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Lord Alton of Liverpool: I, for one, am extremely grateful for the way in which the noble Baroness has responded to the arguments I advanced earlier. I guess that my noble friend Lady Chapman, will reply, as the person who moved the lead amendment in the group. However, I am very pleased at what the noble Baroness has said and look forward to corresponding with her between now and Report.

Baroness Chapman: I thank the Minister for that answer. I ask her to go away and think again because a lot of organisations are extremely worried about this part of the Bill. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 109 not moved.]

Earl Howe moved Amendment No. 110:

The noble Earl said: As it currently reads, Clause 31(4)(b) appears to exclude research on diagnostic issues. The noble Baroness gave an example of such research earlier. Magnetic resonance imaging of the brains of people with learning disabilities has been found to pick up co-existing schizophrenia. A further example is that of imaging and neurological studies to detect prion disease such as variant CJD.

The amendment is a very simple one, designed to rectify what appears to be an omission. I beg to move.

Baroness Andrews: I have a very simple answer, too. Research into new and better diagnostic methods is important, and we are clear that the Bill covers that. Clause 31(4) allows research to be approved if it is intended to provide knowledge of the causes or treatment of, or the care of persons affected by, the
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same or a similar disorder. In the interpretation in Clause 60, on page 33, the definition of "treatment" includes a diagnostic or other procedure. I hope that that helps the noble Earl.

Researchers and RECs have an obligation under the Bill to have regard to and comply with the code. We will be consulting on the code of practice later and will look at the best ways of bringing this range of interpretations to people's attention. We will also seek help from the research groups. There are terms in the Bill which will become clearer in the code of practice—this is one of them.

Earl Howe: I am most grateful to the noble Baroness. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

[Amendment No. 111 not moved.]

Earl Howe moved Amendment No. 112:

The noble Earl said: In Clause 31(5)(a), the term "risk" fails to make clear that it is the extra risk of participating in research that must be minimal. The patient may already face considerable risks by virtue of the condition that he or she is in. I am suggesting, at the prompting of a number of bodies, including the MRC, the Wellcome Trust, the Royal College of Physicians and the Academy of Medical Sciences, that the word "additional" should be inserted before "risk" in line 1 of page 18. I beg to move.

Baroness Andrews: I understand the concerns underlying the proposal. We should be clear that the risk referred to is the extra risk associated with taking part in research. Even if not taking part in a research project, a person may already face certain risks because of his or her underlying condition. We feel that the Bill is sufficiently clear on this point. It refers to,

so we see no need to amend it.

To take one example, research to monitor the levels of oxygen in the brain can improve survival in patients with head injuries. Research involving an additional oxygen probe in the same cranial incision used for the clinically necessary purpose of monitoring cranial pressure may provide valuable knowledge. In this case, the risk associated with the research would come from using a new type of probe, which I think we would agree would be negligible, rather than from the cranial incision.

Including the word "additional" would change the effect of the subsection significantly. We believe it could even have the unintended effect of requiring research ethics committees to look beyond just the risk of participating in the project to the person's general prospects of survival.

We agree that the important factor in looking at the additional quantum of risk is between taking part and not taking part in research. I realise that that is not the
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noble Earl's intention, but there is a real danger that the amendment could lead to a situation whereby a maverick researcher could seek protection behind the severity of a person's underlying condition. He or she may seek to argue that the person's prognosis is so bleak that any additional risk to him or her from taking part in a highly risky project is likely to be negligible. This would have the perverse effect that the more seriously at danger a person is from his or her condition, the more risky the research project could be within the meaning of the Bill. That is not something that we want to achieve. Our advice has been to think very seriously about the implications of that and what it might mean in the way I have described. Although the amendment looks innocuous, we are advised that it could confer some accidental disbenefits. I ask the noble Earl to consider that and to withdraw his amendment.

Earl Howe: That was a very helpful reply. I will indeed consider what the noble Baroness said as it is clearly undesirable to have any perverse effects from an amendment such as this. I beg leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Earl Howe moved Amendment No. 113:

The noble Earl said: There is a concern in the scientific community that the word "significant" in Clause 31(5)(b)(i) will be difficult to interpret or apply in practice. I suggest, at the instigation of the MRC, the Wellcome Trust and others, that we should substitute the word "unduly" for the phrase "in a significant way". The difference may not seem all that material but the word "unduly" is the word used in the next paragraph—I believe appropriately—and it carries with it the notion of proportionality rather than an absolute measure, which may not be easy to measure at all. I beg to move.

Baroness Andrews: We are committed to ensuring that people who lack mental capacity should not be denied the benefits that can be obtained through carefully regulated research. We have spoken at length this afternoon about the importance of safeguards and the need for them to be as strong as possible. Clause 31(5)(b) is very clear—the research must not interfere with the person's freedom or privacy in a significant way.

The Joint Committee on Human Rights has been considering the matter and we value its views. We have explained the meaning of "significant way" in this context. It welcomed the clarification of the drafting and in particular our intention that any interference with a person's privacy or freedom of action should be kept to a minimum. The committee goes on to say that in its opinion it would be clearer to substitute "material" for significant, so that the protection requires that anything done to, or in relation to, the person who lacks capacity will not interfere with their freedom of action or privacy in a material way. This is something we are looking at with interest.
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Although we have not come to quite the same conclusion as the research community, we are looking at the terms, as I say. Therefore, emboldened by the expert views of the Joint Committee, I am bound to say that we do not think the amendment proposed achieves what we and the Joint Committee want. Having looked at this carefully, we feel that changing this to use the word "unduly" would weaken the protections, which I know is not the noble Earl's intention. It would imply that any interference would not be undue—that is, would not be justifiable in view of the aim of the researchers. We have set the test at a low level; that is to say, interference must be kept to a minimum. The noble Earl's amendment would change that. We need to think carefully about that word.

To give an idea of the context in which we are arguing, let us consider an example that has been used in another place of a researcher who may want to observe how a person with learning disabilities solves an abstract puzzle. He or she may need to do so in a way that means the person is not distracted by the presence of the researcher. To achieve that a two-way mirror may be used. That might be said to be a minimal interference with the person's right to privacy. But suppose the researcher wanted to study the sexual behaviour of the person with a learning disability or how that person bathed or undressed. We believe that filming those intimate moments does not constitute minimal interference but rather a gross intrusion. Many people would hold that view. We need to be careful not to accept a provision which might allow a well intentioned researcher to argue to a research ethics committee that this was not an undue interference—the matter turns on the notion of what is undue—because the aims of the research were vitally important.

I hope that with that clarification and bearing in mind what I said about the word "material", the noble Earl will withdraw his amendment.

7.15 p.m.

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