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

Volume 689: debated on Wednesday 21 February 2007

rose to move, That the Grand Committee do report to the House that it has considered the Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2007. 6th Report from the Statutory Instruments Committee.

The noble Lord said: These regulations make transitional arrangements to ease the introduction of new safeguards relating to research involving people who lack capacity to consent. The Mental Capacity Act 2005 provides a statutory framework for people who lack capacity: those who cannot make their own decisions because of an impairment or disturbance of the mind or brain, for instance, dementia, brain injury or mental health problems. The Act includes a statutory framework for research involving people who lack capacity to consent to their participation. The provisions in Sections 30 to 34 of the Act balance the importance of properly conducted research into the treatment and care of people who lack capacity with the need to protect their interests and respect their current and previously expressed wishes and feelings. The Act applies to research that is defined as intrusive, which would normally require a person’s consent in order to be lawful—for example, their consent to the taking of blood during a medical check-up which is part of a research project. The Act applies to a wide range of research into treatment and care and is particularly relevant to health and social care research. The Act does not cover clinical trials of medicines, which are governed by separate regulations that implement EU directives.

The Act requires the researcher to obtain approval from an appropriate body: a properly recognised research ethics committee, as defined in separate regulations made on 19 December 2006. The committee must be satisfied that the research project meets certain requirements set out in the Act: that it is necessary, safe and cannot be done as effectively using people who have mental capacity. It must also be satisfied that arrangements are in place to consult a suitable person, as set out in the Act, about the participant’s previous wishes and feelings and to ensure the participant’s safety. If the person says no, or shows any sign of distress or dissent, the researcher must not include them. The person can also change his mind at any time.

The general policy intent of these regulations was signalled during the passage of the Act and was prompted by points made by noble Lords. The Government recognise the importance of a smooth transition to the new arrangements to give protection to people without capacity without stopping long-term research studies or causing unnecessary bureaucracy for researchers or research ethics committees. Noble Lords will be aware of a number of extremely important long-term health studies that track thousands of people over many years or decades. An example is the outstanding Whitehall study of 10,000 civil servants to study links between work, lifestyle and heart disease. It is of profound importance and has had a great impact on public health issues. It is essential that it continues. In it, people do not have capacity to consent to participate. They attend regular check-ups, perhaps annually, and provide health information and blood samples. Between the check-ups, researchers analyse the information and the blood samples in the laboratory. There may also be links to the patients’ medical records, perhaps identifying particular diagnoses, such as heart disease or angina. Over time, some of the participants may suffer injury or ill health and lose the capacity to consent to check-ups carried out as part of the research or to the collection of data from their medical records.

When the Act is fully in force in October this year, researchers will need to comply with the arrangements that I have described. If they cannot comply with them—approval by a research ethics committee, consultation with an appropriate person and the other protections—they will have to withdraw the person from further medical check-ups as part of the study.

However, we have used powers in Section 34 to make these regulations enabling researchers in certain circumstances to continue research on the information and blood samples taken before the person lost capacity. We have listened carefully to the debate in Parliament and to the views of research groups, such as the MRC and the Wellcome Trust, about the status of consent given by a person with capacity. When we developed the process for consultation, we took full account of those views. We are proposing a mechanism that allows researchers to continue research where the Act would otherwise have applied if a person has consented to participate in an existing study and then loses capacity. This transitional easement applies only to information and material that was collected prior to the person’s loss of capacity. It does not cover any new intervention or collection of any new material. If a researcher wants to take more samples or carry out another health check, he will have to meet the full requirements of the Act. It applies only where the research was started before 1 October 2007 and the person in question consented to take part in it before 31 March 2008.

I should explain that although the regulations are transitional, they will have a long-term effect. I reiterate that they apply only when before 31 March 2008 a person consented to take part in a research project that started before 1 October 2007. They allow for projects that have started when the Act comes into force but have not finished recruiting participants. As long as those conditions are met, the regulations will apply regardless of when the person loses capacity. So a person could join an existing study in October 2007 or January 2008 and lose capacity in the 2020s, and, if the study is continuing, the regulations would apply.

Regulation 3 states that in cases where the regulations apply a researcher can continue to use information obtained before loss of capacity if he satisfies the requirements set out in Schedules 1 and 2. “Information” means “data” as defined in the Data Protection Act, or material containing “human cells or human DNA”. Schedule 1 requires that the research ethics committee has approved a protocol and is satisfied that there are suitable arrangements for complying with it. We see a central role for the expertise on research ethics committees to make judgments about what is appropriate for different types of research. Schedule 2 sets out what the researcher needs to put in place when he becomes aware that a participant has lost the capacity to consent. The schedule repeats the relevant safeguards from Section 32 and 33 of the Act, which mean that a suitable consultee who cares for the person or is interested in his welfare must be identified and given information about the project. He will be asked to advise on whether the person would want the samples or data already taken to continue to be used in the research in line with the arrangements set out in the protocol. The consultee will be expected to consider the facts that the person without capacity would originally have consented to take part and that that should be a powerful indication of his wishes and feelings at that time.

However, they might also be aware of other factors relevant to the decision, such as other views made known by the person who now lacks capacity. The researcher must also respect the wishes and feelings expressed by the persons themselves. They must not do anything which contradicts any advance statement of wishes of which the researcher knows and must not continue if the person indicates in any way that he has an objection. The interests of the person must be assumed to outweigh the interests of science and of society.

On a practical note, the Government have made clear to the research community that there is not a new duty to monitor the capacity of all the research subjects continually. It must be assumed, in keeping with Section 2 of the Act, that a person has capacity unless shown otherwise. If, however, information becomes known to the researcher—perhaps through contact from next of kin, direct observation or from other medical diagnoses—they will need to apply the protocol.

I am aware that researchers and research ethics committees need further advice and guidance on how to apply the Mental Capacity Act. We shall be including a chapter on research in the Mental Capacity Act code of practice that will shortly be laid before Parliament. We are also working with the Central Office of Research Ethics Committees to provide guidance and training materials.

The transitional provisions are intended to help researchers on existing projects with the transition to the new requirements of the Act. I remember the debates in which I participated when the Mental Capacity Bill was debated in 2005. We must of course have safeguards, but it is absolutely essential to reflect on the challenges facing eminent researchers who bring a responsible and strong ethos to the conduct of research. We do not want to erect barriers which may be difficult for them to meet. The transitional regulations before the Committee reflect that balance in the best possible way, and I commend them to your Lordships. I beg to move.

Moved, That the Grand Committee do report to the House that it has considered the Mental Capacity Act 2005 (Loss of Capacity during Research Project) (England) Regulations 2007. 6th Report from the Statutory Instruments Committee.—(Lord Hunt of Kings Heath.)

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.

I, too, thank the Minister for his clear explanation of these interim regulations and we on these Benches are broadly happy with this sensible set of what are almost tidying-up transitional regulations. However, like the noble Earl, Lord Howe, I have a few questions and doubts, which I will go through as quickly as possible because I know that we are running late. First, given that we have had to look at this without the code of practice, it would be good to know when the code of practice for the Mental Capacity Act 2005 will be laid before Parliament, especially the research guidance. The Minister in another place said that it would be before 1 October 2007, but it would be good to have a little more clarity. It would also be good to see it a little sooner than that.

Secondly, there are real questions around the nominated person. Schedule 2(6) says that the nominated person,

“must ensure that nothing is done in relation to [the person or subject] in the course of the research which would be contrary to … an advance decision of his which has effect, or … any other form of statement made by him and not subsequently withdrawn”,

which I think addresses part of the question asked by the noble Earl, Lord Howe. Tim Loughton in another place rightly asked what culpability attaches to the nominated person if those considerations are breached unwittingly. It is very complicated because it is really unclear who can act as a nominated person.

Schedule 2(1), the relevant section, reads that the researcher,

“must take reasonable steps to identify a person who … otherwise than in a professional capacity or for remuneration, is engaged in caring for P or is interested in P’s welfare, and … is prepared to be consulted [by the researcher] under this Schedule”.

It is unclear, because how close a caring connection or how well the nominated person knows the person is not specified at all. Section 2 allows the researcher to nominate someone who is prepared to be consulted by the researcher under this schedule and has no connection with the project, but that could, as stated, be more or less anyone.

We all share the Government’s view that research already ongoing to which the patient has consented hitherto should not be unnecessarily stopped or interfered with. Many of us also agree that the interests of the patient must be assumed to outweigh those of science and society. But if we are talking about the loss of capacity, people change.

The work of Jennifer Radden, the distinguished American philosopher at the University of Massachusetts, teaches us to ask what kind of person someone who has lost capacity becomes. Most of us find it difficult to imagine that we might become very different if, for instance, we suffered from Alzheimer’s. We might be quite content—as we certainly would not be now—to say “Good Morning” to the cat 1,000 times a day. For that reason, it is important that the nominated person has real knowledge of the person concerned and, ideally, was nominated by them before capacity was lost so that they have real knowledge of how they felt.

The question of the professional consultees in paragraph 2 of Schedule 2 remains an issue, as respondents to the consultation suggested. It would be good to hear when the Government will issue their statutory guidance on professional consultees, given that the Explanatory Memorandum tells us only that it will be “at a later stage”.

Questions about who a nominated person or a relative might be were asked during discussions on the Mental Health Bill. Members on these Benches would have grave reservations if the patient who temporarily lacked capacity was not allowed to nominate, within reason, someone other than their nearest relative. In the case that we are discussing, where loss of capacity is permanent, although the consequences are obviously much less serious, the nominated person is appointed much more casually. I hope that the Minister will reflect on why the contrast between the Government’s two positions is so great.

My honourable friend in another place, John Pugh, asked about an audit of the research. I realise that this is a relatively short-term transitional set of regulations for research that starts before October 2007 and is consented to before March 2008, but some of these research projects, such as Sir Michael Marmot’s long-term Whitehall civil servants studies, or studies following groups of children from birth, are very long. People who lack capacity can change. Where is the audit of the views of their carers in these long-term studies?

Taking those questions and caveats into account, however, I am broadly content with these regulations.

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 would be 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.

That completes the business before the Grand Committee today. The Committee stands adjourned.

The Committee adjourned at 8.25 pm