MMR Vaccinations and Autism
10:02 pm
Dr Evan Harris (Oxford West and Abingdon, Liberal Democrat)
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 Association—now the Royal College of Paediatrics and Child Health—in 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 conditions—likely specific clinical benefit to the child—were 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 research—as it was called at that time—where 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:
"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."