Do National and International Ethics Documents Accord With the Consent Substitute Model for Emergency Research?

In 2010 Largent, Wendler, and Emanuel proposed the "consent substitute model" for emergency research with incapacitated participants. The model provides a means to enroll participants in emergency research without consent, if five conditions are met: 1) the research addresses the patients' urgent medical needs, 2) the risk-benefit ratio is favorable, 3) there are no known conflicts with patients' values or interests, 4) cumulative net risk is minimal, and 5) consent is given as soon as possible. We review national and international ethics laws, regulations, and guidelines to determine 1) whether they accord with the consent substitute model's five conditions and 2) the level of congruence across these documents.

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

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.

Assessment of consent models as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review.

Background: We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting.

Methods: A systematic review of the literature on randomised controlled trials in ambulance settings was undertaken. A search of eight databases identified published studies involving recruitment of ambulance service users.

The global governance of human cloning: the case of UNESCO.

Since Dolly the Sheep was cloned in 1996, the question of whether human reproductive cloning should be banned or pursued has been the subject of international debate. Feelings run strong on both sides. In 2005, the United Nations adopted its to try to deal with the issue.

The UNESCO Bioethics Programme: a review.

UNESCO's Bioethics Programme was established in 1993. In twenty years it has adopted three international declarations, on the human genome (1997), human genetic data (2003) and bioethics (2005); produced reports on a wide range of bioethics issues; and developed capacity building and public education programmes in bioethics. Yet UNESCO has sometimes struggled to assert its authority in the wider bioethics world.

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.

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".

The UNESCO Universal Declaration on Bioethics and Human Rights: perspectives from Kenya and South Africa.

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.