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Dr. Harris: I shall certainly give way to the constituency MP for the Royal Free hospital.
Glenda Jackson: I am delighted that the hon. Gentleman remembers that the hospital is in my constituency. Is he disputing the fact that the hospital's ethics committee was concerned, particularly about the fact that the project required children to undergo, as he has just pointed out, an intensive regime of investigation? The hospital's ethics committee put that point to the senior clinical investigator, Professor John Walker-Smith, who replied:
In 1996, just as now, there were tough rules to protect children from being exposed to risk for research purposes. We are not judging this case by the standards of today but by the standards of 1996, when four separate sets of guidelines applied. The guidelines were published and circulated by the Department of Health in 1991, the British Paediatric Associationnow the Royal College of Paediatrics and Child Healthin 1992, the General Medical Council in 1994 and the Royal College of Physicians in 1996. The guidelines made it clear that children should not be exposed to anything more invasive or risky than a blood test unless certain conditionslikely specific clinical benefit to the childwere met; that proper approval be sought in advance from a research ethics committee; that the advice and instructions of the research ethics committee be followed to the letter; that changes to the agreed arrangements be agreed in advance by the research ethics committee; and that patients or their parents be given all the necessary information about risks for them to able to give adequate and adequately informed consent.
The research ethics committee was bound by the same guidelines to refuse permission for any tests or procedures that were more than minimal risk if they were not in the best interests of the individual child. That means that so-called non-therapeutic researchas it was called at that timewhere there was no likely clinical benefit to the child in terms of therapy, was not allowed to involve anything worse than a blood test.
I shall quote some of the guidance that existed around that time. The BPA guidelines 1992 state:
The clinical management and the investigation of these children was performed at the Free by a dedicated team of consultant paediatric gastroenterologists, in full consultation with and agreement of the parents of the affected children."
Glenda Jackson: Will the hon. Gentleman give way again?
Dr. Harris: I wish to make some progress, if I may.
According to papers released to The Sunday Times by the strategic health authority, the research ethics committee did not appear to ask an independent outside expertthat is, someone who is independent and outside and expertwhether the battery of tests could be considered of therapeutic value to the children. In fact, after publication of the paper, the research ethics committee tried to claim that it was not even its job to
make a judgment about whether procedures were in the children's best interests. That in itself is a shocking admission of incompetence, so the Department of Health should investigate every ethics approval that the committee has ever given for research on children, to see whether anything else was allowed throughin effect, on the nod.The published paper stated that the investigations had been granted clinical ethical approval by the ethical practices committee of the Royal Free, but the research ethics committee says, in a letter from the chairman to the dean, dated 24 July 1998:
As it happens, the researchers had submitted their application in a form to which approval might have been given, even if the research ethics committee had looked at it properly. The researchers asked for permission to carry out the tests on 25 children with a condition known as disintegrative disorder, which is also known as disintegrative psychosis or Heller's disease. DD is a much worse form of developmental disorder than autism, and the researchers stressed in their application that it is separate from autism. They said, in paragraph 5, "Scientific background", that
Despite getting research ethics approval to perform the tests only on children with disintegrative disorder and despite the researchers stating that the tests were clinically necessary to benefit the children, the published research shows that not one of the 12 children had DD. One was diagnosed "Autism? DD?", but not one had DD. Most had autism. In another paper published later in 1998an abstract in Gutthe authors admit to carrying out the tests on 30 children, only two of whom had DD. By 2000, some 60 children had been subjected to endoscopies, according to an article in The American Journal of Gastroenterology, of whom only two had DD. When the research ethics committee gave approval for
the application it saw, it made it clear that any changes to the proposed tests or the group of children should be cleared with it in advance. That is standard, and it is written in the letter of approval. The research ethics committee received no such request to change the protocol, so up to 30 children were experimented on with no proper ethical approval and with no likelihood of individual clinical benefit.
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