Patients 'should not be guinea pigs'

One of the incubators involved in the controversial trial

Patients must not be used as guinea pigs, says an inquiry into a controversial trial of ventilators on babies, some of whom died.

Professor Rod Griffiths, who headed the investigation, said a further review was needed of the way research is performed throughout the NHS.

I believe this report will create a foundation for successful research in the NHS, while increasing the confidence of patients that research is done properly and that people are not being used as guinea pigs

Professor Rod Griffiths

And his report into the alleged incidents at North Staffordshire Hospital called for new measures to ensure vital parental consent is obtained.

Ministers have accepted the recommendations.

The hospital was criticised for not keeping parents informed and not obtaining and recording consent properly.

The report was published after a 15-month inquiry into the controversial treatment involving a new type of ventilator at the hospital.

Professor Griffiths revealed that allegations of forged consent forms have been passed to the General Medical Council.

Professor Rod Griffiths: 'Parents lacked confidence in consent system'

The treatment was given to 122 premature babies between 1989 and 1993. Twenty-eight of the babies died and 15 suffered brain damage.

Professor Griffiths said that the Department of Health, professional medical bodies and regulators should co-operate to draw up clear guidance for the issue of consent during clinical trials.

It was not possible to say whether any deaths were caused by the ventilators, he added.

The report also heard evidence on the use of covert surveillance cameras to detect parents who physically abuse their children in hospital in an attempt to draw attention to themselves.

Professor Griffiths wants new guidelines to ensure children's welfare is guarded during surveillance of youngsters deemed to be at risk of harm from their parents, step-parents or carers.

Increasing confidence

"I believe this report will create a foundation for successful research in the NHS, while increasing the confidence of patients that research is done properly and that people are not being used as guinea pigs."

He said: "People didn't have confidence in the process."

The report panel said: "What was totally unacceptable to those interviewed was the apparent lack of adequate explanation, of choice and of consequent properly elicited and recorded consent."

The ventilators are no longer used for premature babies, but are still used for infants.

The investigation by the regional health authority focused on the way the trials, performed by consultant paediatrician Professor David Southall, were carried out.

Professor David Southall: controversial treatments

Professor Southall, who is noted for being in favour of videoing parents suspected of child abuse, and another consultant at the trust are under suspension.

The hospital says consent was obtained. Following publication of the report, David Fillingham of the trust said: "There are a number of lessons that need to be learned."

Carl and Debbie Henshall's daughter Stacey died on the machine in February 1992 and her sister Sophie suffered brain damage and is permanently disabled.

They claim Sophie was put on the trial without their consent.

Mrs Henshall welcomed the report. She said: "There were no easy answers to the concerns we were raising and the whole ethos around research in general.

"The report goes a long way and it's extremely thorough to reassure the public that there's greater protection."

Iron lung

The Continuous Negative Extrathoracic Pressure (CNEP) ventilator used in the trial works in the opposite way to a traditional ventilator, using the same principles as an iron lung.

Health Minster Lord Hunt said he accepted all the report's recommendations.

He said: "There needs to be a culture change in the NHS - a shift in the balance of power in favour of the patient."

Changes had been put in place since details of the North Staffordshire scandal emerged, he added.

These included guidance on the conduct of clinical trials and obtaining consent.

Dr Michael Wilks, chairman of the British Medical Association's Medical Ethics Committee, said: "The boundaries between experimental research and pioneering but unconventional treatment are not always clear.

"That makes it all the more important that doctors are clear about their ethical obligations."