Human embryonic stem cell (hESC) lines approved for federal funding in the USA, may have been derived using sperm or eggs of unconsenting donors. A report published in the journal Cell Stem Cell found that for 61 of the 198 hESC lines listed in the National Institutes of Health (NIH) Registry it is not known whether specific consent for hESC research was given.
The consent of donors is important not only for reasons of privacy, but because 'people have an interest in knowing what's going to happen to the biological materials that they donate', co-author Josephine Johnston, of the bioethics research institute The Hastings Centre, told ScienceInsider.
The NIH guidelines for federal funding, issued in 2009, require that cell lines be derived from 'spare' embryos created in IVF for reproductive purposes. They further stipulate that the embryo donors must have given written consent for the embryos to be used specifically for hESC research. The NIH guidelines make no reference to embryos created from the gametes of third party donors not seeking reproductive treatment.
Investigating the origins of the hESC lines, the researchers found that 104 lines had been created from embryos from IVF with the consent of donors. In a few additional cases gamete donors gave consent for hESC research. But in 67 cases it was unknown whether third party gamete donors had been involved.
However, in 37 cases the providers said that either generic consent to research or consent to hESC work specifically would have been given. This left, the paper concludes, '30 lines for which the providers say they do not know whether gamete donors were involved and whether they provided consent for research (generic or specific to hESC research)'.
National and international guidelines require the consent of all egg and sperm donors before any embryos can be used in hESC research. The 2010 guidelines of the National Academy of Science (NAS) require the written consent of the gamete donors to the generation of hESC lines or, where gametes were donated for reproductive purposes, written consent for subsequent embryo research.
Accordingly, ScienceInsider reports, the ethics committee at Rockefeller University in New York, where two of the authors work, has said it cannot approve requests from researchers to use the lines.
But, the article continues, lead author Amy Wilkerson from Rockefeller University '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'.