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for "unlawful unless" in Clause 30(1). This may seem rather odd, as it might be thought that the phrases are identical in meaning and effect. However, perhaps I may briefly explain the thinking behind it.
There is a concern in the scientific community that the use of the words "lawful unless" implies that Clauses 30 to 33 are not enabling provisions in the fullest sense; that is to say, it cannot be said that it is lawful to include incapacitated adults in intrusive research if all of the requirements of those clauses are met. The interpretation that might be put on the current wording is that Clauses 30 to 33 are not exhaustive but instead impose requirements additional to any that may already exist at law, either under the Bill itself or under the existing common law of necessity.
The current law is in fact unclear and difficult to apply in a research context. The law of necessity requires that the research is in the best interests of the
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patient, which as we know is one of the overarching themes of this Bill. But research is rather different from other sorts of activity done for or on behalf of a patient. The nature of research is such that it is very difficult to say at the outset that its outcomes will benefit those patients participating in it, or, indeed, anyone else. In fact it is that very uncertainty that tends to make the research necessary. Research is really about exploring potential opportunities to benefit patients, present and future. So it is sometimes quite difficult to argue that this kind of activity is in an individual patient's best interests, unless one extends best interests to include the opportunity to fulfil the patient's belief in being altruistic.
I therefore share the misgivings of the scientific community about the appropriateness of the best interests test in a research context. If we insisted upon it, it could jeopardise much valuable research work that could be of great value to those suffering from mental illness or impairment, or at risk of suffering from them. If Clauses 30 to 33 are not enabling provisions and the best interests test under common law will continue to apply in addition to them, very considerable problems will persist as researchers attempt to apply the law. We want the law to be clear, but many fear that these provisions are not as clear as they might be.
I turn briefly to Amendment No. 116, which is in this group. There is a concern that the requirements in Clause 31 have been drawn up on the basis of our current understanding of how medical research works and how it benefits individuals. I am not a great one for giving Ministers more order-making powers, and perhaps the terms of the amendment are rather broader than on reflection I would wish, but this may be one case where a power of some kind is desirable to ensure that if there are scientific developments in the future that we cannot anticipate at present, the law can adapt to those without the need for passing primary legislation.
In passing, and in her absence, perhaps I may refer to Amendment No. 102, standing in the name of the noble Baroness, Lady Finlay. I think that it is appropriate for me to speak briefly to this amendment as it chimes in with an amendment that the noble Lord, Lord Turnberg, moved, I think, on the first day of our Committee proceedings. I believe that we have covered the material point in question that the noble Baroness raises in Amendment No. 102, but perhaps the Minister when replying could respond so that there is a reply on the record.
Lord Turnberg: I should like to support the noble Earl's Amendment No. 101, to which my name is attached. I support it for all the reasons that he has so eloquently set out. The question here is whether the words "unlawful unless" in relation to research are paramount and conflict with the later Clauses 31 and 32, which outline the formal steps researchers have to go through before doing a study. As the noble Earl has suggested, might it not be simpler if the words "lawful
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if such and such were in place" were substituted? I hope that my noble friend the Minister will take that on board.
The principle behind Amendment No. 100 has my full sympathy. I support the amendment, though I am not absolutely convinced about the need for it. If we inserted the words "physical" and "social", I would wonder why we have not included the word "psychological", because psychological research also can be intrusive. It may indeed be the case that we need to introduce too many qualifying terms. Might it not be better to think of intrusive research as meaning any type of research? That might be enough. I just wonder about that.
I should also like to comment on Amendment No. 102, tabled by noble the Baroness, Lady Finlay, in her absence. I think that this is an important amendment and would allow certain types of research not to be lost. If the Committee will forgive me, I can use here the example which I gave in an earlier amendment of the human biobank study in which half a million people are being asked whether they will volunteer to take part in a long-term research project over 10 to 30 years, in which time they will be followed very closely. If, as seems inevitable, some of the 500,000 people become incapacitated at some time, it would be a problem if the data collected on themthe accumulated data availablecould not continue to be used in the research. This amendment seeks simply to ensure that the data for which consent had been obtained can continue to be used as the patient loses capacity. I support this amendment.
Baroness Carnegy of Lour: When the Minister replies to this group of amendments, perhaps he could say a word about the place of local medical research ethics committees in this whole scene. For several years I was the chairman of one of these local committees in Scotland, and we had in our area a hospital where there were a number of people with insufficient capacity to make up their minds for themselves. A great many research projects were put before us, a number of which applied to that hospital.
When these research projects were suggested, I was astonished at the care that the committee which I chaired applied to discussing them. The defence of the patients and the thought about how they might be affected were enormously careful. We were all aware that the best defence of all would be given by the nurses in that hospital, who would not dream of allowing the patient to be exploited. When we are thinking about the Bill's provisions and the process applied to proposed research projects, we must realise that the local ethics committee will take much detailed care over the proposals.
The noble Baroness, Lady Barker, tabled Amendment No. 100 to express her anxiety about the possible intrusiveness of physical or social research. I thought that she made an extremely good point. However, it caused me to remember that when such research was suggested to our committee, it was one of the things about which we were most careful. What the
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noble Baroness says is absolutely right. At the same time, as the noble Lord, Lord Turnberg, pointed out, it is not just social and physical research that might be applied; there are other sorts of research that are not drug trials or strictly medical trials.
I think that the word "intrusive" would have been enough for our committee to go into great detail about exactly what the form of intrusiveness would be. We turned down quite a few trials. I should like to know from the Minister whether a local committee's rejection of a proposal will put a stop to it or whether the Bill will override that. These committees have a very important place. They are not amateur committees at all. They include some non-professionals, and there is usually a philosopher or theologian of some sort to stand back and look at the issues, but they also include professionals from a variety of professions. The committees usually contain bright people who not only know a great deal about the subject but are there specifically to think of individual cases in an individual place. So I would like to know exactly the place of those committees, if the Minister would be willing to give it.
Lord Alton of Liverpool: I would not want the silence at this stage of the debate on research to be misunderstood as agreement with carrying out research in these circumstances unless other safeguards are put in place. Without pre-empting my own Amendment No. 127 and amendments in the name of the noble Baroness, Lady Knight, and others, we will be having that debate a little later. This is almost a back-to-front debate. I think it would have been better in some respects if we had decided whether and in what circumstances there should be research before getting these kinds of detail.
Notwithstanding that, the amendment in the name of my noble friend Lady Finlay of Llandaff clearly relates to someone who has capacity deciding in advance, while they have capacity, that if they lose capacity later, they would wish the research to continue. That seems a perfectly proper approach and is one with which I have no problem. If the other safeguards which we will discuss later are put in place, I do not really have any difficulty with the points that other Members of the Committee have already advanced.
I should like to ask the Minister a question about the use of the word "intrusive", a point touched on by the noble Lord, Lord Turnberg, and the noble Baroness, Lady Carnegy. I wonder whether the word "invasive", which is often used in these circumstances, was considered and why we have chosen "intrusive" rather than "invasive" in these circumstances.
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