Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2007

I thank the Minister for explaining the purport and effect of the regulations. I immediately add that they are not controversial; indeed, I give them my general support. I have a few questions, however. Will the Minister confirm that the main concession to researchers embodied in these regulations is around the minimisation of bureaucracy in a case where a long-term study is being carried out which commences before October this year? As I understand it, if one of the subjects of such a study were to lose capacity halfway through and the full provisions of the Act were to apply, that study—or that part of it, at least—would have to be stopped. As it is, under the transitional regulations before us, any samples or findings collected from the project before P’s loss of capacity could still be used. I hope I am right about that. There is another issue about which I am not clear, which concerns the protocols being developed. The Act says that the only sort of research that may be carried out on a person lacking capacity is that connected with an impairing condition affecting that person or its treatment: those provisions are in Section 31. There may be research projects that find themselves covered by these regulations which do not relate to the impairment or the disturbance in the functioning of the mind or brain. I understand that, if one of the subjects of a research project like that loses capacity and the researchers then wish to gather new samples or information from them, they would have to follow the provisions laid down in the Act. Will any allowance be made in the protocols to permit fresh interventions where these are not connected to a project relating to the impairment of the mind or brain? In other words, would all new interventions in a Whitehall-type study be automatically ruled ineligible for approval, or will the protocols allow for them if a suitable case can be made to the research ethics committee and the carer agrees? Secondly, could the Minister comment on what status a consent by a participant in a research project would have if that consent explicitly anticipates loss of capacity? As I understand it, it would not over-ride the need to go back to the research ethics committee if they lost capacity and the researchers wished to carry out new interventions or to collect new data. Would the consent be likely to carry special weight with a research ethics committee in comparison, say, with a statement from a third party about the reported wishes and feelings of the person? In other words, would it now be prudent for all researchers engaged in long-term studies commencing prior to October 2007 to obtain consent in a form that anticipates the possible loss of capacity, or would it make no difference what form the consent took? On a factual point, can the Minister tell me how many long-term studies and how many research participants these regulations are likely to cover? Is it possible to answer that question even approximately? On a point of interpretation, what sort of principles will underpin the guidance to be issued by the Secretary of State under Schedule 2(2) on who can be nominated as a representative of a person who has lost capacity? Finally, on the vexed issue of fluctuating capacity, what would happen if one of the subjects in a research project covered by the regulations lost capacity but then regained it? There are some syndromes—delirium during infections, for example—where fluctuations can take place on a daily basis. The same can happen where someone is suffering from drug toxicity. One could also imagine someone with Alzheimer’s whose state of mental incapacity is reversed by medication. In circumstances like these, what are the obligations placed on a research team, and will proper guidance be given to cover those situations? Where a research ethics committee has declined to give consent for new interventions on a person who has lost capacity, and that person subsequently regains capacity and renews his consent, what happens then? These are, I believe, sensible, transitional provisions which strike a good balance between protecting the interests of people who lose capacity and those of researchers, and they have my support.