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Fifteen-minute consultation: an evidence-based approach to research without prior consent (deferred consent) in neonatal and paediatric critical care trials
  1. Kerry Woolfall1,
  2. Lucy Frith2,
  3. Angus Dawson3,
  4. Carrol Gamble4,
  5. Mark D Lyttle5,6,
  6. the CONNECT advisory group,
  7. Bridget Young1
    1. 1Department of Psychological Sciences, University of Liverpool, Liverpool, UK
    2. 2Department of Health Service Research, University of Liverpool, Liverpool, UK
    3. 3Centre for Values, Ethics and the Law in Medicine (VELiM), School of Public Health, University of Sydney, Sydney, New South Wales, Australia
    4. 4Department of Biostatistics, University of Liverpool, Liverpool, UK
    5. 5Emergency Department, Bristol Royal Hospital for Children, Bristol, UK
    6. 6Faculty of Health and Applied Sciences, University of the West of England, Bristol, UK
    1. Correspondence to Dr Kerry Woolfall, Department of Psychological Sciences, University of Liverpool, Liverpool L69 3GL, UK; K.Woolfall{at}liverpool.ac.uk

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    What do we mean by research without prior consent (deferred consent)?

    Emergency research with critically unwell children is vital to make sure that the most ill and injured children benefit from evidence-based healthcare.1 Ethical guidance require that consent be sought from parents (or legal representatives) on behalf of their children2 before research is initiated, yet concerns about problems in seeking parents’ consent when their child is critically ill have been a significant barrier to conducting clinical trials.3 ,4 Taking time out to seek informed consent before starting treatment will often be difficult to justify as delaying any intervention in an emergency could diminish a child's chances of recovery. Parents will usually be highly distressed in a critical care situation, and many will struggle to make an informed decision about research in the limited time available.

    Many countries have legislated to permit variations to informed consent and allow progress in research to develop critical care treatments.5–7 While the details vary, a common feature is that informed consent is not requested before the patient receives the intervention being researched.8 In the USA, the Food and Drug Administration (FDA) Exception from Informed Consent (EFIC) essentially ‘waives’ informed consent, although practitioners must show that they have attempted to contact legal representatives and tried to provide the opportunity to ‘opt out’ of a trial.5 ,9 The FDA's detailed guidance aims to assist researchers in implementing EFIC,10 ,11 although the accompanying public consultation requirements have led to varied practice and costly delays in setting up trials.12

    Across European Union countries, legislation7 ,13 enables practitioners to conduct research without seeking prior informed consent from parents when certain conditions are met (see box 1 for UK example). No accompanying guidance has been made available to assist researchers in implementing the legislation. European legislation does not name …

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