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Project Description Project Description Xenotransplantation (in the following XTP), or animal-to-human transplantation involves the transplantation of animal organs, tissues or cells into humans. XTP is based on several medical and scientific developments, in particular: (a) progress in transgenics and immunology, which have made possible the production of genetically modified animal organs which are more compatible with the human immune system, and (b) improvements in regulating the human immune response. XTP raises important ethical problems XTP, like many developments in modern science and technology, is associated with new risks (Bonß 1995) and raises a number of major ethical problems. Whilst XTP could help solve the shortage of organs from human donors and save the lives of many patients waiting for transplantation1, there is a serious risk that viruses which cause animal diseases might cross the species barrier and spread through human populations (Guenzburg/ Salmons 2000). Ethical questions of XTP still to be resolved include: 1. Is it in principle acceptable for reasons of religious believe, cultural values and animal welfare to use animals to provide organs and tissues for transplantation into human beings? 2. Which animals could be used (primates or non-primates)? 3. Is it acceptable to save the life of an individual whilst putting at risk health care professionals, relatives and the general population? 4. Is it acceptable to restrict the individual freedom2 of xenograft recipients to protect public health? 5. Is it acceptable to neglect alternative approaches to solving the donor organ shortage3 and to invest limited research resources into a technology, the success of which is highly insecure? Limited public awareness and debate on XTP in many European countries EU Member States vary considerably in the public awareness and discussion of XTP (Council of Europe 2000). While some countries have already set up expert commissions to investigate the problems of XTP and have started to issue related guidelines - e.g. for the UK (Advisory Group 1996), for the Netherlands (Gezondheidsraad 1998) and for Germany (Petermann/ Sauter 1999) - many other countries have yet to address XTP (Council of Europe 2000). How can modern societies debate ethical problems of XTP? Apart from the lack of a well developed public debate on the ethical issues raised by XTP, a basic and still unresolved problem in many modern societies is: who can legitimately discuss 1 By the end of 1997 the waiting lists for transplantation in selected European countries totaled to: kidneys 30.392, heart 1.853, liver 1.755, lung 705, heart-lung 319, kidney and pancreas 267, pancreas 197. Numbers include: Austria, Belgium, France, Germany, Greece, Luxembourg, Ireland, North-Italy, Portugal, Slovenia, Spain and UK (ETCO: 2000) 2 Proposed measures include e.g. long term or even lifelong monitoring and quarantine which might not only affect the patients but also their relatives and close contacts (Petermann/ Sauter 1999). 3 Alternatives involve measures to increase the numbers of human donors, prevention and improved therapy of diseases leading to organ failure, the development of artificial and bio-artificial organs and therapeutic cloning (Petermann/ Sauter 1999). and resolve ethical problems of science and technology? Is it sufficient to only include professional bio-ethicists or do we need a broader ethical debate, which also involves other actors in the field including the concerned public (c.f. e.g. Chadwick 1999). Furthermore, if a broad public discourse on the ethical problems of modern science and technology is both necessary and desirable, how can these questions be debated and resolved, and what decision- making procedures can legitimately be used to resolve ethical questions? So far a number of approaches of Participatory Technology Assessment (PTA) (Hennen 1999, Joss 1999) such as citizen’s juries (Stewart et al. 1994) focus groups (Hörning 1999) and consensus conferences (Joss/ Durant 1995) have been applied to foster public discussion of emerging technologies. It is the aim of this project to introduce and evaluate a well-established method for resolving ethical issues - the Neo Socratic Dialogue– into debates on technological risks in modern societies. The Neo Socratic Dialogue traces back to the Socratic Dialogue, which has been developed by Leonard Nelson in the 1920s (Nelson 1922, 1965).4 The problem of effective and legitimate resolution of the ethical problems raised by XTP is aggravated by the fact that the development of the technology is international in scope and likely to have a global impact. As a consequence, there is a strong case for common international standards and the harmonisation of European legislation and guidelines regulating the development of XTP. Examining the barriers to developing a common European approach to XTP However, the harmonisation of ethical standards across Europe is impeded by national differences in the perception of the ethical foundations and implications of XTP. Survey data shows that citizens in different European countries vary considerably in their attitude towards XTP and the issues it raises (Ward 1997, Durant et al. 1998, Sanner 1998, Schlitt et al. 1999, Julvez et al. 1999). Furthermore, these surveys only describe differences and do not explain why these variations exist and how they are embedded in and framed by different cultures/discourses, regulatory regimes and socio-economic contexts. An understanding of these factors is therefore central to both the task of developing a common European policy on XTP, as well as defining the limits of any moves towards international harmonisation. It is another aim of this project is to explore these limits and examine how a common European position might be developed. Objectives The proposed interdisciplinary project has the following interrelated objectives: 1. To raise public awareness of and to involve the public in selected EU-Member Countries into the debate of ethical questions of XTP. 2. To develop and evaluate by cross-country comparison a new mechanism of public debate to reflect the ethical foundations and consequences of XTP in three EU Member States. 3. The Neo Socratic Dialogue on XTP has the following goals: a. to raise awareness and sensitivity of actors in the field and the interested/concerned public for ethical problems of XTP b. to reflect the ethical basis and consequences of XTP (“ethical impact assessment”), c. to clarify responsibilities of researchers, policy makers, economic actors and citizens concerning ethical questions of XTP, d. to provide information for decision makers about the ethical basis and 4 For detailed description of the Neo Socratic Dialogue c.f. p. 15 and 12. consequences of XTP, e. to improve communicative patterns and capabilities of actors in the field to cope with ethical questions arising from modern science and technology, f. to create material for qualitative analysis of different cultural, regulative and socio- economic and contexts which affect attitudes towards XTP. XENO will use a broad spectrum of methods to evaluate whether the Neo Socratic Dialogue on XTP reached these goals. State of the art and innovative aspects Although state of the art and innovative aspects of the project are not explicitly mentioned in the Guide for Proposers they are nevertheless explicit evaluation criteria mentioned in the “eligibility and evaluation criteria”. Therefore the following section will describe the innovative aspects of XENO. XENO is innovative in two aspects: 1. XENO will increase public debate on XTP and complement existing studies on XTP by focussing on the ethical aspects of XTP. Moreover, it will contribute to a timely debate on ethical issues of XTP and will broaden the debate to experts/stakeholders and laypersons. 2. XENO will contribute to the development of mechanisms of Participative Technology Assessment (PTA) by introducing a communication technique of social learning (Neo Socratic Dialogue), which is well tested in primary education, higher education, professional ethics and business consultancy. Furthermore XENO will contribute to fulfilling the present need research for comparative evaluation research in the area of PTA (in particular impact evaluation). The experiences gained in XENO can be transferred to public debate in other controversial technologies. The following section will describe the innovative aspects of XENO in more detail: Ad 1. Increasing and broadening public debate on ethical aspects of XTP So far a number of international organisations (Council of Europe 1997 and 2000, OECD 1997, WHO 1998) and national bodies (Advisory Group 1996, Nuffield Council of Bioethics 1996, Gezondheidsraad 1998, Hüsing et al. 1998, Petermann/ Sauter 1999, Swedish Committee on Xenotransplantation 1999) have carried out Technology Assessment (TA) on XTP. In comparison to these research efforts XENO is innovative in the following respect: Increasing public debate on XTP In countries, which carried out TA on XTP, debate is often restricted to experts. Furthermore, many countries lack public awareness and debate on XTP (Council or Europe). XENO will help to increase public discussion of this important issue. Focussing on ethical questions of XTP Existing national and international TA studies on XTP focussed primarily on technical questions (e.g. safety) of XTP and vary regarding the weight they gave to ethical questions. Some reports raised hardly any ethical questions and others treated them rather briefly. XENO will
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