Phenomenological study exploring ethics in prehospital research from the paramedic's perspective: experiences from the Paramedic-2 trial in a UK ambulance service.

OBJECTIVES: We set out to investigate paramedics' views of ethics and research, drawing on experiences from Paramedic-2, a randomised controlled trial comparing epinephrine and placebo in out-of-hospital cardiac arrest (OHCA). METHODS: An interpretative phenomenological approach was adopted. A purposive sample of paramedics (n=6) from North East Ambulance Service NHS Foundation Trust were invited to a semi-structured, in-depth interview. RESULTS: Three superordinate themes emerged: (1) morality, (2) emotion and (3) equipoise. Some viewed Paramedic-2 as an opportunity to improve OHCA outcomes for the many, viewing participation as a moral obligation; others viewed the study as unethical, equating participation with immoral behaviour. Morality was a motivator to drive individual action. Positive and negative emotions were exhibited by the paramedics involved reflecting the wider view each paramedic held about trial participation. Those morally driven to participate in Paramedic-2 discussed their pride in being associated with the trial, while those who found participation unethical, discussed feelings of guilt and regret. Individual experience and perceptions of epinephrine guided each paramedic's willingness to accept or reject equipoise. Some questioned the role of epinephrine in OHCA; others believed withholding epinephrine was synonymous to denying patient care. CONCLUSION: A paucity of evidence exists to support any beneficial role of epinephrine in OHCA. Despite this, some paramedics were reluctant to participate in Paramedic-2 and relied on their personal perceptions and experiences of epinephrine to guide their decision regarding participation. Failure to acknowledge the importance of individual perspectives may jeopardise the success of future out-of-hospital trials.

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

BACKGROUND: We sought to understand the main ethical considerations when conducting clinical trials in the prehospital ambulance based setting. METHODS: A 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. RESULTS: In 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. CONCLUSIONS: Consent 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.

What is dignity in prehospital emergency care?

BACKGROUND: Ethics and dignity in prehospital emergency care are important due to vulnerability and suffering. Patients can lose control of their body and encounter unfamiliar faces in an emergency situation. OBJECTIVE: To describe what specialist ambulance nurse students experienced as preserved and humiliated dignity in prehospital emergency care. RESEARCH DESIGN: The study had a qualitative approach. METHOD: Data were collected by Flanagan's critical incident technique. The participants were 26 specialist ambulance nurse students who described two critical incidents of preserved and humiliated dignity, from prehospital emergency care. Data consist of 52 critical incidents and were analyzed with interpretive content analysis. Ethical considerations: The study followed the ethical principles in accordance with the Declaration of Helsinki. FINDINGS: The result showed how human dignity in prehospital emergency care can be preserved by the ambulance nurse being there for the patient. The ambulance nurses meet the patient in the patient's world and make professional decisions. The ambulance nurse respects the patient's will and protects the patient's body from the gaze of others. Humiliated dignity was described through the ambulance nurse abandoning the patient and by healthcare professionals failing, disrespecting, and ignoring the patient. DISCUSSION: It is a unique situation when a nurse meets a patient face to face in a critical life or death moment. The discussion describes courage and the ethical vision to see another human. CONCLUSION: Dignity was preserved when the ambulance nurse showed respect and protected the patient in prehospital emergency care. The ambulance nurse students' ethical obligation results in the courage to see when a patient's dignity is in jeopardy of being humiliated. Humiliated dignity occurs when patients are ignored and left unprotected. This ethical dilemma affects the ambulance nurse students badly due to the fact that the morals and attitudes of ambulance nurses are reflected in their actions toward the patient.

Ethical challenges in Emergency Medical Services: controversies and recommendations.

Emergency Medical Services (EMS) providers face many ethical issues while providing prehospital care to children and adults. Although provider judgment plays a large role in the resolution of conflicts at the scene, it is important to establish protocols and policies, when possible, to address these high-risk and complex situations. This article describes some of the common situations with ethical underpinnings encountered by EMS personnel and managers including denying or delaying transport of patients with non-emergency conditions, use of lights and sirens for patient transport, determination of medical futility in the field, termination of resuscitation, restriction of EMS provider duty hours to prevent fatigue, substance abuse by EMS providers, disaster triage and difficulty in switching from individual care to mass-casualty care, and the challenges of child maltreatment recognition and reporting. A series of ethical questions are proposed, followed by a review of the literature and, when possible, recommendations for management.

An open letter to institutional review boards considering Northfield Laboratories' PolyHeme® trial.

At the time of this writing, a widely publicized, waived-consent trial is underway. Sponsored by Northfield Laboratories, Inc. (Evanston, IL) the trial is intended to evaluate the emergency use of PolyHeme®, an oxygen-carrying resuscitative fluid that might prevent deaths from uncontrolled bleeding. The protocol allows patients in hemorrhagic shock to be randomized between PolyHeme® and saline in the field and, still without consent, randomized between PolyHeme® and blood after arrival at an emergency department. The Federal regulations that govern the waiver of consent restrict its applicability to circumstances where proven, satisfactory treatments are unavailable. Blood-the standard treatment for hemorrhagic shock-is not available in ambulances but is available in hospitals. The authors argue that the in-hospital stage of the study fails to meet ethical and regulatory standards.

Delivery of ambulance service by volunteers in Victoria, Australia: an ethical dilemma?

The Alexandra District Ambulance Service is the only volunteer-based ambulance service in Victoria, Australia. It provides an opportunity to reflect on the ethical issues surrounding the delivery of ambulance service by volunteers, and its impact on the community.