Following its public consultation, the Human Fertilisation and Embryology Authority (HFEA) has announced its decision that there is 'no fundamental reason to prevent cytoplasmic hybrid research' and that 'individual research teams should be able to undertake research projects involving the creation of cytoplasmic hybrid - or 'cybrid' - embryos if they can demonstrate, to the satisfaction of an HFEA licence committee, that their planned research project is both necessary and desirable'. UK scientists want to use enucleated animal eggs - those from which the nucleus, containing the vast majority of an egg's genetic material, has been removed. Genetic material from human patients could then be added to these empty eggs, and the resulting cybrid embryos used to create embryonic stem cell that are virtually human.
This is good news. Although it will be some time before tangible benefits to patients emerge, the decision is endorsed and welcomed by the patients and families who make up the Genetic Interest Group (GIG) membership because of the potential such research holds for investigating the fundamental biology of many disabling conditions; conditions which can be serious, incurable or untreatable. Patients with these conditions depend on an ambitious and innovative biomedical research programme to deliver future treatments and/or cures. The HFEA decision will at last speed up progress in this area.
It has taken almost a year for the HFEA to be ready to assess the two specific applications for research using cytoplasmic hybrid embryos that were submitted to them (from Newcastle University and King's College London). The lack of progress in this area while the HFEA process has unfolded is regrettable as the uncertainty will have been a disincentive to researchers in the UK. It is to be hoped that the response to the consultation, with almost two thirds of respondents expressing support for cytoplasmic embryo research, will increase the HFEA's confidence in the powers given to them and in their decision-making process. Even when there is doubt that their stance is aligned with public opinion, they have a mandate in law to regulate without recourse to public consultation. Having said that, this latest consultation result should reassure the HFEA as it regulates in future, because it adds to the trend of public support for high quality, properly regulated research aimed at decreasing human suffering, even when that research presents moral challenges to some sections of society. Notable earlier examples include embryo research in general, PGD and saviour siblings.
A second benefit of the HFEA consultation process is that while responses to the consultation inevitably came thickest and fastest from religious and patient groups, the frequent press coverage created a valuable opportunity for increasing awareness among the general public of what the proposed research actually entails. The 'Franken-bunny' stories have just about disappeared and the more nuanced reporting now seen across the media is very welcome.
As legislation in the shape of the draft Human Tissue and Embryos Bill is scrutinised, it is to be hoped that the Government hears the message that the public and patients value medical research and have confidence in existing regulatory procedures. Any change in the regulatory process that makes it more difficult to perform medical research would be a retrograde step. GIG urges the Government to take this into account in its overhaul of the HFEA and the Human Tissue Authority (HTA), and to ensure that the proposed new authority (Regulatory Authority for Tissues and Embryos, RATE) is able to respond quickly and effectively to new regulatory challenges created by scientific progress. Progress that can and will throw up as yet unknowable prospects.
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