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Clause 32 is all about the obligation placed upon a researcher to consult the carer or someone close to a mentally incapacitated patient whenever they are proposing to carry out research on that patient.
However, there are some circumstances in which the clause absolves the researcher from that obligation to consult, and these are set out in subsections (8) and (9). If the patient needs urgent treatment and the researcher judges that it is also necessary to pursue the research as a matter of urgency, he need not consult a friend or relative or carer of the person if to do so would be impracticable. Instead he must consult a doctor who is not concerned in P's treatment or care. If it is not reasonably practicable to do that either, he can go ahead anyway, so long as he is acting within the parameters already laid down by the research ethics committee or other approving body.
That opens up, it seems to me, a number of quite big questions. Are we really saying that no matter what sort of research it is, the researcher can go ahead with it without consultation of any kind? I would challenge that idea. What happens if the research involves invasive procedures? What if it is not research that has any potential to benefit the patient?
I do not say that we should be too restrictive, but what matters above all in these circumstances, surely, is the added risk to the patient by virtue of the research going ahead. If risk is too subjective a concept for a researcher to assess on his ownparticularly in the time available for him to take the decisionthen perhaps a better and more practicable benchmark would be the degree of invasiveness that the research involves. That is what I am suggesting in Amendment No. 119. I am saying that the degree of invasiveness entailed by the research should be no greater than that entailed by the care and treatment that P is receiving. I do think that that would inject a rather better balance to these provisions which are otherwise too open-ended.
Amendment No. 122 deals with another instance of open-endedness here. Subsections (8) and (9), as I have said, absolve a researcher in certain circumstances from having to consult anyone at all. However, the clause says nothing about the need to consult after the event, and there ought to be that obligation. Furthermore, if the person consulted says that P would not have wished to take part in the research, that should be the end of the matter; P should be withdrawn from the project without further ado. Just because it has not been practicable to consult a carer or whoever prior to embarking on the research is no reason not to consult them at the earliest possible moment thereafter and abide by what they say.
In Amendment No. 121, where a doctor is consulted about the possibility of including an incapacitated person in a research project, what counts for the protection of the patient is that that doctor should not be involved in any way in the research project; in other words, that he should have no conflict of interest. The clause as it stands leaves open the possibility of conflict of interest. I cannot see the logic of saying that the doctor who is consulted may not be involved in P's
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treatment or care; indeed that is precisely the category of doctor who ought to be consulted, as he or she will be able to make a much better assessment about how appropriate it is to include P in the study. Can the Minister enlighten us on the thinking behind this provision? I beg to move.
Lord Turnberg: I shall speak to my Amendment No. 120. Subsection (9)(a) of the clause applies in an emergency situation where it is not possible to get immediate agreement from the categories of individuals laid out in earlier provisions of Clause 32. In this case, it allows researchers to seek the agreement of a registered medical practitioner. However, the wording specifically excludes the patient's own doctorthe one who is caring for the patient is excluded. This seems a little odd, as the noble Earl has suggested, because I suspect that many, if not most, patients would be glad if it was their own doctor who was asked for agreement. He is likely to know more about them than another doctor who happened to be passing by.
Furthermore, it is conceivable, according to the wording here, that one of the researchers who was medically qualified could provide the agreement. That is not excluded, but clearly it would be wrong. The researcher should not be in a position to give himself or herself permission to do the research. My amendment removes the idea that the patient's own doctor cannot provide the agreement, and it inserts the safeguard that it cannot be the researcher who gives agreement for the research to be done. There is a potential problem if the researcher also happens to be the clinician in charge of the patient. We need something else to cover that situation which is not covered in any of the amendments. We may have to think about that.
The amendment proposed by the noble Earl, Lord Howe, Amendment No. 121, would achieve more or less the same objective as my amendment and spells out more clearly that the researcher should not be involved in giving permission. I am certainly not wedded to my own form of words. With regard to Amendment No. 119, I wonder whether it would be necessary to insert this amendment specifying the type of research if Amendment No. 120 or Amendment No. 121 were accepted, since we would then have the safeguard that the researcher himself or herself could not give approval.
I am concerned that some research in the emergency situation would be prevented by Amendment No. 119. I give the example of patients in cardiac arrest who have been shown to have an improved survival rate if artificial cooling is given during the arrest. That is now part of standard care. We would not know that if that research, which is relatively invasive, had not been done. I hope that Amendment No. 119 is obviated by either Amendment No. 120 or Amendment No. 121.
Earl Howe: The example given by the noble Lord about cardiac arrest research is research that might well benefit the patients themselves, in which case it would not be caught by my amendment.
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Baroness Masham of Ilton: I support the amendment because the clause as it stands might open a door to researchers. We all know that keen researchers can get completely carried away with their research and perhaps forget the interests of the patient. We need some safeguards here.
Lord Warner: We are all agreed that emergency treatment research is an important part of the Bill, and we all want to get this right. I will make a few remarks of context before dealing with the amendments. The clauses as they stand recognise that some research inevitably takes place in situations where a person is temporarily incapacitated as a result of a sudden trauma, such as a car accident, stroke, or a serious infection. It is important that such people can have urgent medical attention. It is also sometimes the case that vital research can be done in these situations to understand what changes the body undergoes during the first few moments after the event.
In such cases of urgency the next of kin, to use a simple term, is often not with the person when the emergency happens. In such circumstances, the researchers need alternative arrangements for seeking the agreement to P's involvement in the study. This may be a doctor who has no responsibility for treating the person, or it may be another person, if that has been agreed in advance with the research ethics committee. Once the need for urgency has passed, the researchers must, under Clause 32(10), follow the normal arrangements for consent to continue in the research, or consultation with the next of kin if the person still lacks capacity.
The effect of Amendment No. 119 is greatly to limit research to non-invasive procedures that do not go beyond those required for P's treatment and care. While I understand the reasoning behind this amendment, I fear that it will prevent a good deal of vital research. It could be argued that this amendment would mean that if the researchers required a few millilitres of blood that is slightly more than that necessary for P's clinical care they would not be permitted to take it, because that would be additionally invasive. Perversely, it may also prevent the research procedures that are likely to improve P's survival or recovery.
I am aware of some research that involves using an experimental probe to measure oxygen levels in the brain of those who have experienced major head injuries. The research uses the same skull incision that is made for the clinically necessary purpose of measuring brain pressure. Initial findings suggest that maintaining correct oxygenation of the brain is important in promoting recovery. However, under this amendment it would be considered to be unlawful as it is invasive and goes beyond what is necessary for P's care.
On Amendment No. 122, I am again grateful to noble Lords for attempting to specify clearly in the Bill the steps that a researcher must take as soon as
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possible after the emergency passes. It is, of course, accepted by all researchers that the next of kin must be identified as soon as possible, given information about any research, and asked for their views on whether P should remain in the trial. Researchers must respect that view and, if necessary, withdraw P from the research. This is already the effect of the provision in Clause 32(10), which says that the researcher cannot continue to rely on the emergency provisions for longer than is necessary. If he has reasonable grounds for believing that it is not necessary to take action as a matter of urgency he must, retrospectively, consult with a carer and respect their views. While I agree with the steps outlined in the amendment, with respect, they do not take sufficient account of the alternative scenarios that I have mentioned.
For example, it might be the case that shortly after the emergency the person regains sufficient capacity to give or withhold their consent in the normal manner, or they may make it known that they do not wish to continue in the research. The researcher may become aware of the existence of a previous statement of wishes that affects the research. In those circumstances, he would be obliged, under Clause 33, to respect these views. I hope that noble Lords will accept my assurances that the Government want to strike a balance between protecting vulnerable people while permitting important medical research. I hope that noble Lords will be reassured by what I have said.
I have a good deal of sympathy with Amendments Nos. 120 and 121, which attempt to widen the category of doctor who might agree to P's involvement in emergency research. We had already sought to achieve that by means of Clause 32(9)(b), which allows much flexibility in deciding who may agree, provided that the research ethics committee approves the proposed approach when deciding whether to approve the research.
The clauses recognise that some research takes place in the kinds of situations of urgency that I mentioned. However, I accept that Members of the Committee think that they do not go far enough. We already have provisions that might enable an attending emergency healthcare workerperhaps a paramedicto make an initial decision to include a person with a heart attack in a trial of better ways of performing heart massage. In such cases, the decisions need to be made in seconds, not minutes, and a doctor may not always be on hand.
In that regard, it is worth noting that we have announced a consultation on a possible amendment to the clinical trials regulations to provide for emergency research where it is not possible to get consent from a legal representative. I raise that again because the Government feel that we have to make the final arrangements for research in emergencies under the Bill and the clinical trials regulations absolutely consistent. That is important to enable trusts to implement properly the necessary systems for those to be consulted and agree or give consent to a person being included in research or a clinical trial in an urgent situation. It was with that in mind that we sought the ability to produce guidance on the
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appropriate local approaches to the matter. We have included in Clause 32(3) a provision for the Secretary of State to issue guidance on nominating a person who may be consulted on research involving a person without capacity in such circumstances.
I accept that there is more work to be done in the area, but we want to make everything consistent between the clinical trials regulations, the Bill and the code of practice. I therefore suggest that we take away Amendments Nos. 120 and 121 and come back on Report with a considered view on the matter, to try to meet the concerns expressed on them.
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