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.</p

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

Study objective: 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 experts in this field of research.Methods: We employed a qualitative design using semi-structured interviews with a range of expert informants seeking their views and experiences of ethics in ambulance based clinical trials. Participants were chosen because there were actively involved, or had expressed an interest in, ambulance based research. Participants were asked a series of questions regarding their experiences in ambulance trials, their opinions on current regulations and guidelines and the views on ethical considerations more generally. The interview transcripts were digitally recorded, transcribed verbatim, coded by two researchers (SA and AL) and analysed thematically. Results: We interviewed 14 participants including principal investigators, researchers, ethicists and medical lawyers. Six themes were identified: Capacity, Consent, Complexity, Clinical, Consultation and Regulation. Issues regarding consent and capacity in the ambulance setting were foremost in the discussion as all participants highlighted this as an area for concern. The challenges of the ambulance and use of multiple consent models setting spoke to the complexity research in this environment. The clinical theme referred to the use of paramedics in research and how research involving ambulance services is increasingly informing improvements to patient care and outcomes or reducing the burden on hospital services. Most participants felt that current regulations were fit for purpose however, more specific guidance regarding the implementation of the regulations in the ambulance setting would be beneficial for researchers, paramedics and ethics committees. This related closely to the theme of consultation, which examined the key role of ethics committees and other advisory groups such as the Confidentiality Advisory Group (CAG) when dealing specifically with ambulance based research. Conclusions: Research in any setting may be complex but the ambulance context has unique issues due to its time pressured, emergency and remote environment. By interviewing experts in research or ethics in this setting we were able to identify some key issues and highlight areas such as improved guidance that can be developed in the future.</p

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.</p