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Guide to the design and review of emergency research when it is proposed that consent and consultation be waived
  1. Hugh Davies1,
  2. Haleema Shakur2,
  3. Andrew Padkin3,
  4. Ian Roberts2,
  5. Anne-Marie Slowther4,
  6. Gavin D Perkins5
  1. 1Health Research Authority, London, UK
  2. 2Clinical Trials Unit, London School of Hygiene and Tropical Medicine, London, UK
  3. 3Royal United Hospital Bath NHS Trust, Bath, UK
  4. 4Warwick Medical School, University of Warwick, Coventry, UK
  5. 5Warwick Clinical Trials Unit and Heart of England NHS Foundation Trust, Coventry, UK
  1. Correspondence to G D Perkins, Warwick Clinical Trials Unit and Heart of England NHS Foundation Trust, Coventry CV4 7AL, UK: g.d.perkins@warwick.ac.uk

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Like all others, we believe that patients who need urgent treatment should receive evidence-based care. However, until recently, there have been particular difficulties or uncertainties for research when consent and consultation ‘at the time of the emergency’ are impossible or inappropriate and, therefore, should be waived.1 ,2 In this commentary we describe a practical framework of ‘questions and considerations’ for those developing or reviewing such research. The framework was developed in a workshop hosted by the Health Research Authority, UK, with the aim of providing a structured approach to the issues that arise when planning research that involves a waiver of consent or consultation.

The framework …

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Footnotes

  • Contributors HD organised and HS/AP/IR/GDP contributed to the one-day symposium on consent in emergency research. All authors contributed to the summarising the output of the meeting. GDP and AMS provided the worked example. HD/GDP drafted the commentary which has been approved by all authors. HD will act as guarantor.

  • Competing interests GDP and AMS receive funding from the National Institute for Health Research to evaluate the safety and effectiveness of adrenaline for out-of-hospital cardiac arrest [HTA 12/127/126]. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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