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Published online 28 July 2008 | Nature | doi:10.1038/454556a
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Consent issues restrict stem-cell use
Some human embryonic cell lines may not be eligible for research.
Stanford University is to tell its researchers that around one-quarter of the human embryonic stem-cell lines eligible for US government funding are now off-limits because of ethics concerns.
The institute, in Palo Alto, California, is concerned that some of the women who donated the embryos for these stem-cell lines did not give informed consent for the lines to be used in research.
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Story Landis is mistaken in asserting that the analysis in "Informed Consent and Federal Funding for Stem Cell Research" applies 2008 standards to lines that were established in 2001. As the article explicitly notes, the standards for informed consent in the context of embryo donation had been discussed by the Human Embryo Research Panel in 1994, the American Society for Reproductive Medicine in 1997, and the National Bioethics Advisory Commission in 1999, among other places. Moreover, these standards themselves derive from principles about informed consent that, as the article points out, "have been internationally recognized in both ethical discussions and legal regulations for decades." Dr. Landis also says that the NIH registry lines met the criteria put forth by President Bush. But one of those criteria was that the embryos had to have been donated with informed consent, and the analysis goes into some detail as to the ways in which that criterion was not met. Here are two examples. First, the BresaGen consent form provided by the NIH to me does not provide any information to the donors about the research except the information that their surplus embryos may be used for research. On no plausible account of informed consent does that count as sufficiently informed. Second, the Cellartis form provided by the NIH to me states that all cells used in the study will be destroyed after the study is completed. Thus, researchers do not have informed consent to use those cells in subsequent studies. Please see the article itself for more substantiating details. Sincerely, Robert Streiffer