Introduction 1 Universal Declaration on Bioethics and Human Rights 20 Declaration of Helsinki International Ethical Guidelines for Biomedical Research Involving Human Subjects 5 20 1 The objectives of this paper are twofold. The first is to assess the translation of universal principles into national practice. The comparison between the UNESCO declaration and Kenyan and South African bioethics forms the basis for this analysis. The second is to locate the ‘added value’ of the declaration, particularly to developing countries, given the pre-existence of international level bioethics documents. Empirically based, the paper draws on documentary evidence and interviews conducted in Kenya and South Africa in 2005 and 2006. Background The empirical research for this paper was carried out as part of a larger doctoral project on the global governance of human genomic and biomedical research and in particular the part developing countries play in this. The theoretical framework for this project is provided by international relations, a sub-discipline of political science. While international relations theory is not referred to overtly in this paper’s analytical sections, it provides the context for the understanding of universality contained therein. That is, universality is explored pragmatically, with regard to the relationship between broad principles negotiated at international level and their subsequent adaptation to national level policy and practice, rather than philosophically, in terms of universal versus pluralist moral reasoning. ‘Bioethics’ 18 20 Methodology and Limitations 2 3 4 5 6 Previous Studies Developing World Bioethics 8 au fait 14 European Journal of Health Law European Convention on Human Rights and Biomedicine 10 Kennedy Institute of Ethics Journal 6 British Medical Journal Bulletin of the World Health Organization PloS Medicine 3 7 15 1 The UNESCO Declaration Universal Declaration on Bioethics and Human Rights 20 17 19 20 Bioethics in Kenya and South Africa 7 Guidelines for Ethical Conduct of Biomedical Research Involving Human Subjects in Kenya Kenya National Guidelines for Research and Development of HIV/AIDS Vaccines Ethics in Health Research: Principles, Structures and Processes 13 9 13 8 9 11 13 Synergies between the UNESCO Declaration and Bioethics in Kenya and South Africa As the UNESCO declaration is non-binding, if its principles are to be applied universally they will necessarily have to be reflected in national level documents and systems. This section compares the main tenets of the declaration that are of special relevance for developing countries with Kenyan and South African bioethics policy and practice. The comparison has two purposes. The first is to illustrate how internationally determined, universal principles might be implemented at national levels in developing countries. The second is to show to what extent these principles were already reflected in national systems, before the adoption of the declaration. Community Consent—Article 6 20 11 13 9 Vulnerability—Article 8 20 9 11 13 13 Cultural Diversity and Pluralism—Article 9 20 9 13 11 Social Responsibility—Article 14 6 9 13 20 Benefit Sharing—Article 15 20 9 11 13 13 Transnational Practices—Article 21 20 11 10 12 Bioethics Education, Training and Information—Article 23 20 11 9 11 13 Universal Principles in the National Context The South African guidelines read: 13 6 6 Something which became more and more legalistic in the detail and binding but which ignored local realities would be unhelpful. Something which tried to establish clear, agreed principles, which had been widely consulted, not just between member states, but with the kind of communities that are affected, would be very useful. (Interview, K_07:2005) Added Value of the UNESCO Declaration 6 4 21 2 5 1 6 6 16 9 11 13 13 20 12 Conclusion This paper has revealed something of a loose consensus, at least between UNESCO and those involved in bioethics in Kenya and South Africa, on two counts. With regard to universal principles, any attempt to implement them at national levels must be contextualised. Working out how to apply such principles in particular social and economic contexts is arguably as challenging as reaching agreement on how they should be constituted in the first place. With regard to the usefulness of the UNESCO declaration, the significance of its adoption as the first intergovernmental instrument on bioethics must be matched by action in the form of capacity building for it to be of added value in the realm of biomedical research ethics. The scope of this paper has been limited to a primarily pragmatic analysis of how universal principles can be applied at national level. The paper has not commented on whether the value of the universality that UNESCO has aimed towards in terms of a foundation for humanity is compromised if these applications are very different. Deeper reflection on the nature of universality in this context would require the input of trained bioethicists and philosophers. This paper highlights, then, the need for a cross-disciplinary approach to the analysis of international bioethics instruments. The scope of the study that engendered this paper was necessarily limited by the time and resource constraints of doctoral research. Further research could explore whether the experiences of other African countries have been similar to those of Kenya and South Africa. Francophone and lusophone states, in particular, may have quite different bioethical traditions and thus have had very different experiences in implementing bioethics policies.