Use of hPS cells in purely in vitro experiments need not be subject to any review beyond that necessary for any human cell line except that any experiments designed or expected to yield gametes (oocytes or sperm) should be subject to ESCRO committee review.

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 development should be reviewed by ESCRO committees and IACUCs, as are similar experiments that use hES cells.

7.3(b) ESCRO committees should review the provenance of the hPS cells as they review the provenance of hES cells (see section 1.5) to ensure that the cell lines were derived according to ethical procedures of informed consent as monitored by an IRB or equivalent oversight body.

7.3() Proposals for use of hPS cells in animals should be considered in one of the following categories:

1. Permissible after currently mandated reviews and proper documentation [see Section 1.3(a)]: experiments that are exempt from full ESCRO committee review but not IACUC review (experiments that involve only transplantation into postnatal animals with no likelihood of contributing to the central nervous system or germ line).

2. Permissible after additional review by an ESCRO committee, as described in Section 2.0 of the guidelines [see Section 1.3(b)]: experiments in which there is a significant possibility that the implanted hPS cells could give rise to neural or gametic cells and tissues. Such experiments need full ESCRO committee and IACUC review and would include generation of all preimplantation chimeras as well as neural transplantation into embryos or perinatal animals. Particular attention should be paid to at least three factors: the extent to which the implanted cells colonize and integrate into the animal tissue; the degree of differentiation