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Guidelines for Human Embryonic Stem Cell Research
derived is readily ascertainable by the investigator also requires ESCRO committee review and approval.
(c) Research that should not be permitted at this time.
Research involving in vitro culture of any intact human embryo, regardless of derivation method, for longer than 14 days or until formation of the primitive streak begins, whichever occurs first.
Research in which hES cells are introduced into nonhuman primate blastocysts or in which any embryonic stem cells are introduced into human blastocysts.
No animal into which hES cells have been introduced at any stage of development should be allowed to breed.
Because stem cell research is subject to a greater degree of public interest and scrutiny than most other kinds of laboratory research, the committee recommends that each institution should maintain through its ESCRO committee a registry of hES cell lines in use and of investigators working in this field and descriptive information on the types of hES cell research in which they are engaged. The purposes of such a registry include facilitating distribution of educational information in light of evolving ethical, legal, or regulatory issues and enabling the institution to respond to public inquiry about the extent of its involvement in hES cell research.
ADDITIONAL RECOMMENDATIONS
The committee makes several additional recommendations pertaining to the need for IRB review of procurement procedures, the need for voluntary informed consent free of inducements, adherence to standards of clinical care, and compliance with all applicable federal regulations. Those recommendations are summarized here.
Review of the Procurement Process
Research involving hES cells will require access to human oocytes and embryos, necessitating some interaction between oocyte and blastocyst donors and people or institutions seeking to procure these materials for use in hES cell research. Individuals and couples who voluntarily and with full information donate somatic cells, gametes, or blastocysts for hES cell research should be assured that their donation is made for meritorious research and that all efforts will be made by those responsible for handling, storing, and using cell lines to protect donor confidentiality. IRB review of the procurement process, combined with a full informed consent process before donation, will facilitate the ethical conduct of this research.
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