Mr Tim Boswell (Shadow Minister, Home Affairs; Daventry, Conservative)

I beg to move amendment No. 41, in

clause 30, page 16, line 31, after '31', insert—

'(aa) in conformity with an advance decision to permit the carrying out of research on P made while P had capacity, and'.

Mr James Cran (Beverley & Holderness, Conservative)

With this it will be convenient to discuss the following amendments: No. 42, in

clause 30, page 16, line 37, leave out subsection (3).

No. 43, in

clause 30, page 17, line 1, leave out subsection (5).

No. 178, in

clause 31, page 17, line 17, leave out subsection (3) and insert—

'(3) Research shall only be carried out if research of a similar nature cannot be carried out on an adult who is capable in relation to such a decision.'.

No. 179, in

clause 31, page 17, line 21, after 'to', insert 'provide real and direct.'.

No. 44, in

clause 31, page 17, line 23, leave out paragraph (b).

No. 180, in

clause 31, page 17, line 27, leave out paragraph (a), and insert

'that it entails no risk to P or that'.

Mr Tim Boswell (Shadow Minister, Home Affairs; Daventry, Conservative)

Welcome back to the Chair, Mr. Cran.

I am deeply relieved that the officials agree with their Minister, even if my hon. Friend the Member for Tiverton and Honiton had a little disagreement with me. It was about procedure rather than substance, because we all want to get on with discussing the Bournewood gap, but not in relation to these

particular amendments. However, some of the issues about consent, safeguards and the necessary process are as germane to the clauses that we are discussing as they were to that matter.

The Minister will know that these clauses are new clauses in the sense that they have come in since the Joint Committee's report, in response to its recommendation that research issues should be handled, rather than being clauses that have been resurrected from past mental health Bills because of concerns that were expressed at the time. Nevertheless, as I said on Second Reading, some of the issues of principles here give me the greatest difficulty that I have about the Bill. I remain to be convinced whether I can accept them and, if so, in what form.

The group of amendments is rather general, so I will start by setting one or two general points in context. Let us think about what has been done in the name of research, even through the necessary procedures that are internal to the control of that research such as research ethics committees, which have stretched the doctrine of necessity to its limit.

People can well imagine a situation in which somebody's loved grandparent has a stroke, is lying in hospital and a doctor comes along and asks the grandchild whether they can carry out tests on that person. That would be a distressing situation for everyone. There is probably a degree of moral encouragement to do that, because it may be good for granny—it could be argued on those grounds. Even if granny could not benefit, because she was by now past it, perhaps somebody else, or somebody else's granny, might benefit. That is not an unworthy set of human suggestions. We would probably have to say that, in the absence of legislation of this kind, there is no framework to regulate that kind of thing, and some undesirable things have happened. That leads me to observe that the work of research ethics committees—in relation to this and other types of research, and whether carried out on human subjects with consent, animals or whatever—is an important safeguard.

Those of us who have had explained the procedures, the external validation and the protocols that have to be found know that there is no question but that it is taken extremely seriously. I would not wish to signal that people are in some way getting up to wilful malpractice or resorting to practices of which we would be ashamed in principle. That is one important safeguard. The second is set out in the Helsinki convention—the Minister may be more au fait with that than many of us on the Committee. It provides a broad framework within which the issue should be addressed. I take comfort from that, although I warn the Minister that there is a bit of a sucker punch to come in a moment.

I consulted with the Disability Rights Commission on the matter only yesterday because of something that was drawn to my attention. It is only fair to quote what was said on the general point. That was:

''Generally however, the DRC believes that the Government has encompassed the Helsinki convention on research within the Bill and we think this is reasonably sound.''

That is a fair endorsement, and I am sure that the Minister would want the measures to be endorsed. It was also observed to me recently, when I took advice on the matter, that such processes are going on all over Europe. I asked the expert I was consulting whether we were ahead or behind, and the answer was ''probably ahead''.

The civilised world is, as it were, looking at this. There are concerns, and they need to be addressed. There is also an explicit safeguard in the Bill that is already explicit in the practice of research ethics scrutiny in this country. That is entirely proper. Let me say, before anybody gets the wrong idea, that the research should be specific to the person involved. There is no question of taking persons lacking mental capacity, exploiting their lack of mental capacity, and then saying—sadly all members of the Committee can imagine analogies—that these are Untermenschen, people whom we can now use to find out something else that we want to know. That has been done too many times in the last century, and we do not want to see anything like it. I would be the last person to suggest either that it is encompassed in current practice in Britain or in most other countries, or that it would be in any sense facilitated by this Bill. It is absolutely outside it. It has happened in western, democratic countries, as the Minister will know, but we have no time for it. Equally, we should not excite or alarm people into suggesting that it is now taking place.

Having said that, there are some matters of concern in the clauses. The Minister was silent during the exchanges that we had with her counterpart, the Under-Secretary of State for Constitutional Affairs, the hon. Member for Tottenham, in relation to principles and best interests, which we have discussed extensively. One assurance that I received from him was that the principles of clause 1 inform the whole Bill. He gave some explanation as to how they would be taken into account. If one considers clause 30, it is difficult to argue that the principle of best interests, which kicks in when a person lacks mental capacity, is in any way waived by it. The principle of best interests must continue in this clause; it cannot be taken out.

There is an argument involving clause 31, which amendment No. 44 addresses by deleting subsection (4)(b). Subsection (4)(a) states that the objectives of the research might be to

''have the potential to benefit P without imposing on P a burden that is disproportionate to the potential benefit''.

That is perfectly reasonable, and consistent with the best interests principle. However, paragraph (b), which is disjunctive to paragraph (a) as it is related to it by an ''or'' rather than an ''and'', states that the research might

''be intended to provide knowledge of the causes or treatment of, or of the care of persons affected by, the same or a similar condition.''

Therefore, it would be specific to the condition that the person had, but might not be to their benefit. This must be reconciled with the principles in clause 1. It goes to the heart of a lot of concerns. We cannot waive the best interests principle.

I turn to my second point—I warned the Minister of a sucker punch to come. I consulted the Disability Rights Commission because of submissions I received from the I Decide coalition and other interested parties in relation to the Disability Discrimination Act 1995. As the Minister knows, I could weary the Committee talking about that, but I have no intention of doing so. However, if under clause 30 we were to produce, even unwittingly, a regime that in terms of consenting to research is less protective of the interests of those who are disabled because they lack mental capacity than it is of persons with capacity—in other words, if we were to open a gap so that persons who lacked capacity could be made subject to procedures that they would not necessarily experience if they had capacity—we would have a problem, in terms of both disability legislation and the European convention, with discrimination issues. We must not get into that position.

I gave the Minister formal notice that I wanted to raise the matter that my third point addresses. I have not researched this as much as I should, but I am anxious that any regime we adopt be congruent with the Human Tissue Bill, which is being considered in another place. Above all, we cannot have a situation in which living persons who lack mental capacity, albeit they have a decision maker on their behalf, have to undergo more intrusive procedures than might be permitted on cadavers with the consent of the dead person's family or otherwise. The level of safeguards must be at least equivalent, if not higher.

I want to explain the biggest concern I had when I initially read these clauses. Lot of debates about donor cards have arisen as a result of private Member's legislation introduced by the hon. Member for Oxford, West and Abingdon (Dr. Harris). I carry a donor card; I suspect that many Committee members do, too. It is an advance decision of a kind. Many of us would probably be prepared to acknowledge that having a presumed consent to donation would be very convenient and might be in the best interests of medical research and the availability of organs. However, we are holding back from that on the principle of informed consent. We do not feel that it should be presumed that an adult has given consent simply because they have not not given consent. There is a danger when a person lacks capacity and they are not in a position any longer to make their own decision; nobody should be able to take a decision on their behalf that fails to meet the best interests principle.

I hope I have made clear the sort of groundwork from which I approach this matter and the areas in which I have genuine concerns. They have been mirrored in many of the representations made to us.

Amendment No. 41 is the easiest proposal and the Minister might say that it is redundant, but it would provide that research would be all right if it conformed to an advance decision made while P had capacity to permit the carrying out of research on P. In other words, it would extend the earlier provisions on advance decisions to include research, a principle that is not objectionable. Amendment No. 42 would

leave out subsection (3) and amendment No. 43 subsection (5), both of which relate to clinical trials regulations. Not all of us are expert on the clinical trials regulations specified under the Bill. We do not know exactly how they work, whether the safeguards are similar and whether the principles that I have set out, including the best interests principle, operate in the same way across those regulations. If they do not, there could be a difficulty.

Amendment No. 44 would strike out the alternative test. Under clause 31(4)(a), the research must have the ''potential to benefit P''. The alternative test under clause 31(4)(b) is that the research must provide general knowledge of the subject. I am not caricaturing the provision or suggesting that it is way beyond the pale; it is about people researching into Alzheimer's on an Alzheimer's subject, but it is arguable whether that is in the person's best interests. I wish to bring two other considerations to the Committee's attention, the first of which is urgency.

Mrs Joan Humble (Blackpool North & Fleetwood, Labour)

The hon. Gentleman is making an interesting presentation, but the best interests test is deliberately not phrased as the ''best personal interests''. We have had much debate about that. I want to throw a suggestion into the pot. The hon. Gentleman gave an example of an Alzheimer's sufferer. If the research was wide-ranging research, examining the causes of mental incapacity, does he consider that that could comply with the general best interests test, even though it might not be in the personal best interests of the individual because he is beyond that?

Mr Tim Boswell (Shadow Minister, Home Affairs; Daventry, Conservative)

I found it difficult to follow that argument, although I understand why the hon. Lady made it. She is acknowledging the difficulty under the clause. We can either work on the basis that the best interests of the person concerned means what it says it does and legal practice, which is that person and no other person, or we can take the view that there is a general good that transcends that. Let us consider the scheme of the Bill. If we start with the presumption of mental capacity, people may make advance decisions that are contrary to their best interests. However, when they lose capacity, no one is provided under the principles of the Bill with a facility for making decisions for them that would be contrary to their best interests. That is the nature of my concern about the matter and where a difficulty arises.

Mrs Angela Browning (Tiverton & Honiton, Conservative)

We had a lot of deliberation about such matters in the Joint Committee. My hon. Friend will be aware that the Scottish legislation states that the research must be of real and direct benefit to the adult. We heard evidence from Dr. Lyons, who said that that was a difficulty because if the research was of real and direct benefit to individuals—

Ms Rosie Winterton (Minister of State, Department of Health; Doncaster Central, Labour)

They should be having it anyway.

Mrs Angela Browning (Tiverton & Honiton, Conservative)

Yes, because it would not be research, but treatment. A difficulty arises with the definition of research and whether it is someone's best interests.

Mr Tim Boswell (Shadow Minister, Home Affairs; Daventry, Conservative)

Of course there is a difficulty; the inference is that in the end some cases might have to be

resolved by the court. I am conscious that practice that has been ill defined in the past and many such things have taken place. We seek to regularise practice in a way that is congruent with the rights of the individual—indeed, their rights under the convention—as well as with our general wish to support their best interests and to provide a regime under which such support can be provided.

I do not have them before me, but Birmingham university and others have made powerful representations about urgent research, which say that we might effectively stop the research process by imposing restrictions. I understand the concerns about that; I also understand the concerns about achieving the equivalent level of safeguard if there is urgency. Many years ago, I had experience of a family member with a head injury. I did not get to know about it immediately, and was not even in the same country until some time after the event. However, I realised the difficulties involved. The issue is difficult. One does not want to stop all research, or make the system inflexible, but there are issues of principle that are difficult to run away from.

The other technical issue of concern is about whether research is intrusive. I am not sure that that would be a useful test either. The Government are clearly uncomfortable about the issue and talk about the research not involving risk, for example. Additional safeguards are set out in clause 33, which would enable the subject, if they flinch and indicate pain or distress, to stop the trial. In fairness, such safeguards exist already in research protocols; I am not suggesting that they do not. However, I am not sure that trying to rewrite on the basis of what might be termed passive, rather than active, research would be acceptable.

I do not believe that one can ever breach the best interests test; we need to test whatever we come up with against that. There are wider interests, and we have to establish how they can be reconciled. Personally, I feel relatively happy about tests that involve observation or are incidental to another test that is required for therapeutic reasons. If somebody was having a blood test for one purpose, and it was possible to take some cells from that procedure and use them for another purpose—for example, for investigating the causes or other aspects of Alzheimer's disease—I do not think that that would be objectionable in principle or practice. That might be a way forward, but anything that could involve even a little bit of pain or distress would be very difficult to reconcile with best interests. We have to look hard at how we are to deal with that. If one is honest, and the Government might have wanted to look at the issue in this way, one might say that the best interests test is too restrictive. I hope that in practice most of the issues can be resolved.

In conclusion, I offer the Minister one thought, which is about an aspect of best interests that we have not debated, although we have debated nearly everything else about that issue. Clearly, one does not want to harm the individual—indeed, that would not be consistent with the doctor's professional oath. Clearly, one wants to promote the best interests of the

individual, because that is the cardinal principle of the Bill. From time to time, acts will take place that will be difficult to classify as being in a person's best interests or otherwise. They may be neutral acts that do not damage or automatically benefit the individual. However, an individual who is alive, even if they do not have capacity, has to live somewhere. They are alive, breathing and carrying out involuntary actions. It may be that we will come to a point at which we are able to say that some things congruent with the research protocols could be carried out because they would not damage the individual, and that we would let them take place because they were not inconsistent with the individual's best interests. I am using a double negative, but I think that the Minister will understand.

I return to my central point about breaching the best interests test, there is a second aspect to it. If we are to go down this road—perhaps further reflection in the light of the Minister's response is needed at a later stage of the Bill—we must also look quite hard at the safeguards that are built into the process now. There will be urgent cases, and I am conscious of the difficulties that clinicians face, not only in their research but from legal challenges to their actions. We must make absolutely sure that, if we are to countenance this, we do not make it an excuse for practices that we would all live to regret.

Mr. Tom Clarke (Coatbridge and Chryston) (Lab) rose—

Mr James Cran (Beverley & Holderness, Conservative)

I express my thanks to the right hon. Gentleman for taking over earlier and allowing me a modicum of relief.

Mr Tom Clarke (Coatbridge & Chryston, Labour)

I join my hon. Friend the Minister of State in welcoming you as Chairman of our Committee, Mr. Cran. Indeed, during those few moments when I proved to be a wholly inadequate substitute, I realised how onerous are the duties that we impose on you.

Mr James Cran (Beverley & Holderness, Conservative)

Order. Insulting the Chairman is not allowed.

Mr Tim Boswell (Shadow Minister, Home Affairs; Daventry, Conservative)

Or flattering the Chairman.

Mr Tom Clarke (Coatbridge & Chryston, Labour)

The ambiguities that have haunted the Committee thus far continue. From your viewpoint, Mr. Cran, I also realised what a fine body of men and women serve on this Committee.

To turn to the serious aspects of our business, my purpose is to speak to my amendments Nos. 178, 179 and 180. I begin by declaring an interest as the co-Chairman of the all-party group on learning disabilities. I have had a great deal of help from that group as well as the Making Decisions Alliance, which, in truth, has been immensely helpful to all of us on the Committee. We appreciate very much the work that it does.

In the same way that people with impaired capacity should not be excluded from services and medical treatment, it is important not automatically to exclude them from research. I tabled the amendments because I believe that research raises several difficult ethical

questions; hence, the most stringent safeguards must be put in place. Dignity, privacy and protecting people from harm or exploitation must be paramount. I tabled the amendments to give my hon. Friend the Minister and the Committee the opportunity to reflect on and respond to the numerous representations that have been made to me and, doubtless, many other right hon. and hon. Members, not simply from the organisation that I mentioned but also from constituents in our surgeries, offices and elsewhere.

My hon. Friend the Minister said that ''reasonable grounds'' were a high test for someone to pass. Amendment No. 178 would make it absolutely clear in the Bill that it is simply not appropriate to carry out research on people who lack capacity if it is not possible to carry out the same research on people who can give their consent. That is a crucial issue for our discussion. My hon. Friend the Minister will recognise that that test is used in the Adults with Incapacity (Scotland) Act 2000, which has been highly praised on both sides of the Committee again this afternoon, and to which I have referred previously. I should be grateful for further expansion on the reasoning behind departing from that wording. I accept an argument that I myself made earlier: there is no reason, given our commitment to devolution as a United Kingdom Parliament, why we should expect devolved Assemblies to emulate everything that we are doing. It is fair to make that point.

Amendment No. 179 is essentially a probing amendment. I simply want to tease out and put on the record what my hon. Friend the Minister means by ''benefit''. The final amendment in the group, amendment No. 180, is also a probing amendment. It is worth highlighting that, as the clause stands, there are two potential get-outs for researchers. I seek reassurance from the Minister on a point that worries a great number of people, and certainly worries me. Researchers can undertake non-therapeutic research on an incapacitated person if they have

''reasonable grounds for believing . . . that the risk to P from taking part in the project is likely to be negligible''.

The word ''reasonable'' in such close proximity to ''likely'', and the looseness of phrasing, make me feel a little uncomfortable. I look forward to the Minister's explanation. Amendment No. 180 probes the Government's reason for wording the clause in that way.

Mrs Angela Browning (Tiverton & Honiton, Conservative)

Is it not the case that, up and down the land, lawyers are making their fortunes, and always have done, on the interpretation of ''reasonable''? It seems to occur in court cases all the time. It is put into legislation so that, at the end of the day, everything is resolved by case law.

Mr Tom Clarke (Coatbridge & Chryston, Labour)

I am sure that the hon. Lady is making an important point. Tempting though it is to respond to the comment about lawyers, I simply say to the hon. Lady that, if she reads the Hansard in which the right hon. Member for Richmond, Yorks (Mr. Hague) introduced the Disability Discrimination Act to which the hon. Member for Daventry referred, she will see that that was a point of concern even then. I spoke for the Opposition on such matters then, and I fear that we have not removed the concern in the nine years that

have since passed, and I doubt whether we will do so today.

I should be most grateful if the Minister outlined what additional risk P would be exposed to by the use of words such as ''likely to be negligible'', rather than the use of the word ''no''. I hope that she can satisfy those concerns, and I look forward to her reply.

Mr Paul Burstow (Shadow Secretary of State for Health, Health; Sutton & Cheam, Liberal Democrat)

I want to address one of the most difficult issues in the Bill. I suspect that it has been grappled with, at least in part, in some detail and length during consideration of the Human Tissue Bill, when ethical issues about research and when it is appropriate, and the whole question of consent, were considered. I have also been wrestling with the question of quite how to deal with the problem.

I was comforted by the evidence that the British Medical Association submitted to the Joint Committee during its scrutiny of the draft Bill. We were given a presentation from Dr. Nathanson from the BMA, who said that

''a small amount of research does get carried out with very careful review by research ethics committees.''

He was talking about research that was already taking place, albeit outwith a clear legal framework and without real safeguards other than those provided by medical ethics committees. One of the things that we were told on a number of occasions when considering the draft Bill was how the work undertaken by medical ethics committees has evolved over the last 20 years and become a better, more reliable and more robust way of providing safeguards when research is conducted.

It is important to keep in mind the fact that research is already being conducted. We should also bear in mind what happens as a consequence of some of that work. I am sure that other hon. Members have received numerous briefings on the matter. Reference has been made to a briefing that was sent to us from Birmingham. The medical research council of the Wellcome Trust has also provided a good briefing, giving a host of examples of research from which people could cease to gain direct and wider benefit if we took a strict view and said that in no circumstances could research take place if a person lacked capacity.

I shall refer to two examples, the first of which is of a condition called phenylketonuria—I am sure that I have not pronounced that right, so I hope that Hansard will help me out. The Wellcome Trust's briefing says:

''Untreated phenylketonuria (PKU) used to result in profound learning disability. The clinical outcome of this condition has been dramatically altered by studies of adults and children with severe learning disability. These have led to the identification of a biochemical disorder in patients suffering with this condition that is treatable via removal of the amino acid phenylalanine from the diet. The biochemical disorder can be detected in newborn babies by the 'Guthrie test' ''.

The briefing goes on to expand on that. The other example is from the CRASH trial, which looked at people with impaired consciousness and disability:

''This trial examined the potential value of steroids in treating head injury and preventing prolonged disability. The original trial did not directly benefit those participating in it but has led to subsequent studies that have improved the treatment and likely outcome of patients suffering from such injuries.''

Those two examples—there are others—are of studies that would probably not have taken place if we took the view, which some have understandably taken, that there should be no research where a person lacks capacity. As a consequence of that, many people would not benefit.

I understand that that could be seen as a utilitarian argument for allowing research to take place, but it cannot be entirely ignored. That is why I want to develop the point a bit further and get clarification on the wording of the Bill. It is important that some of the amendments seek to clarify precisely what the words are meant to mean. The right hon. Member for Coatbridge and Chryston (Mr. Clarke) raised the juxtaposition of the test of reasonableness, which is a good point.

Can the Minister say more about risk, which is dealt with in clause 31(5)(a)? The degree of risk that we are talking about needs to be clear, because clause 31(5)(a) says that it should be ''negligible''. What does that mean? The explanatory notes are no help whatever in further clarifying that, so I hope that the Minister can say a bit more about it.

Subsection (5)(b)(i) talks about not interfering

''with P's freedom of action or privacy in a significant way'',

but the explanatory notes do not explain what is meant by ''a significant way''. It would be helpful if the Minister gave us a feeling for what it might mean, so that those who will be required to operate under the provisions if the Bill becomes an Act can do so in a satisfactory way.

I was particularly struck by amendment No. 178, which would replace clause 31(3). It was tabled by the right hon. Member for Coatbridge and Chryston (Mr. Clarke), who is right to want to include in the Bill the proposition that it would be wrong for a person who lacked capacity to be the subject of research if a person who had capacity could be the subject of that research, and it would benefit from using such a person. It is important for the Bill to make that clear.

Clause 34 contains the power to stipulate who the appropriate authority or body will be, but it would be helpful if the Minister said a bit more about how that power will be used, because, again, the explanatory notes are far from clear. They state:

''The Secretary of State must specify an appropriate authority for approving research projects'',

and that is likely to be the research ethics committee. However, the explanatory notes do not say what conditions, regulations and requirements might be placed on the appropriate authority. It would be useful to know whether regulations could be laid saying not only that the committee will deal with the work, but how it will conduct that work. Is there scope for that? The way in which the Bill is drafted could be construed as meaning that there is not, but it would be helpful to have that made clear.

I want to conclude my contribution by reading again from the Joint Committee report, which makes some useful and insightful observations on this issue. Speaking of people who lack capacity, it says:

''they should only be involved with medical research, if it is either in their best interests or if it is the only method of conducting research into their particular condition and everyone involved with the person is satisfied that this is a non-exploitative proposal which will not harm or distress the individual involved.''

For those of us who think that research should take place, that must be the touchstone on which everything is based. If we go beyond that, we will get into waters that I would not want us to be in and begin to act in an unethical and unacceptable way.

Mr Tim Boswell (Shadow Minister, Home Affairs; Daventry, Conservative)

The formulation that the hon. Gentleman has given us includes the important disjunctive ''or''. Does he think that the second test that he read out on behalf of the Joint Committee is different from the test of best interests? The difficulty is whether we will be at risk of breaching the principle if we have that in the Bill.

Mr Paul Burstow (Shadow Secretary of State for Health, Health; Sutton & Cheam, Liberal Democrat)

I am grateful to the hon. Gentleman because that allows me to move to my final point. The I Decide coalition has drawn hon. Members' attention to the judgment last year in respect of JS v. An NHS Trust and JA v. An NHS Trust. I want to quote from the judgment because it raises an interesting issue about real and direct benefit:

''It was in the best interests of the patients that the treatment be carried out. Although there was only a slight chance that the treatment would result in an improvement in the teenagers' condition, and there was no chance that the treatment could lead to recovery, both teenagers had lives worth preserving and any treatment that might be beneficial would be of value to them. A reduced enjoyment of life even at quite a low level was to be respected and protected, and even the prospect of a slightly longer life was a benefit worth having for these patients.''

I guess that the dilemma is whether research that will have not even the slightest chance of providing a benefit for the individual should be authorised. Some of the research that I referred to earlier clearly could be in that category.

Ann Winterton (Congleton, Conservative)

The hon. Gentleman quoted research being undertaken now without any regulation. Can he say whether it is being undertaken with the consent of relatives of the patient, if the patient cannot give theirs because of a lack of capacity?

Mr Paul Burstow (Shadow Secretary of State for Health, Health; Sutton & Cheam, Liberal Democrat)

That is a fair question, and I must admit that the briefing material on which I was relying does not answer it. However, it refers to the point that I was making earlier, which is that such research is happening now. If it is to happen—and, on balance, I am coming down on the side of the argument that there are circumstances in which research should take place—it should happen in a framework that provides substantial safeguards. The amendment of the hon. Member for Daventry, which would make it clear, for example, that advance directives have a part to play, is helpful. It is only right that people should be able to stipulate in advance that they are prepared to be a party to research.

It has been put to me that those of us who have the capacity to participate in research do so only when we believe that we will get a direct benefit from it. I think that it is a false proposition based on little evidence. It is a pity that some people hold that view. It should not

be prayed in aid to suggest that those who lack capacity, but have others who can give consent in the circumstances set out in the Bill, should be able to take part in narrowly defined areas of research when there is no other way in which we can learn how to ensure that those people do not suffer in the future. That must be at the heart of our thinking.

I have tried to voice some of my concerns and ask the Minister to clarify a few of the key words in the Bill, so that we can have some more clarity. The clauses try to put in place safeguards. Those safeguards do not exist now, but research is taking place. The clauses are a way of ensuring that there are safeguards in future. For that reason, I broadly support them, although some of the amendments would help to clarify further and to improve the situation.

Ann Winterton (Congleton, Conservative)

May I take the opportunity to thank my right hon. Friend the Member for Coatbridge and Chryston, as, through him, I welcomed you to the Chair, Mr. Cran? It is a bit of a long-winded way to go about it, but it was nevertheless a warm welcome. May I also say how much I look forward to serving under you?

Mr James Cran (Beverley & Holderness, Conservative)

I am not quite sure whether I understand that.

Ann Winterton (Congleton, Conservative)

Perhaps my right hon. Friend will explain it all later—it happened during your absence, Mr. Cran.

We have had an interesting debate on the clauses on research, and I understand the concerns that people have—it is an emotive subject. Before I address the specific amendments, it would be helpful if I outlined some of the broader thinking behind why we have included these clauses and if I explained how we hope to achieve research that can lead to new and effective treatment, using procedures that balance that desire with effective safeguards for the individuals taking part.

It may also be helpful if I gave a clearer picture of the research that is covered and why we have included research that provides knowledge of the causes or treatment of a condition as well as research with the potential to benefit the person with the condition. I hope that that will help to allay some of the concerns about how research provisions fit in with the concept of best interests. It would be helpful, too, if I outlined some of the safeguards on participation in research and how the research provisions in the Bill relate to clinical trials.

Research is understandably a complex area to cover in the Bill, and some stakeholders expressed concern about our allowing medical and other research to take place at all when it involves people who lack the capacity to consent. We also discussed that matter on Second Reading. We appreciate that these are sensitive issues but, as we said to the Joint Committee, if we do not permit research into incapacitating conditions, treatment or prevention for those who could develop the conditions may be inhibited. Our key consideration is how to balance the need for such research with satisfactory safeguards. As the hon. Members for Tiverton and Honiton and for Sutton

and Cheam said, the Joint Committee heard a variety of representations on the issue, but concluded that the Bill should include provisions on research. It said that these should

''enable strictly controlled medical research to explore the causes and consequences of mental incapacity and to develop effective treatment for such conditions. This . . . must include rigorous protocols to protect incapacitated adults from being exploited or harmed.''.

Mrs Angela Browning (Tiverton & Honiton, Conservative)

Will the Minister reflect on sterilisation? Is she content for sterilisation per se to be included in research on incapacitated adults, or does she think that in that area of research it should be subject to an individual approval by the Court of Protection?

Ann Winterton (Congleton, Conservative)

That decision would be taken by a research ethics committee. It would not be for Parliament to dictate what should or should not be in particular areas of research. I am not sure how the hon. Lady imagines the research taking place. The Bill contains clear safeguards about risk, and about not being unduly invasive. I am not sure how she wants us to proceed in respect of the parameters of different research, which would depend on the conditions set by a medical ethics committee, and on the safeguards in the Bill.

Mr Paul Burstow (Shadow Secretary of State for Health, Health; Sutton & Cheam, Liberal Democrat)

Surely sterilisation is a treatment; in the context of our discussion about research, it is not something that one would carry out for research purposes. I would be most concerned if it were considered that it could be dealt with in the context of these provisions. I should have thought that it was outwith them, and I hope that the Minister can reassure us on that matter.

Ann Winterton (Congleton, Conservative)

That is why I was explaining that I did not understand how the hon. Lady was imagining that research—I do not know whether she meant research into sterilisation, and how that would take place—unless it was something that would not necessarily benefit the person, and was also invasive—

Mrs Angela Browning (Tiverton & Honiton, Conservative)

Perhaps I should have coupled sterilisation with fertility.

Ann Winterton (Congleton, Conservative)

Again, I would say that some of these procedures would be treatments, as opposed to research. I am not quite sure whether the hon. Lady was saying that if an individual had been given fertility treatment or had been sterilised, research would then be carried out into the effects of that. That would be a matter for a research ethics committee, within the parameters and safeguards in the Bill, about the extent to which risk should be considered.

The Committee suggested a number of key principles that should govern participation in research. It said that projects should be reviewed by properly established independent ethics committees. We have said that an appropriate body such as an ethics committee must approve all projects.

The hon. Member for Sutton and Cheam asked what other bodies might be appropriate, and whether regulations should set out the way in which they do their work. In some of the social care aspects of research, social care bodies, as opposed to research

ethics committees, will that carry that out. Also, in any code of practice or regulations there would be a clear steer towards sticking to the principles in the Bill with regard to obtaining consent for somebody to participate in the research. We would expect the research ethics committees to adhere to that.

We have made it clear that all research projects must satisfy the strict conditions that we have set out in clause 31 in order to gain such approval. The research ethics committee would examine the requirements in clause 31 before it could give approval. The criteria that such committees would be expected to stick to are in the Bill.

Mr Paul Burstow (Shadow Secretary of State for Health, Health; Sutton & Cheam, Liberal Democrat)

For the sake of clarity, will the Minister confirm whether the power under clause 30(4) will allow the Government of the day, as part of nominating an ''appropriate body'', to stipulate—if they wanted to and felt that it was appropriate—its form, make-up, members and so on? Does it allow the Government to stipulate beyond what the appropriate body will be—for example, the way in which it will conduct its work?

Ann Winterton (Congleton, Conservative)

Yes, it would. The reason why that phrasing is included is that an appropriate body is not necessarily a research ethics committee. As I have said, in some social care research projects it can be a different type of body. The Committee also said that care should be taken to ensure that consent was freely given. That is why we specified in clause 32 that carers must be consulted, or, where no carer exists, that an independent person who can be consulted on the person's participation must be found. The Committee said that discomfort must be minimal, and the researchers should respect any indication of dissent.

Clause 31 is clear that for research that may benefit a person, any burdens must not be

''disproportionate to the potential benefit'',

and that for research to develop new knowledge of the condition, the risks must be ''likely to be negligible''. I understand the point that was made by my right hon. Friend the Member for Coatbridge and Chryston , and I will be talk about that later when dealing with the amendments.

Under clause 33, nothing may be done to a person if he objects, and if at any time he indicates

that he wishes to be withdrawn . . . he must be withdrawn without delay.''

For example, a person might resist when asked to perform a particular task or to be subject to certain procedure, such as blood pressure measurement. He may refuse to co-operate about going into a research clinic. All such wishes must be respected by the researcher at the time. However, the researcher may want to approach P on another occasion or in a different way, in which case P might be more willing to participate.

Alternatively, P may confide in a carer that he does not like the research or that the prospect of it is upsetting to him. The carer can pass that on to the researcher or, if the carer is the person to be consulted, he has the right to say at any time that he wants to withdraw P from the study, and the researcher must

comply with that wish. We consider that the Bill provides a good balance between protecting the individual today and potentially benefiting that individual, or others with similar conditions, tomorrow.

The hon. Member for Daventry referred to the relationship with the Human Tissue Bill and organ donations. If a mentally incapacitated person died, the hon. Gentleman asked whether that person's body could be used for research. Such matters are covered under the Human Tissue Bill. The same provision relates to anyone else. If an incapacitated person dies without having made a prior decision, his body may be used for research with the consent of a nominated representative, if appointed by the person while he had capacity or a person who was in a qualifying relationship as set out under the Human Tissue Bill.

Mr Tim Boswell (Shadow Minister, Home Affairs; Daventry, Conservative)

My concern was not only to make sure that there was a suitable and dignified regime for persons who lacked capacity after they had lost their lives, but to make sure that the safeguards for those persons while in vivo, when research might be conducted on them, are at least as strong as those that would apply to their cadaver after their death.

Ann Winterton (Congleton, Conservative)

That would be the case. As for organ donation, the situation would be the same. If the person carried an organ donor card, his relatives would be informed that that had been his wish. If he did not, the relatives would be asked whether they were happy for his organs to be used for donation. The same would apply to an incapacitated person as to any other person.

We have had extensive discussions about best interests. It could be said that it was difficult to align a narrow interpretation of best interests with some key aspects of research. Some research might benefit a person, but it may not have been established that the treatment under investigation is necessarily better than the standard care already being given. A doctor may decide that P is suitable to be included in a research trial of a promising and safe new surgical procedure. The doctor is expected to make that assessment and treatment decision in P's best interests. However, it may not necessarily be in P's best interests to be subjected to additional X-rays or blood measurements, to be followed up with the extra measurements that are an essential part of the research project.

So there needs to be independent oversight of research by an ethics committee. It should consider whether the research is lawful and whether it will potentially benefit an individual or yield important scientific knowledge. Crucially, the patient should not be harmed or his privacy or rights infringed. If the research has those safeguards, it can be said to be consistent with P's best interests, as it will potentially benefit P or those in a similar position.

We have agreed with the view put to us by many organisations that to deny adults without capacity the opportunity to be involved in well run research would mean that their special requirements and experiences were not considered in developing treatment and care

programmes or evaluating best practice. Ultimately, sometimes there may not be an immediate benefit, but there may be a benefit at a later stage if new treatments or care plans are established as a result of good research evidence.

With amendment No. 41, the hon. Member for Daventry is seeking to ensure that the previously expressed wishes of people who lack capacity are respected when their involvement in approved research projects is considered. The principle is right, but unfortunately the amendment would prevent most people from participating in, and potentially benefiting from, properly conducted clinical and social care research.

We must recognise that many people will not have considered their possible involvement in research before they lost the capacity to consent. Some important groups of adults without capacity may never have had an opportunity to make formal advance decisions before they lost capacity. I am thinking of adults with lifelong learning disability, and those who suffer sudden and unexpected loss of capacity due to a head injury, stroke or infection. Under the amendment, if there were no advance decision authorising research, research would be deemed unlawful. That would mean long delays in enrolling people in research programmes and, consequently, in the development of new treatments.

That said, the Bill recognises the importance of ensuring that research takes proper account of a person's previously stated wishes and feelings. Clause 33(2)(b) says that nothing may be done to P in the course of research

''which would be contrary to an advance decision''.

The clause also requires that any sign of objection by P, or any indication that he wishes to withdraw from research, be respected.

Amendments Nos. 42 and 43 would remove the references to ''clinical trials regulations''. The hon. Gentleman thereby proposes to bring clinical trials of medicines within the scope of the Bill. Perhaps it would make things clearer if I were to compare the main aspects of the regulations with the Bill. The Medicines for Human Use (Clinical Trials) Regulations 2004 cover all clinical research involving investigational medicinal products—trials that will involve giving people active substances such as drugs or vaccines. The Bill covers a much broader area of potential research, such as research on tissue samples taken for clinical purposes, examining medical records or asking patients' views on treatments or care that they have received.

I shall give examples of the sort of research that that means. The clinical trials regulations cover IMAGES—the intravenous magnesium efficacy in acute stroke clinical trial—in which magnesium treatment was shown to be effective in the treatment of strokes. To design that trial, the researchers had carried out observational research on stroke patients, many of whom were unable to consent for themselves. The research included measuring their blood pressure and collecting blood samples repeatedly over a few

days to assess levels of hormones and body salts, including magnesium. The results of the research led to improvements in treatment for stroke patients.

The Bill would cover projects such as research that my Department funds as part of the programme of research on learning disabilities, including studies with adults with learning disabilities on the benefits of health facilitators, spotting symptoms of sexual abuse and assessing the effect of cognitive behaviour therapy. That research is only ever likely to have an indirect impact—if it has any impact at all—by influencing future policy and practice. It might, however, be of direct personal benefit to P at some point in the future, if the services that he or she receives were to be improved as a result of the research.

The clinical trials regulations cover all patients, including those with mental incapacity, and minors, whereas the Bill deals only with people who lack capacity. In both cases there must be approval for research by the Medicines and Healthcare products Regulatory Agency, and by a research ethics committee for clinical trials and an ''appropriate body'' for the Bill, which would probably also be a research ethics committee.

The clinical trials regulations require informed consent given by a legal representative whereas the Bill requires a researcher to consult with someone engaged in caring for, or interested in the welfare of, P. If at any time that person says that P would not have wanted to take part in the research, P must not take part.

The Bill covers a much broader area of research; it therefore seemed right to use different safeguards to cover that broader area. The Bill has been carefully drafted to reflect and respect the extensive work done to develop a harmonised system for clinical trials of new medicines.

The 2001 EC directive sets out internationally accepted standards of good clinical practice and manufacturing practice and also covers independent oversight of clinical trials by ethics committees. It was implemented in full in the UK by 1 May and makes extensive provision for research involving those who lack capacity. Those measures have been agreed internationally as appropriate for research and are aimed at protecting vulnerable groups of people in research that involves giving them active substances such as drugs or vaccines.

However, the Bill's provisions are much wider. They include social care research, such as interviewing service users about their care, or carefully controlled access to data from patient records, with, as I said, all the safeguards that have been built in at the same time. We are very confident that we have two complementary regulatory systems that are equally effective in ensuring the appropriate regulation of research involving adults with incapacity.

Amendments Nos. 178 and 179 would place tighter restrictions on participation in research. Clause 31(3) requires the researcher to have

''reasonable grounds for believing that the research would not be as effective if carried out only on, or only in relation to, persons who have capacity to consent to taking part in the project.''

My right hon. Friend the Member for Coatbridge and Chryston seeks to simplify and clarify the intention of subsection (3). The problem, however, is that the amendment risks making it very much more difficult for a research ethics committee to decide whether the research can be approved.

Subsection (3) is intended to ensure that research is not conducted on a person who lacks capacity if such research could be done equally well on people with capacity. This is sometimes called the no alternative criterion. As I said, the subsection is one of several safeguards that we built into the Bill. It is also important that we recognise that the design and conduct of research become increasingly complex as our understanding of medicine and biology increases. I am concerned that it would become inordinately difficult for a research ethics committee to decide whether another similar line of research exists that might involve adults with capacity.

As I already explained, a researcher must comply with a very strict set of statutory provisions to secure approval for a project. It is right that we allow a research ethics committee to apply its judgment so that each application can be considered on its merits. I understand my right hon. Friend's concerns, but his amendment would restrict research.

Amendment No. 179 would also tighten the criteria for accepting research projects. Again, I am very sympathetic to the sentiment behind the amendment, which obviously aims to leave no room for doubt that research involving an incapacitated person could be carried out only if there was real certainty that it would benefit the person. I re-emphasise that the clause is clear on this point. It states that the research must have the potential to benefit P. Adding the words ''real and direct'' would not improve its clarity. As we have said, this would complicate an already quite difficult judgment.

The Joint Committee agreed that, even if research is therapeutic, it would be difficult for a research ethics committee to be able to say for certain that research can be of real and direct benefit to the person. It would be even more difficult to demonstrate that in other settings, such as social care.

I entirely understand why people are concerned to ensure that research that involves someone who lacks capacity to consent can be approved only if there is real benefit to the person, but again, the evidence to the Joint Committee was quite clear: it can never be guaranteed to benefit an individual. As was said earlier, if the research was guaranteed to benefit a person, what was involved would be given in the first place; there would be no need for the research.

Amendment No. 44 again concerns removing provisions for non-therapeutic research from the Bill. The problem is that the amendment would remove provision for an important area of research. For some research, it may be hard to show that there is direct benefit. For example, in surgery to treat patients with a brain haemorrhage it is vital that patients have sufficient anaesthetic to relieve pain, but not so much

that it might further damage their brain. Research to choose the best pain-monitoring device will benefit future patients, but there can be no certain direct benefit to any particular patient from that study.

Amendment No. 180 would place similar limits on research, stating that there should be ''no risk'' to research carried out. However, just as it is difficult to establish direct benefit, it can be almost impossible to guarantee that there is no risk to any activity. I completely understand the sentiment behind my right hon. Friend's amendment, but it is untenable because it is simply not possible to guarantee that there will be no risk to a person, in that or any other situation.

I hope that, with the reassurances and clarification that I have given, the hon. Member for Daventry feels able to withdraw his amendment.

Mr Tim Boswell (Shadow Minister, Home Affairs; Daventry, Conservative)

I thank the Minister for giving an extended response. She has sought to give explanations and assurances that are helpful to the Committee. We will need to go away, look at the record carefully and reflect on the issue.

My personal reservations have not been entirely allayed. My first reservation involves safeguards. Nobody wants a bureaucratic or complex system that cannot respond to a particular situation. It is equally important, given the sensitivity of the subject,

which has been accepted on both sides of the Committee, to ensure that safeguards are sufficient.

My second reservation involves the principle. I note that the Minister did not specifically respond on whether the best interest test covers this clause, save only by extending the context to the widest possible interpretation of best interest, which is the response I anticipated. I want to reflect on that. In effect, she was saying that if it might do some good either to P or to somebody else with P's condition, this is in P's best interests or is certainly not inimical to them.

I understand that approach. It would be objectionable in principle to exclude best interests from the clause, so we must consider whether this is a legitimate way to deal with the problem. I suspect that it will inevitably end up being tested in court, or possibly in the European Court.

Rather than exercising our right to vote on the matter, we will go away, reflect and consider whether we wish to return to it. I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 30 ordered to stand part of the Bill.

Further consideration adjourned.—[Ms Bridget Prentice.]

Adjourned accordingly at fifteen minutes past Five o'clock till Tuesday 2 November at half-past Nine o'clock.