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 1.2(c)(3) 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 1.2(c)(2) and 1.2(c)(3) 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.
If a U.S.-based investigator collaborates with an investigator in another country, the ESCRO committee may determine that the procedures prescribed by the foreign institution afford protections consistent with these guidelines, and the ESCRO committee may approve the substitution of some of or all of the foreign procedures for its own.
The substantial public support for hES cell research and the growing trend by many nonfederal funding agencies and state legislatures to support this field requires a set of guidelines to provide a framework for hES cell research. In the absence of the oversight that would come with unrestricted federal funding of this research, these guidelines will offer reassurance to the public and to Congress that the scientific community is attentive to ethical concerns and is capable of self-regulation while moving forward with this important research.
To help ensure that these guidelines are taken seriously, stakeholders in hES cell research—sponsors, funding sources, research institutions, relevant oversight committees, professional societies, and scientific journals, as well as investigators—should develop policies and practices that are consistent with the principles inherent in these guidelines. Funding agencies, professional societies, journals, and institutional review panels can provide valuable community pressure and impose appropriate sanctions to ensure compliance. For example, ESCRO committees and IRBs should require evidence of compliance when protocols are reviewed for renewal,