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

Stephanie Armstrong,Adele Langlois,Tom Quinn,Niroshan Siriwardena

doi:10.1186/s12910-019-0425-3

Stephanie Armstrong, Adele Langlois + Show 2 more

Open Access

https://doi.org/10.1186/s12910-019-0425-3

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Abstract

BackgroundPrehospital 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.MethodsWe 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.ResultsFourteen 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.ConclusionsBy 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.

Highlights

Prehospital ambulance based research has unique ethical considerations due to urgency, time limitations and the locations involved
The findings of this study showed strong support among participants for the principles of biomedical ethics, and highlighted the ongoing challenges that ambulance based researchers face in operationalising these in the prehospital setting
Both the literature and our findings suggest that, whilst the ambulance setting offers unique opportunities for research, there are specific ethical challenges to be met

Summary

Introduction

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. Trials involving ambulance services are a rapidly developing field, with increasing numbers and scale of studies globally. In the UK the types of research undertaken within the ambulance service include drugs trials, device trials and investigations into alternative care pathways. These trials can be complex and several papers identify the unique challenges of prehospital research, both ethical and practical [6,7,8]. This study sought to identify these challenges in depth with a range of expert stakeholders.

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Conclusion