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Refining the Enrolment Process in Emergency Medicine Research.

Kate M Sahan1, Keith M Channon2, Robin P Choudhury3

  • 1The 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.

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Summary

Emergency medicine research requires novel consent processes. A new verbal enrolment method, documented during emergencies, refines consent waivers and respects patient capacity variations, with written consent obtained later.

Keywords:
assentconsent waiveremergency medicine researchinformed consentmental capacity

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Area of Science:

  • Emergency Medicine
  • Clinical Research Ethics

Background:

  • Advancing emergency medicine diagnosis and treatment necessitates research in acute clinical settings.
  • Ethical and practical challenges, particularly obtaining informed consent from patients with diminished capacity, hinder emergency research.
  • Existing regulatory frameworks for consent waivers in emergency research overlook the variability of patient mental capacity.

Purpose of the Study:

  • To introduce a novel enrolment process for emergency medicine research.
  • To refine the concept of consent waiver by addressing ethical subtleties related to patient capacity.
  • To develop a process that ensures appropriate patient engagement and context sensitivity.

Main Methods:

  • Development of a novel, verbally documented enrolment process during the emergent phase of research.
  • Independent documentation of the verbal consent process.
  • Focus on context-sensitive engagement with patients, acknowledging varying degrees of mental capacity.

Main Results:

  • The proposed process refines the consent waiver by addressing ethical nuances.
  • It allows for appropriate patient engagement despite acute conditions and variable capacity.
  • The method is context-sensitive and ethically robust.

Conclusions:

  • The novel enrolment process enhances ethical considerations in emergency medicine research.
  • It provides a practical framework for obtaining consent in time-sensitive situations.
  • Full written consent is secured post-emergency for ongoing participation.