The Minister of State, Department of Health(Ms Rosie Winterton): I beg to move,

The regulations make transitional arrangements to assist in the introduction of new safeguards relating to research involving people who lack capacity to consent. First, I want to put the regulations in context. The Mental Capacity Act 2005 provides a statutory framework for people who lack capacity—that is, who cannot make their own decisions because of an impairment, or disturbance of the mind or brain such as 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. These provisions in sections 30 to 34 of the Act balance the importance of properly conducted research on the treatment or 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, consent to the taking of blood during a medical check-up that is part of a research project. The Act applies to a wide range of research and is particularly relevant to health and social care research. However, it does not cover clinical trials of medicines, which are governed by separate regulations that implement European Union directives.

The Act requires a researcher to obtain approval from an “appropriate body”—a properly recognised research ethics committee, as defined in separate regulations made on 19 December 2006 and laid before Parliament on 11 January 2007. The research ethics committee must be satisfied that the research project meets certain requirements set out in the Act—broadly, that the research relates to a condition that impairs or is thought to impair the person’s capacity, and that it is necessary and safe. 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 their safety. For example, if the person at any time says no, or shows any signs of distress or dissent, the researcher must not include them, or must stop including them.

The general policy intention of the regulations was signalled during the passage of the Act in Parliament. The Government recognised the importance of a smooth transition to the new arrangements, to give protection to people without capacity, without having to stop long-term research studies or causing unnecessary bureaucracy for researchers or research ethics committees.

We are aware that there are a number of extremely important long-term health studies that track thousands of people over many years or decades—for example, the “Whitehall” study of 10,000 civil servants to investigate links between work, lifestyle and ill health, such as heart disease. In that, and in most other cases, people have capacity to consent to participate in the study. They attend regular check-ups—perhaps annually—and provide health information and blood samples. Between these check-ups, researchers analyse the information and blood samples in a laboratory. There may also be links to a patient’s medical records to identify particular diagnoses, such as heart attacks or angina. Over time, some of the participants might suffer injury or ill health and lose the capacity to consent to continue participating in the study.

When the Act is fully in force in October, researchers will need to comply with the arrangements that I have referred to, in order to continue to involve the person in the research study—for instance, to take fresh samples at a medical check-up. If they cannot comply with these requirements—approval by a research ethics committee, consultation with an appropriate person and the other protections—they will have to withdraw the person from the study. However, we have used the powers in section 34 of the Act to make these regulations, enabling researchers in certain circumstances to continue research on the information and blood samples taken before the person lost capacity.

The Government listened carefully to the debate in Parliament and the views of research groups such as the Medical Research Council and the Wellcome Trust about the status of consent given by a person with capacity. Sometimes consent will clearly have anticipated the loss of capacity—for instance, consent to research done during surgery—but other consent might not have anticipated it, or the cause of the loss might have little to do with the subject being researched. Consent previously given cannot necessarily be relied on.

When we developed the proposals for consultation, we took all those views into account. We are proposing the development of a mechanism allowing 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. However, that transitional easement applies only to information and material collected prior to the person’s loss of capacity. It does not cover any new intervention, or the collection of new material.

Mr. Peter Kilfoyle (Liverpool, Walton) (Lab): I think that my right hon. Friend has already answered this, but can she confirm that we are talking about permanent incapacity?

Ms Winterton: Yes.

The limits on the transitional easement mean that if a researcher wants to take more samples, or carry out another health check, they will have to meet the full requirements of the Act. The easement applies only in cases where the research has started before 1 October 2007, and where the person consented to take part in it before 31 March 2008.

Although the regulations are transitional, they will have a long-term effect. To reiterate, they will apply only where, before 31 March 2008, a person has consented to take part in a research project that started before1 October 2007. That allows for projects that will have started when the Act comes into force but have not finished recruiting participants. If those conditions are met, the regulations will apply regardless of when the participant loses capacity. For example, a person could join an existing study in October 2007, or January 2008, and might lose capacity in the 2020s, and the regulations would apply.

Tim Loughton (East Worthing and Shoreham) (Con): I may be missing something, but is there any reason why the regulations could not be superseded simply by bringing forward the implementation of the Mental Capacity Act 2005?

Ms Winterton: When the Act comes into force, an entirely different code will apply. I will come to that. Any new research will be covered by different guidance stating that before any research is started, the loss of capacity will be anticipated in the consent that is given. That is what we would advise people to do. We are enabling people to prepare for when the Act comes into force and to take advantage of the transitional arrangements for the use of material that might already have been collected. We are seeking to ensure that the research community has enough time to prepare for the changes.

Regulation 3 states that in cases where the regulations apply a researcher can continue using information obtained before loss of capacity if they satisfy the requirements in schedules 1 and 2. “Information” means data as defined in the Data Protection Act 1998, or material containing human cells or DNA. Schedule 1 requires that the research ethics committee has approved a protocol and is satisfied that there are suitable arrangements for complying with the requirements of schedule 2. We certainly envisage a central role for the research ethics committees’ expertise in judging what is appropriate for different types of research.

Schedule 2 sets out what the researcher needs to put in place when they become aware that a participant has lost capacity to consent. It repeats the relevant safeguards from sections 32 and 33 of the main Act. That means that a suitable consultee, normally someone who cares for the person or who is interested in their welfare, must be identified and given information about the project. They 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, of course, need to consider the fact that the person without capacity would originally have consented to take part and that that should be a powerful indication of their wishes and feelings at that time, but they may also be aware of other factors that are relevant to the decision, such as other views made known by the person who lacks capacity. The researcher must also respect the wishes and feelings expressed by the person involved, so they must not do anything that contradicts any advance statement of wishes of which the researcher knows and they 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 society.

On a practical note, the Government have made it clear to the research community that there is not a new duty continually to monitor the capacity of all of the research subjects. In keeping with section 2 of the Act it must be assumed that a person has capacity unless shown otherwise, but if information becomes known to the researcher, for example, via contact from the next of kin, from direct observation or from other medical diagnoses, they will need to apply the protocol.

The Government are aware that researchers and research ethics committees need further advice and guidance on how to apply the 2005 Act. There is also a need to understand how it aligns with the Data Protection Act 1998 and the Human Tissue Act 2004. We are including a chapter on research in the 2005 Act code of practice that will be laid before Parliament soon. We are also working with the Central Office for Research Ethics Committees and the Medical Research Council to provide guidance and training materials. This, and guidance on the selection of consultees, will be made available between now and 1 October 2007.

The transitional provisions I have outlined are intended to help researchers on existing projects with the transition to the new requirements of the 2005 Act. I emphasise that the Government are extremely supportive of the need for properly conducted research of this kind. We would not wish to stand in the way of research to develop the best treatment and care for people who suffer from conditions that affect their decision-making capacity, such as Alzheimer’s disease, dementia or other causes of chronic ill health. At the same time we are committed to ensuring that the rights and dignity of those who lack capacity are protected.

The regulations achieve a good balance between facilitating research and ensuring protection for participants without capacity. People without capacity have a right to enjoy the benefits of good quality health and social care research and to have their wishes and dignity respected. I commend the regulations to the Committee.

Tim Loughton: These are technical regulations and I commend the Minister on the way she read out the explanation of them. We support what they are trying to do, just as we supported the Mental Capacity Bill. It may take those of us who did not serve on that Committee a little longer to get our heads around the technical implications of these and other regulations associated with the measure.

I shall ask the Minister a few questions for clarification and to obtain more detail on the proposal. The legal protections that are referred to are covered only in common law and it is right that they should be formulated within the Act. It has been widely welcomed by the major medical bodies, so I do not dispute it, but can she give us an idea of how widespread the problem is of research being carried out that must be aborted because of loss of capacity?

She also said that there are a lot of safeguards in the regulations—I agree, and they are right—but that the research would have to be discontinued if the subject showed any distress or harm. It is difficult to find what that might mean. A frail old lady suffering from dementia in a home, from whom a blood sample is taken as part of some of the research that the Minister described, could easily be deemed to suffer distress. Is it as simplistic as that? Would the research have to be discontinued? As the Minister said, we must be able to carry out essential research in matters about which we do not know an awful lot and about diseases that affect an increasing number of ageing people. We must be realistic about how it can be applied, rather than having to discontinue it at the first wince. Could she elaborate on how that will happen?

How many people are we talking about? How many research projects are likely to run in a normal year? Does the Minister expect that as a result of the regulations, we will see a proliferation of research projects because it will now be easier to carry out such research? Is she happy with that by-product?

What sort of research are we talking about? The notes accompanying the regulations refer to invasive research and the use of tissue; the Minister mentioned blood samples. I recently had an interesting letter from a mental health user forum that referred to the practice of lobotomy, which is technically termed “neurosurgery for mental disorder”. I was unaware—I have not checked this, and I would be grateful for her comments, because it is relevant to research covered by the regulations—that it is still practised legally in this country. Indeed, parts of the proposed mental health Bill would make it more widespread. Is lobotomy covered by the regulations? Apparently, neurosurgery for mental disorder is performed in two locations in the United Kingdom—the University hospital of Wales in Cardiff and Ninewells hospital in Dundee.

The Chairman: Order. We are keeping to research, are we not?

Tim Loughton: Lobotomy is specifically for research, Mr. Martlew. Previously, it was practised quite widely in the US, Japan and Britain, and an estimated 50,000 patients were practised on in the UK alone. Some of that might have been deemed to be of therapeutic benefit, but a lot of it was deemed to be for research. The operation involves removing part of the brain’s frontal lobes or severing the neural fibres connecting the frontal lobes to the limbic system, the part of the brain concerned with emotional response and functions not under conscious control. I was slightly alarmed when I read the letter. Hypothetically, the regulations could apply technically to lobotomy. I should be grateful for the Minister’s clarification. It would be useful to know the invasiveness of the research.

Schedule 1 refers to protocols having to be established. How are those protocols to be established? Will they be set down by national bodies? Is their establishment going to be left to local health bodies carrying out the research or to the trust effectively controlling them? Will the Government be setting down parameters for the protocols?

Schedule 2 refers to nominated persons, a carer or family member perhaps, being kept in touch with the patient’s condition and being able to take a decision as to whether they want the research discontinued. How will they be kept in touch with that research? These are very technical issues. Again, will there be protocols set down as to whether they should be notified on a regular basis as to how the research treatment is taking place? How will they be judged to be able to make a reasonable judgment themselves as to whether that research should be discontinued?

Paragraph 6 of schedule 2 says that the nominated person must ensure

the person or subject during

What culpability attaches to the nominated person if those considerations are breached unwittingly? What liability falls on the nominated person to make sure that he or she is fully apprised of advance decisions and statements? The statement may have been made by somebody who has capacity while in a residential home to somebody else, but is not then communicated to the person who is or becomes the nominated person. I foresee the possibility of the nominated person being kept slightly out of the loop—because they could not possibly understand the extent of the research—by some over-keen researchers. We do not want the whole thing to be aborted because of misunderstandings and somebody believing on unreasonable grounds that harm is being done to the patient.

I will make a couple of other points. The regulations say that any research must benefit the person directly, or people in the same category. How does the Minister define that therapeutic benefit? Interestingly, that is potentially in conflict with what the she wants to achieve with the Mental Health Bill, in which she is trying to remove the treatability or therapeutic benefit provisions. Is there going to be an inconsistency between how we treat one type of person lacking mental capacity under the regulations and another type of person covered by the Mental Health Bill?

The Alzheimer’s Society says that many local ethics committees turn down research applications flat on the basis that people in the later stages of dementia cannot consent to research. Apparently, positive proposals are not even considered by ethics committees because of consent issues. How will the Minister ensure that professionals receive proper training in, and knowledge of, the new regulations to make sure that ethics committees are rather more flexible and sensitive to the value of certain research? What consultations have the Government carried out to ascertain the effect of the regulations and whether they achieve the balance between protecting individuals and carrying out valuable research?

Finally, my hon. Friend the Member for Daventry (Mr. Boswell), who served on the Committee considering the Mental Capacity Bill and is far more au fait with its contents and implications, has raised a couple of points, which he has asked me to put before the Committee. He queries whether it would be possible in practice to differentiate information or material obtained with consent before the loss of capacity from that obtained subsequently, after the loss of capacity and therefore under a different legal regime. How do the thresholds come in? When is it deemed that someone has lost their capacity in relation to when the research took place? We are not necessarily talking about a point on a certain day that observations were made. We are talking about continuing research observations over a longer period of time.

Secondly, are the safeguards set out in the regulations for the exceptional cases that we are talking about during the transition period absolutely square with those for research projects undertaken after the start date? Thirdly, as my hon. Friend the Member for Daventry mentions, in normal circumstances the research will require sanction by an ethics committee. There will be additional safeguards such as family consent. On the other hand, if the person concerned is in a permanent state and unlikely to recover during the research project, it could be argued that the clauses are not compliant with the general principle of best interest. Perhaps the Minister could comment on that.

I have a series of questions, some of which are almost as technical as the regulations themselves, but I hope that the Minister can give a general response to them. If there are further considerations, she may want to come back to those. I am particularly intrigued by the scenario of lobotomy. Her answer will enable me to reply to the people who sent me that query. I will be grateful for any answers that she can provide.

Dr. John Pugh (Southport) (LD): I have no problem with the intent of the regulations. It is their effect that concerns me, and there remain some residual doubts even after the Minister’s very good explanation. As I understand it, the object is to authorise research involving, but not necessarily benefiting, people with limited or no mental capacity.

There are good reasons for research. Some conditions are extremely dangerous, hazardous and unfortunate and research needs to take place. However, there are also real concerns, because we are talking about people who are vulnerable and often institutionalised. I think that we all accept that there is a definite need to see that such people are not simply used as research tools to their obvious detriment, and that is what the regulations intend to address. They do not insist that there must be a recognisable benefit.

I will try to explain to the Minister the situation as I see it, and she can correct me, presumably from a point of greater knowledge, when I go wrong. The regulations do not necessarily have to result in a recognisable benefit for the person being researched on. They seem to include simple research into data and DNA matters, but they insist on all research being properly authorised by what is called an appropriate body. The hon. Member for East Worthing and Shoreham has said that he would like some more clarification on what an appropriate body might be. I think that it is specified in the Mental Capacity Act 2005, but the Minister will no doubt clarify that.

There must be prior consultation with a carer who is not professionally involved in any therapeutic procedure with the patient or the individual being researched on. The carer must be willing to be consulted. If such a person cannot be found, a nominee uninvolved in the research must be appointed subject to the guidance of the Secretary of State. That guidance is not currently before us. Further precautions appear to be that the identified person—the nominee or carer—must be consulted on the nature of the research and give some view on what the patient wishes. Overriding that is any expressed wish of the patient themselves, which must be attended to and responded to emphatically. A further caveat is that throughout the whole procedure, the dominating principle is that the patient’s wishes are to be put before the interests of science and society. Based on that, it could be suggested that the regulations are a belt-and-braces job.

I have certain reservations, and I would like the Minister to reassure me about the issues that concern me. First, the guidance from the Secretary of State about who is an appropriately nominated person needs to be fleshed out. Who can be nominated? Can it be any person of appropriate experience? Does it need to be a person who knows the particular subject of the research? The relationship of the carer is somewhat loosely defined. Both the carer and nominated person are the gatekeepers for the research. I am not convinced that the gate is quite as effectively attended as it might be.

Secondly and more substantially, there does not seem to be any procedure for a sustained audit of the research. In other words, once the research is under way, I am not satisfied on the basis of what I can see at the moment that due concern will always be in place. The carer with permission might be relatively remote, the researcher might be easily persuaded and the individual might be simply incapable of understanding what is going on. I doubt whether we will get to a stage at which pre-frontal lobotomies are done casually in the nature of research—I understand that, pre-war, that was a standard therapeutic procedure for violent schizophrenics—but I cannot imagine any research project getting through an ethics committee by suggesting that such a procedure is simply research, however badly informed the committee might be.

Various other considerations that are beyond my ken might impact on some of the reservations that I have put forward. Clearly, there are regulations regarding clinical trials, and, if things go wrong, there might be a threat of subsequent liability and court procedures to give a caution to any researcher who is thinking of pushing the boundaries a little.

I could be reassured if the Minister told me that the regulations had been properly consulted on and endorsed by all relevant groups that have an interest. I was not on the Committee that considered the Mental Capacity Bill, and I have not seen the subsequent code of practice of which the Minister spoke—I do not think that anyone has—so I remain sceptical, but open to persuasion. Obviously, I would be more reassured if I was told that the arrangements and the regulations are of a purely provisional and technical kind, as they might be. I would be equally reassured if she said something about what consultation preceded them and what further pieces of legislation are needed to improve and clarify the position.

Mr. Robert Goodwill (Scarborough and Whitby) (Con): I have just one question. Has the Minister anticipated circumstances in which a carer withdraws a patient from a trial for reasons other than their welfare? For example, the carer might have strong views on animal testing and part of that research might also involve animal testing. Would the carer have to justify withdrawing the patient on the ground that it affects their welfare, or could the carer make that decision for other reasons that are not connected to the patient without there being any recourse to challenge that decision?

Ms Winterton: I thank Opposition Members for their support for the regulations, which is in keeping with the spirit of the Mental Capacity Act. We must be clear about what we are discussing with these regulations. Normally, the Act would cover research that involves people without capacity. Starting from there, the research would need to be on something affecting the person without capacity. For example, research on someone with Alzheimer’s would have to be related to that kind of condition or to losing capacity. However, the regulations are concerned with people who have been involved in a long-term study that might not be related to capacity—I referred to the “Whitehall” study that looked at the links between work and heart disease.

The regulations cover the information and data collected when such a person had capacity and what can be done with them when that person loses capacity. If a researcher wished to continue to take blood samples from such an individual as part of an ongoing study, they would have to return to the research ethics committee and follow all the regulations under the Act on whether they could do so. They would have to consult the carer or other relevant person on whether tests should continue. The regulations are about information and data gathered during research prior to a person losing capacity and how that research can continue.

In future, when a research study starts, those undertaking it will know our guidance to the research ethics committees and will anticipate what might happen if a person loses capacity, so their wishes will be obtained beforehand. The regulations cover a narrow set of circumstances. As for ongoing studies, which the hon. Member for East Worthing and Shoreham mentioned, there are probably about 20 major projects to which the regulations will be relevant. Those studies will not have to be aborted; the regulations relate to how information collected in them on somebody who subsequently lost capacity can be used.

The hon. Gentleman asked about people in care homes who show signs of distress. As I have said, if a researcher wanted to continue to do research on such people, he or she would have to get permission in line with the Act. If someone shows any sign of distress, such as pulling their arm away when blood is to be taken, that will be taken as a sign of their not wanting to participate and the researcher will have to stop. They will also have to stop if a person says, “No, I don’t want you to do that.” That point does not apply to the regulations, which are just on information and data already collected.

The hon. Gentleman asked whether the regulations would lead to a proliferation of new projects. We expect long-term projects to continue, but we will address in the code of practice and with the research ethics committees how we anticipate them working. We anticipate that the projects will remain the same but that the problem of people losing capacity will be covered.

Lobotomies are a procedure quite different from the long-term research projects that we are discussing today. If somebody were to have a lobotomy and gave permission in advance for residual tissue to be used, that would not come under the regulations.

We are working with the ethics committees on the protocols that will be established. It is important to recognise that we are not trying to lay down what every research ethics committee should do when a researcher makes proposals to get consent and deal with the matters in question. We are working with the Central Office for Research Ethics Committees, which advises and issues guidance to ethics committees, on how to implement the 2005 Act, and we shall continue to do so.

Tim Loughton: I want to return to the issue of lobotomies, because I am unclear about the distinction between research and procedures. The regulations refer to tissues. I presume that some form of procedure would be required to obtain tissues from somebody. I want an assurance from the Minister, because my reading of the regulations is that a lobotomy could take place in the name of research.

Ms Winterton: I am not aware of any long-term studies on lobotomies. We are talking about somebody who may be participating in a long-term trial involving taking blood samples over time and storing those. We are talking about how to get consent to use those blood samples for ongoing research if a person loses capacity. A lobotomy is significant surgery that can only be carried out if it is in a person’s best interests and is appropriate as part of their care. There may be an element of research—the use of data or samples gathered as part of the surgery—but the provisions that we are talking about do not authorise any risks to be taken that would not be medically appropriate.

Mr. Kilfoyle: On a more relevant point, I echo what the hon. Member for Southport said about the audit. The Minister knows, as do other Committee members, that we cannot foresee every eventuality. I am mindful of what happened with the organ retention scandal at Alder Hey, which was acting within the parametersset for research at the time. However, a set of circumstances had evolved that led to quite a scandal. Without providing details, I can envisage a similar situation arising, if we were not careful, if such research was not properly audited.

Ms Winterton: We introduced the Human TissueAct 2004 in response to the tragic events at Alder Hey. However, research in respect of people without capacity comes under the Mental Capacity Act 2005. Through a combination of the 2004 Act and the changes that we are making here, we are trying to establish a proper legal framework for any research that takes place, so that proper consent is obtainable and not getting that consent is against the law. It is important that that legal framework is in place so that people who go outside it would be breaking the law. We will continue to work with research ethics committees and to issue guidance so that they can be clear about what researchers are and are not able to do.

Hon. Members have touched on an important question: how do we ensure that a person has lost capacity? How would that be checked? Much research may take place after a person has a medical check once a year. Once a person is in touch with a clinician, I should have thought that it would be obvious if they had lost capacity. However, some studies have regular newsletters and so on, and we would expect next of kin to inform the researchers that a person had lost capacity. We should not expect researchers constantly to go back to individuals to check whether they have lost capacity; that is what the research community was worried about. The subjects are not necessarily people who are constantly in touch with the medical profession; they might just have an annual check at which a blood sample is taken. That is the point at which, if it is obvious that the person has lost capacity, the requirements of these regulations will have to be met.

The regulations apply simply to the data—blood samples, for example—that have been collected, and whether they can continue to be used for research purposes. For new interventions, researchers have to go back and get proper authorisation. The regulations do not permit any physical intervention; that would require full compliance with the Act. That covers the point that was made about lobotomy.

Dr. Pugh: The audit that I mentioned was not in connection with whether the person has capacity—that can be clearly established, and there is probably no disagreement about it. We are trying to rule out processes that are more intrusive than simple blood samples, and asking whether a continuing check is taken on research to see that it has all the benign effects that the people who originally consented to it thought that it had.

Ms Winterton: As I have said, if there is continuing physical intervention, the researcher has to go back to the ethics committee, and he has to obtain consent from a relative carer for any new intervention. Once it has been established that a person has lost capacity, the Act kicks in with regard to continuing intrusive intervention. Intrusive interventions are considered to be procedures for which one would normally have to obtain consent, such as the taking of a blood sample.

It is important to take advice about advance decisions because they concern areas in which, at some stage, a best judgment must be made. In this case, if an individual had participated in a research project during the whole time that he had capacity, had signed up to it and had gone along willingly, one could safely assume that he would want the results of what had happened during that time to be used. Of course, if the person advising on whether that individual would want the research to continue felt suddenly that it had entered an area that they did not approve of—this is so unlikely—they would be able to say, “Stop!” But, quite honestly, when people take part in research, they must be absolutely clear in the first place as to what is involved.

The “Whitehall” study looked in particular at the relationship between work and lifestyle, and heart disease. If a person suddenly changed their mind in the last few months of having capacity and decided that they did not want further research done into heart disease, a relative could say, “Well, they changed their mind at the last minute and decided that they did not like research into heart disease”. Therefore, that point would be covered. On the points raised by hon. Member for Scarborough and Whitby, as I have said, withdrawal from research is not really covered by the regulations because they relate to previously collected information.

Finally, the regulations were consulted on, between June and September 2005, with a wide range of groups. We received 38 responses, all of which are addressed in the regulations and the documents relating to them, which have been provided to the Committee. We also debated the matter quite a lot during the passage of the Act. We did not want to stop any ongoing research or create confusion over what was going to happen, and a transitional process was requested.

I shall check the record to see if there is anything that I have not covered, but I hope that with those reassurances, the Committee will support the regulations.

Question put and agreed to.

Resolved,

Committee rose at thirteen minutes to Ten o’clock.