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Mrs. Browning: Would not the scenario that the Minister has outlined equally apply to somebody with capacity? For example, there might be a patient in hospital who has capacity, but who perhaps lived a lifestyle that gives cause for concern that they might be carrying HIV. So, in that circumstance, there would be equal treatment between those with and without capacity.

Ms Winterton: Obviously, if someone had capacity, there would be the ability to ask them whether they consented to such a test. The consent rule would still apply there. There is, in a sense, a slight difference here;
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if someone cannot give consent because they are incapacitated, there have to be other ways in which the approach could be made.

Mr. Heath: I am slightly concerned by the Minister's linkage between the investigation and the efficacy of treatment. It seems to me that there are plenty of other reasons, which are for the general benefit of the patient, for that diagnosis to take place. However, to link it too expressly with an effective start—an early start—to a therapy is unhelpful to the argument. I hope it is not an exclusive argument that she is making.

Ms Winterton: I am simply saying that, in circumstances where it is impossible to know whether the incapacitated person might or might not be suffering from such a condition, if there is reasonable cause to think that they might be, it would be in their interest, and of benefit to them, to have a test so as to start treatment. Someone who has capacity, however, obviously still has the ability to refuse to be tested. If they are asked, however, and they refuse to be tested, it is extremely difficult to force them.

5 pm

Mr. Grieve: In the case of an incapacitated patient, there is an entitlement to presuppose that in relation to treatment for their own benefit, they would act as a reasonable patient with capacity would. That is what large chunks of the Bill are all about. As long as a direct benefit to the patient can be shown, the problem raised by the right hon. Member for Rother Valley (Mr. Barron) does not arise, and he need not be troubled by it. The problem, which is at the heart of these clauses, comes when research is not at all for the benefit of that patient or his immediate management.

Ms Winterton: Perhaps I can address some of those issues shortly. I want to reassure my right hon. Friend the Member for Rother Valley that we will make it clear in the code that, in such cases, the possible wider benefit that accrues from testing, which has been endorsed already in legal judgments, will continue to be an important factor in determining best interests. If a diagnostic test is in P's best interests, it should be lawful, and doctors performing such tests have the protection from liability afforded by clause 5. We will also consult on a role for the independent consultee in such decisions, so that there are mechanisms other than the Court of Protection to ensure that P's best interests are met in the light of the specific circumstances of each case. In the light of the explanations and, I hope, reassurance that I have given, I therefore ask my right hon. Friend to withdraw his amendment.

With regard to amendment No. 43, I agree that it is important that we make sure that people without capacity are properly protected. That is why we have included in the Bill some stringent safeguards. It is more difficult to define best interests in this area than in other parts of the Bill. The most that we can ask of research is that it offers a potential benefit to people. There cannot be guarantees, because, as was pointed out in Committee, if there were, such treatment would be offered. There is no way that researchers can prove in advance that something will be of benefit; they can only say that it may be of direct benefit. Were we to
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undermine that and say that it had to be of benefit, a lot of research would not take place, and some research being done would have to cease.

Mr. Grieve: What, then, is the ethical basis for the research clauses as they stand? That is not a trick question for the Minister; it is a fundamental issue. The Government must explain to the House the ethical basis of carrying out experimentation or testing on someone who is incapacitated, cannot give consent and has no direct benefit from such tests.

Ms Winterton: Let us be clear; we are talking about potential benefit. As to the ethical basis, however, we must agree about whether or not we want to carry out research on the conditions, or the causes of the conditions, of people with incapacity. The safeguards put into the Bill make it clear that such research will only be that which cannot be carried out on someone with capacity; that relates to the causes or conditions of the person's incapacity; that the person has the absolute right to withdraw at any time from such research if there is any indication that they do not want to be involved in it; and that if somebody else objects to their inclusion in such research, they should be withdrawn from it. It must be approved by a research ethics committee, which will also look at the way in which consent has been obtained.

The Joint Committee gave careful consideration to the issue. It decided that, on balance, despite concerns about research of this kind, it was not right for people who had incapacity not to benefit from the research in the same way as those with capacity. A number of groups made representations to the Government, and I am sure the hon. Member for Tiverton and Honiton (Mrs. Browning) will agree that they were made to members of the Committee. Those groups told us that excluding people without capacity from research would be detrimental to them.

As I have said, it is always difficult to prove that something can be in someone's best interests. We can only say that it is of potential benefit to that person, or might benefit him or her in the longer term, or might benefit him or her indirectly once more research has been done, or might benefit others with the same condition now or in the future.

Mr. Grieve: It is that last point that bothers me. The others do not trouble me all that much. Even potential benefit might be a justification, but the nub of the issue is research carried out on an individual that is of no possible benefit to that individual, but is justified on the ground that it is there for the wider public good. Are the Government comfortable with that set of ethical values?

Ms Winterton: I am very comfortable that we are introducing a number of safeguards in the Bill. As the hon. Gentleman has said, research already can be carried out, but now safeguards will be introduced. I am confident that, as far as possible, medical ethics committees will ensure that research benefits individuals at the time. It may not always be possible for some research, particularly when it looks into causes, to be of
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direct benefit immediately, but it could well be in the future. It might also lead to alleviation of current symptoms.

Mr. Boswell: This is a difficult argument, but I think that the principle is simple. Clause 1(5) makes a commitment that embraces the whole Bill—that acts done or decisions made should be in the best interests of the person involved. Is the Minister saying that that best-interests principle is suspended in the case of the research clauses? Yes or no?

Ms Winterton: I am not saying that it is suspended, but I think that given the direct way in which it is interpreted in other parts of the Bill, it will be inevitably interpreted slightly differently in this part, for the simple reason that it is always extremely difficult to say that research is absolutely in someone's best interests. It is in the nature of research that it is almost impossible to prove that it would be of direct benefit.

Mr. Cash: Would it not be possible to overcome some of the difficulty by making it clear in the principles that the provision would apply when it was of direct benefit to the person concerned, but not when it was of indirect benefit?

Ms Winterton: As I have said, although one would hope that such research would be of direct benefit, it is not possible in every circumstance to prove that it would be. The Bill's provisions are absolutely consistent with all international legal and ethical norms and instruments. The Bill also makes it clear that if the research is for the benefit of others, the risk must be obviously negligible.

Mrs. Browning: Will the Minister give way?

Ms Winterton: I will, but I am anxious to move on and I know that the hon. Lady will want to discuss the independent consultee.

Mrs. Browning: I thank the Minister and I shall be brief. Incapacity usually has a neurological base, and the benefit of research into conditions such dementia and Alzheimer's often lies in post-mortem pathology, rather than in research on living people. So I hope that the Minister will focus on such opportunities, rather than on performing research on people who are still alive.

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