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British Journal of Anaesthesia, 2001, Vol. 86, No. 4 469-472
© 2001 The Board of Management and Trustees of the British Journal of Anaesthesia

Editorial

Editorial III

Lessons from Stafford

J.R. Sneyd

In the early 1990s, Professor David Southall supervised paediatric research studies at North Staffordshire Hospital. Following complaints and allegations by the parents of the participating children, a review was set-up and its findings have been published.1 The process of the review and the fairness of its report have been criticized2 3 and defended.3 This editorial addresses the findings of the review and their implications for clinical research in anaesthesia.

The research

The CNEP study
A novel system for ventilation of neonates was evaluated in a randomized controlled trial against standard intensive therapy. The CNEP Ventilator applied a continuous negative extrathoracic pressure as an alternative to tracheal intubation. A report of the study, published in 1996, concluded that CNEP reduced the requirement for tracheal intubation and decreased the duration of oxygen therapy required. However, it was associated with increased mortality, cranial ultrasound abnormalities and pneumothoraces (although these increases were not statistically significant).4

The hypoxia study
This investigation simulated the effects . . . [Full Text of this Article]

Academic criticism of the hypoxia study
Other issues
Evidence given to the inquiry

Allegations from parents
Evidence about research supervision
Guiding principles for those obtaining consent

The Nuremberg code
The Helsinki declaration
Good clinical practice
Equipoise
Current practice for obtaining consent to anaesthesia research

Consent for anaesthesia studies
Consent in obstetrics
Consent in intensive care
Research supervision
Recommendations of the inquiry

How might this affect research in anaesthesia?

Consent
Supervision
References


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