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The Parliamentary Under-Secretary of State, Department of Health (Lord Warner): I thank noble Lords for raising a number of important points about the inclusion of provisions on research in the Bill and about the purpose of Clause 30 in particular. As this is the first group of amendments on research, it might be
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helpful for me to give a full response to the amendments and say a bit about the thinking behind our approach to this section of the Bill.
Clauses 30 to 33 make provision for research to be conducted involving people who lack capacity, but only where it complies with the relevant conditions and safeguards, about which I will say more later. The Government can be said to have taken careful note of the view of the Joint Committee that if the Bill did not address research it would leave considerable uncertainty about what research would be lawful. The provisions are based on international consensus set out by groups such as the World Medical Association, as recommended by the Joint Committee.
The research provisions in Clauses 30 to 33 established a requirement to put the interests and wishes of P at the forefront of considerations. All intrusive research, that is research that would require consent if an adult had capacity, is covered except for clinical trials of medicines, which are subject to separate and equivalent regulation in accordance with a European directive. Under this Bill, research would only be lawful if it is approved by an appropriate body as set out in regulations. Such a body would normally be an independent research ethics committee such as those set up by the NHS. We have left provision for specifying this by means of regulations, because a number of noble Lords may remember that during the course of the Human Tissue Bill I announced that we were reviewing the functioning of NHS research ethics committees and changes to the structures that appoint and provide operational support to research ethics committees. There had been some concern to see whether we could improve some of those procedures and processes. That is what we are doing as part of this review. On the assumption that spring is a little late, I hope that we may be able to make a further announcement around that time.
My department is also developing a research governance framework for social care research to complement that for NHS healthcare research. I say to the noble Baroness, Lady Carnegy, that under the terms of this Bill the research ethics committees, which I agree take a great deal of trouble over the applications in front of them, will have to approve proposals before they can proceed.
The noble Baroness, Lady Barker, has proposed inserting "physical or social" after "intrusive" in the opening reference to the general provisions in Clause 30. I understand her purposes, but her wording narrows the terms of the Bill. We must not forget that the safeguards in Clause 31 make it clear that the research is to be connected in some manner with the thing that leads to the impairment or results from it, and to improve treatment, care or advance scientific understanding. This all means that it is clear that the provisions relate to scientific, health or social care research in the full sense of those terms, not to other types of research, such as market surveys.
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The code of practice sets out a definition based on widely accepted principles of research governance, which I will not read out in full, but as the noble Baroness will see, paragraph 12.5 of the draft code already says:
"Research has been defined as an activity that attempts to derive new knowledge by addressing clearly defined questions (hypotheses) using systematic and rigorous methods. The knowledge gained may provide information that can be generalised to the particular illness, disorder, or circumstances under investigation".
That is the scope of research, and it has to be intrusive. I infer from the question asked by the noble Lord, Lord Alton, that there is doubt about the meaning of "intrusive". It is emphatically not synonymous with "invasive". "Intrusive" means doing research activities that would ordinarily, if the person had capacity, require their consent. It could be analysing a questionnaire or their medical notes; it could be doing research on some tissue removed from them during surgery. It is not the same as "invasive", which applies to research acts that require putting something into a person's body, perhaps to remove a sample, to provide some therapeutic substance, or to measure some characteristic of their body. It is wider than "invasive".
With that in mind, while I welcome any additional elements which reinforce this intention, I am reluctant to consider changes that have the effect of narrowing too far the scope of research clauses in the Bill. We feel that these already provide an appropriate balance between enabling research and protecting vulnerable individuals. We would not wish to see their scope drawn too narrowly.
Also, and with great respect, I fear that the amendment does not achieve the desired effect of improving clarity. For example, it would unfortunately give an impression that the scope of the clauses is limited to research that involves physical contact with the person who lacks capacity. Some may feel that this is all that the Bill should cover, but we have sought to ensure that it covers the whole range of research activities that would require a person's consent if that person had capacity, which includes research involving them, their tissue or their data. As I understood from the noble Baroness, Lady Barker, it was these wider issues that she was most concerned about. For example, some researchers may want to film the person without capacity through a two-way mirror to study something related to the working of their mind. Some researchers may want to use their personal and medical data, but these might not be said to be "physical" research activities. Are they "social" research activities? It is unclear. Therefore, we used a broader term and related it to capacity.
We want an independent research ethics committee to have the power to refuse approval to a project that made unjustified invasions of privacy, every bit as much as controlling direct, hands-on clinical research. In the light of those comments, I encourage the noble Baroness to withdraw her amendment.
I understand why Amendment No. 101 has been proposed. We have carefully considered the concerns expressed at Second Reading. Several important and
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respected organisations engaged in research have provided comments on this point, and they were alluded to by the noble Earl, Lord Howe. The Academy of Medical Sciences, the Medical Research Council, the Wellcome Trust and the Royal College of Physicians have raised the question of whether the provisions in Clauses 30 to 33 on research are enabling provisions, or whether they simply impose additional requirements beyond the common law and the other provisions of the Bill. Let me be clear. As regards treatment, the common law doctrine of necessity is replaced by the statutory provisions in the Mental Capacity Bill. Clause 5 codifies elements of the doctrine of necessity in relation to the provision of care and treatment according to a person's best interests. Clauses 30 to 33 deal with research. The Bill's provisions about the assessment of capacity apply across the whole Bill.
The purpose of Clauses 30 to 33 is to make provision for acts in connection with research that cannot necessarily be shown precisely to coincide with the person's best interests. It may be that the research procedure involves different or additional approaches to a person's care, which might not meet a narrow assessment of best interest. It is also clear that properly conducted research can, overall, lead to improvements in the lives and the health of individuals and of others with the same condition. Morally, the case can be made to permit carefully controlled research involving those without capacity.
The provisions regarding research are framed as they are because of the need to allow for situations where research is but one aspect of the clinical or professional care of the person who lacks capacity. Any research has to be against a background of the other needs that the person has, and those must in turn comply with the provisions of the Bill, particularly in relation to the determination of best interests. But that does not mean that a research procedure which is part of an approved research project in which the person who lacks capacity has been properly enrolled has to be, in addition, judged against the best interests test. In that respect, the research procedures provide an alternative to a best interests determination.
Clause 30 makes it clear that research that would normally require consent if the person had capacity will be unlawful unless it is done as part of a project approved by an appropriate bodyusually a research ethics committeeand in accordance with the requirements for consultation with a carer or other nominated person. It must also respect any prior statement made by the person and any indication that he or she wants to be withdrawn from the study.
Although the amendment is well intentioned, it is not acceptable, unfortunately. It is legally not possible to make such a change to satisfy researchers that those research provisions are an exhaustive list of the legal duties that apply to research involving adults who lack capacity. Alongside the Bill, researchers must also consider their wider legal duties, such as requirements of confidentiality, data protection, health and safety at work or their employer's liability insurance. We
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cannot accept an amendment along those lines, because it would involve giving researchers some false notion of indemnity against their wider legal obligations. In practice, we want to continue to promote proper research governance arrangements, of the sort required for NHS research. Those can help to ensure that researchers consider all their legal and professional duties, including those set out in the Bill.
A number of Members of the Committee spoke to Amendment No. 102 in the absence of the noble Baroness, Lady Finlay. It raises some important issues, and I recall that she made similar points during the passage of the then Human Tissue Bill. I will repeat the assurances made previously by my noble friend Lady Andrews. Researchers need to understand clearly whether consent given in advance to an ongoing or long-term research project continues to be valid when the person concerned loses capacity. We need, of course, to make sure that adequate safeguards are in place to protect the individuals who may lose capacity during a research project. We need to ensure that we put proper arrangements in place so that existing research projects are not adversely affected by the Bill where that would be inappropriate.
I can go further today in addressing the specific points raised in the amendment. If we consider Clause 30, the definition of what is intrusive research hinges on whether a person with capacity would have to consent to it for it to be lawful. If a researcher has the consent of a person to carry out research involving them, that consent endures beyond loss of capacity, but only up to a point. That point is when the researcher wants to do some act to which a person who had capacity could refuse consent, such as a request to take a further blood sample, perform a physiological measurement or answer some personal or health question.
If the participant lacks capacity to consent to that additional matter, or to withhold or refuse consent to it, the safeguards in the Bill should apply so that the person has equivalent protections that a person with capacity would have. In particular, the researcher needs to approach the person's carers for advice and to respect the views of the person without capacity and any objections that they may make.
I can give one or two simple examples to illustrate how we believe that the provisions around intrusive research apply. In a simple case, I may be about to have routine surgery. My surgeon seeks my consent to do some research involving a new medical device while I am under the anaesthetic. At that stage, I have temporarily lost capacity, but it does not follow that the surgeon has to undertake the additional procedures called for in Clauses 32 or 33. I had given my consent to the research while I had capacity, so what is being done to me in the name of research is not intrusive research under Clause 32(2). Therefore, my consent survives the onset of the temporary incapacity.
That is a simple example. Others may be more complex. I shall take a different case to illustrate the matter. I may consent to join a long-term research study to follow my general health over the course of
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several decades. That is not fanciful; there are many such research studies. I have appointments with the research team each year and they take my blood, my blood pressure and so on and ask me some health questions. I initially consented to them doing so, and to them studying my blood samples in the laboratory and analysing my health data in their computers. But between research appointments, I unexpectedly lose capacity due to some injury or illness. The researchers are not to know that, and it would therefore follow that my consent to their laboratory researches should endure.
However, when the time comes for my next appointment, it will become clear that I have lost capacity. At that point, the researchers' actions will depend to some extent on what was decided in their research protocol or their original consent. The research design may mean that they do not want me in the research any longer. They may not want any new samples or information from me, but may wish to keep the previously collected data. Alternately, they may have anticipated that some people in such a long study would lose capacity and made arrangements.
If the latter is the case, the Bill requires that the researchers comply with Clauses 30 to 33. In particular, they would need to identify my carer, next of kin or other person interested in my welfare, tell them about the research and ask what, in their opinion, my wishes and feelings would have been. They would also, under Clause 32, ask whether my carer or next of kin thought that I still wanted to be part of the study. They would also, so far as possible, try to find out what I wanted. If my next of kin or I indicated that I did not want to be sampled or studied any longer, that would be that. No further samples could be taken from me. But that is not to say that the earlier samples would automatically need to be destroyed or removed from the analysis. That would depend to an extent on what I had consented to in advance.
I set that out at some length so that people can read it afterwards, because the area is complex. I hope that I have explained that we need to cover a range of circumstances. As my noble friend Lady Andrews said, we will want to look carefully at what should happen to research that started before the Bill came into force. I therefore repeat her assurances that we will look carefully at the suggestion and consult on it. I do not want to make any promises, but we will see whether an amendment can be brought forward to tackle some of the issues.
I am grateful to the noble Earl for tabling Amendment No. 116; as he said, it reflects concerns in the medical research community. Clause 31 contains some of the core safeguards that affect research. Every research project involving those who lack capacity must be approved by the appropriate body, the research ethics committee. It is required to be satisfied that the research is connected to a condition that affects P and is linked to the impairment of mind or
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brain. Crucially, it must be satisfied that the research could not be done as effectively with those who could consent.
Then there is the question of whether the benefit to P of the research is not disproportionate to the burdenthe inconvenience, discomfort or bother of the study. If the research is not likely directly to benefit P, there have to be assurances that the risk to them is negligible, that it will not interfere with their privacy in a significant way, and that it is not unduly invasive or restrictive. We must not forget that there is a need for each individual to be properly enrolled in a study, in consultation with their carers or other nominees, and also respect P's previous and ongoing wishes and views. Those are all already extremely important safeguards, and it is true that they are based on our current understanding ofand, to a large extent, the international consensus onresearch involving those without capacity.
I set out this matter at length, because it crossed my mind that there may be some disquiet in some quarters that Ministers, other than the present benign lot, could omit or vary some of those safeguards by means of an order. I detected that the noble Earl, Lord Howe, might have a twitch of doubt about that as he spoke to this amendment. I sympathise with the research community's desire to lay down flexible rules governing research that can adapt to advances in scientific knowledge, but we must bear in mind the strong safeguards in the Bill.
The Bill requires an independent research ethics committee to exercise judgment in the light of the facts of the research. That is why we tend to resist attempts to alter those safeguards. Another important way of enabling a flexible, yet strict, approach to research is the code of practice. I hope that the research community will work with us to ensure that the code is sufficiently detailed in that regard.
However, as someone who has done his best to co-operate with the research community, I recognise some of the issues with which they are concerned and we wish to ensure that there is sufficient flexibility in the Bill and to provide for that to be adapted in the light of experience, if that is necessary. Without giving any commitments at this stage, we would be glad to consider this issue further and return to it on Report, to see whether there can be any movement in this area.
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