By LEE BOWMAN
Scripps Howard News Service
April 26, 2005
Because rules set up by the Bush administration in 2001 restrict federal support to studies of only a handful of stem-cell lines, many researchers have turned to private donors or state-sponsored foundations to back their work.
The panel, set up by the Institute of Medicine at the National Academies of Science, noted that because of the limited federal role, "there is a patchwork of existing regulations that are applicable to human embryonic stem cell research, many of which were not designed with this research specifically in mind."
The academies are an independent institution chartered by Congress to advise the government on scientific matters, but took on development of these guidelines without government involvement at the request of the scientific community.
These stem cells form in the first few days of a developing embryo and are thought to be capable of becoming any type of cell in the body. Researchers hope the cells can one day be used to regenerate large quantities of cells, tissues and even entire organs damaged by disease and injury.
Such research is controversial because stem cells have been obtained from fertilized eggs donated by couples who no longer need them. The embryos are destroyed about three to five days after fertilization, but before the stage of implantation in the uterus. The stem cells are then cultured in labs to be used in research.
President Bush banned federal backing of any studies that use stem-cell lines created after Aug. 9, 2001. Scientists say they need to be able to generate new lines, including cells specifically cloned to carry certain genetic traits that may not be available from donated eggs, to adequately study human disease and possible cures.
"A standard set of requirements for deriving, storing 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," said Richard Hynes, a professor of cancer research at the Massachusetts Institute of Technology and co-chair of the committee.
Hynes noted that there are "public concerns that this research may be done unethically, but there are also public concerns that not enough research is being done in this field, and we wanted to try and address all of this."
Central to the plan would be a local committee at each research facility that would review all proposals for creation of new embryonic stem-cell lines. The panel also suggested that an independent national scientific and ethics board be established to follow advances in this technology and address any new issues they might raise.
Among the panel's recommendations:
- All donors of material - eggs, sperm or cells from which genetic material is transferred _ must give consent before stem cells could be cultured or used in research, which means that no eggs fertilized from anonymous sperm donors would be used.
- Donors are not to be paid, and researchers who would use a new stem-cell line should not deal directly with potential donors at fertility clinics or other facilities.
- All institutions should maintain registries, including donor details and characterization of genetic traits, that are coded to protect privacy.
- No animal embryonic stem cells should be transplanted into a human embryo, and a special review should be done before human embryonic cells are implanted in an animal. Due to concerns about the possibility of exchanging genetic material between humans and non-human primates, the committee recommends that no such transfers be done. Similarly, implants of human stem cells into any other mammal should be viewed cautiously.
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