1.1(c) Research supported by NIH funds using NIH-approved hES cell lines is governed by NIH guidelines.
1.1(d) The guidelines do not cover research that uses nonhuman stem cells.
These guidelines also do not apply to reproductive uses of nuclear transfer, which are addressed in the 2002 report Scientific and Medical Aspects of Human Reproductive Cloning, in which the National Academies recommended that “Human reproductive cloning should not now be practiced. It is dangerous and likely to fail.” Although these guidelines do not specifically address human reproductive cloning, it continues to be the view of the National Academies that research aimed at the reproductive cloning of a human being should not be conducted at this time.
These guidelines specify categories of research that:
Are permissible after currently mandated reviews and proper notification of the relevant research institution.
Are permissible after additional review by an Embryonic Stem Cell Research Oversight (ESCRO) committee, as described in Section 2.0 of the guidelines.
Should not be conducted at this time.
Because of the sensitive nature of some aspects of hES cell research, these guidelines in many instances set a higher standard than is required by laws or regulations with which institutions and individuals already must comply.
Purely in vitro hES cell research that uses previously derived hES cell lines is permissible provided that the ESCRO committee or equivalent body designated by the investigator’s institution (see Section 2.0) receives documentation of the provenance of the cell lines including (i) documentation of the use of an acceptable informed consent process that was approved by an Institutional Review Board (IRB) or foreign equivalent for their derivation (consistent with Section 3.6) and (ii) documentation of compliance with