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

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.

Evaluation of Paramedic Views of Their Role in Ambulance Based Clinical Trials: An Interview Study

“…It has been suggested that the prehospital setting will be the next great clinical 'laboratory' for advancing emergency treatments (7). Through this study we hoped to gain further insight into the role of paramedics in facilitating research and in particular any ethical considerations.…”

“…Previous research has suggested that length of service and education has an impact on paramedics' willingness to participate in research, with so-called 'old school' paramedics being less willing to be involved in recruiting patients onto research or taking part in research themselves as participants (7,16). This did not appear to be the case in this study where there was an equal ratio of short to long serving paramedics (> 10 years, n = 7; <10 years, n = 8) (see Table 1).…”

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

“…We chose this model because previous research has demonstrated the difficulties involved in seeking informed consent in emergency medical research. [17][18][19][20][21][22][23][24][25][26] Largent et al provide an alternative to unsatisfactory consent processes used in this context. Furthermore, their model continues to be cited regularly in the emergency research literature.…”

“…We compared the five conditions of the consent substitute model with the emergency research provisions within international and national ethical frameworks, to determine whether it could be employed by researchers adhering to these frameworks. We chose this model because previous research has demonstrated the difficulties involved in seeking informed consent in emergency medical research 17–26 . Largent et al provide an alternative to unsatisfactory consent processes used in this context.…”

Randomised controlled trials in pre-hospital trauma: a systematic mapping review

“…From a conduct perspective, the importance of timeliness with regard to accessing the patient, randomisation (often remotely) and delivery of the intervention is also key. The broader ethical considerations relating to recruitment, capacity and consent under the challenging circumstances surrounding major trauma also need to be considered [ 12 ]. Futhermore, the complex nature of traumatic injuries can result in patients receiving multiple interventions (that may not be standardised in or between trauma centres) both pre and within hospital, making it very difficult to disentangle intervention effect on outcomes such as mortality [ 8 ].…”