Mental Capacity Bill

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Ms Winterton: 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

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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. Boswell: 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 Winterton: 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

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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.

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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. Boswell: 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. Clarke: 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. Boswell: I beg to ask leave to withdraw the amendment.

Amendment, by leave, withdrawn.

Clause 32 ordered to stand part of the Bill.

10.15 am

Clause 33

Additional safeguards

Mr. Clarke: I beg to move amendment No. 183, in

clause 33, page 19, line 3, at end insert

'or wishes expressed by P in a LPA.'.

The Minister might shorten our proceedings on the amendment by accepting it. However, if she does not, I am sure she will respond carefully to the points that I am about to make. The amendment would be an additional safeguard to the clause in that it recognises the role that an LPA could play alongside an advance decision by setting out P's wishes and feelings about taking part—or not taking part, which is just as important—in particular research. It would ensure that LPAs had parity with other forms of advance decision making about research. I look forward to hearing her response.

Mr. Paul Burstow (Sutton and Cheam) (LD): I support the amendment, which would achieve a helpful further development of the role of LPAs in research. LPAs could be used in such a way because it is up to individuals to decide what they want to stipulate in such procedure. Has the Minister been

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persuaded by the representations that all members of the Committee have received from Fiona Randall, a consultant at the Royal Bournemouth and Christchurch hospital? Her helpful letter was referred to in previous sittings. She has made some telling points, particularly on the need for such matters to be clearly documented and for advance statements to be clearly documented and signed. Will the Minister comment on that, especially the fact that such decisions need to be in a written form? The Bill clearly states that LPAs must be in a written form, but, according to representations that we have received, advance statements also need to be in a written form.

 

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Prepared 2 November 2004