Exploring Ethics of Ambulance Trials

  • Research type

    Research Study

  • Full title

    Exploring Ethics of Ambulance Trials (EEATs): a qualitative interview study of patients, relatives and paramedics.

  • IRAS ID

    203946

  • Contact name

    A Nirohan Siriwardena

  • Contact email

    nsiriwardena@lincoln.ac.uk

  • Sponsor organisation

    University of Lincoln

  • Duration of Study in the UK

    0 years, 11 months, 31 days

  • Research summary

    We aim to explore experiences, perceptions and challenges reported by patients and/or their relatives and paramedics regarding the ethics of recruiting patients to a trial in a prehospital ambulance setting.

    Trials involving ambulance services are a rapidly developing field with increasing numbers and scale of studies. Our aim reflects: the lack of evidence in this field; the need for early interventions in time-critical conditions such as out-of-hospital cardiac arrest, myocardial infarction (‘heart attack’) and stroke; and the need to redesign emergency and urgent care systems under pressure from increasing demand and new treatments.

    Randomised Controlled Trials (RCTs) in ambulance settings pose particular challenges, including urgency of conditions and treatment, and difficulties with recruitment, randomisation and informed consent with limited time or impaired patient capacity. Trials have used the notion of ‘assent’ (agreement to participate by the patient, relative or staff) followed by later full patient consent. This research environment is in its infancy compared to research in hospital and primary care due to ethical and logistic barriers.

    We will focus primarily on the ethical challenges for stakeholders (patients, public, healthcare organisations, practitioners) and their solutions.

  • REC name

    South West - Cornwall & Plymouth Research Ethics Committee

  • REC reference

    16/SW/0100

  • Date of REC Opinion

    18 May 2016

  • REC opinion

    Further Information Favourable Opinion