lines in use at the institution were acceptably derived (see Section 1.5). 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. 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.


3.1 An IRB, as described in federal regulations at 45 CFR 46.107, should review all new procurement of all gametes, morulae, blastocysts, or somatic cells for the purpose of generating new hES or hPS cell lines. 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. Even people who have given prior indication of their intent to donate to research any blastocysts and/or morulae that remain after clinical care should nonetheless give informed consent at the time of donation. Donors should be informed that they retain the right to withdraw consent until the blastocysts and/or morulae are actually used in cell line derivation.

3.3 When donor gametes have been used in the IVF process, resulting blastocysts and/or morulae may not be used for research without consent of all gamete donors. Written agreement at the time of gamete donation that one potential use of the blastocysts and/or morulae is embryo research will constitute sufficient consent.

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