The angry mother of a child involved in clinical research projects at the North Staffordshire Hospital - now the subject of a government-ordered review - has said she was "fooled twice" by doctors, and did not know that her daughter's treatment was part of a trial with experimental equipment.
The British Department of Health yesterday confirmed that an inquiry has already started into "the general framework" for approving and monitoring research at the hospital in Stoke-on-Trent, where an experimental treatment was carried out on 122 premature babies. Forty-three of the infants died or suffered permanent injury.
The Staffordshire case comes on the heels of revelations that Bristol Infirmary had kept the hearts of 170 dead babies for scientific evaluation. In that case parents of children who died after unsuccessful surgery have not yet been told which babies' hearts were kept for this purpose.
A spokesman for the NHS Trust hospital yesterday said the Staffordshire review did not address similar issues to those in the Bristol heart babies case, and insisted that the parents of all the children involved in the clinical study had given written permission.
That was strenuously denied by Mrs Debbie Henshall, whose first child died and whose second was left a quadriplegic. "They certainly didn't get consent from me," she told BBC Breakfast News: "I wasn't asked to sign any consent form or given any written information."
Mrs Henshall said: "I didn't find out until my second daughter, who had received the treatment, was four years old that the treatment was part of a trial and the equipment was experimental. I find that incredible. I just can't believe they can do that. I know my way around a `prem' unit, having had six premature babies, but basically they fooled me." She went on: "They fooled me not once but twice. I am angry about that."
The experimental treatment at North Staffordshire involved the use of a new type of ventilator, likened to a modern version of the iron lung to help babies breathe. Between 1989 and 1993, a total of 122 babies had the new treatment; 28 died and 15 suffered brain damage. The ventilators are still in use for older infants but are no longer used for premature babies.
The London Independent said yesterday that the inquiry, ordered by the health minister Baroness Hayman, would focus on what parents were told about the trial: whether it was properly approved and monitored by the hospital's ethics committee and whether it was permitted to continue after the number of unsuccessful cases was apparent.
Baroness Hayman ordered the review after representations from Labour MP Mrs Llin Golding, who had failed to persuade the previous government to launch an inquiry. Yesterday's statement said the hospital was aware and concerned that some parents felt they were not fully informed but continued: "When these concerns were first raised in May 1997 the hospital put on record that it holds the consent forms for this study. These are signed by the parents and exist for every child included."
But Mrs Golding said: "Despite what the hospital say about consent, a number of families believe they were not given enough information. Some parents just want to forget about the whole thing and mourn their children but others are joining the campaign. Parents may have known what was going on but they did not properly understand and this needs to be looked at."