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Lord Turnberg: I am not sure that I can dream up a research project on the spot. I imagine that patients with learning disability have specific defects in their learning. One would want to conduct the research on that particular element. One would want to know how and why the learning difficulty affected them and perhaps try to improve on their management. The aim would be directly to benefit those with learning difficulty, but one could never be sure of improving directly the care and attention of that specific patient on whom the research was conducted.

In general terms, quite a lot of research demonstrates that people who engage in research projects—that is, the subjects—receive better care and
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attention and fare better than those who are not involved in research projects. That is an indirect effect, which is due to the fact that greater attention is paid to their care.

Earl Howe: In Amendment No. 106, I take a slightly different tack from that adopted by my noble friend. As I said earlier, I think that the words "have the potential to" are the only appropriate words in the context of research, which is, by definition, exploratory. I agree fully with what the noble Lords, Lord Hunt and Lord Turnberg, said in that connection.

Having said that, I am sympathetic to my noble friend's wish to insert the word "directly" here. Surely, we are talking about two distinct types of research in paragraphs (a) and (b). Paragraph (a) is research where there is a possible benefit to P; and paragraph (b) is research where there will be no benefit to P, but potential benefits to other people.

That is a perfectly valid distinction; it is undesirable to blur the line between the two. I am not happy that, as the clause is now worded, the first category could include research where the potential benefits to P are not direct therapeutic benefits at all, but benefits that are, at best, indirect and certainly nothing to do with the patient's actual condition. For example, the patient may be suffering from an irreversible genetic condition. The research conducted on him may be designed primarily to benefit a family member with the same genetic profile. In the loosest sense, the research could be taken as benefiting P, but it would not be of direct benefit to P. That sort of research should rightly fall under paragraph (b), but it would get in under the wire of paragraph (a).

What is the merit in not being absolutely clear cut about the distinction? It is a distinction that matters because the wording of Article 17 of the European convention makes a particular point of distinguishing research that has,

and research that,

The second sort of research may be authorised only under exceptional circumstances. I have resisted the idea of introducing the word "real" here—as I said, the convention talks about "real and direct benefit"—because I am not at all sure what the word "real" means or what force it carries. But the word "direct" has a very clear meaning and reduces the potential for lines to be blurred. If the European convention contains it, why have the Government not included it?

Baroness Andrews: This has been an absolutely fascinating debate. I shall try my best to answer the questions raised. I want do so carefully and to be careful not to use emotive language. I will not use the word "experimentation", although I understand the noble Baroness's reasons for using it. The debate has
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enabled us to explore the safeguards that must be met before people who lack capacity can be involved in research. I respect the intention behind both amendments.

I shall begin by talking about consent. The noble Baroness based a large part of her argument on the assumption that people who do not have capacity do not have to give consent to be involved in research. That is not true. In Clause 30(2)(2), we make it absolutely clear that those who lack capacity can be involved in research only if they have given consent. As the noble Baroness went on to say, in other cases carers and families are most closely and carefully involved. So just as none of us can be involved in a research project without giving our consent—the noble Baroness was quite right about that—neither can anyone who lacks capacity. They must give consent or, if there are difficulties with interpreting consent, their carers and families must give consent on their behalf.

Baroness Knight of Collingtree: I am most grateful to the noble Baroness for giving way. She referred to Clause 32(2). Was that what she meant? I am finding a little difficulty in following that, but I shall think very carefully about the rest of what she said.

Baroness Andrews: I meant Clause 30(2)(b). If there is any further ambiguity, we can discuss that later.

I appreciate that the noble Baroness and other noble Lords do not want people without capacity swept up into research on a casual, frivolous basis, or being exploited in any way because researchers are too lazy to search for a control group of people with capacity or are simply not scrupulous enough to follow up their best interests. Absolutely not; I could not agree more. None of us wants that. That is precisely why we have drawn the Bill so carefully; why its language is careful; and why the safeguards are strong. I shall come to the safeguards in a moment.

6.15 p.m.

I shall try to reassure the Committee about the purpose of research. That has been very well addressed by my noble friends Lord Turnberg and Lord Hunt. I remind the Committee what we said. My noble friend Lord Warner cited the code of practice, which states:

Research is about finding out things that we do not know. Research involves intellectual risks. It involves elusive uncertainties. Important discoveries are made by accident, so to say that research should not explore potential to benefit is exactly like saying that research should explore only what is known. That is a contradiction in terms.

When we took the advice of the Joint Committee about including research, we took its point that the Bill would be incomplete without reference to such a critical activity that promises so much benefit to our understanding and treatment of distressing conditions. The committee said that it was right that
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people who lack capacity should not be denied the benefit of research. On Second Reading, I was struck by what the noble Baroness, Lady Barker, told us: that a person who is disabled or lacks capacity may still have the capacity to want to give, to want to contribute. It is part of the civil rights of those who lack capacity to be involved, where they want to and are able to. That has been echoed by the Making Decisions Alliance. I am sure that we all agree with that.

I turn to the amendment. Let me explain what we want to achieve for people with mental incapacity and those who may develop conditions in future. As I said, research is a complex term. It is challenging. It is based on the collection, testing and validation of evidence. When I address issues such as what is reasonableness, I shall talk about the nature of evidence and what we mean by it. It must be constantly reviewed and refined.

We do not want potentially to condemn people with incapacitative conditions to medical treatments that are based on extrapolation from studies involving only people who consent. Some research can, to be effective, be done only with consent from people who have the condition. Otherwise, if we are extrapolating from people without the condition, we may end up with incorrect solutions, or we may err unnecessarily on the side of caution. In any case, that conflicts with the principle of evidence-based medicine.

The desire that we all share is for well regulated, properly conducted research with maximum safeguards that will lead to new and effective treatments and improvement in services for people who lack capacity and to ensure stringent safeguards for the people who take part in research. Very often, we know only with the benefit of hindsight which treatment produces more benefits for the participants.

I shall give the Committee one example. Research proceeds on the basis of testing and discarding hypotheses. There was a recent trial, called the CRASH trial, of the therapeutic value of steroids for head injuries. It was supposed to prove the effectiveness of a standard treatment of steroids to prevent brain damage in those with serious head injuries. That was the aim. Instead, research showed that steroids reduced survival and that it was wrong to assume that what was effective for other trauma was equally effective for head injuries.

We need to perform such research to test some assumptions that have been the basis of medical practice for many years. We now have the knowledge and, often, the technology, to revisit some of our medical assumptions. That is extremely important, because it is the only way that people will benefit in future. We perform research not only for those who are suffering today but those who can be prevented from suffering tomorrow.

Our key consideration in the ethical governance of research, and in the Bill, is how to balance the need for the ability to benefit from the full range and the full methodologies of research—from its purest form, looking for a cure, to its most applied form, looking at
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how we manage and improve the situation of people in, say, care homes. We want to enable and support all forms of research to get the maximum benefit.

The noble Baroness was concerned about our safeguards. They are very strict, indeed uncompromising, and there are four of them in Clauses 30 to 33. In determining approval for research at the first stage, research will be carried out on people lacking capacity only if a research ethics committee agrees that the project is necessary, based on its collective wisdom and experience. Again, I refer to what the noble Baroness, Lady Carnegy, said about the scrupulous way in which the experience of the research ethics committee is brought to bear on those people. She said that more time and care is taken with people who have problems with capacity and other more vulnerable people. That is what we would expect to happen. As she said, these are not amateur bodies. Research will be carried out only if it is safe in relation to the likely benefit to that person or to others.

I shall talk about what we mean by "disproportionate burden" because that involves what we mean by "safe". The research will include participants with mental incapacity only if it cannot be done effectively using people who have mental capacity. The researcher must make the strongest possible case to the research ethics committee that there is not another group of people with capacity who can equally produce the valid research that will make the difference. Those are not simple tests. Noble Lords who have been involved in research know that they are stringent tests, where the evidence is challenged by experts. Most importantly, as I said, the research will be carried out only if the person is content to participate and his or her family or carer agrees that the individual can be part of the research.

There are three other conditions. The research must be into the condition that the person has or is in; it must not be possible to carry out research involving those with capacity. The research must have the potential to benefit and must not be disproportionate to the risk or burden. What do we mean by the notion of safety? By "burden" we mean the risk or inconvenience of a trial. For example, researchers might submit a proposal to use an MRI scanner to understand the brain structures of people with dementia or schizophrenia. It might be of potential benefit to their treatment. But if the use of an MRI scanner required long confinement—we know that people with mental capacity or those suffering from cancer or claustrophobia can be very vulnerable to extreme worry in these situations—or perhaps regular or frequent scans, an ethics committee might decide that the research would simply not bring enough benefit to justify the extra scans or trauma that might be involved. So the request to carry out research could be rejected.

It is for the experienced research ethics committee to make those decisions. We must also bear in mind that, to be valid, research must achieve what we call equipoise: the aim and design of the research must produce the valid result and not something that is skewed accidentally. We must not overlook the
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provisions about safeguards on research once consent for the individual's participation has been obtained—the noble Baroness paid a lot of attention to that.

Every person who lacks capacity will have to be properly enrolled in the study and the views of his or her carers sought. The noble Baroness asked who would speak up for the participant. Anyone who is involved can object, not only to the person's participation in the research but to their response to being in the project. Under Clause 33(3), anyone who comes into contact with the person and who has an interest can say that the person is not responding well to the research and that they would like him to be withdrawn or not to take part in the first place. The person's current or previous views must be respected. Researchers must respect any request or indication from a carer.

It is wrong to assume that researchers will be more cavalier about the safety and comfort of research participants who do not have capacity. The amendment would remove the requirement that the research "have the potential to" benefit the person. My noble friend Lord Hunt spoke powerfully about what that means. What would we lose if we were only to research problems that could guarantee a direct benefit? What about accidental discoveries?

An example is that research using MRI scanners has shown that the brains of people previously thought to have learning disabilities resembled those of people with schizophrenia. That has indicated that the primary problem is schizophrenia and there are therefore huge differences in diagnosis and treatment. Until the research was carried out, we would not have known that. Obviously, if the researcher had not been able to satisfy the research ethics committee, it would never have agreed to the research.

The amendment is well intentioned, but there is serious danger that much of the vital research that we count on to make the difference with people with mental incapacity could be imperilled. We must be very careful.

What can we do to strengthen the safeguards? What assurances can I give the noble Baroness? We have a code of practice to accompany the Bill. We are looking very closely at the issue, and this debate is important in the process. We will consult widely and look hard at how else we can assist and guide ethics committees and researchers in the appropriate interpretation of the provisions. There will be very full consultation.

The noble Earl's amendment would insert the word "directly". We dealt with the problem in principle, but I must tell him that, contrary to his assertion that the amendment would clarify the provision, it could seriously complicate what we are trying to do. How would one define "direct"? As an immediate, specific change affecting the person, in a day, a week or a month? How would you measure it? If defined as a marked change of condition, who would determine that? Would it be a new therapy or a new treatment, for example? Our conclusion is that to make the test any stricter would mean that ultimately only the courts could decide what was or was not a direct benefit.
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In response to the noble Baroness, the noble Earl and the noble Lord, Lord Alton, who is concerned that we have not lowered the threshold for acceptability, the point about "direct" is covered in a way that is not dealt with in the international conventions, which is why we are confident about our approach. We must not make the mistake of looking only at Clause 31(4) and overlooking the importance of Clause 31(2). The clause ties the research to a condition that the person is in and to the cause of their incapacity. There is interlinking between subsections (2), (3) and (4). It will be bound to follow that the end benefit that accrues from the research, and the way that it is packaged, will be of direct and real relevance to the committee.

The joint scrutiny committee wrestled with the notion of "direct". It drew attention to the difficulty of applying the equivalent Scottish Act's test of "real and direct". It heard from a Scottish clinician that one of the provisions was that research must be likely to be of real and direct benefit to the adults. But the judgment was that there was real difficulty in doing that. The doctor in question said that, if they were going to do what would be of real and direct benefit, they would be doing it; they would not be researching it. That is a fairly substantial answer.

To prove reasonableness, there must be a test of evidence. "Reasonable grounds" is not a casual or low threshold. The research councils must satisfy themselves that the conditions have been met and there must be reasonable grounds. To establish reasonable grounds, they must show that they have knowledge of relevant facts or have taken into account relevant information, which includes matters of which they ought to have knowledge, and that they have not taken account of irrelevant information in reaching their determination. For example, under Clause 31(5) they should be able to show what evidence they used to assess the degree of risk to P from taking part in the project.

The noble Lord has referred to the international conventions. The Bill is consistent with, but not identical to, the Council of Europe biomedicine convention. We are aware that that is now eight years old. It has already spawned an additional protocol. The Council of Europe will seek the views of member states on aspects of the convention; so the convention is not immovable. It is only one of a number of important sources that we are drawing on.

6.30 p.m.

I hope that I have addressed most of the issues that were raised. I have not addressed the distinction between Clause 31(4)(a) and (b), to which the noble Lord was right to draw attention. We will come to that in the next group of amendments, in, I hope, a little less detail. It looks as if I have not addressed most of the points raised by Members of the Committee, but I have done my best. Perhaps the noble Baroness will feel able to withdraw her amendment at this stage.

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