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2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research (2008)
Board on Life Sciences (BLS)
Board on Health Sciences Policy (HSP)

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. "Appendix A: National Academies' Guidelines for Human Embryonic Stem Cell Research Amended as of September 2008." 2008 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research. Washington, DC: The National Academies Press, 2008.

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The National Academies’ Guidelines for Human Embryonic Stem Cell Research

An institution conducting stem cell research should make information from the registries (including, but not necessarily limited to, project abstracts and source of funding) available to the public and the media through the institution’s Web site.

  1. Facilitate education of investigators involved in hES cell research.

An institution that maintains its own ESCRO committee should also conduct periodic audits of the committee to verify that it is carrying out its responsibilities appropriately. Auditable records include documentation of decisions regarding the acceptability of research proposals and verification that cell lines in use at the institution were acceptably derived (see Section 1.6). Institutions should make the results of these audits available to the public.


An institution that uses an external ESCRO committee should nevertheless ensure that the registry and educational functions of an internal ESCRO committee are carried out by the external ESCRO committee on its behalf or internally by other administrative units. Those institutions that use external ESCRO committees are also responsible for ensuring that these committees are likewise carrying out their responsibilities appropriately.


2.1 For projects that involve more than one institution, review of the scientific merit, justification, and compliance status of the research may be carried out by a single ESCRO committee if all participating institutions agree to accept the results of the review.

3.0
PROCUREMENT OF GAMETES, BLASTOCYSTS, OR CELLS FOR hES GENERATION

3.1 An IRB, as described in federal regulations at 45 CFR 46.107, should review all new procurements of all gametes, blastocysts, or somatic cells for the purpose of generating new hES or hPS cell lines. 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. Even people who have given prior indication of their intent to donate to research any blastocysts that remain after clinical care should

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