BMJ 2000;320:1291 ( 13 May )

News

Hospital criticised for not obtaining proper consent

Adam Legge , Bristol
The first 150 words of the full text of this article appear below.

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;98:1154-60).

The review's author is Professor Rod Griffiths, director of public health at the West Midlands regional office of the NHS Executive. He concluded: "What was totally unacceptable to [parents] was the apparent lack of adequate explanation, of choice and consequent properly elicited . . . [Full text of this article]
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