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Lord Alton of Liverpool: Before the noble Baroness withdraws her amendment, I should like the Minister
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to return to a point that was raised earlier as regards the direct interest that a researcher might have with the person on whom research was taking place. Should a suitable barrier be in place so that no researcher should ever be able to give the authority for research to proceed?
Baroness Andrews: I cannot give the noble Lord a swift answer on that. It may be that there are protocols in the governance of research which prevent that from happening. I shall have to seek advice from my noble friend, but I shall be happy to look into it and to answer the question.
Baroness Knight of Collingtree: I am grateful to the noble Baroness for much of what she said. I confess that I do not think that all of my concerns have been met, but I have no doubt that she has done her very best.
Either I misunderstood the noble Baroness or one of us is wrong. I understood her to say at the beginning of her remarks that Clause 30(2) indicated that a mentally handicapped person could not be used without his consent. But I do not think that Clause 30(2) means that. It states: "Research is intrusive"but what is "intrusive"?
Baroness Andrews: The noble Baroness and I will have to disagree. My interpretation and best advice is that no research will be carried out that would be unlawful on a person with capacity. Consent must be obtained from the person without capacity. I will write to the noble Baroness to give her more supporting and contextual evidence.
Baroness Knight of Collingtree: I am most grateful for that point. In my experience, during discussions outside this Chamber but within this House with people who are in some way impaired, I was very pleased to find that quite a number of them do not lack capacity.
I am not in any way against research. I am trying to say that one must never make use of a person who cannot give consent. In connection with that, European legislation makes it clear that the interests of the patient alwaysI repeat, alwaysprevail over those of science and society. It is that that I am so
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anxious to preserve. I wish we couldperhaps we maylook at the numbers of people who might agree when it is explained to them. Those people can grasp a situation. Many of them want to help. I would not be against using them at all.
My major concern is that it is wrong to use people who are incapable of saying "yes", just because they are there and have a certain condition. That is what is behind this amendment. If I withdraw this amendment, perhaps we may return to my great concern on this matter and try to seek better protection and another way of doing it.
Baroness Andrews: We look forward to the next round of debate. I will see what I can do to clarify the assumptions made by the noble Baroness. I would just stress that we believe in all sincerity that the safeguards that we have got, the conditions that are attached, the language that we use and the protocols that already exist are very robust, even compared with some of our international partners. The point made by the noble Baroness about science and society will be addressed in a later amendment in the name of the noble Lord, Lord Alton.
The Deputy Chairman of Committees (Viscount Simon): In calling Amendment No. 107, I must advise the Committee that if it is agreed to I cannot call Amendments Nos. 108 to 110 inclusive because of pre-emption.
The noble Baroness said: I can see that there is an argument for research to be carried out for "the greater good". However, I feel that we should not encourage a "we can so we will" attitude to research. Although the Minister has allayed some of my concerns, we must remember that in 60 years' time we will be judged on how we cared and protected the most vulnerable members of our society. Do we want to be remembered for legalising experimentation on people who lack capacity?
If there is no potential to benefit the patient, no research or experimentation should be carried out on someone who lacks mental capacity, unless specific permission has been given in an advanced decision. If we include Clause 31(4)(b) without a "must have" subsection (4)(a), we cast doubts over the kind of society that we are. We are supposed to be a caring, compassionate and humane society. Let us keep it that way. I beg to move.
Lord Alton of Liverpool: Amendment No. 127 is grouped with Amendment No. 107, which was moved by my noble friend Lady Chapman. Perhaps I may say
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in parenthesis that I strongly support the sentiments that she has just expressed. During our previous debate, we had some discussion about the safeguards of the use of medical research ethics committees. Quite a lot of store has been placed on them, following the intervention made by the noble Baroness, Lady Carnegy.
Before moving to the major argument that I want to put forward in favour of Amendment No. 127, it might be worth saying to the noble Baroness, Lady Andrews, thatgiven the kinds of concerns that my noble friend has just expressedthere are representative statutory organisations, such as the Disability Rights Commission, the Disability Rights Alliance and the groups that we have been hearing from during these proceedings. In addition to those people who already serve on the ethics committees, it might be worth the Government's while to think about including someone specifically from the Disability Rights Commission or one of its nominees to serve on such committees to act as a watchdog.
I serve on my university's ethics committee. It looks at issues, such as the use of animals in experimentation. Under Home Office guidance, it is required that someone is there to put the case of whether the experiments are necessary or repetitive, and so on, which is the role that I perform on that committee. It seems to me that that would not be a bad model to have in this context. It might give some comfort to some of those who have expressed anxiety of the sort that we have heard in Committee.
In the 23rd report of the Session 200304 of the Joint Committee on Human Rights, there was severeI use that word deliberatelycriticism of this Bill's proposals on medical research on the mentally incapacitated, as the noble Baroness, Lady Knight, rightly said at the conclusion of her earlier remarks. The Joint Committee pointed out that the provisions of the Bill do not match those of the European Convention on Human Rights and Biomedicine. The UK has not yet ratified the convention, but in relation to the provisions on research it does accept that it represents "longstanding international consensus", a phrase that the Government themselves have used.
"It seems to us, on initial consideration, that the introduction of the reference to there being reasonable grounds for believing that the research would be less effective if carried out only on persons with capacity is a significant dilution of the condition contained in the Human Rights and Biomedicine Convention, which states the requirement as a matter of fact rather than as a matter of reasonable belief.
"We find it impossible to avoid the conclusion that the nature of the benefit from the research required in clause 31(4) of the Bill has the effect of lowering the threshold of when research will be permissible compared to the standards contained in the Convention. The absence of a reference to the potential benefit being 'real and direct' in clause 31(4)(a)"
I shall quote a little further from the Joint Committee because we should take great account of these deliberations. They are obviously of huge importance and they reflect directly on the provisions now being considered:
A few moments ago the noble Baroness, Lady Andrews, told us that the Government are satisfied that the position taken by the Bill is a stronger one. But that is not the position outlined by the Joint Committee on Human Rights. It says that it is a much weaker requirement than that contained in the convention. The report goes on to state:
"The introduction again of a reference to 'reasonable grounds for believing', the reference to 'negligible' rather than 'minimal', and the introduction of the qualification that the impact on the person's rights should not be 'significant', all in our view reduce the threshold for the carrying out of research on people lacking capacity, and therefore make it more likely that such research will be carried out in circumstances which are not contemplated by the Human Rights and Biomedicine Convention".
"Securing the benefits of research for people who lack capacity is a legitimate aim, but pursuit of it must be accompanied by strict safeguards in order to be compatible with the rights of people lacking capacity".
It is difficult to comprehend why a Bill which purports to safeguard the rights of the mentally incapacitated should allow research to take place on these people without their consent and without benefit to the person being experimented upon. Assurances from the BMA and others that everything will simply be all right and we just have to trust the researchers do not really wash with the general public, nor do I believe that they should do so with Members of the Committee.
The Minister knows that I am unhappy with the principle of non-therapeutic research on the mentally incapacitated. It is a view that I expressed during the recent briefing that was kindly organised by Ministers, and I have also been in correspondence with the Government on the matter. It does not fit well with the overriding principle in the Bill that any acts done or decisions made on behalf of a person who lacks capacity must be in their "best interests".
The fact that the research may be for the benefit of a wider section of society is arguably irrelevant. After all, if I am a person of full capacity and a doctor asks me whether I would be prepared to consent to tests, albeit not massively intrusive tests, which are not for my direct benefit but might benefit thousands of other
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people, as the law in this country currently standsthank goodnessit is my right to say no. The idea that if I were incapacitated someone could make the decision for me is therefore deeply troubling.
The Government have argued that they have departed from the language used in the European Convention on Human Rights and Biomedicine and the Helsinki Declaration principally because the Mental Capacity Bill is intended to cover a broader range of research than direct medical interventions on the person, extending also to health and social care research projects which may include accessing medical records or observation of the person in their care setting. Yet there is nothing in the Bill to make that explicit. As the Joint Committee on Human Rights has observed,
"designing a single set of provisions which is designed not only to cover intrusive medical research but also other less intrusive types of research has the effect of diluting the standards applicable to the former type of intrusive research".
No doubt the Government are studying the recommendations of the Joint Committee on Human Rights and I am sure that when the noble Baroness comes to reply, she will want to give at least an interim response. But I hope that the Government will feel able to be flexible and positive in their response to these recommendations. For some time now I have argued that the very fears that many hold about research, and which were so eloquently expressed by my noble friend Lady Chapman earlier, could be assuaged if the Government were to include in the Bill the words from the Helsinki Declaration: where research is being considered, the,
"The clinician and health-care workers responsible for the care of P shall remain responsible for protecting the life and health of P and shall, at all times, ensure that P's life and health are protected during the course of research.
"At all times, the life, health and well-being of P shall take precedence over the research [the Helsinki point] being carried out on P and, in the event of any danger to P's life, health or well-being, P must be withdrawn from the project unless his life, health and well-being can be protected by the research being undertaken in a different manner".
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