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Conclusions and recommendations The Committee's detailed conclusions and recommendations are as follows: stem cell research (i) Stem cells appear to have great therapeutic potential for the treatment of many disorders that are both common and serious and for the repair of damaged tissue. (ii) Until recently most research on stem cells has focussed on ES cells from animals and the derivation of ES cell lines from them; cell lines from human ES cells have the potential to provide a basis for a wide range of therapies. (iii) Recent research on adult stem cells, including stem cells from the placenta and umbilical cord, also holds promise of therapies; and research on them should be strongly encouraged by funding bodies and the Government. (iv) To ensure maximum medical benefit it is necessary to keep both routes to therapy open at present since neither alone is likely to meet all therapeutic needs. (v) For the full therapeutic potential of stem cells, both adult and ES, to be realised, fundamental research on ES cells is necessary, particularly to understand the processes of cell differentiation and dedifferentiation. (vi) Future developments might eventually make further research on ES cells unnecessary. This is unlikely in the foreseeable future; in the meantime there is a strong scientific and medical case for continued research on human ES cells. (i-vi paragraph 3.22) status of the early embryo (vii) Whilst respecting the deeply held views of those who regard any research involving the destruction of a human embryo as wrong and having weighed the ethical arguments carefully, the Committee is not persuaded, especially in the context of the current law and social attitudes, that all research on early human embryos should be prohibited (paragraph 4.21). (viii) Fourteen days should remain the limit for research on early embryos. (paragraph 4.22) (ix) Embryos should not be created specifically for research purposes unless there is a demonstrable and exceptional need which cannot be met by the use of surplus embryos. (paragraph 4.28) cell nuclear replacement and cloning (x) Basic research is a necessary step to developing treatments and facilitating the potential use of adult stem cells and should be permitted under the Regulations in the same way as more directly applied research to which it is designed to lead, provided that it is subject to strict regulation. (paragraph 5.4) (xi) Although there is a clear distinction between an IVF embryo and an embryo produced by CNR (or other methods) in their method of production, the Committee does not see any ethical difference in their use for research purposes up to the 14 days limit. (paragraph 5.13) (xii) Even if CNR is not itself used directly for many stem cell-based therapies, there is still a powerful case for its use, subject to strict regulation by the HFEA, as a research tool to enable other cell-based therapies to be developed. However, as with embryos created by IVF for research, CNR embryos should not be created for research purposes unless there is a demonstrable and exceptional need which cannot be met by the use of surplus embryos. (paragraph 5.14) (xiii) If CNR is permitted in certain limited circumstances, oocyte nucleus transfer should also be allowed for research purposes. (paragraph 5.20) (xiv) Given the high risk of abnormalities the scientific objections to human reproductive cloning are currently overwhelming. (paragraph 5.21) (xv) There are further strong ethical objections in addition to those based on the risk of abnormalities, although not all the arguments deployed against reproductive cloning are equally valid. The most powerful are the unacceptability of experimenting on a human being and the familial and child welfare considerations arising from the ambiguity of the cloned child's relationships. (paragraph 5.21) (xvi) The Committee unreservedly endorses the legislative prohibition on reproductive cloning now contained in the Human Reproductive Cloning Act 2001. (paragraph 5.21) (xvii) The HFEA has an excellent record in ensuring that IVF clinics comply with the law, and we are satisfied that its regulatory powers, now reinforced by a specific statutory prohibition, provide sufficient protection against the development of CNR leading to reproductive cloning in the United Kingdom. (paragraph 5.24) (xviii) The Government should take an active part in any move to negotiate an international ban on human reproductive cloning. (paragraph 7.22) legislation and regulation (xix) At an appropriate time, perhaps towards the end of the decade, the Government should undertake a further review of scientific developments, particularly of the progress of adult stem cell research and therapies, and of the development of stem cell banks, with a view to determining whether research on human embryos is still necessary. (paragraph 8.4) (xx) The Government should keep the funding of the HFEA under review and ensure that its resources are commensurate with its increased responsibilities. (paragraph 8.5) (xxi) The HFEA and the Department of Health should consider how a review of the outcomes of research licensed under the Act might be undertaken and updated on a regular basis (paragraph 8.6) (xxii) The Department of Health should examine with the HFEA the possibility of drawing up indicative guidance as to what constitutes serious disease (paragraph 8.9) (xxiii) When the Government bring forward legislation they should consider making express provision for such basic research as is necessary as a precursor for the development of cell-based therapies (paragraph 8.15) (xxiv) The separation of clinical and research roles should be standard practice for donation of eggs or embryos. The prohibition in the United Kingdom of payment to donors for gametes has been an important element in preventing undesirable commercialisation of this aspect of assisted reproduction and should be strictly maintained (paragraph 8.21) (xxv) The Department of Health should consider either establishing a body similar to the Gene Therapy Advisory Committee with oversight of clinical studies involving stem cells, or extending the membership and remit of GTAC to achieve the same ends. The Committee sees no other special need at present for additional regulation of the use of stem cells in the treatment of patients (paragraph 8.23) (xxvi) The Department of Health's proposals to establish a stem cell bank overseen by a steering committee, responsible for the custody of stem cell lines, ensuring their purity and provenance and monitoring their use, are endorsed. As a condition of granting a research licence, the HFEA should require that any ES cell line generated in the United Kingdom in the course of that research is deposited in the bank. Before granting any new licence to establish human ES cell lines, the HFEA should satisfy itself that there are no existing ES cell lines in the bank suitable for the proposed research. (paragraph 8.29) (xxvii) The HFEA should ensure that the implications arising from the "immortality" of stem cell lines are fully covered in obtaining informed consent from donors giving embryos for the potential establishment of ES cell lines for research. To prevent future restrictions in using ES cell lines (and therefore minimise the need to generate new ES cell lines) the HFEA should not permit ES cell lines be generated from donated embryos unless informed consent places no specific constraint on their future use. Where parents wish to restrict the type of research which can be undertaken, for example specifically for reproductive purposes, the embryos donated should be used for purposes other than the generation of ES cell lines. (paragraph 8.33) ------------------------------------------------------------ -------------------- Bob Martone [log in to unmask] http://www.samlink.com/~bmartone ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn