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The noble Baroness said: In moving Amendment No. 123 I shall speak also to Amendment No. 124. I do not want to pre-empt amendments we shall reach in a short while, but for the purpose of these amendments I am acting as advocate for the noble Baroness, Lady Finlay, given that she cannot be here. I assure the Committee that I am independent and not in the pay of the noble Baroness.
In the context of research, the purpose of these two amendments is to seek clarification of the meaning of subsection (2). Throughout our debate on the clauses covering research, while noble Lords have approached the matter from different starting points, they all have the same intent; that of trying to establish that what is provided for in the Bill guarantees that a person who
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lacks capacity and is involved in some form of research is not subject to exploitation, degrading treatment and so forth. Our differences are really ones of operation.
The noble Baroness, Lady Finlay, is well known to noble Lords for her wide practical experience of these issues. The aim of her amendments is simple; to establish, for example, that a clinician can hold someone's arm when taking blood. Otherwise, in the attempt to take blood people may pull in the wrong direction or become confused. The result is that they may suffer damage from the needle.
The noble Baroness has also referred on many occasions to the physical side effects of some forms of injury. In particular, she has said that when someone sustains a severe head injury, they may make spinal reflexes which suggest that they are endeavouring to pull away from painful stimuli. In fact, all they are doing is responding physically to the stimulus rather than withdrawing consent. In her briefing to me, the noble Baroness also explained the operation of the Glasgow Coma Score levels, which are detailed measures of physical responses to stimuli.
I suspect that there is something of a crossover here between research procedures and some of the signs one might look for when seeking to establish communication with those who do not have the capacity to speak. I realise that we are straying into detailed operational territory, but given the arguments put forward by the noble Baroness, it would be helpful if this subsection were clarified further. I beg to move.
Lord Warner: I am sympathetic to the matter raised. I understand that there may be times when a person in research might temporarily or instinctively resist the application of some essential procedure that is intended to protect them from risk of harm, distress or pain. It is certainly not our intention to require researchers to discard standard safety measures simply because a person without capacity objects to them.
The researchers have, and continue to have, a duty of care and perhaps also a statutory duty under health and safety legislation to protect their research participants. I agree that this clause should not interfere where it might be necessary gently to hold a person so that a sample or measurement can be safely obtained.
However, I hope that noble Lords, and the noble Baroness in her absence, will accept that the amendments tabled here may not achieve the necessary effect of providing for another kind of objection or resistance to be respected. The way in which they are drafted at the moment could cause problems in another area; they may go too far. I accept that the amendment would retain the principle in Clause 33(3) that if the person indicates in any way that he may want to be withdrawn, that must happen.
But I want to look again at other related amendments, together with these, and reflect further on what the appropriate balance must be within research. So I accept that there is something in the amendment that we need to address in order to protect participants under normal duties of care. I am not sure
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that this wording does the trick. We are getting into complex areas where one amendment may interfere with another amendment. There is a complex set of relationships and we want to come out of this with the balance right so that real objections expressed by someone participating are observed, listened to by the researcher and acted upon. But gentle guiding in order to protect someone who may react too precipitately to a procedure has to be respected.
I hope that the noble Baroness will accept that I wish to reflect on this issue and take further advice before returning with any necessary amendment at Report stage. With that assurance, I hope that the amendment can be withdrawn.
Baroness Barker: I thank the Minister for that reply. This is an issue that should be pursued. I hesitate to suggest that it is an area in which one would do well to consult with clinicians in order to be quite clear about the point we are trying to reach and to come up with wording which reflects that. None of us would wish to see a situation where people were in pain and were unable to have their views considered; neither do we wish to stop people from being involved in simple, routine procedures that may be to their benefit. I beg leave to withdraw the amendment.
"( ) But (save only for an advance decision of P which has effect and of which R is aware) nothing in this section requires treatment that P has been receiving as part of the project to be discontinued if R has reasonable grounds for believing that there would be a significant risk to P's health if it were discontinued."
The noble Earl said: Clause 33(4) sets out an additional safeguard relating to research carried out on someone who lacks capacity to consent to it. It states, quite rightly, that if at any point in the project the researcher discovers that any of the statutory conditions laid down in Clause 31 are no longer met in relation to the patient's participation, he must immediately withdraw the patient from the project.
My amendment seeks to add a small rider to that which is intended to mirror the very similar provision contained in Clause 32(6). That provision states that where a patient is withdrawn from a research project because the person being consulted says that it would run contrary to P's wishes and feelings, withdrawal from the project need not involve halting any treatment being given to P as part of the project if the doctor's judgment is that there would be a significant risk to P's health in doing so.
Baroness Andrews: The noble Earl is quite right: we need to have consistency on this issue, and I
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understand why he has raised it. It affects situations in which the person without capacity asks or indicates that he or she no longer wants to be part of the research. The amendment would mean that a researcher would not have to stop any treatment that is given as part of the research if he or she felt that doing so would mean a significant risk to the patient's health.
Noble Lords may be aware that the Government introduced precisely this safeguard at Report in another place as part of an amendment to remove the right of researchers to apply to the court to overturn the decision of a carer that the person should be withdrawn from the research. The existing Clause 32(6) says that in such cases, the request to withdraw should not automatically mean that treatment would have to stop if the researcher felt that there would be a significant risk to the person's health.
As presently drafted, Clause 32(6) applies only where the carer requests removal from the study, not where the person himself indicates that he does not want to continue. We are extremely sympathetic to the purpose of the amendment. It seems nonsensical to have the one and not the other. However, I should like to take advice on whether we need a single set of safeguards around withdrawal or similar clauses in respect of withdrawals under Clauses 32 and 33. We will work that out between now and Report. On that basis, I am sure that the noble Earl will withdraw his amendment.
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