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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
×

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

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.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
×

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, conclusions, 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, http://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 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 2010 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
×

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. 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 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. Charles Vest are chair and vice chair, respectively, of the National Research Council.


www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
×

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 Commissioner 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.

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
×

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

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
×

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

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
×

Acknowledgments

The Committee acknowledges the input received from members of the stem cell research and oversight communities and 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:

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

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
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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 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. 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.

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
×
Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
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Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
×
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 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. doi: 10.17226/12923.
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In 2005, the National Academies released the book, Guidelines for Human Embryonic Stem Cell Research, which offered a common set of ethical standards for a field that, due to the absence of comprehensive federal funding, was lacking national standards for research. In order to keep the Guidelines up to date, given the rapid pace of scientific and policy developments in the field of stem cell research, the Human Embryonic Stem Cell Research Advisory Committee was established in 2006 with support from The Ellison Medical Foundation, The Greenwall Foundation, and the Howard Hughes Medical Institute.

As it did in 2007 and 2008, the Committee identified issues that warranted revision, and this book addresses those issues in a third and final set of amendments. Specifically, this book sets out an updated version of the National Academies' Guidelines, one that takes into account the new, expanded role of the NIH in overseeing hES cell research. It also identifies those avenues of continuing National Academies' involvement deemed most valuable by the research community and other significant stakeholders.

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