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
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 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 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 is 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.”
“In effect the combination of a slightly complacent local research ethics committee, an enthusiastic and assertive researcher, and a vacuum in research governance in the trust led this trial to run in a less than adequate way,” it says.
Professor Southall has been suspended by the trust, and its chief executive, David Fillingham, said that two consultant paediatricians are the subjects of disciplinary procedures. He added that evidence has also been given to the United Kingdom Central Council for Nursing, Midwifery, and Health Visiting, which confirmed that two nurses are being investigated.
Professor Griffiths said that some allegations surrounding the case would be very serious if proved and that such allegations had been drawn to the attention of the General Medical Council. One of the allegations is that signatures on consent forms had been forged.
An audit of all children who received CNEP ventilation is to be set up to discover whether any long term problems can be attributed to the technique. But Mr Fillingham emphasised: “It's clear that the trial design was within guidance that stood at the time, although it would not fit in with best practice now.”
The Department of Health has announced that a comprehensive research governance framework for the NHS is being developed and will produce new procedures to ensure valid consent is obtained.
Report of the Review into the Research Framework in North Staffordshire is available from the Communications Unit, Bartholomew House, 142 Hagley Road, Birmingham B16 9PA (tel 0121 224 4600) or at www.doh.gov.uk/wmro/northstaffs.htm.