6.5 Transplantation of differentiated derivatives of hES cells or even hES cells themselves into adult animals will not require extensive ESCRO committee review. If there is a possibility that the human cells could contribute in a major organized way to the brain of the recipient animal, however, the scientific justification for the experiments must be strong, and proof of principle using nonhuman (preferably primate) cells, is desirable.


6.6 Experiments in which hES cells, their derivatives, or other pluripotent cells are introduced into nonhuman fetuses and allowed to develop into adult chimeras need more careful consideration because the extent of human contribution to the resulting animal may be higher. Consideration of any major functional contributions to the brain should be a main focus of review. (See also Section 1.3(c)(iii) concerning breeding of chimeras.)


6.7 Introduction of hES cells into nonhuman mammalian blastocysts should be considered only under circumstances in which no other experiment can provide the information needed. (See also Sections 1.3(c)(ii) and 1.3(c)(iii) concerning restrictions on breeding of chimeras and production of chimeras with nonhuman primate blastocysts.)


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)

7.1
Derivation

Because non-embryo-derived hPS cells are derived from human material, their derivation is covered by existing IRB regulations concerning review and informed consent. No ESCRO committee review is necessary, although the IRB may always seek the advice of an ESCRO committee if it seems desirable. The IRB review should consider proper consent for use of the derived hPS cells. 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



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