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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
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2007 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.
www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
×

THE NATIONAL ACADEMIES PRESS

500 Fifth Street, N.W. 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 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.

Additional copies of this report are available from the

National Academies Press,

500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu.

Copyright 2007 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. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
×

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

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
×

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

1

Resigned from committee effective December 18, 2006.

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
×

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

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
×

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

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
×

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

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
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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.

Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
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Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
×
Page R8
Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
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Suggested Citation:"Front Matter." Institute of Medicine and National Research Council. 2007. 2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press. doi: 10.17226/11871.
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In 2005, the National Academies released the report 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 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. This letter report is the committee's first set of amendments to the Guidelines and clarifies earlier recommendations and conclusions, including the criteria for determining which stem cell lines it is acceptable to use. Future deliberations of the committee will address items for which additional information gathering and more extensive debate and discussion will be necessary.

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