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Babies used in research trials without consent

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March 17, 1995

More than 50 babies referred with their parents to a paediatric team currently attached to Keele University were involved without their parents' knowledge in a previously undisclosed research project, whose existence has just been confirmed in an anonymously leaked letter.

The letter, written in November 1993 by David Southall, professor of paediatrics at Keele, of which an anonymised copy is in the possession of The THES, confirms that investigations into "fabricated and induced illness" involving "32 cases detected by covert video surveillance" were "continued research into the subject".

Published annual reports of the local research ethics committee attached to Keele University confirm that there is no record of any authorised research into this form of illness, with or without covert video surveillance.

Thirty two of the babies secretly recruited to the project were subjected to controversial child abuse investigations using covert video surveillance. 20 were involved in other investigations.

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The existence of such research has long been suspected, not least by some of the parents involved. In February one expert claimed in the Journal of Medical Ethics to have identified its existence and objectives solely from the team's own published papers.

Professor Southall has repeatedly denied the existence of any "formal" research in which child abuse investigations played any part.

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The team led by Professor Southall was formerly part of London University Heart and Lung Institute at the Royal Brompton Hospital, until early 1992, when it relocated to Keele's postgraduate medical campus at North Staffordshire Hospital, Stoke on Trent.

Other published correspondence discloses that there were 18 cases observed under Covert Video Surveillance prior to moving to Keele.

The Royal Brompton Hospital has said that it gave approval for Covert Video Surveillance for procedural purposes only, not as a research project. The chair of North Staffordshire Hospital local research ethics committee said that the committee was not asked to consider Covert Video Surveillance as a research project either. Last December, in a written answer to a question by Welsh opposition health spokesman Rhodri Morgan, John Bowis, junior health minister, said that Covert Video Surveillance was not a "research experiment", but acknowledged it was one of a number of "innovative developments" available for the treatment of individual children.

However, writing in the leaked letter to another doctor, Professor Southall justifies disputing an Appeal Court judgment returning a baby to its mother by reference to: "Our continued research into the subject", fabricated and induced illness, "involving now 32 cases detected by covert video surveillance and an additional 20 in which I have been an expert witness".

He wrote: "Consistently, we see parents when they are being videoed acting extremely well to their children in the presence of nursing or medical staff, but as soon as the staff move out of the room, leaving the parent alone with the child, the abuse and estrangement from the child occurs."

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Mr Morgan said: "The minister used weasel words in an attempt to avoid admitting this work was research. The babies involved have been guinea pigs for an unauthorised experiment."

According to published literature, the Keele team had hoped to find a way of using traces taken on an Event Recorder at home during suspected suffocation attempts, as diagnostic, without the use of CVS. But to achieve this traces needed to be taken during suffocation attempts observed under CVS.

Parents were filmed for up to 20 seconds at a time attempting to suffocate their babies. The outcome of this work was reported in November 1993 in the Journal of Pediatrics, but in respect of suffocation was declared to be inconclusive. It was not declared to be research.

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Most families referred to Keele live in other parts of the country. But one mother living in Staffordshire accused of Munchausen Syndrome by Proxy after referral to Keele, who acts as a local co-ordinator for an informal group campaigning for an official inquiry into the Keele team, said: "I don't think they should be allowed to continue this work until any unauthorised research has been fully investigated."

Her children were taken into care last year after a child-abuse investigation not involving CVS, and returned after a court hearing, but she is still unable to be identified for legal reasons.

She added: "Professor Southall can't have it both ways. He holds opinions he claims are backed by his research, but when asked if his work is research he denies it."

Keele has referred queries on Professor Southall's work to the hospital, and last November hospital management said it would not respond to any more enquiries. Last week, it did not respond to a query as to whether it was satisfied on reading Professor Southall's claim as to "continued research" that there has been no unapproved research in his department.

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