The scientific research community in the US has had much cause to celebrate this past year following President Obama taking office and swiftly implementing a decidedly more liberal policy towards human embryonic stem cell (ES cell) research than was hitherto in place. Earlier this month the National Institutes of Health (NIH) approved 13 new ES cell lines under the new ethical standards. However, the granting of federal funding for research projects on ES cell lines - a key policy change - has turned out to be more restrictive than previously anticipated. Funding will only be provided in strict accordance with the research purposes stated on the embryo (from which the stem cell line was derived) donor consent form.
Last week, on 14 December 2009, Dr Francis Collins, Director of the NIH, with the support of a unanimous advisory committee, limited federal funding for research on 27 cell lines to the exact purposes outlined in the relevant consent form. The consent forms signed by the donors stated that the cell lines derived from the embryos 'will be used to study the embryonic development of endoderm with a focus on pancreatic formation', with a view to developing diabetes treatment. As the cell lines in question were derived almost 10 years ago and were anonymised, it is impossible to trace the donors and take their consent to conduct other, unspecified research.
'This is going to be a recurring issue for the NIH', says Robert Streiffer, a bioethicist at the University of Wisconsin-Madison, 'it is going to look at consent forms that either include restrictive language, or failed to include enough information about the broad array of research possibilities... Either of those situations is a problem from the perspective of informed consent'.
Collins' decision to restrict federal funding to a literal interpretation of the stipulated research purposes is being regarded as indicative of future NIH funding policy. This will require much closer attention being paid to the language used in donor consent forms in order to ensure that the necessary and relevant scope of research will be eligible for federal funding. Professor George Daley, stem cell researcher and creator of several of the recently approved 'ethical' stem lines remains optimistic: 'Part of the advantage of having a policy that will have hundreds of new lines is that everybody should be able to find lines that are suitable for their own work', he said.
At present 80 cell lines are awaiting NIH approval - and the subsequent research funding - and scientists are preparing a further 242 cell lines to submit for approval.