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Did Sperm and Egg Donors Unwittingly Contribute to NIH-Approved Stem Cells?
7 February 2013 12:15 pm
A review of the 200 or so human embryonic stem cell (hESC) lines approved by the National Institutes of Health (NIH) for federal funding has found a possible ethical problem: Some of the cell lines may have involved sperm or egg donors who didn't consent to having their material used in research. University oversight committees should be aware that these cell lines may not meet widely accepted standards, the authors say.
In July 2009, following an order from President Barack Obama, NIH issued guidelines laying out ethical standards that all hESC lines studied with NIH funding must meet. The cell lines must have been derived from surplus embryos donated by couples receiving fertility treatments, for example. But the guidelines don't discuss the possibility that some embryos made have been created using donor eggs or sperm, even though 2005 National Academy of Sciences (NAS) guidelines call for consent from gamete donors. Research administrators at the Rockefeller University in New York City became concerned about this gap last year after a survey suggested that U.S. in vitro fertilization (IVF) clinics usually don't tell egg donors that their eggs could be used in research.
So Rockefeller's Amy Wilkerson and Kathaliya Wongsatittham and bioethicist Josephine Johnston of The Hastings Center in Garrison, New York, looked into the origins of the approved NIH hESC lines. They tracked down (from Web sites or direct requests) information on the sources of the gametes. For about half the lines (104 of 198), the embryo donors provided the egg and sperm, so there was no problem. In a few cases, gamete donors gave consent for research. For many other lines, the provider said that if donor gametes were involved, the donors would have consented to hESC studies or research in general.
For 30 of the lines, however, the cell line providers didn't know if donor sperm or eggs had been involved in the creation of the embryo, or if they had been, whether the donors gave consent. In addition, the providers of 19 lines did not respond to the request for consent information, Wilkerson and her co-authors report in a letter today in Cell Stem Cell.
That lack of information on a total of about 50 cell lines in the NIH registry is a problem, Wilkerson says. The ethics committee that oversees ES cell research at Rockefeller and two partner institutions has since decided it cannot approve requests from their researchers to use these lines. (Fortunately, she says, this list doesn't include such popular lines as H1 and H9.)
Wilkerson says the point isn't that NIH needs to remove the lines from the registry or revise its guidelines. Rather, other university ethics committees reviewing hESC research should be aware that some lines on NIH's list don't meet the NAS standards and decide accordingly. In addition, IVF clinics should obtain consent from gamete donors for hESC research, and researchers who develop new hESC lines should make information about any gamete donors readily available. "It shouldn't be as hard to get as it is," Wilkerson says.
In an e-mail to ScienceInsider, NIH pointed out that the agency did discuss gamete donors in a preamble to the 2009 guidelines. The agency wrote that "the risks are associated with privacy" and would be covered by existing rules protecting human subjects in research. But Johnston argues that the ethics issues go beyond privacy to the need to inform people that their sperm or egg donation could be used in hESC research: "People have an interest in knowing what's going to happen to the biological materials that they donate," Johnston says.