The National Academies today 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.
"Heightened oversight is essential to assure the public that stem cell research is being carried out in an ethical manner," said committee co-chair Jonathan D. Moreno, Emily Davie and Joseph S. Kornfeld Professor of Biomedical Ethics and director of the Center for Biomedical Ethics at the University of Virginia, Charlottesville. "The oversight we call for will in many instances set a higher standard than required by existing laws or regulations. And while we were hesitant to recommend another bureaucratic oversight entity, the burden in this case is justified, given the novel and controversial nature of embryonic stem cell research."
"A standard set of requirements for deriving, storing, distributing, and using embryonic stem cell lines -- one to which the entire U.S. scientific community adheres -- is the best way for this research to move forward," added committee co-chair Richard O. Hynes, Daniel K. Ludwig Professor of Cancer Research and a Howard Hughes Medical Institute investigator at the Massachusetts Institute of Technology, Cambridge.
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.
Although an ESCRO committee should approve new stem cell research, federal regulations already require institutional review boards (IRBs) to review the procurement of all eggs, sperm, or blastocysts to be used in generating new stem cell lines, and they should continue to do so, according to the new guidelines. An IRB also should review the donation of somatic cells to be used in creating a blastocyst via nuclear transfer.
Donor consent must be obtained before a blastocyst is used to generate stem cells, and donors should be informed that they have the right to withdraw their consent at any point before a stem cell line is derived, the guidelines say. Practices for obtaining consent should be scrutinized for potential conflict of interests; for example, researchers proposing to derive stem cells should not influence decisions about creating embryos for fertility treatment. The guidelines also emphasize that no payments should be made to donors. Blastocysts left over at IN VITRO fertilization clinics may not be donated for research without consent, and researchers should not ask fertility doctors to create more embryos than necessary for reproductive treatments.