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 concentrate on ethical questions of XTP and in this way complement existing TA on XTP. Contributing to a timely debate on XTP In the past the ethical and legal problems raised by scientific and technical progress have often been addressed with considerable delay. Consequently, issues of social conflicts surrounding, for example, brain death (e.g. Hoff/ in der Schmitten 1995), prenatal diagnostics (e.g. Chadwick/ Levitt 1996) and reproductive medicine (e.g. Harris/ Holms 1998) have been left undecided for years. In contrast, the debate on XTP offers a realistic chance that different interest groups might discuss the possible consequences and risks of this technology at the same time as the technology’s medical and scientific development. A broad debate about the risks of XTP will create transparency and might help to prevent unfounded negative attitudes towards its application. Without open public debate, XTP as well as allo-transplantation might face serious problems created by a lack of public confidence. XENO will therefore support attempts to increase public awareness and involve the public in the XTP debate.

Broadening debate on XTP Most national and international TA studies on XTP focussed so far on classical TA, which strived for the improvement of decision-making by the production and provision of knowledge (Nuffield Council on Bioethics 1996, Council of Europe 1997 and 2000, OECD 1997, Gezondheidsraad 1998, WHO 1998, Petermann/ Sauter 1999, Swedish Committee on Xenotransplantation 1999). TA research in the last 15 years criticized this TA-approach as ineffective (e.g. Albaek 1995, Klüver et al. 2000), because it would simplify policy-making processes and overvalue the potential impact of TA on these processes. Policy-making does not follow rational choice but is a chaotic process (Cohen et al. 1972, March/ Olsen 1989) in which scientific knowledge is only one resource among others. As a consequence PTA advocates for broadening TA and to include the perspectives of experts/stakeholders as well as laypersons (Klüver 2000). This would improve the TA process on a cognitive5, normative6 and pragmatic level7.

In contrast to that, very few existing national and international TA studies on XTP have involved the public in any significant way. Some studies have attempted to involve public actors and Non Governmental Organisations (NGOs) (Nuffield Council on Bioethics 1996, Hüsing et al.: 1998), whilst others have involved members of Parliament or public committees (Swedish Committee on Xenotransplantation 1999, Advisory Group 1996). In summary, however, most studies rely completely on experts from science, medicine and government or are compiled by just one author (Council of Europe 1997, OECD 1997). In contrast, XENO, which can be regarded as a PTA project with focus on ethical questions will increase public involvement and broaden public XTP-debate by actively involving experts/stakeholders and laypersons in a series of dialogues.

Involving ethical actors into the debate on XTP Ethical questions relating to modern science and technology are not only within the competence and responsibilities of (bioethics) experts, but are the responsibility of people directly involved in relevant practical fields. We will call these groups “ethical actors”, i.e. professionals from research, medicine, nursing, social work, public administration, insurance companies and interest groups (including environmental as well as animal welfare groups), as well as patients and their relatives, who each will have to deal with the ethical questions raised by XTP in their everyday life (Chadwick 1999). XENO will broaden the debate on

5 PTA strives for completeness and balance in analysis by including the knowledge from those affected. 6 PTA strives for democratisation by involvement of those previously excluded from decision making. 7 PTA creates space for social learning. ethical questions of XTP by actively involving these ethical actors from the following groups: research8, industry, professional groups (e.g. surgeons, nurses), ministries, governmental bodies, NGOs (patient organizations, self help groups, religious groups, animal welfare and environmental groups), statutory health insurance and private insurance companies, media. Thus, unlike other forms of PTA the Neo Socratic Dialogue will not involve randomly selected laypersons. Instead, deliberately selected key (ethical) actors will be chosen to participate and will be encouraged to reflect on the ethical implications of XTP for their everyday life and work.

Ad 2. Developing a methodology for Participatory Technology Assessment of ethical questions raised by modern technologies

In the last 30 years a number of approaches of Participative Technology Assessment, (PTA) have been explored, such as citizens’ jury processes (Crosby 1996), citizens’ juries (Stewart et al. 1994), citizen panels (Hörning 1999) and consensus conferences (Joss/ Durant 1995). In comparison with these broadly similar approaches and the existing TA studies on XTP, XENO is innovative in the following respect:

Contributing to comparative evaluation of PTA PTA needs some kind of tested procedure to discuss ethical implications of XTP. Although a wealth of PTA have been carried out so far on various technologies in the USA and Europe9, at present comparative evaluation of PTA does hardly exist. A recent TSER-Project funded by the EU compared 16 PTA-projects in EU-Member-States (Klüver et al. 2000). However, these case studies used different PTA-methods at different points in time, in different institutional settings, on different technologies. XENO will contribute to the development of PTA methods because it will evaluate and compare the application of one and the same methodology (Neo Socratic Dialogue), at one and the same time, in different European countries, on one technology (XTP). At present there is a lack of evaluation data on the impact of PTA (Klüver et al. 2000). XENO will create such data, in particular by systematically interviewing participants before and after the NSD about their expectation and experiences. Furthermore XENO will document and analyse the “resonance” (c.f. p. 14) of the NSD in the public debate. Thus, comparative evaluation will assess the value of the Neo Socratic Dialogue for PTA in international perspective and its possible use in the debates surrounding other fields of technology.

8 e.g. researchers active in the development of XTP, virologists, immunologists, epidemiologists, economists, psychologists, sociologists 9 Including the scenario workshop approach used by European Commission, c.f. www.cordis.lu/easw.hoke.html Introducing a well tested communication technique into PTA Existing PTA often define the role and qualifications of the facilitator as well as the methodology of discussion between experts/stakeholders and laypersons only vaguely (Klüver et al. 2000). XENO introduces a communication methodology (Neo Socratic Dialogue) into PTA, which is well established and tested in primary education (Murris 2000, Krohn et al. 2000), higher education (Gronke/ Stary 1998), medicine (Birnbacher 1999), as well as business consultancy (Kessels 1996 and 1997, Gronke 2000). Furthermore, the formalized training and certification of facilitators of the Neo Socratic Dialogue assures that they have the necessary qualifications to moderate such a process (c.f. p. 14). XENO will investigate the possibilities of this method to discuss ethical questions of modern technology to underpin policy making. Emphasizing social learning Ethical questions of new technologies challenge our existing decision making mechanism. The questions in this context are not only: Who is going to decide? And: On which basis are we going to decide? But also: In which way can we debate these complex issues? Recent comparative research on PTA (Klüver et al. 2000) stressed the significance and potential of social learning processes of PTA. XENO stands in line with these efforts. The Neo Socratic Dialogue is a communicative method, which fosters social learning. XENO will create a discursive space where experts/stakeholders and laypersons will be able to reconcile conflicting claims and deliberate the ethical implications of XTP. The main emphasis of a Neo Socratic Dialogue is consensus building and the fostering of trust in an open and rational dialogue between ethical actors. 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