The US National Institutes of Health (NIH) has published new rules that will govern state funded embryonic stem cell (ES cell) research now that the seven years of restriction under the Bush administration have come to an end. The new rules restrict research to stem cells sourced from surplus embryos donated by IVF patients and, consequently, forbid research on any embryo that was created specifically for the purposes of research (either through voluntary donation of human eggs or by employing animal eggs, as legalised in the UK under the Human Fertilisation and Embryology Act last year). Additionally it is required that documentation showing full and informed consent of the donor be provided in order for an embryo to be used.
The principle concern of US researchers has been that the rules would prevent access to many of the 700-plus privately funded ES cell lines created during the years of the Bush administration. It was thought that it might even exclude access to those 21 lines that were accessible under President Bush's rules (these having been in existence prior to August 2001). The new rules, however, make allowances for many of these earlier lines, permitting their use so long as they were created in line with the spirit of the new requirements.
Though President Obama lifted Bush's restriction in January, he left the formulation of the new rules on what research was ethical to the NIH. To further simplify the process of determining which lines do and do not meet the standard, the NIH will create a registry listing which lines do fall within the rules. While it is yet to be determined which of the old lines will qualify, acting director of the NIH, Richard Kingston, told the Associated Press that 'judgement is necessary' and that 'this is a reasonable compromise to achieve the president's goal of both advancing science while maintaining rigorous ethical standards'.
US federal law still forbids the use of public funds to create or destroy embryos for research purposes and the new rules serve to clarify that only embryos created for reproduction and which meet strict informed consent requirements will be eligible for access to state funding. That the rules do not go further in liberalising the creation of specific embryos means that techniques employed in the UK, such as the creation of embryos using SCNT, somatic cell nuclear transfer (the cloning technique used to create Dolly the Sheep) to include specific genetically linked conditions, will still not receive state funding in the US.