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Embryonic stem cell research guidelines announced

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In a report released today through the National Academies, 10 scientists, including two from MIT, offer guidelines for research involving human embryonic stem cells, the cells taken from a five-day-old fertilized egg that may be tweaked to become any organ within the body.

The report comes at an opportune time for Massachusetts as House and Senate leaders come closer to passing a bill that will promote human embryonic stem cell research in this state.

Although compliance is voluntary, some institutions have already agreed to abide by the guidelines, according to Richard O. Hynes, co-chair of the committee. Hynes is the Daniel K Ludwig Professor of Cancer Research at MIT. The Academies are urging all institutions conducting human embryonic stem cell research to establish oversight committees to ensure that the new guidelines are followed.

"These guidelines are important because stem cell research is potentially a very valuable way of treating people for a variety of diseases, but the whole field of stem cell research is surrounded by disparate ethical viewpoints," said Hynes, who is also a Howard Hughes Medical Institute Investigator.

"The aim here is to try to get everybody on the same page to do things properly," he said. "For example, if stem cell research is to be allowed, then there has to be a very careful, informed consent process. 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."

Hynes' co-chair on the committee is Jonathan D. Moreno, a professor of biomedical ethics and director of the Center for Biomedical Ethics at the University of Virginia, Charlottesville. Nobel laureate Robert H. Horvitz, an MIT professor of biology, is also on the committee.

Guidelines from the report include:

  • Embryonic stem cell research oversight (ESCRO) committees should be established. These committees should include legal and ethical experts, as well as representatives of the public, and experts in biology and stem cell research.
  • 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.
  • Nuclear transfer must not be used for reproductive cloning.
  • 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 begin to form.
  • 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.
  • No payments should be made to donors.
  • The ESCRO committee should maintain a registry of stem cell lines that includes proof of informed consent and the medical history of donors.
  • Human embryonic stem cells should be introduced into nonhuman mammals only under circumstances where no other experiment can provide the information needed.

The 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. They 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. No human embryonic stem cells should be put into nonhuman primates.

The executive summary is available for downloading and the full report can be browsed at the National Academies Press web site ( Copies of the guidelines will be available for purchase later this spring from the press.

The National Academies consist of the National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine, and the National Research Council.

A version of this article appeared in MIT Tech Talk on April 27, 2005 (download PDF).

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