I shall certainly give way to the constituency MP for the Royal Free hospital.
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:
"I can confirm that the children would have these investigations even if there were no trial."
That is the key question, which I shall deal with. If that were the case, there would be less of a problem, although there would not be no problem at all. I do not believe that that was right then or that it is now.
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.
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I shall quote some of the guidance that existed around that time. The BPA guidelines 1992 state:
"Children are unique as a research group for many reasons. They are the only people, in British law, on whose behalf other individuals may consent to medical procedures. Many children are vulnerable, easily bewildered and frightened, and unable to express their needs or defend their interests . . . The physical integrity of children, as of all other people, is protected by law. Unless they, or their parents or guardians acting on their behalf, agree to it, nothing can be done lawfully that involves touching them . . . Parental consent will probably not be valid if it is given against the child's interests. This means that parents can consent to research procedures which are intended directly to benefit the child, but that research that does not come into this category can only be validly consented to if the risks are sufficiently small to mean that the research can be reasonably said not to go against the child's interests."
The Department of Health guidelines 1991 are similarly clear:
"Where the proposal is for non-therapeutic research, all of the above applies"
criteria for other patients
"but in addition the child must be subject to no more than minimal risk as a result of his/her participation."
The local research ethics committee
"should note that those acting for the child can only legally give their consent provided that the intervention is for the benefit of the child."
The BPA was very clear about what sort of procedures were considered minimal risk, low risk and high risk:
"High risk procedures . . . should be carried out only when research is combined with diagnosis or treatment intended to benefit the child concerned. It would be unethical to submit child subjects to more than minimal risk when the procedure offers no benefit to them, or only a slight or very uncertain one."
Is the hon. Gentleman disputing what Professor Humphrey Hodgson, the vice-dean and campus director at the Royal Free and University college medical school, said in a statement issued on behalf of the school and the Royal Free Hampstead NHS trust:
I disagree with the Royal Free when it says that the protocol was subject to rigorous ethical analysis, and I shall say why I do not think that the necessary requirements were met.
Will the hon. Gentleman give way again?
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
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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:
"On 9th July you wrote to me for my comment on the letter of Professor David Hull. In his letter Professor Hull states: 'I see that the investigations were approved by the Ethical Practices Committee of the Royal Free Hospital NHS Trust.' This is, of course, incorrect. We did not approve the investigations."
However, the paper says clearly that the investigations were approved by the ethical practices committee of the Royal Free hospital. They cannot both be right. I suspect that both are wrong, in some ways, but one at least is wrong.
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
"disintegrative disorder differs from autism in the loss of motor and self-help skills and usually, too, in the lack of more complex stereotype behavioral patterns".
The researchers were clear on that point, and it is still the accepted view today. DD is of later onset and involves significant loss of acquired skills. DD is rare and, in a few cases, can be caused by a metabolic disorder that can be detected by high lactate levels in the cerebrospinal fluid. It could be argued that doing spinal taps on such children would allow doctors to diagnose a metabolic disorder, or to rule it out. Since such diseases are not treatable, generally speaking, the benefit is limited, but at least a benefit can be argued. However, no major group of doctors in the UK argued at the time, or argues now, that spinal taps be performed on children with autism for any clinical benefit, and certainly not as an excuse to obtain cerebrospinal fluid for private research contracts.
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
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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.