Prehospital ambulance based research has unique ethical considerations due to urgency, time limitations and the locations involved. We sought to explore these issues through interviews with experts in this research field. We undertook semi-structured interviews with expert informants, primarily based in the UK, seeking their views and experiences of ethics in ambulance based clinical research. Participants were questioned regarding their experiences of ambulance based research, their opinions on current regulations and guidelines, and views about their general ethical considerations. Participants were (...) chosen because they were actively involved in, or in their expert capacity expressed an interest in, ambulance based research. Fourteen participants were interviewed including principal investigators, researchers, ethicists and medical lawyers. Five major themes were identified: Capacity, Consent, Clinical Considerations, Consultation and Regulation. Questions regarding consent and capacity were foremost in the discussions as all participants highlighted these as areas for concern. The challenges and use of multiple consent models reflected the complexity of research in this environment. The clinical theme referred to the role of paramedics in research and how research involving ambulance services is increasingly informing improvements to patient care and outcomes and reducing the burden on hospital services. Most felt that, although current regulations were fit for purpose, more specific guidance on implementing these in the ambulance setting would be beneficial. This related closely to the theme of consultation, which examined the key role of ethics committees and other regulatory bodies, as well as public engagement. By interviewing experts in research or ethics in this setting we were able to identify key concerns and highlight areas for future development such as improved guidance. (shrink)

The completion of the Human Genome Project has opened up unprecedented possibilities in healthcare, but also ethical and social dilemmas in terms of how these can be achieved. Genomic information can be seen as a "global public good" (GPG), in that it is represented by knowledge in the public domain and across national boundaries. Lack of investment, infrastructure and expertise in developing countries means that they are unable to take advantage of these GPG characteristics to address their health needs, fuelling (...) fears of a growing "genomics divide". Some have suggested an international knowledge sharing and capacity building network, a Global Genomics Initiative, as a means to harness the potential of genomics to reduce inequalities in health between North and South. Three UNESCO declarations also call for cooperation between developed and developing countries in genomics research and science and technology in general. Using international relations theories around global governance and networks as a conceptual framework, this paper examines whether these initiatives are likely to succeed in providing effective governance of genomics. (shrink)

In October 2005, UNESCO (the United Nations Educational, Scientific and Cultural Organization) adopted the Universal Declaration on Bioethics and Human Rights. This was the culmination of nearly 2 years of deliberations and negotiations. As a non-binding instrument, the declaration must be incorporated by UNESCO’s member states into their national laws, regulations or policies in order to take effect. Based on documentary evidence and data from interviews, this paper compares the declaration’s universal principles with national bioethics guidelines and practice in Kenya (...) and South Africa. It concentrates on areas of particular relevance to developing countries, such as protection of vulnerable persons and social responsibility. The comparison demonstrates the need for universal principles to be contextualised before they can be applied in a meaningful sense at national level. The paper also assesses the ‘added value’ of the declaration in terms of biomedical research ethics, given that there are already well-established international instruments on bioethics, namely the World Medical Association Declaration of Helsinki and the CIOMS (Council for International Organizations of Medical Sciences) guidelines on biomedical research. It may be that the added value lies as much in the follow-up capacity building activities being initiated by UNESCO as in the document itself. (shrink)