Seminar hears calls for openness and international engagement on ethics in medical research

October 15, 2003

Brussels, 14 Oct 2003

During an international seminar on ethics in medical research in Brussels on 13 October, one of the few points on which most were agreed was that tackling such issues on an international basis is an extremely difficult proposition.

Yet despite the difficulty of maintaining an international discourse on ethical matters, many of those attending the event, organised jointly by the Norwegian research and innovation forum and the Slovenian ministry of education, science and sport, concluded by calling for an increase in such exchanges.

According to Barbara Rhode, head of unit for ethics and science at the Commission's Research DG, for the European Union the subject of ethics is a difficult one in general, whether related to medical research or other areas of science. 'Though there is a commitment to respect fundamental ethical principles within the Sixth Framework Programme [FP6], the EC has no competence to deal with ethical issues as they arise out of national diversity and sensitivities and are thus subject to the principle of subsidiarity,' said Ms Rhode.

The key ethical standards set out under FP6 are that participants in EU funded research must conform to the regulations and ethical rules of the country where the research will be carried out and, where appropriate, researchers must seek the approval of the relevant national or local ethics committee prior to beginning work, Ms Rhode continued.

Furthermore, when proposals are submitted to the Commission to carry out research into ethically sensitive areas, a multidisciplinary panel of experts reviews the plan and adjustments can be made to projects that could impinge on fundamental ethical principles.

Ms Rhode said that that one of the difficulties the Commission faced was that many researchers were not aware of the ethical regulations in place in their own countries before they submitted their proposals, and she called on Member States to do more to inform them of the relevant legislation and guidelines.

Professor Joze Trontelj, Chairman of the Slovenian national medical ethics committee, was asked to assess the particular ethical challenges faced by central and eastern European countries. He warned that many examples of ethically questionable practices could still be found in the region, especially in the area of clinical trials on human subjects.

One of the key problems in trying to identify and root out such abuses, said Professor Trontelj, was that the bodies responsible for carrying out ethical reviews in these countries were overloaded, due to the burden of bureaucratic regulations and sheer numbers of trial applications. With no international guidelines yet available for the ethical administration of research on stem cells and in vitro embryos, Professor Trontelj expects the problem to get worse before it gets better, and said that an important step forward would be an additional protocol to the Convention on human rights covering research ethics.

For Professor Jan Helge Solbakk, Director of the centre for medical ethics at the University of Oslo, establishing a debate at international level is the key to reaching practical agreements. He warned of the dangers involved in overselling therapeutic potential in order to promote a particular field of research, and said that regions like Europe had an obligation to scale up their spending on research into diseases affecting the developing world.

'As long as 90 per cent of the estimated 60 billion euro spent each year on medical research is devoted to the health needs of the richest 10 per cent of the population, those countries not willing to contribute to the wider global health effort should be held responsible for gross human rights violations in the name of biomedical research,' Professor Solbakk said.

Ms Rhode agreed that the EU itself has not been as engaged in the developing world dimension of ethical research as it should because it had been more focussed on issues related to internal diversity. That experience and diversity, however, meant that the EU has an important role to play in the global process, added Ms Rhode.

In drawing conclusions from the seminar, Mr Christian Hambro, Director General of the research council of Norway, said that some of the ethical issues raised in medical research were too important to be taken by individual scientists, or even by the scientific community as a whole. Professor Trontelj echoed this belief, and demanded that the public be consulted, and reminded of their duty to learn about the issues from credible sources. 'We must separate ethics from politics, and scientists should not be allowed to fuel the unrealistic expectations of science that politicians sometimes demand.'

Ms Rhodes concluded by agreeing that more EU cooperation is needed with the candidate countries and the developing world. Finally she stressed that, despite the complexity of the issues: 'ethics should not be seen as a barrier or bureaucratic hurdle to progress, but as an enabler of science.'

For further information, please consult the following web address:
http:///www.europa.eu.int/comm/research/s cience-society/ethics/research_en.html

CORDIS RTD-NEWS / © European Communities

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