Guidelines Released for Embryonic Stem Cell Research

The National Academies announced recommended guidelines for research involving human embryonic stem cells, “and urged all institutions conducting such research to establish oversight committees to ensure that the new guidelines will be followed. The guidelines are intended to enhance the integrity of privately funded human embryonic stem cell research by encouraging responsible practices, said the committee that wrote the report, a joint project between the National Academies' National Research Council and Institute of Medicine…

Embryonic Stem Cell Research Oversight, or ESCRO, committees should be established, but not as replacements for other research compliance bodies such as institutional review boards, the guidelines say. In addition to experts in biology and stem cell research, ESCRO committees should include legal and ethical experts as well as representatives of the public.

Stem cells usually are harvested after three to five days from a blastocyst -- an early stage of development before implantation in the uterus. The ESCRO committees should review proposals for research that takes stem cells from excess blastocysts at in vitro fertilization clinics or from blastocysts created expressly for stem cell research. They also should review any proposed use of blastocysts created by nuclear transfer, often referred to as therapeutic cloning. Nuclear transfer must not be used for reproductive cloning, the guidelines committee said, reiterating a recommendation from a previous National Academies report.

Proposals to generate additional human embryonic stem cell lines by any means should be reviewed and approved by an ESCRO committee, the guidelines say. They add that human embryos used for research should not be grown in culture for longer than 14 days, or until the point when the body axis and central nervous system -- called the primitive streak -- begin to form…

The ESCRO committee should maintain a registry of stem cell lines banked at an institution, the guidelines add. The registry should include a proof of informed consent, a medical history of the donors, and a characterization of any genetic markers on the cell lines. Repositories of stem cell lines also need a secure coding system to protect the identity of donors.

The Academies' guidelines also address how far scientists should go in mixing human and animal cells to create so-called chimeras, which researchers may need to do in order to test the therapeutic potential of human stem cells in animal models. The guidelines say no animal embryonic stem cells should be transplanted into a human blastocyst, and approval by an ESCRO committee should be secured before any human embryonic stem cells are put into an animal. Also, no animal into which human embryonic stem cells have been introduced should be allowed to breed. In addition, no human embryonic stem cells should be put into nonhuman primate blastocysts.

Human embryonic stem cells should be introduced into nonhuman mammals only under circumstances where no other experiment can provide the information needed, the guidelines say. Experiments in which there is a possibility that human cells could contribute in a "major organized way" to the brain of an animal require strong scientific justification, the committee added.

The committee urged the formation of a national independent body to periodically review whether the guidelines need to be updated in light of unforeseen advances in stem cell science and evolving public attitudes.

The National Academies developed the guidelines on behalf of the scientific community and without government involvement. Although compliance is voluntary, the committee called on private funders, professional societies, journals, research institutions, and others involved in embryonic stem cell studies, to require adherence to the guidelines."

From this press release.