The Governance of Genomic Information: Will It Come of Age?

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

Research ethics in developing countries

The UK funds an increasing amount of biomedical research in developing countries. Research proposals are reviewed by research ethics committees, usually in both the UK and the countries where research is to take place. Exact ethical requirements vary according to national policy, funding body and research institution. A key international document on research ethics, the Declaration of Helsinki, will be revised in 2008. This POSTnote describes the types of research conducted in developing countries, the ethical review process and the arising issues

The global polio eradication initiative in India: an analysis of international and national level perspectives on its efficacy

In 1988, the World Health Organization launched the Global Polio Eradication Initiative (GPEI), which has become the biggest international public health effort to date. By 1999, the annual caseload had reduced by an estimated 99 per cent and polio is now endemic to only three countries. Yet support is not universal. This article analyses Indian medical journals and GPEI documents from 2004 onwards to determine the range of views on polio eradication efforts in India, where transmission of the disease was declared interrupted in early 2012. One group of public health professionals believe the GPEI was forced on their country, to the detriment of other health programmes. A second set, who are broadly supportive of the initiative, question why Indian experts were not consulted about the best way to administer polio vaccines in the Indian context. Specifically, they have concerns about the safety of oral polio vaccination (the method recommended by the World Health Organization), the impact on other health services and the apparent distrust of the programme among some marginalised communities. Using the global health diplomacy literature as a framework for discussion, the article concludes that if the GPEI is to achieve maximum efficiency and certify the world as polio-free by 2018 (the latest goal), it must pay greater heed to expert and lay voices from the contexts in which it operates

PP8 Paramedic views and experiences of the ethical considerations in ambulance based clinical trials: an interview study.

Background: Prehospital ambulance based research has unique ethical considerations due to urgency, time-limitations and the locations (home, ambulance) involved. We sought to explore these issues through interviews with paramedics that have research experience. Methods: We undertook semi-structured interviews with paramedics, seeking their views and experiences of undertaking research in ambulance based clinical trials. Participants were purposively chosen because they were actively involved research and had enrolled one or more patients into a clinical trial. Participants were questioned regarding their experiences of the enrolment and consent process, and their opinions regarding the facilitators and barriers to ambulance based research. Transcripts were digitally recorded, transcribed verbatim, and analysed thematically. Results: We interviewed 15 paramedics. They ranged from newly qualified to experienced advanced paramedics. Mental capacity and consent were discussed and the time and complexity for undertaking these processes were highlighted. Participants discussed problems with completing paperwork due to the complexity of recording systems. Most highlighted paramedic training and experience as a potential barrier to research, stating that those that had gone through a university education in general seemed more open to research than those that had ‘learnt on the job’. It was also felt that more information on the benefits of a trial to both patients and practice were needed from the outset to allow paramedics to make an informed decision about whether to take part in research or not. Several stated that they did additional reading around the subject before signing up. All stated that the training given prior to commencing the research was good and appropriate to each trial. Conclusions: We identified patient capacity and consent, paramedic training and experience and complexity of processes as important potential barriers to prehospital research. There is scope to improve guidance for prehospital research studies in future

Ethical considerations in prehospital ambulance based research : qualitative interview study of expert informants

Abstract: Background: 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. Methods: 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 (e.g. law) expressed an interest in, ambulance based research. Results: 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. Conclusions: 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

Networked Governance: Bridging the 'Genomics Divide'?

The completion of the Human Genome Project has opened up unprecedented possibilities in healthcare, but also ethical and social dilemmas. Some fear that the health concerns of developed countries will take precedence over those of developing countries, thereby creating a 'genomics divide'. Partly to address such issues, UNESCO has adopted three international declarations on human genomics and bioethics, whilst the Toronto Joint Centre for Bioethics (TJCB) has proposed the formation of a Global Genomics Initiative (GGI). Both UNESCO and TJCB require the support of governments to implement their programs. In her book 'A New World Order', Anne-Marie Slaughter proposes a global governance framework centered on government networks and the disaggregated state. This paper explores whether her framework might be applied to the UNESCO declarations and the GGI. Drawing on empirical data from fieldwork conducted in Kenya and South Africa in 2005 and 2006, the paper concludes that government networks could strengthen these genomics governance mechanisms, but that integration rather than disaggregation at national level would be essential to the success of any such endeavour

The report of the International Bioethics Committee on vulnerability: a review

The Universal Declaration on Bioethics and Human Rights, adopted by the United Nations Educational, Scientific and Cultural Organization (UNESCO) in 2005, contains 28 articles, 15 of which (3 to 17 inclusive) expound bioethical principles. To help states and other stakeholders to promote and uphold these principles, UNESCO’s International Bioethics Committee produces reports explaining them in depth and advising on their implementation. To date, it has published on consent (2008), social responsibility and health (2010), vulnerability (2011), traditional medicine (2013), non-discrimination and non-stigmatisation (2014) and benefit sharing (2015). In the Foreword to the first of these reports, on consent, Pierre Sané, then Assistant Director-General for Social and Human Sciences at UNESCO, emphasised that the principles in the Declaration are not ‘abstract’, but ‘about real and pressing ethical issues that shape our daily lives’. Thus, ‘Immediately after the adoption of the Declaration, IBC committed itself to contribute to the promotion of the Declaration by pursuing and deepening the reflection on the principles set forth therein’ (UNESCO, 2008, 5). This chapter analyses the International Bioethics Committee’s report on vulnerability in the light of the broader bioethics literature on this subject. The report elaborates Article 8 of the Universal Declaration on Bioethics and Human Rights, ‘Respect for human vulnerability and personal integrity’: "In applying and advancing scientific knowledge, medical practice and associated technologies, human vulnerability should be taken into account. Individuals and groups of special vulnerability should be protected and the personal integrity of such individuals respected. (UNESCO, 2005)" The chapter draws not only on the report itself, but the author’s observations of the drafting process and subsequent discussions at meetings of UNESCO’s International Bioethics Committee and Intergovernmental Bioethics Committee in 2010 and 2011. The report makes a significant contribution to bioethical reflections on the concept of vulnerability by (a) broadening its application beyond the research context, to healthcare and biotechnology and (b) considering societal as well as individual means of addressing vulnerability. Yet for these means to be implemented by states, ethics committees and communities, more detailed examples and guidance will be required

A critical year for African development

2005 was a critical year for Africa, with high profile issues being raised and discussed at international level. Adèle Langlois considers why this was an important time for Africa, and the major issues under discussion in our article 'A critical time for Africa'

The global governance of bioethics: negotiating UNESCO’s Universal Declaration on Bioethics and Human Rights (2005)

UNESCO’s Universal Declaration on Bioethics and Human Rights (2005) was drawn up by an independent panel of experts (the International Bioethics Committee) and negotiated by member states. UNESCO aimed for a participatory and transparent drafting process, holding national and regional consultations and seeking the views of various interest groups, including religious and spiritual ones. Furthermore, reflecting UNESCO’s broad interpretation of bioethics, the IBC included medics, scientists, lawyers and philosophers among its membership. Nevertheless, several potential stakeholders—academic scientists and ethicists, government policy-makers and NGO representatives—felt they had not been sufficiently consulted or even represented during the Declaration’s development. Better communications and understanding within and between national, regional and international layers of governance would help to avoid a recurrence of this problem in future negotiations

Global bioethics

This chapter explains the evolution of global bioethics, in relation to inequalities of health, vulnerability and climate change, from an international relations perspective. It also explores Western bias within global bioethics and how this might be overcome