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Report: Stem Cell Research Needs Ethics Guidelines

A government advisory group proposed national ethical guidelines for human embryonic stem cell research (search) Tuesday and recommended research institutions establish oversight committees to enforce them.

"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," said Richard O. Hynes, professor of cancer research at Massachusetts Institute of Technology.

Hynes is co-chair of the committee that prepared the report for the National Academies, an independent organization chartered by Congress to advise the government on scientific matters.

Embryonic stem cells form in the first few days of a developing embryo and are capable of becoming any type of cell in the body. Researchers hope that they can find ways to use these cells to cure a variety of illnesses, but the research has been controversial because the embryo is destroyed in collecting the cells.

President Bush banned federal funding for stem cell research (search) except for already existing cell lines (search), but private funding is continuing some new research.

The new report urged that new stem cell oversight committees be established in addition to other institutional review boards, which also review stem cell research.

In addition to experts in biology and stem cell research, the committees should include legal and ethical experts as well as representatives of the public, the report said.

Among the recommended guidelines:

— Donors must give their consent before their embryo could be used to produce stem cells and they should be informed that they have the right to withdraw their consent at any point before a stem cell line is derived. In addition, donors should not be paid.

— Consent forms should inform the donor that embryos will be destroyed in the process of deriving stem cells and that the resulting cell lines may be kept for many years.

— Donors should be informed that research involving their stem cells may have commercial potential, but they will not share in any financial benefit.

— An oversight committee should keep a registry of stem cell lines banked at an institution, which 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 need a secure coding system to protect the identity of donors.

— No animal embryonic stem cells should be transplanted into a human embryo and approval by a review committee should be secured before any human embryonic stem cells are put into an animal. No human embryonic stem cells should be put into nonhuman primates.

The report also called for a national independent organization to periodically review stem cell research and determine whether guidelines need to be updated.

The report was funded by the National Academies with additional support from the Ellison Medical Foundation and the Greenwall Foundation.