Click for next page ( 168


The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement



Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.

OCR for page 167
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

OCR for page 167
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 recom- mendations 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 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, 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

OCR for page 167
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 engi- neers. 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 engineer- ing 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

OCR for page 167
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 1Resigned from committee effective December 18, 2006. iv

OCR for page 167
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 v

OCR for page 167
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 vi

OCR for page 167
Acknowledgments The Committee would like to acknowledge the input received from mem- bers 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 vii

OCR for page 167
viii Acknowledgments 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 com- ments 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 com- ments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

OCR for page 167
Contents Introduction 1 Clarifying the Phrase “Provenance of the Cell Lines” 4 1.2(a) hES Cell Research Permissible After Currently Mandated Reviews 5 Use of NIH-Approved hES Cell Lines 5 1.4 Use of NIH-Approved hES cell lines 6 Importation of hES Cell Lines into an Institution or Jurisdiction 7 1.5 Acceptability of Research Using hES Cell Lines Imported from Other Institutions or Jurisdictions 8 ESCRO Committees Serving Multiple Institutions 8 2.0 Establishment of an Institutional Embryonic Stem Cell Research Oversight Committee 10 Frozen IVF Blastocysts Derived from Anonymous Sperm Donors: Absence of Informed Consent 11 ix

OCR for page 167
x Contents Considering the Science in hES Cell Research Proposals: Advice for ESCRO Committees 12 Sample Questions for Reviewing hES Cell Research 13 Appendixes A National Academies’ Guidelines for Human Embryonic Stem Cell Research, Amended as of February 2007 15 B Committee Biographical Sketches 29

OCR for page 167
2007 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research INTRODUCTION The National Academies’ report Guidelines for Human Embryonic Stem Cell Research was developed by the Committee on Guidelines for Human Embryonic Stem Cell Research and released in April 2005. The body of the report provided the background and rationale for the choices involved in formulating the guidelines, which were compiled in its final chapter. Because human embryonic stem (hES) cell research touches on many ethical, legal, scientific, and policy issues that are of concern to some people, the Guide- lines are intended to make explicit how research with hES cells can be pursued most responsibly. While the Guidelines are primarily intended to address researchers in the United States, they may have applicability interna- tionally as well. The 2005 publication of the Guidelines 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. Many have found the guidelines useful, but several constituencies identified sections of the Guide- lines that they believe should be clarified. In addition, numerous scientific organizations and individuals encouraged the National Academies to estab- lish an advisory committee to keep the Guidelines up to date, given the rapid pace of scientific developments in the field of stem cell research. Further, 1

OCR for page 167
26 Appendix A (xi) When appropriate, creation of a clear Material Transfer Agreement or user agreement. (xii) A liability statement. (xiii) A system for disposal of material. (e) Clear criteria for distribution of cell lines, including but not limited to evidence of approval of the research by an ESCRO committee or equivalent body at the recipient institution. 6.0 RESEARCH USE OF hES CELL LINES Once hES cell lines have been derived, investigators and institutions, through ESCRO committees and other relevant committees (such as an IACUC, an IBC, or a radiation safety committee) should monitor their use in research. 6.1 Institutions should require documentation of the provenance of all hES cell lines, whether the cells were imported into the institution or generated locally. Notice to the institution should include evidence of IRB approval of the procurement process and of adherence to basic ethical and legal prin- ciples of procurement. In the case of lines imported from another institution, documentation that these criteria were met at the time of derivation will suffice. 6.2 In vitro experiments involving the use of already derived and coded hES cell lines will not need review beyond the notification required in Section 6.1. 6.3 Each institution should maintain a registry of its investigators who are conducting hES cell research and ensure that all registered users are kept up to date with changes in guidelines and regulations regarding the use of hES cells. 6.4 All protocols involving the combination of hES cells with nonhuman embryos, fetuses, or adult animals must be submitted to the local IACUC for review of animal welfare issues and to the ESCRO committee for consider- ation of the consequences of the human contributions to the resulting chime- ras. (See also Section 1.2(c)(3) concerning breeding of chimeras.)

OCR for page 167
Appendix A 27 6.5 Transplantation of differentiated derivatives of hES cells or even hES cells themselves into adult animals will not require extensive ESCRO com- mittee review. If there is a possibility that the human cells could contribute in a major organized way to the brain of the recipient animal, however, the scientific justification for the experiments must be strong, and proof of principle using nonhuman (preferably primate) cells, is desirable. 6.6 Experiments in which hES cells, their derivatives, or other pluripotent cells are introduced into nonhuman fetuses and allowed to develop into adult chimeras need more careful consideration because the extent of human contribution to the resulting animal may be higher. Consideration of any major functional contributions to the brain should be a main focus of re- view. (See also Section 1.2(c)(3) concerning breeding of chimeras.) 6.7 Introduction of hES cells into nonhuman mammalian blastocysts should be considered only under circumstances in which no other experiment can provide the information needed. (See also Sections 1.2(c)(2) and 1.2(c)(3) concerning restrictions on breeding of chimeras and production of chimeras with nonhuman primate blastocysts.) 6.8 Research use of existing hES cells does not require IRB review unless the research involves introduction of the hES cells or their derivatives into pa- tients or the possibility that the identity of the donors of the blastocysts, gametes, or somatic cells is readily ascertainable or might become known to the investigator. 7.0 INTERNATIONAL COLLABORATION If a U.S.-based investigator collaborates with an investigator in another country, the ESCRO committee may determine that the procedures prescribed by the foreign institution afford protections consistent with these guidelines, and the ESCRO committee may approve the substitution of some of or all of the foreign procedures for its own. 8.0 CONCLUSION The substantial public support for hES cell research and the growing trend by many nonfederal funding agencies and state legislatures to support this field requires a set of guidelines to provide a framework for hES cell re-

OCR for page 167
28 Appendix A search. In the absence of the oversight that would come with unrestricted federal funding of this research, these guidelines will offer reassurance to the public and to Congress that the scientific community is attentive to ethical concerns and is capable of self-regulation while moving forward with this important research. To help ensure that these guidelines are taken seriously, stakeholders in hES cell research—sponsors, funding sources, research institutions, relevant oversight committees, professional societies, and scientific journals, as well as investigators—should develop policies and practices that are consistent with the principles inherent in these guidelines. Funding agencies, profes- sional societies, journals, and institutional review panels can provide valu- able community pressure and impose appropriate sanctions to ensure com- pliance. For example, ESCRO committees and IRBs should require evidence of compliance when protocols are reviewed for renewal, funding agencies should assess compliance when reviewing applications for support, and jour- nals should require that evidence of compliance accompanies publication of results. As individual states and private entities move into hES cell research, it will be important to initiate a national effort to provide a formal context in which the complex moral and oversight questions associated with this work can be addressed on a continuing basis. Both the state of hES cell research and clinical practice and public policy surrounding these topics are in a state of flux and are likely to be so for several years. Therefore, the committee believes that a national body should be established to assess periodically the adequacy of the policies and guidelines proposed in this document and to provide a forum for a continuing discussion of issues involved in hES cell research. New policies and standards may be appropriate for issues that cannot now be foreseen. The organization that sponsors this body should be politically independent and without conflicts of interest, should be respected in the lay and scientific communities, and able to call on suitable expertise to support this effort.

OCR for page 167
Appendix B Committee Biographical Sketches CO-CHAIRS R. Alta Charo, J.D., is the Warren P. Knowles Professor of Law and Bio- ethics at the University of Wisconsin–Madison, on the faculties of both the Law School and Medical School, and, in 2006, was Visiting Professor of Law at the University of California, Berkeley, Boalt Hall School of Law. Professor Charo is the author of nearly 100 articles, book chapters, and government reports on topics including voting rights, environmental law, family planning and abortion law, medical genetics law, reproductive tech- nology policy, science policy, and medical ethics. Professor Charo is a member of the boards of the Alan Guttmacher Institute and the Foundation for Genetic Medicine, a member of the National Medical Advisory Commit- tee of the Planned Parenthood Federation of America, and a member of the ethics advisory boards of the International Society for Stem Cell Research, the Juvenile Diabetes Research Foundation and WiCell. In 2005, she was appointed to the ethics standards working group of the California Institute for Regenerative Medicine and was elected as a fellow of the Wisconsin Academy of Sciences, Arts, and Letters. In 1994, Professor Charo served on the NIH Human Embryo Research Panel, and from 1996 to 2001 she was a member of the presidential National Bioethics Advisory Commission where she participated in drafting its reports on Cloning Human Beings (1997); Research Involving Persons with Mental Disorders That May Affect 29

OCR for page 167
30 Appendix B Decisionmaking Capacity (1998); Research Involving Human Biological Materials: Ethical Issues and Policy Guidance (1999); Ethical Issues in Hu- man Stem Cell Research (1999); Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries, and Ethical and Policy Issues in Research Involving Human Participants (2001). Since 2001, she has been a member of the National Academies’ Board on Life Sciences and since 2006, she has been a member of the Institute of Medicine’s Board on Population Health and Public Health Practices. Professor Charo was elected to the Institute of Medicine in 2006. Richard O. Hynes, Ph.D., is the Daniel K. Ludwig Professor for Cancer Research at the MIT Center for Cancer Research and Department of Biol- ogy, and a Howard Hughes Medical Institute investigator. He was formerly head of the Biology Department and then director of the Center for Cancer Research at MIT. His research focuses on fibronectins and integrins and the molecular basis of cellular adhesion, both in normal development and in pathological situations, such as cancer, thrombosis, and inflammation. Dr. Hynes’ current interests are cancer invasion and metastasis, angiogenesis, and animal models of human disease states. He is a member of the National Academy of Sciences and the Institute of Medicine and is a Fellow of the Royal Society of London and the American Academy of Arts and Sciences. In 1997, he received the Gairdner International Foundation Award. In 2000, he served as president of the American Society for Cell Biology and testified before Congress about the need for federal support and oversight of embryonic stem cell research. He co-chaired the 2005 National Academies’ Guidelines for Human Embryonic Stem Cell Research. MEMBERS Eli Y. Adashi, M.D., M.S., FACOG, is currently the Dean of Medicine and Biological Sciences and the Frank L. Day Professor of Biology, the Warren Alpert Medical School of Brown University. Previously, Dr. Adashi served as the professor and chair of the Department of Obstetrics and Gynecology at the University of Utah Health Sciences Center. Dr. Adashi is a member of the Institute of Medicine of the National Academies, a member of the Asso- ciation of American Physicians, and a fellow of the American Association for the Advancement of Science. Dr. Adashi is a former member of the Advisory Council of the National Institute of Child Health and Human Development and a former president of the Society for Reproductive Endo-

OCR for page 167
Appendix B 31 crinologists, the Society for Gynecologic Investigation, and the American Gynecological and Obstetrical Society. Dr. Adashi is also a former examiner and director of the Division of Reproductive Endocrinology of the American Board of Obstetrics and Gynecology. Finally, Dr. Adashi is a founding member and treasurer and, more recently, chair of the advisory committee of the Geneva-based Bertarelli Foundation, dedicated to promoting the wel- fare of the infertile couple and to addressing the current “epidemic” of high- order multiple gestations. Brigid L.M. Hogan, Ph.D., is the George Barth Geller Professor and Chair of the Department of Cell Biology, Duke University Medical Center. Prior to joining Duke, Dr. Hogan was an Investigator of the Howard Hughes Medi- cal Institute and Hortense B. Ingram Professor in the Department of Cell Biology at Vanderbilt University Medical Center. Dr. Hogan earned her Ph.D. in Biochemistry at the University of Cambridge. After completing her Ph.D. she was a postdoctoral fellow in the Department of Biology at MIT. Before moving to the United States in 1988, Dr. Hogan was head of the Molecular Embryology Laboratory at the National Institute for Medical Research in London. Her research focuses on the genetic control of embry- onic development and morphogenesis, using the mouse as a model system. Her laboratory developed methods for deriving mouse pluripotential embry- onic germ (EG) cell lines. She was Co-Chair for Science of the 1994 NIH Human Embryo Research Panel and a member of the 2001/2002 National Academies’ Panel on Scientific and Medical Aspects of Human Cloning. Within the past few years, Dr. Hogan has been elected to the Royal Society of London, the American Academy of Arts and Sciences, the Institute of Medicine, and the National Academy of Sciences. Marcia Imbrescia is the current owner of Peartree Design, a landscape de- sign firm, and was previously the media director for Drumbeater, a high- technology advertising agency. She holds B.A. degrees in marketing and journalism, and a graduate certificate in landscape design. Ms. Imbrescia has a passion for health advocacy and helping people with illness and dis- ability. She is a member of the Board of Trustees of the Arthritis Founda- tion (AF), for which she has participated as a volunteer at the chapter and national levels. She served as member (1996–1998, 2001) and chairperson (2002–2003) of AF’s American Juvenile Arthritis Organization. In 1992, she received the Volunteer of the Year Award from the Massachusetts Chap- ter of AF. Her volunteer efforts include program development, conference planning, public speaking, fundraising, and advocacy. She served on the

OCR for page 167
32 Appendix B National Academies’ Committee on Guidelines for Human Embryonic Stem Cell Research in 2004–2005. Terry Magnuson, Ph.D., is Sarah Graham Kenan Professor and chair of the Department of Genetics at the University of North Carolina. He also directs the Carolina Center for Genome Sciences, and is the program director of cancer genetics at the Lineberger Comprehensive Cancer Center. Dr. Magnuson’s research interests include mammalian genetics, genomics, and development. His laboratory has developed a high-throughput system to study the effects of mutations on mouse development with mouse embryonic stem cells. He is particularly interested in the role of chromatin remodeling complexes in processes such as autosomal imprinting, X-inactivation, and anterior-posterior patterning of axial structures in mammals. He is a mem- ber of the Board of Directors of the Genetics Society of America and of the Society for Developmental Biology. Linda B. Miller, OTR, M.S. in Hospital Administration, is President of the Washington, D.C.-based Volunteer Trustees Foundation, a consortium of not-for-profit hospital governing boards. She has extensive experience in trustee education, advocacy, and the legal, ethical, and policy issues facing voluntary health care institutions. Recently, she has worked closely with the states’ attorneys general in developing guidelines for protecting the commu- nity interest in the sale and conversion of nonprofit hospitals, as well as in designing models for practice and legal oversight. She was elected to mem- bership in the Institute of Medicine in 1997. Ms. Miller has been a frequent speaker on health policy issues and has been published extensively in both the medical and popular press, including the New England Journal of Medicine, Health Affairs, USA Today, the Washington Post, and New York Times, among others. She served as a Special Assistant to the Secretary of Health, Education and Welfare (now HHS) and on numerous health-related policy councils and advisory commit- tees, including the National Institutes of Health’s Consensus Panel on Liver Transplantation and, most recently, the Institute of Medicine’s Committee on Spinal Cord Injury. Ms. Miller currently serves on the Advisory Board of the University of Louisville-based Institute for Cellular Therapeutics, headed by Dr. Suzanne Ildstad, which does research in adult bone marrow trans- plant, and has been a member of several academic and health care institu- tions’ board of governors, including Blythedale Childrens Hospital in New York, Capital Hospice in the national capital region, and Cornell University’s Alumni Council, among others.

OCR for page 167
Appendix B 33 Jonathan D. Moreno, Ph.D., is the David and Lyn Silfen University Profes- sor at the University of Pennsylvania. Until 2007, he was the Emily Davie and Joseph S. Kornfeld Professor of Biomedical Ethics at the University of Virginia where he also directed the Center for Biomedical Ethics. Dr. Moreno is a member of the Institute of Medicine of the National Academies. He is also a bioethics advisor for the Howard Hughes Medical Institute, a faculty affiliate of the Kennedy Institute of Ethics at Georgetown University, and a Fellow of the Hastings Center. During 1995–1996 he was Senior Policy and Research Analyst for the President’s Advisory Committee on Human Radia- tion Experiments and during 1998–2000 was a senior consultant for the National Bioethics Advisory Commission. He co-chaired the 2005 National Academies’ Committee on Guidelines for Human Embryonic Stem Cell Re- search and is a consultant to the Ethical, Social, and Cultural Program of the Bill & Melinda Gates Foundation Grand Challenges in Global Health initia- tive, for ethical and regulatory issues regarding stem cell research in China. Stuart H. Orkin,1 M.D., is the David G. Nathan Professor of Pediatrics at Harvard Medical School, Chair of the Department of Pediatric Onocology at the Dana-Farber Cancer Institute, and an Investigator with the Howard Hughes Medical Institute. His laboratory utilizes multidisciplinary ap- proaches to understand how mammalian cells choose specific fates and how mutations in important transcriptional regulators lead to developmental defects or malignancy. Recent and ongoing work falls into several overlap- ping areas, including study of essential hematopoietic transcription factors, the genetic pathogenesis of two forms of leukemia, and whether some of the lessons of hematopoiesis may be applied to consideration of the pathogen- esis of solid tumors. Finally, the fundamental properties of stem cells— pluripotency and self-renewal—are being addressed from a biochemical per- spective in mouse embryonic stem (ES) cells. In the future, his laboratory will pursue the functions of the associated proteins in order to unravel the biochemistry of ES fate specification. This strategy may ultimately suggest how directed manipulation of somatic cells to an ES cell fate might be achieved. Pilar N. Ossorio, Ph.D., J.D., is Associate Professor of Law and Bioethics at the University of Wisconsin–Madison, and Program Faculty in the Graduate 1Resigned from committee effective December 18, 2006.

OCR for page 167
34 Appendix B Program in Population Health at UW. Prior to taking her position at UW, she was Director of the Genetics Section at the Institute for Ethics at the American Medical Association, and taught as an adjunct faculty member at the University of Chicago Law School. For the 2006 calendar year, Professor Ossorio was a visiting professor of law at the University of California, Berkeley, Boalt Hall School of Law. Dr. Ossorio received her Ph.D. in Microbiology and Immunology in 1990 from Stanford University. She went on to complete a postdoctoral fellowship in cell biology at Yale University School of Medicine. Through- out the early 1990s, Dr. Ossorio also worked as a consultant for the federal program on the Ethical, Legal, and Social Implications (ELSI) of the Human Genome Project, and in 1994, she took a full-time position with the Depart- ment of Energy’s ELSI program. In 1993, she served on the Ethics Working Group for President Clinton’s Health Care Reform Task Force. Dr. Ossorio received her J.D. from the University of California at Berkeley School of Law (Boalt Hall) in 1997. While at Boalt she was elected to the legal honor society Order of the Coif and received several awards for outstanding legal scholarship. Dr. Ossorio is a fellow of the American Association for the Advance- ment of Science (AAAS), on the editorial board of the American Journal of Bioethics, an advisor to NHGRI on ethical issues in large-scale sequencing, and a member of UW’s institutional review board for health sciences re- search. She is a past member of AAAS’s Committee on Scientific Freedom and Responsibility, a past member of the National Cancer Policy Board (Institute of Medicine), and has been a member or chair of several working groups on genetics and ethics. She has published scholarly articles in bio- ethics, law, and molecular biology. E. Albert Reece, M.D., Ph.D., is currently Dean of the University of Mary- land School of Medicine and Vice President for Medical Affairs at the Uni- versity of Maryland, Baltimore. Previously, he was Vice Chancellor and Dean of the University of Arkansas College of Medicine. Dr. Reece received his undergraduate degree from Long Island University, his M.D. (Magna Cum Laude) from New York University, his Ph.D. degree in biochemistry from the University of the West Indies, and his M.B.A. degree from the Fox School of Business and Management of Temple University. He completed a residency in OB/GYN at Columbia University–Presbyterian Hospital, and a fellowship in maternal-fetal medicine at Yale University School of Medi- cine. He served on the faculty at Yale for 10 years, and was the Chairman of the Department of Obstetrics, Gynecology, and Reproductive Sciences at

OCR for page 167
Appendix B 35 Temple University. Dr. Reece has published over 400 journal articles, book chapters, and abstracts, and 9 textbooks including Diabetes in Pregnancy; Medicine of the Fetus & Mother; and Fundamentals of Ultrasound in Ob- stetrics & Gynecology. He is an editor for the Journal of Maternal-Fetal Medicine and a reviewer for several other scientific journals. His research focuses on diabetes in pregnancy, birth defects, and prenatal diagnosis. Dr. Reece is a member of the Institute of Medicine. Joshua R. Sanes, Ph.D., is Professor of Molecular and Cellular Biology and the Paul J. Finnegan Family Director of the Center for Brain Science at Harvard University. He was previously Alumni Endowed Professor of Neu- robiology at the Washington University School of Medicine. Dr. Sanes earned a B.A. in biochemistry and psychology at Yale and a Ph.D. in Neuro- biology at Harvard. He studies the formation of the synapses that intercon- nect nerve cells, including pioneering work on the signals exchanged be- tween nerve cells and their target muscles as new connections are made. He is also using the vertebrate visual system to examine how nerve cells develop and migrate to the right location in the body. He was elected a Fellow of the American Association for the Advancement of Science in 1992 and a mem- ber of the National Academy of Sciences in 2002. Harold T. Shapiro, Ph.D., is President Emeritus of both Princeton University and the University of Michigan and is currently Professor of Economics and Public Affairs at Princeton University. His research interests include bioeth- ics, the social role of higher education, hospital/medical center administra- tion, university administration, econometrics, statistics, and economics. Dr. Shapiro currently chairs the Board of Trustees of the Alfred P. Sloan Foun- dation, is presiding director for the Dow Chemical Company, and is a member of numerous boards including the Robert Wood Johnson Medical School, HCA, the Merck Vaccine Advisory Board, the Knight Foundation Commission on Intercollegiate Athletics, U.S. Olympic Committee, and the Stem Cell Institute of New Jersey. He is a former Chair of the Association of American Universities and the National Bioethics Advisory Committee and Vice Chair of the President’s Council of Advisors on Science and Technol- ogy. He has also served on the Board of Directors of the National Bureau of Economic Research, Inc. and the Board of Trustees of the Universities Re- search Association, Inc. He has chaired and served on numerous National Academies committees including the Committee on the Organizational Struc- ture of the National Institutes of Health and the Committee on Particle Physics. Dr. Shapiro was awarded the 2006 American Association for the

OCR for page 167
36 Appendix B Advancement of Science’s William D. Carey Lecture for his leadership in science policy. He earned a Ph.D. in economics from Princeton University and holds 14 honorary doctorates. John E. Wagner, Jr., M.D., is a professor of pediatrics at the University of Minnesota Medical School. He is the first recipient of the Children’s Cancer Research Fund/Hageboeck Family Chair in Pediatric Oncology and also holds the Variety Club Endowed Chair in Molecular and Cellular Therapy. He is the director of the division of Pediatric Hematology/Oncology and Bone Marrow Transplantation and Scientific Director of Clinical Research of the Stem Cell Institute. Dr. Wagner is a member of numerous societies, including the American Society of Hematology, the International Society of Experimental Hematology, and the American Society of Blood and Marrow Transplantation. He is a member of several honorary societies including Alpha Omega Alpha (1980), the American Society of Clinical Investigation (2000), and the Association of American Physicians (2006). Dr. Wagner holds a patent on the isolation of the pluripotential quiescent stem cell population. Dr. Wagner holds a B.A. in Biological Sciences and a B.A. in Psychology from the University of Delaware and an M.D. from Jefferson Medical College. Dr. Wagner’s research has focused on the development of novel cellular therapies for tissue repair and suppression of the immune response using subpopulations of neonatal umbilical cord blood and adult bone marrow and peripheral blood. Projects are funded by both NIH (P01 CA65493, Biology and Transplantation of the Human Stem Cell; and N01- HB-37164, Somatic Cell Therapeutics) and industry (ViaCell, Inc., on the transplantation of expanded umbilical cord blood hematopoietic stem cells; and Athersys, Inc., on the large-scale development of multipotent adult progenitor cells). In addition, Dr. Wagner pioneered the use of embryo selection to “create” a perfectly tissue matched stem cell donor in the treat- ment of genetic disease. Dr. Wagner has authored more than 180 articles and book chapters on the subject of hematopoietic stem cell transplantation. He currently co-chairs the Graft Sources and Manipulation Working Com- mittee of the Center of the International Blood and Marrow Transplant Research, serves on the Scientific Board of Directors of the National Mar- row Donor Program, and is a member of the Scientific and Medical Ac- countability Standards Working Group of the California Institute of Regen- erative Medicine. Dr. Wagner has previously served as a member of the Institute of Medicine’s Committee on Establishing a National Cord Blood Stem Cell Banking Program.