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In moving Amendment No. 119 I shall speak at the same time to Amendments Nos. 121 and 122.
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 own—particularly in the time available for him to take the decision—then 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 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.