A review of embryonic stem cell (hESC) lines 0 or more human endorsed by the National Institutes of Health (NIH) for federal funding has found a potential ethical problem: Some of cell lines may have sperm or egg involved who has not consented to their material used in the research. University of monitoring committees should be aware that these cell lines can not meet widely accepted standards, say the authors.
In July 09, following an order from President Barack Obama, the NIH issued guidelines setting the ethical standards that all hESC lines studied with funding from the NIH must address. Cell lines must have been derived from surplus embryos donated by couples who receive fertility treatments, for example. But the guidelines do not discuss the possibility that certain facts embryos were created using eggs or sperm, although 05 National Academy of Sciences (NAS) guidelines require the consent of gamete donors. research administrators at Rockefeller University in New York expressed concern about the gap last year after an investigation suggested that the United States in vitro fertilization (IVF) clinics usually egg donors say their eggs could be used in research.
So Amy Wilkerson Rockefeller and Kathaliya Wongsatittham bioethicist and Josephine Johnston of the Hastings Center in Garrison, New York, looked into the origins of the NIH-approved hESC lines. They tracked down (from websites or direct requests) information on the sources of gametes. For about half of the lines (104 to 198), the embryo donors provided the egg and sperm, so there was no problem. In some cases, the gamete donors have given their consent for research. For many other lines, the supplier said if gamete donors were involved, donors have agreed to study hESC or research in general.
For 30 lines, however, cell line providers did not know if donor sperm or eggs had been involved in the creation of the embryo, or had they been, if donors have given their consent. In addition, suppliers of 19 lines has not responded to the request for consent information, Wilkerson and his co-authors report in a letter today Cell Stem Cell .
This lack of information on a total of approximately 50 cell lines in the NIH registry is a problem, said Wilkerson. The ethics committee that oversees research on ES cells Rockefeller and two partner institutions has since decided that it can not approve requests of their researchers to use these lines. (Fortunately, she said, this list does not include popular lines such as H1 and H9.)
Wilkerson said the point is not that the NIH should remove the registry lines or revise its guidelines. In contrast, other ethics committees research university hESC review should be aware that some lines on the NIH list do not meet the standards NAS and decide accordingly. In addition, IVF clinics must obtain the consent of gamete donors for hESC research and researchers who develop new hESC lines should make information about gamete donors readily available. "It should not be as difficult to obtain as it is," said Wilkerson.
In an e-mail to Science Insider, NIH noted that the Agency has discussed the gamete in a preamble to the 09 guidelines The agency wrote that "the risks associated with privacy" and would be covered by the existing rules of protection of human subjects in research. But Johnston argues that the ethical questions go beyond privacy with the need to inform people that their sperm or egg donation could be used in hESC research: "People have to know what interest will happen to the biological materials they give, "Johnston said.
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