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Summer 2005 Vol. 5 No. 2

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Colored scanning electron micrograph of human embryonic stem cells, ©Simon Fraser/University of Newcastle Upon Tyne/Science Photo Library Stem Cell Research

Report Offers Scientists Direction in Controversial Area

Stem cell research is an exciting new frontier in medical science. Under the right conditions, these all-purpose cells can be coaxed to develop into more specialized cells, which could be powerful tools for scientific inquiry and improved therapies for treating disease. But like any other frontier, this area of research has yet to be fully explored. And given its controversial nature, there should be clear boundaries for how it is carried out.

A new report from the National Academies provides guidelines for research involving human embryonic stem cells, and says that a standard set of requirements for obtaining, storing, distributing, and using embryonic stem cell lines -- one embraced by the entire U.S. scientific community -- is the most responsible means to achieve advances in this area.

In previous reports, the National Academies have recommended that both adult and embryonic stem cell research should go forward, including research using a lab technique called nuclear transfer to derive stem cells, but that human reproductive cloning should not be attempted. In view of current restrictions on federal involvement in human embryonic stem cell research, the scientific community needs guidelines to ensure that the work is conducted responsibly.

Human embryonic stem cells may be obtained from blastocysts -- three- to five-day-old embryos -- left over at fertility clinics; created specifically for research; or produced by nuclear transfer. The guidelines say that Embryonic Stem Cell Research Oversight, or ESCRO, committees should be set up to monitor scientific investigations involving these cells at all institutions conducting such work. But the oversight committees should not replace other research compliance bodies, such as institutional review boards.

ESCRO committees should review all research proposals that involve human embryonic stem cells. Any proposal to generate new stem cell lines using human embryos should also be vetted by ESCRO committees, the guidelines say.

Researcher examining stem cells, ©Sandy Huffaker/Getty Images Practices for obtaining donated eggs, sperm, or blastocysts should meet the highest ethical and scientific standards, the guidelines stress. Before conducting studies, researchers must obtain donors' consent to use their blastocysts to generate stem cells, and donors should not be paid. Donors also should be told that they have the right to withdraw their consent at any point before cell lines are derived, and whether information on personal identity would be encoded and their privacy protected. Furthermore, donors should be made aware that embryos would be destroyed in the process of generating stem cells, resulting cell lines could be kept for years, and that the cells might be genetically modified or transplanted into animals for further scientific investigation. Researchers should not ask fertility doctors to create more embryos than are needed for fertility treatment.

The guidelines recognize that scientists may need to combine human and animal cells for animal studies that would gauge whether human stem cells could treat people with various ailments. But animal embryonic stem cells should not be transplanted into human blastocysts. Also, human embryonic stem cells should not be placed in the blastocysts of nonhuman primates.

ESCRO committees must approve any placement of human embryonic stem cells into animals. Animals used in such experiments should not be allowed to produce offspring, however. And human embryonic stem cells should be introduced into nonhuman mammals only when no other experiment can provide the information needed.

The report also recommends the creation of an independent body to periodically review the guidelines, taking into account advances in stem cell science as well as evolving public attitudes. It is essential to assure the public that this research is being conducted ethically and responsibly.   -- Vanee Vines & Bill Kearney

Guidelines for Human Embryonic Stem Cell Research. Committee on Guidelines for Human Embryonic Stem Cell Research; Board on Life Sciences, Division on Earth and Life Studies, and Board on Health Sciences Policy, Institute of Medicine (2005, approx. 272 pp.; ISBN 0-309-09653-7; available from National Academies Press, tel. 1-800-624-6242; $44.95 plus $4.50 shipping for single copies).

The committee was co-chaired by Richard O. Hynes, Daniel K. Ludwig Professor of Cancer Research and a Howard Hughes Medical Institute investigator, Massachusetts Institute of Technology, Cambridge; and Jonathan D. Moreno, Emily Davie and Joseph S. Kornfeld Professor of Biomedical Ethics and director of the Center for Biomedical Ethics, University of Virginia, Charlottesville. The study was funded by the National Academies with additional support from the Ellison Medical Foundation and the Greenwall Foundation.

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Copyright 2005 by the National Academy of Sciences