of other non-embryonic human pluripotent stem cells (hereafter referred to as hPS cells) does not require special stem cell expertise and is adequately covered by current Institutional Review Board (IRB) regulations. It does not require additional review by an ESCRO committee. The Committee notes in particular that under federal regulations, even IRBs would not be required to review the generation of hPS cells from existing anonymized somatic cells from surgical waste, tissue banks, or commercial entities that provide tissue for research, nor would they be required to review the generation of hPS cells from cadaveric tissue, whether or not it is anonymized. Similarly, with few exceptions, purely in vitro experiments with hPS cells do not raise ethical concerns beyond those encountered with any human cell line and also do not require ESCRO committee review.

However, as mentioned above, introduction of any hPS cells and introduction of some multipotent stem cells (such as neural stem cells) into animals raises issues similar to those pertaining to hES cells. The earlier versions of the Guidelines placed responsibility for review of such experiments with hES cells in the hands of ESCRO committees and Institutional Animal Care and Use Committees (IACUCs), and it is logical to do the same for hPS cells and for stem cells with more limited potential for differentiation. The revisions presented in this document provide guidance on the levels of review for various categories of experiments with iPS and other hPS cells and on categories of research for which such review is not necessary. Most of the changes appear in a new Section 7, “Recommendations for Research on Non-Embryo-Derived Human Pluripotent Stem Cells (hPS Cells)”, although some provisions of Sections 1, 3, 4, and 5 are also affected, as follows (new or revised wording is underlined, and deleted text appears in strikeout form):

From Section 1


1.1 What These Guidelines Cover


1.1(a) These guidelines cover all derivation of hES cell lines and all research that uses hES cells derived from

  1. blastocysts made for reproductive purposes and later obtained for research from in vitro fertilization (IVF) clinics,

  2. blastocysts made specifically for research using IVF,

  3. somatic cell nuclear transfer (NT) into oocytes.



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