Final Report of the National Academies' Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research (2010) / Chapter Skim
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Appendix C: National Academies' Guidelines for Human Embryonic Stem Cell Research, Amended as of May 2010
Appendix C: National Academies' Guidelines for Human Embryonic Stem Cell Research, Amended as of May 2010
Pages 19-36
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From page 19... ...
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 issues these guidelines New or modified wording is indicated by underlining.
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From page 20... ...
These guidelines cover all derivation of hES cell lines and all research that uses hES cells derived from (i) blastocysts and/or morulae made for reproductive purposes and later obtained for research from in vitro fertilization (IVF)
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From page 21... ...
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 22... ...
In this context, expedited review means that the ESCRO committee chair or others designated by the committee chair act on behalf of the committee to deter mine that the hES cells have been acceptably derived (see Section 1.5) and report to the entire committee.
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From page 23... ...
1.4 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, morulae, blastocysts, or somatic cells and be sensitive to public concerns about research that involves human embryos.
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From page 24... ...
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 re search, each many institutions currently require that research should have activities involving hES cells should be overseen by an Embryonic Stem Cell Research Oversight (ESCRO)
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From page 25... ...
Alternatively, an institution may have its proposals reviewed by an ESCRO committee of another institution, or by an independent ESCRO committee. An ESCRO committee should include independent representatives of the lay public as well as persons with expertise in developmental biology, stem cell research, molecular biology, assisted reproduction, and ethical and legal issues in hES cell research.
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From page 26... ...
This includes the procurement of blastocysts and/or morulae 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 27... ...
3.6 In the context of donation of gametes, morulae, 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.9 (a) A statement that the blastocysts, gametes, morulae, blastocysts, or somatic cells will be used to derive hES or hPS cells for research that may include research on human transplantation.
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From page 28... ...
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 29... ...
4.3 Research teams should demonstrate appropriate expertise or training in derivation or culture of either human or nonhuman ES cells before permission to derive new lines is given. 4.4 When NT experiments involving either human or nonhuman oocytes are proposed as a route to generation of hES cells, the protocol must have a strong scientific rationale.
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From page 30... ...
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 reposito ries and should adhere to high ethical, legal, and scientific standards.
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From page 31... ...
(ii) A system for a secure audit trail from primary cell lines to those submitted to the repository.
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From page 32... ...
and 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.
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From page 33... ...
Some of the recommendations for informed consent that apply to hES cells also apply to hPS cells (see Section 3.6) , including informed consent to genetic manipulation of resulting pluripotent stem cells and their use for transplantation into animals and humans and potentially in future commercial development.
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From page 34... ...
7.3 Use in Experiments Involving Transplantation of hPS Cells into Animals at any Stage of Development or Maturity 7.3(a) Research involving transplantation of pluripotent human cells derived from nonembryonic sources into nonhuman animals other than humans or primates at any stage of embryonic, fetal, or postnatal develop ment should be reviewed by ESCRO committees and IACUCs, as are similar experiments that use hES cells.
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From page 35... ...
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 36... ...
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 com munity pressure and impose appropriate sanctions to ensure compliance.
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