Advanced Cell Technology’s (ACT) Ethics Advisory Board (EAB) provided oversight and counsel for the research that culminated in publication of the landmark paper “Human Embryonic Stem Cell Lines Derived from Single Blastomeres” in the August 24, 2006 edition of Nature. The EAB and ACT’s IRB, acting in compliance with federal and state regulations, approved the research procedures and the informed consent documents used in this research.
Following these approvals, ACT researchers obtained embryos produced by in vitro fertilization (IVF) that were donated by couples who generated them for their own infertility treatment but no longer intended to use them. The researchers then developed a method of producing stem cell lines by extracting and biopsying single cells (blastomeres) from these embryos. This technique, which leaves the embryos developmentally viable, offers a promising new way of ethically deriving human embryonic stem cell (hESC) lines for research and clinical therapies. It also offers an approach that could overcome the legal and political barriers that have severely limited federal funding for hESC research.
Thousands of human embryos have already been subject to single cell biopsy in connection with a procedure known as preimplantation genetic diagnosis (PGD). This allows couples at risk of transmitting a serious genetic disease to produce a sample of embryos via IVF, to test each embryo for the presence or absence of the disease-causing mutations, and select for implantation only those embryos that are healthy. There is no evidence from this experience and related animal studies that embryos have their capacity for healthy development impaired by having one or two cells removed.
Right now, many stem cell lines for research and clinical use can ethically be derived from embryos undergoing PGD. Because a cell must be taken from these embryos for the testing procedure, the use of these cells to develop a stem cell line presents no additional risk to the embryo. Many people will regard this as an ethically acceptable way of deriving new stem cell lines that are urgently needed for research.
Research on stem cells derived in this manner may also be suitable for federal funding. Current U.S. law prohibits funding for “research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death . . .” Since the procedure of single cell blastomere biopsy does not itself harm or destroy embryos, there is reason to believe that informed legal opinion will permit the use of stem cells derived in this way.
In 2001, President George W. Bush, on the grounds that human life should not be sacrificed to save life, established current U.S. stem cell policy prohibiting any further destruction of human embryos to establish stem cell lines. More recently, in his veto of HR 810, a bill to expand the number of stem cell lines derived from embryos remaining from infertility procedures, he reiterated his opposition to any approach that destroys human embryos in the name of research. Single cell blastomere biopsy offers the President an opportunity to remain consistent with the moral values that have informed his position while greatly expanding the number of stem cell lines available for federally funded research.
It is unusual that a scientific breakthrough helps resolve ethical debates. This is one of those rare occasions. The success of the single cell blastomere biopsy procedure demonstrated by ACT researchers provides an opportunity for citizens of diverse moral viewpoints to join together to accelerate stem cell research.
Ronald M. Green, Ph.D.
Chair, Ethics Advisory Board
Director, Ethics Institute, Dartmouth College
This Ethics Advisory Board (EAB), comprised of leading bioethicists and cell scientists, is autonomous and is charged with providing Advanced Cell Technology with advice and counsel on ethical matters relevant to the company’s activities, both at its own initiative and pursuant to specific inquiries. Members of this board have no financial interest in Advanced Cell Technology, and are compensated for their time in accordance with NIH per diem guidelines.
Ronald M. Green, Ph.D., serves as the Chair of the Ethics Advisory Board; other members include Judith Bernstein, RNC, MSN, Ph.D., Kenneth W. Goodman, Ph.D., M.A., Jeremy B.A. Green, Ph.D., Robert Kaufmann, MD, Carol Tauer, Ph.D, and Kier DeVries.
A member of Dartmouth’s Religion Department since 1969, Professor Green also directs Dartmouth’s Ethics Institute, whose mission is to further teaching and research in applied and professional ethics. He is a summa cum laude graduate of Brown University and received his Ph. D. in religious ethics from Harvard University in 1973. In 1996 and 1997, Prof. Green served as Director of the Office of Genome Ethics at the National Human Genome Research Institute of the National Institutes of Health. Prof. Green’s research interests are in genetic ethics, biomedical ethics, and issues of justice in health care allocation. He is the author of six books and over one hundred thirty articles in theoretical and applied ethics. His most recent book, The Human Embryo Research Debates: Bioethics in the Vortex of Controversy, was published in 2001 by Oxford University Press. In 2005, Prof. Green was named a Guggenheim Fellow.
Dr. Judith Bernstein, Associate Professor of Maternal and Child Health, Boston University School of Public Health, and Associate Professor of Emergency Medicine, Boston University School of Medicine, has been a nurse-researcher and public health professional for the past 30 years. She has worked with both inner-city and rural communities to develop comprehensive integrated approaches to women’s health. Dr. Bernstein holds an MSN in psychiatric nursing and a doctorate in health policy. She is certified in reproductive endocrinology and infertility, and in recognition of her critical role in the development of this specialty, was the 1995 recipient of the national NCC award. Dr. Bernstein is also a member of the Committee on Ethics of the American College of Obstetricians and Gynecologists.
Kenneth W. Goodman, Ph.D., is founder of the University of Miami Forum for Bioethics and Philosophy and is currently the Director of the Bioethics Program. Dr. Goodman holds appointments in the University of Miami’s Department of Medicine, Department of Philosophy, School of Nursing, and Department of Epidemiology and Public Health. In the School of Medicine he shares responsibility for student and/or resident ethics programs in the departments of Medicine, Pediatrics, Family Medicine, Psychiatry, and Epidemiology and Public Health. He serves on and has helped establish several hospital ethics committees, institutional review boards, animal studies committees, and a variety of other institutional and community panels, and consults for numerous health care, business and governmental organizations.
Jeremy Green is a Senior Lecturer at King’s College London and was for ten years Assistant Professor of Genetics at Harvard Medical School. He has served on the Ethics Advisory Board of the Dana Farber Cancer Institute, Boston and has experience as a fertility patient. He has written on ethical issues in science for the BBC and the American Journal of Bioethics.
Dr. Kaufmann is subspecialty board certified in Reproductive Endocrinology and Infertility by the American Board of Obstetrics and Gynecology. Prior to joining Dallas Fort Worth Fertility Associates in Fort Worth, Texas, Dr. Kaufmann served as Division Head for Medical University of South Carolina’s Department of Reproductive Endocrinology in Charleston. Dr. Kaufmann earned his doctorate at Tel Aviv University’s New York State Sackler School of Medicine. His internship, residency and fellowship were completed at Wayne State University’s Hutzel Hospital in Detroit, Mich in 1990. Following his fellowship he received a prestigious NIH grant to perform pioneering work in PGD (Preimplantation Genetic Diagnosis) at the internationally renowned Jones Institute for Reproductive Medicine.
Carol Tauer is Professor of Philosophy Emerita at the College of St. Catherine in St. Paul, Minnesota and is currently Visiting Professor at the Center for Bioethics. She holds a PhD in mathematics from Massachusetts Institute of Technology and PhD in philosophy from Georgetown University with a concentration in bioethics. In 1994 she was a member of the NIH Human Embryo Research Panel that was charged to make ethical recommendations for federal funding of research on infertility, preimplantation diagnosis, and stem cell research. In 1999 she was a member of the NIH Working Group on Pluripotential Stem Cell Research that developed specific recommendations for federally funded human embryonic stem cell research.
Kier DeVries, is a community member whose graduate studies were philosophy/bioethics, with a particular focus on feminist ethics. She works as an editor and a writer.