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

I thank the noble Earl and the noble Baroness for their constructive comments and general welcome for the transitional regulations, which I believe constitute a balanced approach to difficult issues and ensure that the rights of participants are fully protected when they lose capacity and that this very important research continues. The noble Earl, Lord Howe, correctly described the intent of the regulations. He was right to stress that the only samples that could be used are those that were given before capacity was lost. It is important to restate that point. He then asked what would happen if further samples were required. There is no question but that that will fall under the main provisions of the Act. That is a very strong safeguard in terms of how the measure will operate in the future. We are talking about samples that were given with consent before the person concerned lost their capacity. We are talking about the availability of samples that already exist up to the point that capacity is lost. The noble Earl, Lord Howe, asked about the numbers involved. I have a very long list which I am happy to send to him. However, I refer to the three national birth cohorts who have reached adulthood, which started in 1946; the 1958 birth cohort study; the 1970 British cohort study; the Avon longitudinal study of parents and children—14,000 children in the Bristol area; the millennium cohort study—19,000 babies born between 1 September 2000 and 31 August 2001; the Aberdeen children; the Southampton women’s survey; and the Whitehall and Whitehall II surveys. There are about 20 studies, so we are talking about a lot of people. In a sense, that reflects two things: the importance of what we are talking about; and the need to balance safeguards with the avoidance of bureaucracy. If there were a requirement to go back to each person, that would be very difficult to do. That is why the Wellcome Trust, other bodies, and the noble Lord, Lord Turnberg, were so concerned about that matter. I well understand that there are substantive issues to do with consulting, which is a very important matter. It was considered in detail during the passage of the Act. As the noble Baroness, Lady Neuberger, said, Section 32 requires that a researcher must take steps to identify someone who cares for the person or is interested in their welfare, except in a professional capacity, and who is willing to be consulted about the person’s participation in a research project. If this is not possible, the researcher must nominate a third party unconnected with the research who is willing to act as a consultee. That person—here is the safeguard—must be identified in accordance with guidance issued by the Secretary of State. Section 32(3) states that a person consulted must have, "““no connection with the project””." That must be right. On the substantive points, the Secretary of State’s guidance—as foreseen in Section 32(3)—will spell out what sort of connection we mean. I take the points that were made about that, but we must also avoid an incredibly bureaucratic approach. I am thinking about our forthcoming debate on the nearest relative in the Mental Health Bill, in which it is made very explicit who is considered the nearest relative. Noble Lords may wish to change that. However, I do not think that there is a case for having such an explicit requirement for the matters that we are considering now. We shall issue guidance. I shall, of course, take account of noble Lords’ communications with me and of the debate held here and in the other place about issues that ought to be included in that guidance. I cannot say exactly when the guidance will be issued, but if I find out, I shall communicate it to noble Lords. On fluctuating capacity, it is clear to me that the transitional provisions will come into play if at any point it becomes clear to the researcher that a person has lost capacity. I imagine that it would be difficult to anticipate at that point—we have debated anticipating benefit and other matters—whether that person would continue to be without capacity or whether it would fluctuate. However, the provisions dig in the moment the researcher becomes aware that the person has lost capacity. As I said, there will be guidance to consultees about what happens when a person has no family and when it is not obvious whom the researcher should contact. I am clear that the provisions of the Act must apply in full to new interventions and new invasive procedures. There are no provisions under the Act that make any exceptions to this rule, and nor should there be. Will consent before loss of capacity carry special weight? Both under the Act and under these regulations, a researcher must consult a person about the participant’s wishes and feelings; that is, what they would have been in the consultee’s opinion. Prior consent here must be a good indicator of this, although other factors or subsequent changes of mind may be relevant. For instance, animal research was mentioned in the other place. It was suggested that the person consulted might have an ethical objection to animal research and that they understood that the research with the person who had lost capacity had some connection with animal research. We cannot anticipate all these matters. However, I imagine that if the person had originally made it clear that they gave consent and were very happy with the research, but the person consulted knew that the person was violently opposed to animal research but may not have known that it would be undertaken at the time of giving consent, that was a powerful indicator for the person consulted to say, ““The person without consent does not give approval””. I do not want to suggest that that is a definitive view but it seems a common-sense approach. We must rely on common sense here. The code of practice is due to be issued shortly, I am glad to say. As I said, guidance is due to be consulted on. I cannot give the exact date, but the aim would be to issue it before October. It will cover the nominated person and take account of the many points that noble Lords have made tonight. I think that I have answered most of the points. These are very important transitional regulations, which safeguard the interests of those people who have consented to research and who may lose capacity. They meet the needs of legitimate and important research, and I commend them to the House. On Question, Motion agreed to.