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2008 AMENDMENTS
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
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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, 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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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.
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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.
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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
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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
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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
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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
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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