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Hospital criticised for not obtaining “properly elicited consent”

BMJ 2000; 320 doi: https://doi.org/10.1136/bmj.320.7245.1296/f (Published 13 May 2000) Cite this as: BMJ 2000;320:1296
  1. Adam Legge
  1. Bristol

    Tighter controls on clinical research in the NHS are to be introduced by the government in response to a highly critical review of a study carried out at North Staffordshire Hospital NHS Trust.

    The review has raised serious concerns over the issue of consent for a trial on neonates with respiratory failure run by Professor David Southall, consultant paediatrician at the hospital. The randomised controlled trial looked at the effect of treating premature babies with continuous negative extrathoracic pressure (CNEP) ventilation instead of standard ventilation. The results showed improved respiratory outcomes with the new method but an increase (which was not statistically significant) in baby deaths (Pediatrics 1996;98:1154-1160).

    The review's author is Professor Rod Griffiths, director of public health at the …

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