2007 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research (2007) / Chapter Skim
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Appendix A National Academies' Guidelines for Human Embryonic Stem Cell Research, Amended as of February 2007
Appendix A National Academies' Guidelines for Human Embryonic Stem Cell Research, Amended as of February 2007
Pages 15-28
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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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1.1(a) What These Guidelines Cover These guidelines cover all derivation of hES cell lines and all research that uses hES cells derived from (1)
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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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1.3 Obligations of Investigators and Institutions All scientific investigators and their institutions, regardless of their field, bear the ultimate responsibility for ensuring that they conduct themselves in accordance with professional standards and with integrity. In particular, people whose research involves hES cells should work closely with oversight bodies, demonstrate respect for the autonomy and privacy of those who donate gametes, blastocysts, or somatic cells, and be sensitive to public concerns about research that involves human embryos.
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This is in accord with the requirement in Section 2.0 of the Guidelines that calls for ESCRO committees to maintain registries listing the cell lines in use at their institutions. 2.0 ESTABLISHMENT OF AN INSTITUTIONAL EMBRYONIC 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 involving hES cells overseen by an Embryonic Stem Cell Research Oversight (ESCRO)
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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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(g) A statement that the hES cells and/or cell lines might be used in research involving genetic manipulation of the cells or the mixing of human and nonhuman cells in animal models.
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. 4.0 DERIVATION OF hES CELL LINES 4.1 Requests to the ESCRO committee for permission to attempt derivation of new hES cell lines from donated embryos or blastocysts must include evidence of IRB approval of the procurement process (see Section 3.0 above)
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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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(v) A Web site that contains scientific descriptions and data related to the cell lines available.
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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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