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 and recorded consent, and of involvement in later decision making.”
The review was set up after Carl and Debbie Henshall, whose two daughters received CNEP ventilation, took their complaints to their local MP. Their first baby, Stacey, died while on a ventilator in February 1992, and they allege that a “trainee midwife” asked if they would like her to receive “a kinder and gentler treatment” rather than having a tube inserted into her throat, while at no point explaining that it was an experimental treatment.
Their second daughter, Sofie, was admitted to the neonatal intensive care unit 10 months later and received CNEP ventilation, although the Henshalls say that they did not sign a consent form.
The review says that Professor Southall “seems to have assumed that the obtaining of consent was proceeding as intended but does not appear to have ensured that each member staff who might be involved in the project was trained or supervised.”
Although Professor Southall was responsible to a “significant extent” for the design of the study, the local research ethics committee comes in for criticism. They failed to examine the study closely enough to see that supervision and management failures “were virtually built into the design.”
Report of the Review into the Research Framework in North Staffordshire is available at www.doh.gov.uk/ wmro/northstaffs.htm.
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Professor Rod Griffiths: lack of explanation to parents was “totally unacceptable”