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Lord Turnberg: I do not think it will come as a surprise to the noble Lord, Lord Alton, to learn that I have a lot of sympathy for his amendment. I like the idea that he expresses because it places emphasis on the role of the clinician, the person looking after the patient, to act as a sort of protector during research. That is absolutely critical.

While I have some problems with the exact wording used in the amendment, I like the idea behind it, but there may be a possible conflict with an advance
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directive if a clinician is responsible for protecting the life of a person against his advance directive. Some confusion may arise on that. However, I like the suggestion that the clinician looking after the patient must take some responsibility in this area.

Earl Howe: In Amendment No. 109 I approach this issue from a rather different angle from that of my noble friend in the last set of amendments because I do accept that there are circumstances when it is ethically justifiable to carry out research on someone who is mentally incapacitated, even though there is no prospect that the research will benefit them directly. I must make my apologies to my noble friend for taking a different view.

It is a principle recognised in the European convention. I believe that that is quite right because without such research we would not be able to advance our knowledge of possible treatments for genetic disorders, to take but one example. A whole host of compelling examples could be cited in this category of research, such as the possible link between Down's syndrome and pre-senile dementia, research into the right amount of anaesthetic for patients who have suffered a bleed on the brain, and research into dementia and variant CJD. So, with great respect to my noble friend, I do not think that we can or should prohibit this type of research, provided that it is carried out only under very strict conditions.

However, like the noble Lord, Lord Alton, what concerns me is that paragraph (b) is worded too loosely. The key requirement in the European convention is that this type of research should be "exceptional". It should,

I have abbreviated the quotation.

Where in this clause of the Bill is the word "exceptional"? Where is there a mention of the words "significant improvement in scientific understanding"? The words are not there. The clause simply refers to,

That seems to be a much, much weaker formulation. I have to ask the Government why that is. Adding to the sum of general knowledge is not the same as contributing a significant understanding where the circumstances are exceptional. We need much more convincing answers from the Government than the ones they furnished on these issues to the Joint Committee on Human Rights.

Lord Hunt of Kings Heath: Perhaps I may ask the noble Earl whether one of the problems is that it is very difficult to forecast in advance whether a particular piece of research will be highly significant. When we embark on research, we set out on a journey.

The noble Earl did not mention the safeguards contained in subsection (5). If subsection (4)(b) is the only reason that you can rely on research being
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authorised, and if you do not have the comfort of subsection (4)(a), you then have built-in the safeguards contained in subsection (5).

We must have safeguards but we also have to reflect on the challenges which face eminent researchers who, in large regard, bring a strong and responsible ethos to the conduct of research. Some of the barriers which noble Lords have suggested researchers should go through may be very difficult for them to meet.

Earl Howe: I have no problem with the thrust of the safeguards in subsection (5); I think they are admirable. We shall come on to debate their detail in a while.

I agree with the noble Lord that research is by its nature exploratory and that you cannot guarantee anything in advance. However, the convention states—and I cannot find fault with it in this respect—that this type of research should have the aim of contributing through significant improvement in the scientific understanding of the individual's condition to results capable of conferring benefit and so on.

So the aim should be there. It seems to me that that aim should be capable of being demonstrated to a research ethics committee. If a research ethics committee is satisfied that, in good faith, a research team has that aim and that the research is capable of producing that kind of result, I have much less problem. I do not think that that is an unobtainable thing to ask of a research team. It is not asking the research team to commit itself to absolute certainty in advance; it is stating that the research involved should not be a tinkering at the edges of something that is of no material gain to medical knowledge but that it should be something significant. The word "significant" is an important addition to the wording.

Baroness Andrews: I am grateful for the opportunity to explore some other aspects of these issues, particularly in relation to the research defined in subsection (4)(b). The previous amendments allowed us to debate the relationship between the potential and direct benefits of research. These amendments drive the debate further, as the noble Lord, Lord Alton, said, because they are specifically concerned with research that provides new scientific knowledge. The noble Lord went on to describe the ways in which that can bring benefits.

I can see why noble Lords have raised concerns about this clause because, in a sense, it is furthest away from the concept of the individual benefiting. In Clause 31(4) and (5) this is expressed in terms of research that is intended to provide knowledge of the causes or treatment of, or the care of, persons affected by the same or a similar condition.

But, because it is further away from the notion of individual benefit, we have put stricter safeguards around it. There must be grounds for believing that the research will contain minimal risk to the person—that is a unique condition—and that anything done will not interfere with a person's freedom or privacy in a
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significant way or be unduly invasive or restrictive. Those are very specific criteria which attach only to this particular class of research.

It will perhaps be helpful if I briefly describe the kind of research that might be covered. It could, for example, include interventional research—which is sometimes misleadingly called therapeutical research—where the intention is to do something different in the person's treatment or care and to compare it with other approaches or standard best practice. Another category is observational research and studies to understand what is happening to a person or his condition and what might have been the underlying cause; or, in a social research context, how he goes about his daily life and his relationship with family and carers. Although it is a slightly academic framework it can provide a huge range of specific direct and indirect benefits.

So that is the context in which we are operating. If we had not permitted observational research we might, for example, have lost out on understanding the genetics of the defective gene PKU. Years ago we made the surprising discovery that a simple genetic error of metabolism meant that infants who ate a normal diet suffered major developmental impairment and developed severe learning difficulties. Understanding the genetics of that gene by studying those with the impairment led to the simple screening test called the Guthrie infant heel prick that all babies are now offered routinely. It is an extremely effective way of preventing a devastating condition.

The question is—I am sure we would all say yes to this—whether it is wrong to conduct research involving those without capacity even if there is no guarantee that there is a direct benefit to them. As I have said, the safeguards are higher for this class of research. Researchers have to convince a research ethics committee of three main safeguards: that what will be done relates to the person's condition and the causes of impairment; that it could not be done as effectively by involving those who might consent; and that the research is to provide knowledge of the causes or treatment of people with the same or similar learning disability.

As I have said, it has to involve negligible risk. "Negligible" means the same as "minimal", which is exactly the same as the terminology that appears in international instruments such as the Council of Europe Biomedicine Convention.

Amendment No. 109 seeks to remove the whole of subsection (4)(b) while leaving subsection (5) in its place. In answering the questions raised by the noble Earl, perhaps I may use the language of the convention itself. Why have we framed this in the way it has been framed? Part of that question has been answered by my noble friend Lord Hunt when he explained the difficulty of determining what is "significant".

Why do we not use the term "exceptional" and follow the Biomedicine Convention? I understand that the convention does not state that subsection (4)(b)-type research is permitted only in exceptional—that is to say, rare—circumstances. In fact, it states that there
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is an exception to the general rule, which is about the subsection (4)(b)-type of research. The convention explanatory notes, I understand, refer to this as a supplementary condition. So it may be that we are struggling with a misapprehension about what "exceptional" means in this context and what the convention is designed to do. It is an ambiguity trap which we have fallen into. To be quite clear about it, I would prefer to write to noble Lords and spell it out in more detail, so that the supplementary information can be put on the record.

We are concerned about the effect that Amendment No. 109 would have. It would remove the whole of subsection (4)(b) while leaving subsection (5) in its place. In effect, an ethics committee would require any research to be minimally invasive. We would be outlawing a huge range of research on that basis, which is one reason why we cannot accept the amendment. However, I will return to that point when I deal with the amendment of the noble Lord, Lord Alton.

The noble Baroness, Lady Chapman, has proposed replacing "or" with "and", thus linking the requirements of subsections (4)(a) and (b). That would require research to be of direct benefit to the person without capacity and to provide new knowledge. Again, that would extend the very strict safeguards in subsection (5) to subsection (4)(a), and for all the reasons that I have given, it would have the unfortunate effect of significantly restricting the scope of research that may provide a benefit to the person without capacity.

7 p.m.

On Amendment No. 127, and the issue of the JCHR, we believe that the arguments we put forward in our first response still hold. We are talking about a different class of research in the UK and we have a broader definition of health in the Bill. Of course we are considering how we are best able to respond to this; we will have some things to say about these very difficult and sensitive issues.

The amendment would place on the face of the Bill a positive duty of care on the part of researchers. It is a laudable aim, with which we are fully in agreement. This is a standard professional duty of care, required by the Government's framework for research, and it sits within the international definitions.

The Helsinki Declaration is constantly being revisited. It was clarified most recently in 2004. It says:

That is precisely what the noble Lord, Lord Alton, has asked us to put in the Bill. Paragraph 10 says:

Those principles appear in relation to clinical trials. We are very sympathetic to the need to consider some elements. We wish to consider how we might see some of those fine principles on the face of the Bill. It would have to be very clear to whom the duty fell—that is
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what we have to establish correctly. There would need to be a limit to what researchers were responsible for and to what extent they could be expected to have regard to all the dangers that a person who is part of a research project might encounter. The amendment does not recognise that duty of care and suggests that the researcher shall "at all times" protect the person's life and health. There is a complex relationship between clinical research and treatment.

The amendment does not take due heed of the other protections in the Bill. It does not, for example, recognise that under Clause 42, ill treatment or neglect are criminal offences.

We have some misgivings about the requirement to withdraw the person from research if there is a danger to a person's life, health or well-being. The amendment has some potential pitfalls. However, despite those concerns, let us take this away and look at what we can do to pursue the principles which the noble Lord has very eloquently outlined. I will read very carefully what he said about his amendment in the context of the Helsinki Declaration.

I have gone at rather a fast pace, and there may be questions I have not addressed, but I can write to the noble Lord.

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