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Baroness Barker: I thank the Minister for that detailed and considered answer, which contained some very helpful information. However, there was much in his comments that left me with more doubts about the extent to which different types of research will fall within the provisions of the clause. I appreciate the point made by the noble Lord, Lord Turnberg, about the imperfections of the amendment—it was tabled solely as a means of having this debate. In my defence, I should say that all the amendments relate to medical research. Indeed, the only bodies mentioned in all these clauses are medical, so it is not surprising that those who have considered this Bill have focused on medical research. That is right, because medical research is the most contentious issue.
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I was grateful to the noble Baroness, Lady Carnegie of Lour, for talking so knowledgeably about the work of her committee, and how, even for medical ethics committees, questions of social research are those that cause the greatest difficulty. I am sorry that the noble Lord, Lord Alton, did not receive the reply he had hoped for, because his point about "invasive" versus "intrusive" went to the heart of the matter. But the Minister then continued to use the word "invasive" throughout his response. So I am somewhat concerned about that.

The Minister mentioned that the Department of Health was setting up a research governance framework for social research, and that is most welcome. Could he, for my benefit, at some point explain the nature of the mechanism that will implement that governance framework? Will it run parallel to the local ethics committees? That would be extremely useful. Perhaps we will have to leave it to the noble Baroness, Lady Finlay of Llandaff, to respond to the Minister's reply to her amendment. From the two examples that he gave, I picked up conflicting messages about the extent to which consent can endure when it is given by someone with capacity; although I was interested in the detailed example given by the Minister about how someone taking part in a longitudinal research programme could continue to be a participant, despite lacking capacity. I suspect that what he says is what happens—that researchers in those circumstances do consult families about whether or not research would be appropriate.

I accept the mild criticism given by the noble Lord, Lord Alton, that we were jumping into a far wider debate, but this has been a useful place from which to start. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendments Nos. 101 and 102 not moved.]

On Question, Whether Clause 30 shall stand part of the Bill?

Earl Howe: Before we bid farewell to Clause 30 there is one issue on which I hope that the Minister can be of assistance. The noble Lord was kind enough to write to me and others last month, setting out some of the Government's thinking on this part of the Bill and relating these provisions to the corresponding provisions in the Human Tissue Act and the clinical trials regulations. I thank him for doing that, as I found his letter most helpful.

He said in his letter, rightly, that it was essential for the various elements of the legislative framework for research on mentally incapacitated people to be mutually consistent and to march together in harmony. I have compared the three sets of provisions and they seem, to me at least, to sit comfortably with each other. However, can the Minister say whether he and his department are entirely satisfied on that question? He mentioned that Ministers were looking at the possibility of amending the clinical trials regulations to enable research in emergencies to proceed. That is a provision that we shall shortly
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debate in the Bill. It would be useful to hear whether that is the only adjustment that the Government are contemplating and when those regulations are likely to come forward. Can the Minister say when the Government expect to bring forward regulations under the relevant provisions of the Human Tissue Act in relation to storage and use of tissue from mentally-incapacitated patients?

Lord Warner: Apart from the emergency research areas, which the noble Earl mentioned, I am unaware of any other areas where we have concerns. I hope that the letter and the chart were helpful. I cannot provide a precise timetable regarding the amendments arising out of emergency research. We are undergoing a consultation process on that. I shall need advice on where we stand on the Human Tissue Act. I shall write to the noble Lord on both issues.

Clause 30 agreed to.

Clause 31 [Research]:

Lord Turnberg moved Amendment No. 103:

The noble Lord said: My reason for moving the amendment is that there are several complications which occur in patients who lack capacity, which are associated with, or attributable to, their lack of capacity, but which do not directly affect the mind or the brain. It is equally as important to research those areas as it is to research the conditions that only affect the mind or the brain.

I shall give some examples. First, a patient brought into hospital after a head injury sustained in, say, a motor car accident, may have multiple injuries which require research. Secondly, patients in coma after a stroke may be particularly susceptible to infection and their immune systems may be awry. The reasons for that need to be examined, while a search is made for a treatment which may combat or prevent the complications.

Patients who go into hospital after a heart attack may lose consciousness, but the research that is needed will be on the heart, the circulation, the lungs and the kidneys—all of which may be affected. There are many other examples of disorders which affect only incapacitated patients, but do not involve the mind or the brain in any direct manner.

I hope that I have said enough to convince my noble friend of this matter. I should say that it is possible that the same end may be achieved by Amendment No. 104, tabled by the noble Earl, Lord Howe, so I am not wedded to my own amendment, as one can achieve the same ends in different ways. I beg to move.

5.30 p.m.

Earl Howe: I am not sure that I totally subscribe to the wording of the amendment in the name of the noble Lord, Lord Turnberg. I think that he may have sacrificed explicitness for neatness and therefore the amendment may not achieve all that it should. But that is not to say that I claim anything like perfection in
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relation to my own amendment—Amendment No. 104—even though its aim, as the noble Lord rightly said, is broadly the same.

I share the noble Lord's welcome for this clause. Indeed, perhaps I may say that the changes made in another place to this part of the Bill were extremely helpful. But I am worried that the wording remains ambiguous. As we debated earlier, research is all about exploration. When you start it, you do not know whether, at the end, your initial hypothesis will be borne out in full, partly or not at all. It seems to me that the wording in Clause 31(2)(b) is too categoric. While you can posit beforehand that a particular condition is,

an impairment of the mind or brain, you cannot be sure that your eventual conclusions will bear that out. Nor can a researcher necessarily read into the words "connected with" that it would be legal for him to investigate the side effects of a drug which is used to treat a particular condition. So, like the noble Lord, Lord Turnberg, I think that the wording of this part of the clause needs to be reconsidered.

Baroness Andrews: I am very sorry that my noble friend and the noble Earl cannot agree about their amendments. I hope that I can bring comfort to both of them in what I say.

Perhaps I may start by addressing Amendment No. 104. We are grateful to the noble Earl for proposing the amendment and we certainly understand his reason for tabling it. We are also aware that it reflects concerns put forward by some of the leading medical bodies.

As the noble Earl said, in another place we have already moved to clarify the original policy intention—and very necessary that was too. We accepted that the original drafting of Clause 31(2)(b) unintentionally prevented research into a condition or illness that causes incapacity. For example, it would have prevented research into the prion proteins that are believed to cause variant CJD or, indeed, into the genetic causes of early-onset Alzheimer's disease, even where that might have been of benefit to the person involved.

So the amendment ensures that research connected to a condition affecting the person without capacity and which causes or contributes to, as well as being attributable to, the person's condition would be covered. It is also consistent with the spirit of, and the policy intention in, the Bill. Therefore, as the noble Earl said, the amendments which are usefully before us are another attempt to reduce ambiguity.

Before I say how we are going to proceed, I shall briefly address what the clause aims to do. It specifies that the research must be relevant to the patient's (P's) condition—that is, the condition affecting the patient—or in some way be linked to the impairment or disturbance in the functioning of P's mind. As noble Lords will know, that is directly related to the principle in Clause 2, which sets out when people are considered to lack capacity. We have set out elsewhere what we
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consider to be the diagnostic test and have said that impairment or disturbance could be due to a range of conditions, including psychiatric illness, a learning disability, dementia, a head injury and so on. It may also be permanent or temporary.

Why is the link with impairment or disturbance such an important and explicit safeguard? It is because the notion that we are discussing is a widely accepted principle in the governance of research—one to which we shall return in later amendments. The research involving those who lack capacity must be related to the condition that causes the incapacity. That is an important but elusive concept. For example, the Helsinki Declaration requires that,

The Law Commission put it more clearly by recommending that research should be lawful if,

So in these amendments we are discussing how to define and be absolutely clear about that link and, of course, the research ethics committee must also be clear about it.

We have spelt that out in a way which, in our view, allows a wide range of research into conditions which result from the incapacitating condition, subject to the other safeguards. For example, it can include clinical research into the effects on bodily systems following severe head injuries, and research into gene mutations or infectious disease agents and so on. But, as was pointed out by the noble Baroness, Lady Barker, who is not in her place, it also covers direct health and social care problems.

The amendments invite us to extend the scope of the definition to include conditions which "commonly accompany" a mentally incapacitating condition or research into the side effects of the management of the condition. I know that the noble Earl has been referred by researchers to instances which appear to be ambiguous and where there is a question over whether they are covered. One example was whether the drafting permits research into sexual dysfunction (the condition) that commonly accompanies schizophrenia (the impairment). In short, we believe that if all the other conditions were satisfied, that piece of research would indeed be covered by the drafting, but the research ethics committee would have to be satisfied that that was the case. It was very useful to hear the tribute paid by the noble Baroness, Lady Carnegy, to the expertise and good common sense of the research ethics committee.

The second part of the amendment is about side effects. Again, we believe that such research may be approved by an REC if it is satisfied that the side effect is attributable, albeit perhaps indirectly. The second example, which I think the noble Earl will have seen, is research into obesity associated with certain drugs used to treat schizophrenia. Again, we believe that that would be regulated under the clinical trials regulations because those regulations, and not the Bill, deal with the safety or efficacy of medicinal products.
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I have gone into detail in my reply because, although we believe that the type of example and the concerns raised could be covered by the Bill, we understand that it is very important to be as clear as possible on this matter, with all the attendant safeguards. So we shall now consider whether there needs to be further amendment to the clause, with a possible view to returning to the issue on Report.

I am also aware that there is a need for clear advice on how the Bill relates to recent legislation, such as the Human Tissue Act, the clinical trials regulations and so on, and the noble Earl has referred to the useful analysis that we set out. We are now looking at how to achieve that by means of the code of practice and other guidance. We obviously want to consult the medical bodies fully and, as my noble friend said, we are looking forward to considering with them what we might do.

I turn to Amendment No. 103. Again, I understand my noble friend's concerns. As he said, at times researchers may wish to examine other aspects of a person's condition which do not have a direct causal relationship with the disturbance of the mind. He gave an example that I can endorse. It related to research into how to prevent heart failure during a coma induced by an infection or organ failure following a major trauma. Such research might well be of good therapeutic benefit.

The aim of the clause is to specify that the research must be relevant to P's condition or be linked to the illness, impairment or trauma that causes P to lack capacity in relation to consent to research. Again, I can sympathise with concerns about the current drafting. It may not be drawn widely enough to allow potentially beneficial research into something that may not be linked causally. But there may also be a danger of circularity: incapacity is not defined and that would lead back directly to the terminology in Clause 2. As I said earlier, we have used the same form of words—"impairment of", and so on—that appear in Clause 2. That lays down the general interpretation of the Act, and we would not want to tinker with Clause 2 because it is of such fundamental importance. We do not want to weaken it.

However, as I said, we are sympathetic to the issues raised by the probing amendments concerning the vocabulary and the implications. We shall reconsider the issue to see whether there needs to be a further amendment to the clause—again, with a view to coming back on Report. I hope that noble Lords will be pleased with our openness in this matter and that my noble friend Lord Turnberg will be able to withdraw his amendment.

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