Key stem cell guideline ignored in US

Michael Cook
22 Feb 2013
Reproduced with Permission

After President Obama reversed his predecessor's stand on embryo research in 2009 shortly after his inauguration, the battles seemed over. The main ethical consideration was ensuring that the donors of embryos and gametes gave their informed consent to research.

However, a review of human embryonic stem cell lines in the US has raised concerns about informed consent amongst gamete donors. Some of the stem cell lines, though approved by the National Institutes of Health, may have involved gametes from donors who had not consented. The review, conducted by academics from Rockfeller University and The Hastings Center, a bioethics think tank, identified 30 lines of approved stem cells with unknown provenance. These cells may very well have come from non-consenting gamete donors. In addition to this, the providers of 19 lines did not respond to requests for consent information.

The authors of the review criticised American IVF clinics, from which many of the embryos were sourced, for failing to obtain consent from gamete donors: "just 30% of oocyte donor consent forms in surveyed US IVF clinics mention the possibility that resultant embryos might be donated to research, and only 8% mention donation to hESC research specifically" the authors of the review stated in a letter to Cell Stem Cell.

They also stressed that "information about the provenance of the hESC lines should be public and readily available", particularly for the hESC research community. They conclude:

"With such rapid advances occurring in stem cell research, it is critical that consent forms for donation of gametes to IVF refer not just to the possibility of future research use, but also to derivation of hESCs specifically. Also, information about the provenance of the hESC lines should be public and readily available. The hESC research community will be best served if their essential research materials - gametes and embryos - are donated by individuals who knowingly and willingly agree to the use of those materials in hESC research."