§ Motion made, and Question proposed, That this House do now adjourn.—[Mr. Peter Lloyd.]2.36 pm
§ Mr. David Amess (Basildon)
I wanted the House to debate the subject of experimentation on premature babies because of my profound respect for life and my conviction that Parliament is failing miserably to protect it. In the remarks I shall make, it is not my intention to undermine the confidence or support that the general public has in and for the medical profession. However, I regret that among some quarters, especially those in support of experimentation, there is an arrogance, almost amounting to insolence, that the medical profession knows best and that Joe Public does not know what he is talking about and has no right to an opinion. Such a view is unacceptable. The mood of the British people is changing. We have a right to know the truth. That is what we expect; nothing less.
Most people accept that life begins at conception. I am not aware of any opponent of that view having been able to disprove it. With that in mind, the House will not be surprised at how concerned I and many other people were when the findings of a report published by the Institute of Medical Ethics was released. People were appalled to learn that about 2,000 sick or premature babies are used in medical experiments each year without parental consent. The Sunday Express published a leader headlined "A Sick Society" which stated:We have allowed abortion to grow into a major industry which kills the unborn as a matter of routine. We permit medical science to conduct experiments on the human foetus. It is commonplace now for scientists to argue that embryos should be produced solely for the benefit of research. Will it really be any surprise if future generations look back on the evils we permit and conclude that our society was rotten beyond redemption?I am pleased to see that my hon. Friend the Member for Hyndburn (Mr. Hargreaves) is in his place in the Chamber. He will recall a conversation that we had some weeks ago with an eminent doctor who had just returned from visiting an abortion clinic in London. That clinic specialised in late abortions that were given primarily to people from overseas. So late were those abortions that a mincing machine had to be used to destroy the limbs. Only a few weeks ago we read of an abortion where the child was still alive. If ever those words of the leader in the Sunday Express were true, they are true now.
The medical experiments to which I shall refer involve invasive procedures, some of which could prove harmful to the babies, whilst others could benefit them. Some might be quite simple techniques, such as taking blood samples. Others could be far more harmful. We do not know. Nor do we know how many of those experiments would be in connection with developing new forms of treatment. I am told that a number would be in connection with learning more about the basic physiology of premature babies and, in some cases, improving the care of those infants, perhaps by the use of drugs or other means.
As for parental consent, if research involving invasive techniques was carried out on a child for whom no direct benefit was intended and that research might damage that child, I regard it as irrelevant to be told that the parents gave permission. Surely in this country giving my 657 permission would not make lawful any kind of assault on my children, no matter how beneficial the result may be in helping other children. That was the view of the DHSS and the Medical Research Council only six years ago when, in 1980, a report from the Social Services Committee on perinatal and neonatal mortality was published and highly publicised as the Short report. In that report, parliamentarians were told that the MRC said:in the strict view of the law, parents and guardians of minors cannot give consent on their behalf to any procedures which are of no particular benefit to them and which may carry such risk of harm".The DHSS said:the position in law is that no parent or guardian of tender years is entitled to give consent to any procedure which is not for the benefit of the child.Of course, there was something of an outcry at the time about the suggestion that newborn handicapped babies might be used for experimental purposes.
As the Short report claimed that there was nostatute law or case lawon which to base the DHSS and MRC advice, counsel's opinion was sought by the pro-life lobby. In this, counsel quotes the Children and Young Persons Act 1933 as amended by the Children and Young Persons Act 1963 and the Children Act 1975 and says:If any person who has attained the age of 16 years and has the custody, charge or care of any child or young person under that age wilfully assaults, illtreats, neglects, abandons or exposes him or causes or procures him to be assaulted, illtreated, neglected, abandoned or exposed in a manner likely to cause him unnecessary suffering of injury to health, that person shall be guilty of an offence.The view of counsel was that this covered any invasive procedures on a child that could do it harm, were not for the direct benefit of the child concerned and that were prohibited by that legislation as well as by trite law.
During the study by the Society for the Study of Medical Ethics, many reports of research on children undertaken in the United Kingdom and published in British journals were examined. Few described a project that might have been unethical, although some projects could be described as being unkind. However, some research projects carried out overseas would have been most unlikely to receive ethical approval from any British research ethics committee. A French researcher performed four lumbar punctures each on 57 newborn babies in the first two weeks of their life, in an unsuccessful attempt to find biochemical support for a rather unlikely scientific theory about brain damage in infants. An Indian team performed liver biopsies on 29 children with biochemically normal liver functions, because the children had sibling with Indian childhood cirrhosis and the researchers were looking— unsuccessfully I might add—for evidence to support the idea that that disease had a genetic origin.
I understand that, at the Cambridge neonatal intensive care unit, it is not the practice to get consent from parents for all experiments. The Institute of Medical Ethics bulletin includes a report from a meeting at which a Cambridge consultant actually said that it was unethical to obtain permission from parents and that they should be told as soon as possible afterwards. The same unit has been examining the respiratory distress syndrome and has been trying to find a way of getting the missing chemical 658 back into the lungs of premature babies. Having met with no success, is it worth while continuing and is such research of benefit?
I have to tell the House that I, along with many other people, am not satisfied with controls on experimentation on life. The DHSS, following a recommendation, put out a circular in 1975 calling for research ethics committees to be established as an obvious safeguard and form of control. As far as I am aware, absolutely nothing has happened since that recommendation. I would be interested to know what safeguards the Department requires on experimentation. What procedures have to be adhered to? What checks are carried out, and how?
I fully recognise the marvellous advances that medical science has made in so many areas of health care. However, in certain quarters there is an arrogance that amounts to a view that research is all-important regardless of the lives being used or destroyed to that end.
Only this week, the largest lobby of this Session—well over 10,000 women, men and children—took place in support of the Bill which my hon. Friend the Member for Hyndburn sought to introduce. I say to my right hon. Friend the Minister and to my party, if we are looking for popular legislation to introduce, that which would outlaw experimentation and give protection to the unborn child is what the whole nation cries out for. If we fail to act on these matters, we shall rightly be regarded with contempt. If we grasp the nettle, future generations will salute this Parliament as a Parliament of Kings.
§ Mr. Ken Hargreaves (Hyndburn)
I am most grateful to my hon. Friend the Member for Basildon (Mr. Amess) for allowing me to speak in his Adjournment debate. Like him, I was concerned to read the report produced by the Institute of Medical Ethics, and, like him, I was delighted that the Sunday Express published an important leader on the subject—a leader which I feel put forward the views of the overwhelming majority in this country.
It was a brave gesture on the part of the Sunday Express when one considers that the largest rally I have seen this Parliament—some 10,000 people lobbying Members of Parliament against research on human embryos on Wednesday—was totally ignored by the national press and television, with the exception of a few lines in The Guardian My appearance on Central television was cancelled because the viewers were likely to be upset by the subject.
The pro-life issue is not a popular one with the media, or the Government who seem to accept abortion on demand and apparently condone experiments on embryos. Having set up the Warnock committee because they recognised the danger of developments in embryology, they have done nothing about it.
If we have no respect for human life at its earliest and most vulnerable stage, should we be surprised that at a later stage, muggings, rape and murder increase? Do they not stem from the same lack of respect we show if we support abortion on demand and experiments on embryos and premature babies?
In 1980 a highly regarded parliamentary Select Committee concluded that the law prevented any invasive procedures on a child which could do it harm and which were not for the direct benefit of the child involved. That view of the law was confirmed by the DHSS and the Medical Research Council. Indeed, the Select Committee 659 recommended that the DHSS should arrange for further medico-legal discussions, with a view to amending the law as it relates to research on newborn infants. No such discussions have taken place and certainly no Bills of such a nature have been put before the House. Yet within six years we learn that the medical establishment—playing God — has started undertaking these practices in hundreds, possibly thousands, of cases.
The latest report contradicts the Short report and tells us that these procedures are allowable. However, it says that efforts should be made to develop scales quantifying risk and benefit—to others, not to the child concerned—so as to reduce reliance on the qualitative description of risk in use at present.
The report is a chilling insight into the activities of some doctors. It is very worrying for parents and patients, and makes all patients wonder whether they are being used as human guinea pigs. The way ahead for research is through mutual trust and not hoodwinking trusting, unsuspecting people, be they patient or parent.
§ The Minister for Health (Mr. Barney Hayhoe)
I congratulate my hon. Friend the Member for Basildon (Mr. Amess) on choosing the subject of experiments on premature babies for his Adjournment debate. He gave time to our hon. Friend the Member for Hyndburn (Mr. Hargreaves), but I must reject the latter's assertions about the Government's attitude to abortion and research on human embryos that he included in his short intervention.
I am very glad to have the opportunity to reply to this debate on the important topic of research on premature babies. The vulnerability of children and of young babies makes particularly repugnant any suggestion that research is being carried out on them which is either harmful or unethical. I share the concern, so eloquently and properly expressed by my hon. Friend the Member for Basildon, arising from the recent report from the working group of the Institute of Medical Ethics on medical research with children, which suggests that breaches of existing codes of practice in that area may be taking place. While my officials are not aware of any direct evidence to that effect, I can assure my hon. Friend that I shall look carefully at what he has said today and make urgent inquiries about the matters that he has raised or that others raise with me as a result of the debate, because I fully accept the great importance of the subject.
The conduct of clinical research in this country is governed by the provisions of the general law and by the ethics of the medical profession. It is, I understand, widely accepted that research investigations on human beings should be governed by codes of practice such as those of the World Medical Association and of the Medical Research Council. Those are general statements of principle. More detailed guidance on the application of those principles has also been issued in this country by the Royal College of Physicians, in 1967, 1973 and most recently in 1984 and, specifically on research on children, by the British Paediatric Association in 1980.
In 1962, the Medical Research Council issued a statement on responsibility in investigations on human research because rapid advances in medical knowledge over the preceding 50 years were posing increasing legal and ethical problems for both investigators and their subjects. In 1967 the Royal College of Physicians recommended that clinical research investigations should 660 be subject to ethical review. In 1973 the college made detailed recommendations on the composition and scope of the ethical committees which conduct that review.
In 1984 the college published further guidelines on the practice of ethics committees in medical research, which summarised aspects of the practice of ethics committees and the problems that they face. That guidance again stresses the importance of all research projects affecting human subjects going before an ethics committee for consideration of both the ethical aspects and quality of the proposal, makes recommendations for the membership and mode of working of ethics committees and gives guidance on some of the particular issues that the committees need to consider in relation to each project that comes before them. They would, for example, include the way in which consent is to be obtained, the involvement of vulnerable groups in research and so on. Those guidelines are relevant to the conduct of all research, including trials, and the particular dilemmas of conducting research on children are clearly acknowledged.
The ethics of health research in this country has traditionally and generally been for self-regulation by the health professions. However, in 1975, as my hon. Friend said, the Department of Health and Social Security gave advice to health authorities based on the Royal College of Physicians' deliberations. The then Secretary of State accepted the college's recommendations on the composition of ethical committees and asked health authorities to put those recommendations into effect. Two matters of particular importance were drawn to health authorities' attention. First, health authorities were asked to note the Royal College of Physicians' report recommendation that all proposed clinical research investigations should be referred to an ethical committee. The second concerned clinical research investigations of children or mentally handicapped adults. The DHSS guidance drew attention to the uncertainties of the law of consent in that respect. I shall return to that in more detail in a moment.
This departmental guidance was issued more than a decade ago and I am glad to confirm to my hon. Friend that consideration is being given as to whether new guidance from the Department is now required. While I cannot yet say what such new guidance might cover, subjects for inclusion could well be the composition, status and functioning of ethical committees and the need for all clinical research investigations in NHS institutions to be referred to them. In the light of the recent report on research on children, the need to include up-to-date advice on the position of minors in research trials is also very much in my mind.
As things stand, all the available guidelines recognise the problems involved in considering research on children. However, there is a wide range of views about the type of research of which children might ethically be the subject and on questions about who can consent to a child's involvement in a research project. The Medical Research Council's advice issued in 1962 said:The situation in respect of minors (and mentally subnormal or mentally disordered persons) is of particular difficulty. In the strict view of the law parents and guardians of minors cannot give consent on their behalf to any procedures which are of no particular benefit to them and which may carry some risk of harm. Whilst English law does not fix any arbitrary age in this context, it may safely be assumed that the Courts will not regard a child of 12 years or under (or 14 years or under for boys in Scotland) as having the capacity to consent to any procedure which may involve him in an injury. Above this age the reality of any purported 661 consent which may have been obtained is a question of fact as with an adult the evidence would, if necessary, have to show that irrespective of age the person concerned fully understood the implications to himself of the procedures to which he was consenting.Even when true consent has been given by a minor (or a mentally subnormal or mentally disordered person) consideration of ethics and prudence still require that, if possible, the assent of parents or guardians or relatives, as the case may be, should be obtained.Investigations that are of no direct benefit to the individual require, therefore, that his true consent to them shall be explicitly obtained. After adequate explanation, the consent of an adult of sound mind and understanding can be relied upon to be true consent. In the case of children and young persons the question of whether purported consent as true consent would in each case depend upon facts such as the age, intelligence, situation and character of the subject and nature of the investigations".There can be no question of purported consent in relation to premature babies.
That was the MRC's statement of the position in 1962. But legal advice coming to me now talks in terms of the maturity and degree of understanding that the young person demonstrates — a somewhat different concept. The implications of the House of Lords' judgment in the Gillick case will have some relevance in relation to consent for research, but clearly not in the context of premature babies. As a non-lawyer, I am straying on to dangerous ground and I shall return to the broader approach.
The World Health Organisation has accepted that the participation of children in research is indispensible for research on diseases of childhood and conditions to which children are particularly susceptible. It suggests that it is acceptable to allow children to participate in projects aimed at gaining knowledge on physiological or pathological conditions peculiar to infancy and childhood. The British Paediatric Association guidelines issued in 1980 assume that research which involves a child but is of no benefit to that child is not necessarily either unethical or illegal.
The Institute of Medical Ethics report suggests that the position should now be that the parent may consent to a research procedure if, when judged objectively, any risk involved in the research procedure is so small that it would not be against the child's interest to be exposed to that risk. It recommends that further efforts should be made to develop scales quantifying risk and benefit, as my hon. Friend said.
In an area which is governed by common law, and in the absence of any decided cases on the subject, it is not possible to be certain about how the courts would currently respond to this question. However, in view of the evident confusion that exists, I am sure that this must be carefully considered and these matters are included in the review of existing guidance I referred to a moment or two ago.
662 However, I receive very clear legal advice that, except in an emergency, a doctor may not lawfully give treatment which involves touching a person without that person's consent. And consent is valid only if it is given voluntarily by the person who has the capacity to consent and after appropriate information has been given to enable the decision of consent to be made. If a doctor fails to obtain a valid consent he will commit the tort and crime of battery and may also incur liability in negligence. It would also lay the doctor open to disciplinary action by the General Medical Council.
Early-day motion 916 of which my hon. Friends are cosponsors also refers to the subject of this debate. It suggests that the existing law is inadequate in this respect. However, I hope that what I have just said makes it clear that the law as it currently stands would not sanction experiments on young babies without their parents' knowledge or consent.
Let me make it quite clear that research on young children should take place only in well understood and properly authorised circumstances. The Institute of Medical Ethics working party was not, I understand, set up because the institute had any specific reason to believe that breaches of existing guidelines or ethical standards were taking place. It has helped to identify the very real ethical difficulties which can confront researchers in undertaking research on children and in obtaining parental consent to research on young babies.
Let there be no doubt about the widespread public concern that would be aroused if investigators were to develop an inflated sense of the importance of research and place this above the rights of children and their parents. Let me quote again from the 1962 report of the Medical Research Council:It should be clearly understood that the possibility or probability that a particular investigation will be of benefit to humanity or to posterity would afford no defence in the event of legal proceedings. The individual has rights that the law protects and nobody can infringe those rights for the public good. In investigations of this type it is, therefore, always necessary to ensure that the true consent of the subject is explicitly obtained.I hope that this short debate will have helped to clarify some of the confusion that undoubtedly exists. I also hope that the consideration that I have said is being carried out will help to put these matters on to a better and proper footing.
Reference was made to legislation dealing with the Warnock report and to experiments on the human embryo. It is appropriate for me to say again that on the crucial issue of experiments on human embryos the Government's position, as has been stated very many times, is one of neutrality and that legislation on these matters will be introduced by the Government as soon as practicable.
Question put and agreed to.
Adjourned accordingly at five minutes past Three o'clock.