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

I beg to move amendment No. 45, in clause 32, page 18, line 19, leave out 'or is P's deputy'.

Mr Alan Hurst (Braintree, Labour)

With this it will be convenient to consider the following amendments: No. 181, in clause 32, page 18, line 20, at end insert

'but a deputy shall not be able to consent to research under 31(4) unless the court has conferred on the deputy express authority to that effect.'.

No. 182, in clause 32, page 18, line 21, leave out subsection (7).'.

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

In a sense, these discussions all hang together. Clauses 32 and 33 relate to safeguards for P if P is participating in a research project. By definition, P lacks capacity if those clauses apply. Amendment No. 45 touches simply—or perhaps not so simply—on the independence of persons who may be consulted about that.

There is a welcome provision in clause 32 for carers and other related persons to be consulted. Subsection (6) refers to

''the donee of a lasting power of attorney'',

who might well be a relative of the person who executed that LPA, so it would be ridiculous to rule them out of being considered as the relevant carer. I ask the Committee to pause and think about the deputy, however, because that person is appointed by the court. He or she may well be a professional person—one who is involved, for example, in social services—who is appointed because there is no attorney and P lacks capacity. People may feel that

there is a potential clash of interest for the deputy, who may have other commitments and be guided by his own professional codes or his employers' instructions, and thus may not be able to give an unfettered view. More particularly, as the Committee may realise, even if that person can act in good faith on behalf of the person for whom he is the deputy, other people from outside might question whether he is truly independent. There are a number of solutions to that problem.

I invite the Minister to take this matter away, because I do not want to re-open the debate on clause 31. However, in particularly difficult cases, it may be sensible for the court or a deputy appointed for the specific consideration of the research project to be right outside the box. In such circumstances I would be relaxed about dealing with somebody who was already a court deputy. I am not clear whether, under the proposed legislation, it would be possible to have two people with that formal function in different respects, or whether the court could appoint an independent person who is not called a deputy for that purpose.

I do not want to speak about this at length again, but during earlier discussions I suggested a ''mixed economy'', with as many people involved as might reasonably be possible. It would be all right to use a court deputy, provided that there was another person outside the box of whom it could not be said that they were already committed, or compromised, in taking the decision or giving the advice. I realise that these are difficult matters, but there are a number of ways of solving the problems and the Minister needs to reflect about things, not least because of her concerns about the sensitivity of research going on at the very edge of what might be deemed to be in the person's best interests. That is an underlying principle of the Bill. She needs to reflect on an overt clash of interests that might arise from the drafting of the Bill, or on any potential charges of misconduct that might be levelled at a deputy, even when they were giving advice with the best of motives and in good faith.

It is important to state that we are talking about a person on whom research may be performed, but who lacks capacity. It is extremely important that nobody should be seen to be manipulating the situation to his or her own advantage and not in the best interests of the person involved. We have to maintain that underlying principle throughout these clauses.

Mr Tom Clarke (Coatbridge & Chryston, Labour)

I rise to speak in favour of amendments Nos. 181 and 182, which are probing amendments tabled to enable my hon. Friend the Minister of State to set out in more detail the Government's thinking on the appropriate safeguards to protect incapacitated people from exploitation.

I am concerned, in amendment No. 181, about a court-appointed deputy deciding whether an incapacitated person should take part in research that does not directly benefit P unless the court has conferred on the deputy express authority to that effect. I would welcome comment from my hon. Friend the Minister as to when she thinks it might be

appropriate for a deputy to make a decision about research on P's behalf, and whether she thinks that such an occurrence might be common.

Amendment No. 182 deals with my concern about clause 32(7). It is worth noting that the title of that clause is ''Consulting carers etc'', yet subsection (7) gives researchers the right to ignore what carers say are P's wishes and feelings—that P does not want to take part in research—and go to the Court of Protection to obtain permission anyway. That requires an explanation.

Given the absolute need to err firmly on the side of caution, if the researcher knows that P is unlikely to want to take part in research, my gut feeling is that that should be the end of it. I would welcome hearing what my hon. Friend thinks about this, and in particular whether she thinks it likely that a researcher would go to the Court of Protection to get permission to undertake research on P if that researcher knew, as far as possible, that neither P nor P's family would like to take part in that research. That is an extremely important question.

I would like my hon. Friend to give us the benefit of her thinking on these probing amendments.

Mrs Angela Browning (Tiverton & Honiton, Conservative)

I support the amendments to which the right hon. Gentleman has spoken. I have huge reservations about this section of the Bill. I am not totally opposed to people who lack capacity participating in research that benefits a third party, but the question of giving permission, and who gives it and in what circumstances, must be absolutely watertight. I share his concern.

My concern is that all too often the medical profession is terribly gung-ho about research and that sometimes it is difficult for people to feel that they are getting a genuinely independent second opinion. Particularly for the person giving permission, the medical detail and the science behind it might not be fully understood. As a rule, we still tend to take it on trust that what is being suggested is right. That is especially the case when somebody is an in-patient; I am thinking in particular of when P is an in-patient. There are feisty old things like me who always challenge and question, but probably not enough of us do so.

In the medical profession, second opinions have not always necessarily been independent. They have often been based on the old-boy network; people have relied on someone they know to give them an endorsement. Therefore, the Bill should contain checks and balances so that the person acting on P's behalf—whatever the relationship—has the opportunity to ensure that the advice is truly independent.

I support the two amendments tabled by the right hon. Member for Coatbridge and Chryston. They are intended to strengthen this part of the Bill, about which I have grave concerns. I have a horrible nagging feeling in the back of my mind that if we do not get this absolutely right, for all the reasons that have been given we will open the door to situations that we will find unacceptable. We are dealing with somebody who

has lost capacity and with regard to whom any treatment, therapy or invasion will be for somebody else's benefit. That is not a bad thing in principle if we can place our hands on our hearts and honestly say, ''If that person had capacity, they would say yes,'' or, in this case, the person acting on their behalf would say yes.

I want to raise an issue about the next of kin. Often, people lose capacity during their stay in hospital; they may be compos mentis when they go in and then lose capacity while they are an in-patient. When they are admitted, they are asked not about all the detail that we have before us now but, ''Who is your next of kin?'' That is what they write down on a hospital admission form. However, the next of kin may not be the person who will ultimately be consulted under the terms of this legislation. Therefore, it is quite possible that the next of kin may have a view—and, I assume, may still have a legal view—on P, but that they may not be very much involved in this type of decision-making.

The next of kin may be a frail spouse who is unable to visit regularly but still has capacity. They may be in a residential home. That is particularly the case with regard to elderly couples: when one goes into hospital, the other might be in residential care but cannot visit. Legally, they may be the person who should be consulted, but they will not be around.

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I wonder how the hospital would get right the balance between the next of kin whose name had been written on the admission form and some other person who would then appear. If the other person had to appear on P's behalf, it seems only right and proper that they should get the right authority to make decisions, give P's view or sanction things to happen on P's behalf. The issue worries me considerably.

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

As Committee members have said, clause 32 deals with the arrangements for seeking agreement for individuals to be part of the research study, once that has been approved. It sets out the importance of consulting those who are best placed to comment on the likely wishes and views of the person who lacks capacity before that person can take part in that research.

The clause also sets out an important safeguard: if the carer or nominated individual consulted advises against involving the person in the research, that person cannot be a participant—it will be as simple as that. The code of practice sets out in more detail the requirements for consulting on an individual's involvement in research.

The amendments focus on providing safeguards for people who lack capacity and on ensuring that they are protected against inappropriate involvement in research. I fully agree with the intention underlying the amendments and with the points that right hon. and hon. Members have made. We want to get the safeguards right.

Amendments Nos. 45 and 181 focus on ensuring that a deputy could not be consulted on P's involvement in research. Amendment No. 182 would remove researchers' right to contest in court a decision on non-participation. I have given serious thought to

those issues and say up front that I want to consider seriously the points made in Committee. I have reservations, which I will go through, about accepting the amendments as drafted, but I certainly agree with their spirit.

On amendments Nos. 45 and 181, I acknowledge the concern of the hon. Member for Daventry and of my right hon. Friend the Member for Coatbridge and Chryston to protect a person who lacks capacity from a decision by a court-appointed deputy whom they had not chosen to represent them. I also take on board the points made by the hon. Member for Tiverton and Honiton (Mrs. Browning).

Clause 32 makes it clear that a researcher would have to take steps to identify someone, other than a person acting in a professional capacity, who cared for the incapacitated person and would be willing to be consulted on the incapacitated person's participation in an approved research project.

It is clear that the role of the consultee would be to consider what was involved in the project and what the incapacitated person would feel about being involved. To do that, the person consulted would have to be made aware of the aims of the research, the procedures involved and the risks or inconvenience that might ensue. They would then have to give advice on whether the person without capacity should take part and on their wishes and feelings about the project. Importantly, the consultee would need to ensure that any previous statements that indicated a refusal to be involved in research, including any advance decisions, were respected.

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

The Minister is, very helpfully, setting out some conditions. Does she agree that, as the normal practice of a research ethics committee and under the protocols that it establishes for research, those proposing the research should set the conditions out in writing, and in a clear format, for the consideration of the independent person? That is unless there is some urgency condition that is separately covered. Some of us are concerned that words may be whispered in corridors rather hastily and that people may feel that they have not had time to consider the decision. If a case involves an independent person, it is important that an audit trail for that decision be established.

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

What is important is that research ethics committees stick to the principles laid out in the Bill and draw attention to them when setting out how research is to be undertaken. The hon. Gentleman will see that clause 31(6) says:

''There must be reasonable arrangements in place for ensuring that the requirements of sections 32 and 33 will be met.''

As I have said, in such circumstances, the consultee will certainly need to ensure that previous statements are respected, including any advance decisions to refuse to be involved in research.

In relation to research, it is important that the consultee knows the person well as a carer or is otherwise interested in their welfare. For that reason, the Bill states that when someone is appointed a deputy or has a lasting power of attorney, it does not

automatically follow that they cannot be consulted on research if they otherwise meet the requirements for a consultee. As we have said, deputies and attorneys may often be a parent or spouse, or may know the person better than anyone else.

My worry about accepting the amendment as drafted is that it could have the perverse effect of denying a close relative or spouse any direct say in P's involvement in the research. That in turn might mean that the researcher had no one else to turn to. He would then have to avail himself of another person, appointed under the guidance in subsection (3). That person would need to have regard to the same factors as any other consultee, but would not necessarily be well placed to reflect P's feelings and wishes other than by consulting the close person who was a deputy—often a paid carer.

However, I am sympathetic to the point made about the possibility of a deputy or a person with a lasting power of attorney who had no real personal interest in P's welfare or care being asked about research. Subsection (2) states that the person consulted must not be acting

''in a professional capacity or for remuneration''.

That would rule out, for example, a solicitor who was handling financial matters for an unbefriended person without capacity.

It is important to consider the issue in the context of the clause, and particularly in relation to the arrangements under subsection (3), so that we can ensure that we have proper safeguards for people who may not have personal knowledge of the person. I ask the hon. Member for Daventry and my right hon. Friend the Member for Coatbridge and Chryston not to press their amendments so that we can consider the matter further.

I understand the concern, expressed in amendment No. 182, to ensure that where a carer or independent person has said that someone should not take part in research that should be the end of it, with no further recourse to the court to overturn the decision. My right hon. Friend asked for some of the thinking behind the Bill. As I have said, I appreciate the concern that if the carer has been consulted and has said no, that should be the end of the matter. However, subsection (7) was included to provide a mechanism whereby disputes could properly be resolved.

If a researcher believed that the research had the potential to benefit the person lacking capacity and wanted to challenge the views of the carer or nominated person, it would be for the court to decide whether the research would be of benefit to P and not disproportionate to the risks. I would expect such an occurrence to be rare and would not wish the provision to override the prior views of the person without capacity as relayed by the carer or person interested in their welfare. To be absolutely clear, the provision should certainly not apply to any non-therapeutic research. However, I will consider carefully whether subsection (7) as drafted is the most appropriate way to involve the court in resolving disputes about beneficial research activity.

We are aware of previous High Court decisions that have authorised experimental treatments under principles of best interests. For example, a case of a young man who suffered from variant CJD went to the High Court. We want to consider how we get the balance between the two, with people saying, ''Well, this may be of benefit, even if somebody else objects.'' At the same time—as my right hon. Friend and others have pointed out—it is important that we respect the wishes of the person, if they have been conveyed very strongly.

In view of the fact that I want to consider all the amendments, I hope that the hon. Member for Daventry will withdraw his.

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

I thank the Minister for her response on a delicate issue. Nobody wishes to frustrate useful research, if it is appropriate, but it is also right that we look for safeguards. The Minister has approached the matter in the right way, both in her acceptance of that general principle and in her readiness to look again at the wording. It is sensible for us to follow her advice.

Mr Tom Clarke (Coatbridge & Chryston, Labour)

Likewise, I have listened carefully to my hon. Friend the Minister, who said on several occasions that she will consider our views seriously. I am sure she means what she said. I am happy to agree to her request, Mr. Hurst, particularly because I am looking forward to catching your eye on new clause 27.

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

I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 32 ordered to stand part of the Bill.