Adele Langlois

Getting from the Ethical to the Empirical and Back Again: The Danger of Getting it Wrong, and the Possibilities for Getting it Right

‘Bioethics: past, present and future’ was a conference whose purpose was to create a snapshot of postgraduate work in bioethics. This work, it was hoped, would be illustrative of the new generation of academics working in the field, and of their attitudes towards their discipline. The conference attracted postgraduates from diverse areas and backgrounds, unified by their shared work in bioethics. Given such a disparate group one might have thought there would be a great deal of disagreement about what bioethics is and what counts as ‘doing bioethics’, yet this was not the case. There were variations of interpretation as to what constitutes bioethics, but the points on which there was agreement were far more striking. Throughout the 2 days of the conference, during formal presentations and informal

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 Declaration on Human Cloning to try to deal with the issue. The declaration is ambiguously worded, prohibiting “all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life”. It received only ambivalent support from UN member states. Given this unsatisfactory outcome, in 2008 UNESCO (the United Nations Educational, Scientific and Cultural Organization) set up a Working Group to investigate the possibility of a legally binding convention to ban human reproductive cloning. The Working Group was made up of members of the International Bioethics Committee, established in 1993 as part of UNESCO’s Bioethics Programme. It found that the lack of clarity in international law is unhelpful for those states yet to formulate national regulations or policies on human cloning. Despite this, member states of UNESCO resisted the idea of a convention for several years. This changed in 2015, but there has been no practical progress on the issue. Drawing on official records and first-hand observations at bioethics meetings, this article examines the human cloning debate at UNESCO from 2008 onwards, thus building on and advancing current scholarship by applying recent ideas on global governance to an empirical case. It concludes that, although human reproductive cloning is a challenging subject, establishing a robust global governance framework in this area may be possible via an alternative deliberative format, based on knowledge sharing and feasibility testing rather than the interest-based bargaining that is common to intergovernmental organizations and involving a wide range of stakeholders. This article is published as part of a collection on global governance.

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

BackgroundWe sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting.MethodsA 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. Four independent authors undertook abstract and full-text reviews to determine eligibility and extract relevant data. The data extraction concentrated on ethical considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis.ResultsIn all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Type of consent differed depending on the condition or intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from consent appeared to be most commonly used. A wide range of terms were used to describe consent.ConclusionsConsent was the main ethical consideration in published ambulance based research. A range of consent models were used ranging from informed consent to exception from consent (waiver of consent). Many studies cited international guidelines as informing their choice of consent model but diverse and sometimes confused terms were used to describe these models. This suggests that standardisation of consent models and the terminology used to describe them is warranted.

PP15 Consent as an ethical consideration in the conduct of prehospital ambulance randomised controlled clinical trials: a systematic review

Background Clinical trials in the ambulance setting are essential for providing the basis for evidence based healthcare in the prehospital environment. As the number and complexity of ambulance trials increases the ethical issues involved in such trials. We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. Methods We conducted a systematic review of ethical issues considered in randomised controlled trials in ambulance settings. A search of eight databases identified ethical issues discussed in published studies involving recruitment of ambulance service users. Four independent authors undertook abstract and full-text reviews to determine eligibility and then extracted relevant data. The data extraction concentrated on ethical considerations, with any discussion of ethics being included for further analysis. The resultant data were combined to form a narrative synthesis. Results In all, 56 papers were identified as meeting the inclusion criteria. Issues relating to consent were the most significant theme identified. Several consent models were used ranging from informed consent to exception from informed consent (also termed waiver of consent). Type of consent differed depending on the clinical condition or the intervention being studied. The country in which the research took place did not appear to influence the type of consent, apart from the USA where exception from informed consent appeared to be most commonly used. Many studies cited international guidelines as informing their choice of consent model and diverse and sometimes confused terms were used to describe these models. Conclusions Consent was the main ethical consideration in published ambulance based research. A wide range of terms was used to describe consent and terms were sometimes confused or used inconsistently. This suggests that standardisation of consent models and the terminology used to describe them may be helpful for researchers, ethics committees and research participants.

The UNESCO Bioethics Programme: a review

Abstract 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. Some bioethicists have criticized the 2005 declaration and suggested that the World Health Organization might be better placed to advance bioethics. In 2011, after four years of debate, UNESCO decided not to draft a convention on human reproductive cloning, because consensus on the issue proved impossible. This article reviews the standard setting and capacity building activities of the UNESCO Bioethics Programme. While the Programme faces challenges common to most intergovernmental organizations, its achievements in expanding international law and building bioethics capacity should not be underestimated.

Getting from the ethical to the empirical and back again

‘Bioethics: past, present and future’ was a conference whose purpose was to create a snapshot of postgraduate work in bioethics. This work, it was hoped, would be illustrative of the new generation of academics working in the field, and of their attitudes towards their discipline. The conference attracted postgraduates from diverse areas and backgrounds, unified by their shared work in bioethics. Given such a disparate group one might have thought there would be a great deal of disagreement about what bioethics is and what counts as ‘doing bioethics’, yet this was not the case. There were variations of interpretation as to what constitutes bioethics, but the points on which there was agreement were far more striking. Throughout the 2 days of the conference, during formal presentations and informal

Getting from the Ethical to the Empirical and Back Again: The Danger of Getting it Wrong, and the Possibilities for Getting it Right 2008 Bioethics Special Edition: Editorial 2

‘Bioethics: past, present and future’ was a conference whose purpose was to create a snapshot of postgraduate work in bioethics. This work, it was hoped, would be illustrative of the new generation of academics working in the field, and of their attitudes towards their discipline. The conference attracted postgraduates from diverse areas and backgrounds, unified by their shared work in bioethics. Given such a disparate group one might have thought there would be a great deal of disagreement about what bioethics is and what counts as ‘doing bioethics’, yet this was not the case. There were variations of interpretation as to what constitutes bioethics, but the points on which there was agreement were far more striking. Throughout the 2 days of the conference, during formal presentations and informal