title: Refining the Enrolment Process in Emergency Medicine Research.
abstract: Research in the emergency setting involving patients with acute clinical conditions is needed if there are to be advances in diagnosis and treatment. But research in these areas poses ethical and practical challenges. One of these is the general inability to obtain informed consent due to the patient's lack of mental capacity and insufficient time to contact legal representatives. Regulatory frameworks which allow this research to proceed with a consent 'waiver', provided patients lack mental capacity, miss important ethical subtleties. One of these is the varying nature of mental capacity among emergency medicine patients. Not only is their capacity variable and often unclear, but some patients are also likely to be able to engage with the researcher and the context to varying degrees. In this paper we describe the key elements of a novel enrolment process for emergency medicine research that refines the consent waiver and fully engages with the ethical rationale for consent and, in this context, its waiver. The process is verbal but independently documented during the 'emergent' stages of the research. It provides appropriate engagement with the patient, is context-sensitive and better addresses ethical subtleties. In line with regulation, full written consent for on-going participation in the research is obtained once the emergency is passed.
authors: The Ethox Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF; NIHR Biomedical Research Centre, Oxford, The Joint Research Office, Block 60, The Churchill Hospital, Old Road, Headington, OX3 7LE.
authors: Kate M
authors: KM
authors: Sahan
authors: Radcliffe Department of Medicine University of Oxford, Level 6, West Wing, John Radcliffe Hospital, Headington, Oxford OX3 9DU; NIHR Biomedical Research Centre, Oxford, The Joint Research Office, Block 60, The Churchill Hospital, Old Road, Headington, OX3 7LE.
authors: Keith M
authors: KM
authors: Channon
authors: Radcliffe Department of Medicine University of Oxford, Level 6, West Wing, John Radcliffe Hospital, Headington, Oxford OX3 9DU; Oxford Acute Vascular Imaging Centre, Division of Cardiovascular Medicine, University of Oxford.
authors: Robin P
authors: RP
authors: Choudhury
authors: Radcliffe Department of Medicine University of Oxford, Level 6, West Wing, John Radcliffe Hospital, Headington, Oxford OX3 9DU; NIHR Biomedical Research Centre, Oxford, The Joint Research Office, Block 60, The Churchill Hospital, Old Road, Headington, OX3 7LE.
authors: Rajesh K
authors: RK
authors: Kharbanda
authors: NIHR Biomedical Research Centre, Oxford, The Joint Research Office, Block 60, The Churchill Hospital, Old Road, Headington, OX3 7LE.
authors: Regent
authors: R
authors: Lee
authors: The Ethox Centre, Nuffield Department of Population Health, University of Oxford, Old Road Campus, Headington, Oxford OX3 7LF; NIHR Biomedical Research Centre, Oxford, The Joint Research Office, Block 60, The Churchill Hospital, Old Road, Headington, OX3 7LE.
authors: Mark
authors: M
authors: Sheehan
keywords: assent; consent waiver; emergency medicine research; informed consent; mental capacity