2007 AMENDMENTS THE NATIONAL ACADEMIES’ GUIDELINES FOR HUMAN EMBRYONIC STEM CELL RESEARCH
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu
THE NATIONAL ACADEMIES PRESS
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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.
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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.
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
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
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
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
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.