banking hES Cells   81 6   National Academies Guidelines for Research on Human Embryonic Stem Cells   97     References   109     Glossary   115     Abbreviations   121     Appendixes     A   Compilation of Recommendations   123 B   Committee Biographies   131 C   Workshop Agenda and Speaker Biographies   137     Index   155

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