This research was undertaken as part of a Wellcome Trust Seed Award grant, and as such there were limited time and funds available. Therefore, the study concentrated on a single Ambulance Trust. There are 10 Ambulance Trusts in England, East Midlands Ambulance Service NHS Trust (EMAS) serves 4.8 million people in a large geographical area encompassing five counties (Derbyshire, Leicestershire, Lincolnshire, Nottinghamshire and Northamptonshire) and has approximately 3,700 paramedics of which fewer than 0.5% are research active. EMAS is a strongly research active Trust and at the time of the study was actively involved in multiple trials.
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). There was a wide range in the length of service with the least experienced paramedic having qualified less than one year prior to the interview and the most experienced having served 28 years within the ambulance service. Increasingly in the UK, paramedics are expected to undertake a Higher Education qualification in Paramedic Science rather than taking the vocational route to professional registration via Institute of Healthcare and Development (IHCD) certification. This is reflected in the demographic data for this study with those paramedics with 5 years or less experience having entered the profession through the Higher Education route. Again, this did not appear to have an impact on whether a paramedic decided to be interviewed for this study.
Through the analysis of the interview data seven themes were initially identified for further consideration, these were: barriers and facilitators; benefits of research; consent methods; future trials; managing patients; problems with consent; and reasons for participating (or not). Table 2 provides supplementary information for each theme along with relevant quotes. As with previous research in this field some of the participants responses related to operational aspects of the paramedic role and the impact of research on these rather than specific ethical considerations. The themes were further analyzed and regrouped into two broad areas that centered on ethical considerations.
Challenges to gaining consent (consent methods and problems with consent)
Paramedics did not generally have concerns about being asked to take consent for research as they felt consent (for treatment) was an integral part of the role:
“…we have to obtain consent for everything that we do, even you know down to doing blood pressure…you are always explaining what you are doing and why.” [Paramedic > 10 years-service]
Three participants mentioned the difference between consent to treat patients and consent for research. They particularly mentioned that in order to achieve informed consent they need to ensure that they could fully explain the intervention:
“I was terrified about recruiting my first patient into RIGHT2 because I was thinking this is going to be such a difficult thing to explain to somebody. Then I got my first stroke patient and did it…it seemed to flow really easily.” [Paramedic 1–5 years-service]
All of the paramedics interviewed felt that it was best to gain consent directly from the patient and that in most cases, except where the patient was unconscious, this was possible. Some paramedics went further implying that the consent process had a positive impact on the patient and their relatives:
“…I’ve used it like a calming sort [of] tool…It’s like not only are you there to help them but Oh my God, this paramedic is part of a national trial to do with strokes. It does come across as positive.” [Paramedic > 10 years-service]
The next preferred option was to gain surrogate consent from a relative. Several pointed out that family members played an important role in the consent process regardless of the patient’s capacity to consent for themselves. Often patients would seek the opinion of people with them:
“I tend to notice that if the patient is slightly older, even though you are talking to the patient, and they’ve got capacity…the first thing they do is look over at the family and go ‘what do you think?’” [Paramedic 1–5 years-service]
The ability to waive consent for research enrolment was also discussed, particularly with reference to the cardiac arrest trial. The paramedics taking part in that trial felt comfortable with not gaining informed consent as the patients were unconscious and the protocol allowed the paramedics to act in their best interests. The remaining paramedics who were not involved in this trial agreed that waiver of consent would be appropriate as long as they (the paramedic) felt they were working in the patients’ best interests. One paramedic pointed out that including the sickest patients was important for research to progress:
“And I think there does come a point with things where we have to involve people even if they haven’t consented because we’re never going to improve our clinical practice if we don’t do that.” [Paramedic > 10 years-service]
The final consent model of using paramedics as a professional representative or proxy, where paramedics would sign the consent form on behalf of a patient who lacked capacity provided they met the inclusion criteria of the trial, was perceived as more controversial and generated conflicting views among participants. The majority felt that as long as the patient clearly met the criteria and the potential benefits outweighed any potential harms, they would be able to sign on the patient’s behalf. One felt however that is was never right for a paramedic to sign without at least gaining verbal consent, stating:
“To me it’s dodgy for a paramedic to do it without knowing the full history because they may be suffering from an unknown illness.” [Paramedic > 10 years-service]
Another pointed out that a paramedic cannot be aware of a patient’s wishes regarding research:
“…it’s obviously a bit nerve wracking because you’re making a decision for somebody you’ve only known for a few minutes.” [Paramedic > 10 years-service]
One issue that did raise ethical concerns was whether patients really understood what they were consenting to. One paramedic described a situation whereby the patient had capacity but seemed overwhelmed by the situation, stating:
“I was looking at him thinking ‘I know you are saying yes and I know you are understanding it now, but I bet if I ask you in half an hour or an hour’ ….there’s just not enough time and brain space for them to take it in.” [Paramedic > 10 years-service]
Related to this several paramedics felt that time pressure was an issue when it came to gaining consent and that any consent gained was not necessarily informed.
“And sometimes it does feel that it can be a little bit long winded, particularly if I am acutely aware that you know this patient is time critical and needs to go. It’s not something that the family can sit around the table and discuss it over a cup of tea. You know ‘well what would Dad want’.” [Paramedic > 10 years-service]
The interview participants did express pressure to enroll patients onto trials and in some cases, this led to paramedics persuading patients to consent.
“But then trying to convince a patient to go onto it or give them the information to go on it. And then they ask you your personal opinion.” [Paramedic > 10 years-service]
These interviews indicated a general consensus that consenting patients to research should not be seen as a barrier to ambulance-based research. The paramedics interviewed felt that as long as they themselves believed in the research and that there were clear implications for developing future practice, they would be confident in enrolling patients onto trials.
Other ethical challenges of undertaking research in the ambulance setting (barriers and facilitators; and managing patients)
Whilst consent itself was not seen as a barrier to research, participants did perceive a number of other obstacles. By far the most common cause for concern was the additional paperwork required as part of the trial. All interviewees mentioned paperwork however, for the stroke trial in particular, this was seen as problematic as the patient needed to have a copy of the consent form. Although completion of paperwork may not be directly seen as an ethical consideration the need to complete paperwork before arrival at hospital potentially interfering with patient care is an ethical concern as summarized by one paramedic:
“Because there’s all the paperwork… there’s my consent form - do that one first, then I’ve all these 3 to fill out and I’ve got my obs[ervations] before and after… right then there’s another sheet here… then I have to remind myself well what color belongs to what. Because there is all different sheets and they’re all different colors… so that’s my copy, that’s the patients copy, that’s the one for… and by the time you’ve done that you’re at the hospital and you’ve not looked at your patient once.” [Paramedic > 10 years-service]
Several participants pointed out that they had not received any training on completing the paperwork, which added to their anxiety when they were using the forms for the first time with a patient. Overall, they were satisfied with the trial specific training but felt that having access to the trial pack and paperwork before enrolling the first patient was important.
As previously, stated some paramedics reported that time pressures made it difficult to obtain truly informed consent because of this, others reported not attempting to recruit patients in some circumstances.
“Sometimes you can walk in and it’s not quite as cut and dry as you think. And then it becomes more complicated so you’re then thinking doing best for the patients as well as then thinking can I enroll them in this trial? So, then you’ve got to make that decision as to whether I enroll them in this trial or whether I just scrap it.” [Paramedic > 10 years-service]
This could be considered unethical since patients who were otherwise eligible were not given the opportunity to take part when they would potentially have wished to. Where the paramedics decision not to offer the opportunity is based on convenience (time pressures) rather than medical need this could be seen as problematic.
The overall feelings of the interviewees were summarized nicely by one participant who said in response to the question of why they might engage in research:
“I think it’s becoming more and more obvious now that the paramedic profession is changing and we need to become more involved in research and in steering the profession.” [Paramedic 5–10 years-service]