Guidelines for Human Embryonic Stem Cell Research (2005) / Chapter Skim
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Appendix: 2007 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research
Appendix: 2007 Amendments to the National Academies’ Guidelines for Human Embryonic Stem Cell Research
Pages 167-212
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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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All rights reserved. Printed in the United States of America
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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.
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HUMAN EMBRYONIC STEM CELL RESEARCH ADVISORY COMMITTEE R ALTA CHARO (Co-Chair)
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BOARD ON LIFE SCIENCES KEITH YAMAMOTO (Chair) , University of California, San Francisco ANN M
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BOARD ON HEALTH SCIENCES POLICY FRED GAGE (Chair) , The Salk Institute for Biological Studies, La Jolla, California GAIL H
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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.
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viii Acknowledgments Gail Martin, University of California, San Francisco P Pearl O'Rourke, Partners HealthCare System, Inc.
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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
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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
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While the Guidelines are primarily intended to address researchers in the United States, they may have applicability internationally 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.
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committees.1 This panel shared their experiences in working with the content and procedures of the Guidelines. 1The 2005 Guidelines called for institutions involved in hES cell research to establish ESCRO committees to provide institutional oversight on all issues related to derivation and use of hES cell lines and to facilitate education of investigators involved in hES cell research.
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; 2A summary of the AAMC meeting was subsequently published as "Human Embryonic Stem Cell Research: Regulatory and Administrative Challenges." This AAMC monograph is available at |
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advice for ESCRO committees in establishing criteria for considering the science in hES cell research proposals. CLARIFYING THE PHRASE "PROVENANCE OF THE CELL LINES" The National Academies' Human Embryonic Stem Cell Research Advi sory Committee has received many comments from the scientific community questioning the meaning of the phrase "provenance of the cell lines," which occurs in Sections 1.2(a)
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USE OF NIH-APPROVED hES CELL LINES The National Academies' Guidelines were issued a few years after a limited number of cell lines were deemed as useable in federally funded research in the United States.4 As of the publication of this report in early 2007, these "NIH-approved cell lines" are the only hES cell lines that may be used in federally funded research. NIH-approved cell lines were derived before August 2001 under protocols that predated the issuance of the National Academies' Guidelines in 2005.
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The clarification is not in tended to "encourage" the use of these cell lines, either inside or outside the United States. For these reasons, retroactive application of the Guidelines is not warranted in this circumstance.
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For example, hES cell line derivations in the United Kingdom are managed through a licensing procedure that differs from the IRB and ESCRO committee review processes recommended in the Guidelines. Within the United States, state laws may vary from the Guidelines.
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the donation protocol was reviewed and approved by an IRB or, in the case of donations taking place outside the United States, a substantially equivalent oversight body; (2) consent to donate was voluntary and informed; (3)
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2007 Amendments 9 some of these recommendations need clarification. Although the text of Chapter 3 contains the statement that "In some cases, smaller institutions may wish to avail themselves of the services of larger facilities that have ESCRO committees," the idea that it is acceptable for institutions to use a nonlocal (external)
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2.0 ESTABLISHMENT OF AN INSTITUTIONAL EMBRY ONIC STEM CELL RESEARCH OVERSIGHT COMMITTEE To provide oversight of all issues related to derivation and use of hES cell lines and to facilitate education of investigators involved in hES cell research, each institution should have activities involv ing hES cells overseen by an Embryonic Stem Cell Research Over sight (ESCRO) committee.
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maintain registries of hES cell research conducted at the institution and hES cell lines derived or imported by in stitutional investigators, and (5) facilitate education of investigators involved in hES cell research.
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to reflect accurately outcomes of the procedures commonly used in IVF practices.8 The information returned in response to the Committee's request indicated that the number of blastocysts created with anonymous donor sperm in SART member practices is only about 3.5 percent.9 Given this small number, it is the Committee's view that maintaining the requirement for sperm donor consent in cases where human embryonic stem cell lines are to be derived from excess IVF clinic blastocysts should not significantly affect the availability of blastocysts for donation to research. The Committee, therefore, has concluded that it is not necessary to modify the Guidelines by "grandfathering" the frozen embryo population in IVF clinics and exempting them from the informed consent requirement for sperm donors.
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Additional questions arise in considering protocols involving introduction of hES cells or cellular derivatives thereof into an animal host to form a chimera. Some of those questions were addressed in the 2005 Guidelines for Human Embryonic Stem Cell Research, and the committee intends to revisit these issues in future discussions.
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cell lines. They provide an oversight process that will help to ensure that research with hES cells is conducted in a responsible and ethically sensitive manner and in compliance with all regulatory requirements 1New or modified wording is indicated by underlining.
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Many, but not all, of the guidelines and concerns addressed in this report are common to other areas of human stem cell research, such as (1) research that uses human adult stem cells, (2)
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1.2(a) hES Cell Research Permissible After Currently Mandated Reviews Purely in vitro hES cell research that uses previously derived hES cell lines is permissible provided that the ESCRO committee or equivalent body designated by the investigator's institution (see Section 2.0)
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(2) Research in which hES cells are introduced into nonhuman primate blastocysts or in which any embryonic stem cells are introduced into human blastocysts.
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"Acceptably derived" means that the cell lines were derived from gametes or embryos for which (1) The donation protocol was reviewed and approved by an IRB or, in the case of donations taking place outside the United States, a sub stantially equivalent oversight body; (2)
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review compliance of all in-house hES cell research with all relevant regulations and these guidelines, (4) maintain registries of hES cell research conducted at the institution and hES cell lines derived or imported by institutional investigators, and (5)
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Whenever it is practicable, the attending physician responsible for the infertility treatment and the investigator deriving or proposing to use hES cells should not be the same person. 3.6 In the context of donation of gametes or blastocysts for hES cell research, the informed consent process, should, at a minimum, provide the following information: (a)
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In addition, donors could be offered the option of agreeing to some forms of hES cell research but not others. For example, donors might agree to have their materials used for deriving new hES cell lines but might not want their
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3.7 Clinical personnel who have a conscientious objection to hES cell research should not be required to participate in providing donor information or securing donor consent for research use of gametes or blastocysts. That privilege should not extend to the care of a donor or recipient.
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As hES cell research advances, it will be increasingly important for institutions that are obtaining, storing, and using cell lines to have confidence in the value of stored cells -- that is, that they were obtained ethically and with the informed consent of donors, that they are well characterized and screened for safety, and that the conditions under which they are maintained and stored meet the highest scientific standards. Institutions engaged in hES research should seek mechanisms for establishing central repositories for hES cell lines -- through partnerships or augmentation of existing quality research cell line repositories and should adhere to high ethical, legal, and scientific stan dards.
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(vii) A process for tracking disbursed cell lines and recording their status when shipped (such as number of passages)
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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.
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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
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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.
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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 Committee 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.
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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.
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she was a postdoctoral fellow in the Department of Biology at MIT. Before moving to the United States in 1988, Dr.
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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.
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He co-chaired the 2005 National Academies' Committee on Guidelines for Human Embryonic Stem Cell Research and is a consultant to the Ethical, Social, and Cultural Program of the Bill & Melinda Gates Foundation Grand Challenges in Global Health initiative, for ethical and regulatory issues regarding stem cell research in China. Stuart H
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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.
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Appendix B 35 Temple University.
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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)
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