2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research (2008) / Chapter Skim
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Appendix A: National Academies' Guidelines for Human Embryonic Stem Cell Research Amended as of September 2008
Appendix A: National Academies' Guidelines for Human Embryonic Stem Cell Research Amended as of September 2008
Pages 21-38
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From page 21... ...
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 pertaining to biomedical research in general. The National Academies are issuing ew N or modified wording is indicated by underlining, deleted text by strikeout.
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From page 22... ...
These guidelines cover all derivation of hES cell lines and all re search that uses hES cells derived from (i) blastocysts made for reproductive purposes and later obtained for research from in vitro fertilization (IVF)
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From page 23... ...
1.3(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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From page 24... ...
( ii) 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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1.6 Acceptability of Research Using hES Cell Lines Imported from Other Institutions or Jurisdictions 1.6(a) Before approving use of hES and hPS cell lines imported from other institutions or jurisdictions, ESCRO committees should consider whether such cell lines have been "acceptably derived." 1.6(b)
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From page 26... ...
This is in accord with the requirement in Section 2.0 of the Guidelines that calls for ESCRO commit tees 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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From page 27... ...
This includes the procurement of blastocysts in excess of clinical need from infertility clinics; blastocysts made through IVF specifically for research purposes; and oocytes, sperm, and somatic cells donated for development of hES cell lines derived through NT or by parthenogenesis or androgenesis; and hPS cells derived by any means that require human subjects review. 3.2 Consent for donation should be obtained from each donor at the time of donation.
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From page 28... ...
3.6 In the context of donation of gametes, blastocysts, or somatic cells for hES cell research or for hPS cell research that requires human subjects review, the informed-consent process, should, at a minimum, provide the following information.
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From page 29... ...
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 materials used, for example, for NT.
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From page 30... ...
. 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 evi dence of IRB approval of the procurement process (see Section 3.0 above)
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From page 31... ...
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 standards.
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(ii) system for a secure audit trail from primary cell lines to those A submitted to the repository.
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From page 33... ...
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 consideration of the consequences of the human contributions to the resulting chimeras.
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From page 34... ...
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 patients 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 Recommendations for Research oN non-embryo derived human pluripotent stem cells (hPS CELLS)
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From page 35... ...
Research involving transplantation of pluripotent human cells derived from non-embryonic sources into nonhuman animals at any stage of embryonic, fetal, or postnatal development should be reviewed by ESCRO committees and IACUCs, as are similar experiments that use hES cells.
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From page 36... ...
7.5 Prohibition on Breeding No animal into which hPS cells have been introduced such that they could contribute to the germ line should be allowed to breed. 7.6 Guidance for Banking and Distribution Institutions should consider the value of banking and distributing hPS cells using the guidance and rules that are already in place for hES cells and the value of including hPS cell lines in their registries.
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From page 37... ...
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, professional societies, journals, and institutional review panels can provide valuable community pressure and impose appropriate sanctions to ensure compliance. For example, ESCROs and IRBs should require evidence of compliance when protocols are reviewed for renewal, funding agencies should assess compliance when reviewing applications for support, and journals should require that evidence of compliance accompanies publication of results.
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