Ethics committee urges caution on human stem cell research
In its much awaited opinion on 'ethical aspects of human stem cell research and use', the European Group on Ethics (EGE) recognises the interest of scientific research into human stem cells, but urges caution. In the opinion, the EGE examines the controversial issues of obtaining cells for research, the ethical acceptability of embryo research, the control of research activities, the creation of embryos for research purposes, embryonic research in the context of the European Commission's research programmes, anonymity, confidentiality, traceability and commercialisation. Stem research has attracted a great deal of interest from researchers who regard it as a source of essential knowledge on many human diseases and disorders. Culturing human stem cells could, for example, aid understanding of the reasons for birth defects, infertility and pregnancy loss. It could also provide valuable information on both normal and abnormal human development. Research also allows studies of human diseases on animal models, which can, for example, be used in order to address the causes of Alzheimer's disease. Stem cell research is not limited to understanding the causes of suffering, but extends to improving treatment. Culturing specific differentiated cell lines can be used for pharmacology studies and toxicology testing. Gene therapy is another prospect, offering possibilities such as the genetical modification of stem cells in order to make them resistant to HIV. Production of specific cell lines for therapeutic transplantation, if feasible, would be the most promising therapeutic application of embryonic stem (ES) cells. This could lead to attempts to produce cardiac muscle cells to alleviate heart disease, pancreatic cells to treat diabetes, liver cells for hepatitis and neural cells for degenerative brain diseases such as Parkinson's disease. Research in this area has produced promising results, but clinical application remains a challenge for the future. Despite the clear advantages to pressing forward with stem cell research, there are many ethical considerations, which should be taken into account. These are the focus of the EGE's report. The crux of the debate concerns the prospect of new therapies, which may, in the future, offer an alternative to organ and tissue donation on the one hand, and the question of ethics concerning the use of human embryos for scientific research on the other. More specifically, a wider scope of research is now being considered, marking the end of research limited to the areas of reproduction, contraception and congenital diseases. Whereas in the past embryos used for research were destroyed afterwards, researchers are also now looking at creating cell lines which can continue to be used, for therapeutic purposes. Perhaps the most sensitive issue is the creation of embryos for research purposes. The prospect of producing stem cells identical to a patient's cells, creating a form of personal cell bank, and thus avoiding possible problems of rejection in the future is now a possibility. Sensitivity is focused not only on the objectives of the stem cell research, but on the source of the stem cells used. Whether these cells are adult stem cells or taken from the umbilical cord after delivery, the EGE's opinion emphasises the necessity of obtaining the donor's free and informed consent. Where retrieval of foetal tissues is concerned, the EGE stresses that no abortion should be induced for the purpose of obtaining tissues, and the timing of a termination should in no way be influenced by plans for cell retrieval. Referring to the derivation of stem cells from embryonic blastocysts (a very early stage in the development of an embryo, before differentiation into tissues has begun), the opinion states: 'it is up to each Member State to forbid or authorise embryo research. In the latter case, respect for human dignity requires regulation of embryo research and the provision of guarantees against risks of arbitrary experimentation and instrumentalisation of human embryos.' The EGE supports further research with the aim of improving infertility treatment in countries where such research is not forbidden, stating: 'it is hard to see any specific argument which would prohibit extending the scope of such research in order to develop new treatments to cure severe diseases or injuries.' The Group notes that, as embryos which have been used for research are required to be destroyed, 'there is no argument for excluding funding of this kind of research from the Framework Programme of research of the European Union if it complies with ethical and legal requirements.' The EGE recommended however that ES cell research be placed under strict public control by a centralised authority. Particular concern was voiced by the EGE with regard to the creation of embryos for the sole purpose of research. The Group observed that this 'represents a further step in the instrumentalisation of human life.' The creation of embryos using sperm and ova donated for the purpose of stem cell procurement is 'ethically unacceptable' when 'spare' embryos are available. The Group noted the interest in performing somatic cell nuclear transfer (SCNT) as a means to investigate the 'reprogramming' of human cells, but found the risk of trivialising the use of embryos too great, asserting that 'it is not sufficient to consider the legitimacy of the pursued aim of alleviating human sufferings, it is also essential to consider the means employed. [...] [T]he creation of embryos by somatic cell nuclear transfer for research on stem cell therapy would be premature.' In view of the importance of stem cell research, the opinion advocates a specific Community research budget, which should in particular be directed at testing the validity of recent discoveries about the potential of differentiation of adult stem cells. The EGE charges the EU with the responsibility of providing funding for cell research, for monitoring its implementation and for ensuring results are published, and not hidden for reasons of commercial interest. The protection of individuals is a subject reiterated many times by the ethics committee. Women undergoing infertility treatment and those suffering from conditions such as Parkinson's disease, heart disease or diabetes should not be placed under any unnecessary strain. Those donating to research should have a thorough understanding of the possible uses of embryonic cells thus enabling free and informed consent. Full consent must also be given by recipients. Anonymity and confidentiality must be guaranteed with regard to both donors and recipients, this being assured by cell banks, which should, records the opinion, 'be regulated at European level in order to facilitate the implementation of a precautionary approach'. Whilst cell banks should ensure confidentiality, they must also guarantee traceability: 'If unsatisfactory side effects occur, it should be possible to trace donor and recipient and to reach their medical files. Traceability must be one of the conditions required for the authorisation of cell banks at national or European level.' Traceability is one of the ways in which the Group urges caution. In addition to this precondition for clinical trials, the opinion also asserts that 'the possibility that irreversible and potentially harmful changes are introduced in clinical applications of stem cell research should be minimised.' For this reason, researchers should use techniques which can be reversed if necessary. Summing up the Group's precautionary stance, the opinion states: 'It is important that the potential benefits for the patients should be taken into account but not exaggerated. The grounds of a precautionary approach need to be taken into account.' Finally the opinion underlines that acquiring embryos for research must never become a commercial activity, and that 'measures should be taken to prevent such commercialisation.' One such method should be licensing of stem cell imports and exports by public authorities at either national or European level. The European Group on Ethics in Science and New Technologies is a multidisciplinary body answering directly to the president of the European Commission. Its role is to advise the Commission as well as the European Parliament and the Council of Ministers, all of which are able to refer questions to the Group on how the ethical values of European society can be taken into consideration in the scientific and technological development promoted by Community policies. The Group on Ethics has been asked by Romano Prodi, president of the European Commission to prepare a further opinion on 18 October 2000. This separate opinion will address questions relating to patenting of inventions involving human stem cells, and will be made public in Brussels at a later date.