Wednesday, August 13, 2008

Informed Consent Issues May Restrict Stem Cell Research

By Randy Hendrickson

According to a recent article in Nature, Stanford University has run into informed consent issues for their human embryonic stem cell lines, and these lines may be restricted for use in research because of ethical concerns. The women who donated the embryos for these stem cell lines did not give adequate informed consent for their use in research. Bioethicist Robert Streiffer, from the University of Wisconsin, obtained copies of the informed consent forms of the donors of the 21 lines that the NIH approved for federal research funding, and none of the forms met the guidelines that were set by an advisory committee of the US National Academy of Sciences (NAS) in 2005. These guidelines covered the types of experiments that could be conducted as well as the proper treatment of the donors of the gametes and embryos. Streiffer’s review of the consent forms found that there were wide variations and discrepancies in the forms that were used. In many cases, the donors were in no way sufficiently informed.

Now, these stem cell lines were obtained before August 2001, when President George Bush mandated that only stem cell lines already in existence would be eligible for federal support. Story Landis, head of the NIH’s Stem Cell Task Force, stated that the NIH will not be taking any stem cell lines off its registry because these guidelines only came into existence in 2005. Landis claims that Streiffer’s analysis “deals with application of 2008 standards to cell lines that were put on the registry in 2001,” and that the registry lines meet the 2001 standards.

As a result of this conflict, “ethics oversight committees across the United States are questioning which lines should be permissible for research—hoping that another agency, such as the NIH or a state government, will make the decision for them.” Frank Sharples, director of the NAS advisory committee, stated that “the NAS will revisit the issue of which lines are acceptable at a meeting later this year.”

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