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Lord Alton of Liverpool: My Lords, I rise briefly to support the amendment standing in the name of the noble Baroness, Lady Knight, as I did at an earlier stage. Members of your Lordships' House will recall that, when the amendment was tabled on the previous occasion, it was more widely drawn. There was some concern that it included the phrase "in any circumstances whatsoever". I think that the noble Baroness, Lady Andrews, was right to say that that would cause a number of problems in interpreting the amendment.

The noble Baroness, Lady Knight, has done us a service in taking away the amendment and drawing it more tightly. She has also provided us with an amendment that is entirely compatible with the preceding paragraphs in Clause 32(3) on page 19 of the Bill. Paragraph (a) states that the person is,

under paragraph (b), that he,

If the noble Baroness's amendment were accepted, the subsection would go on to say that the person,

I think that that is entirely consistent with the way in which the Bill is phrased, and it would add one more safety clause to the Bill—one that I would personally welcome.

As this is the only opportunity to say anything further on the research provisions in the Bill, and as this is germane to the amendment, I thank the noble Baroness, Lady Andrews, for her letter of 24 March. It responds to a point raised during our Report stage, when I asked about significant discrepancies that might arise between the research provisions in the Bill and the Council of Europe's convention on human rights and biomedicine. I was extremely grateful to the Minister for setting out those points and for copying them to other noble Lords who had taken part in the debate. Perhaps she could arrange for a copy of the letter to be placed in the Library so that others who might be interested in this issue are able to read it.

Lord Turnberg: My Lords, I have to apologise to the noble Baroness, Lady Knight, for always seeming to speak against her amendments. However, I do so with some humility because, on the previous occasion that we debated this amendment, I agreed with the principle behind it and I still do.

I think it is right that someone who has some direct close connection with R should not be the person finally to give permission for the research to be undertaken. I accept that entirely. However, as I see it, the problem with the amendment is that a person "having no connection with R" could apply to anyone on the staff of the hospital, anyone on the staff of the
 
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medical school and anyone in a relationship of any kind with R or even anyone who knows R. It would be extremely difficult to find someone who did not know R in the environment in which permission was being sought. So I do not think that the amendment is workable. In fact, it would prevent anyone doing research in the situation that we are talking about—that is, the emergency situation.

Subsection (3)(b) states:

That would include anyone who had a pecuniary interest in ensuring that the research was carried out—that is, someone who would make some money or profit from it. I think that that is covered by the words "no connection with the project". That, at least, would get round the problem of the person giving the permission not even having to know the person doing the research.

Baroness Knight of Collingtree: My Lords, before the noble Lord sits down, I am very grateful because he always listens most courteously to what I have to say. I cannot quite link up the notion that if the researcher must have no connection with the consultee, he might be someone who works in the same hospital. Could it not cause a difficulty under Clause 32(3)(b) if the patient is in the same hospital as the project, as the noble Lord specifically mentioned? I cannot see that I am so wrong in tabling this amendment inserting paragraph (c). If there is a difficulty, and I do not accept that there necessarily is, why does it not apply to paragraph (b)?

Lord Turnberg: My Lords, the difficulty does not apply to Clause 32(3)(b) because a person can quite easily be in a hospital, not know anything about a research project in the same hospital, and still know the researcher. That would be entirely reasonable.

Lord Patten: My Lords, I rise to agree with the noble Lord, Lord Turnberg, in his support of my noble friend's underlying principles. However, I respectfully disagree with his dissent from my noble friend's excellent redrafted amendment. I think it is crystal-clear and in tip-top shape. I do not think that it gets in the way of pukka research in any way. I support my noble friend.

Baroness Andrews: My Lords, I am grateful to the noble Baroness for giving us another opportunity to explore this issue and for the beam of light that she has shed on it. In earlier stages of the Bill, we had a good debate on research and I am very glad that we were reconciled on Amendment No. 60. But the noble Baroness has done the House a service by raising issues about the connections between people involved in research projects and the safeguards about who speaks for them and represents them.

I was impressed that she recast her amendment in a more specific manner, as the noble Lord, Lord Alton, noted. I wish that I could say that it satisfies our concerns, but it does not. I hope that I can convince her
 
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of why. I shall also take the opportunity to explain in more detail why we believe that the statutory guidance will do the job that she wants.

I shall start by saying that the issue she has raised is extremely important and it is right that we should consider it in detail. We must be as secure as possible that the interests of the people involved are being served. I promised that we would reflect. I take on board the worry that there might be a mendacious researcher who would be able to nominate a compliant friend or family member in order to enrol an unbefriended person in research. We looked very hard at what she was saying. We looked at different ways in which we could express this and flesh it out so that it would be clear to noble Lords and to researchers in the field.

Having considered that, I have concluded in all sincerity, and with the best consultation and advice, that we are best advised to strengthen the statutory guidance rather than to attempt to resolve the matter on the face of the Bill.

I shall explain why. I shall briefly offer three valid reasons that have led us to this conclusion. The primary reason is that the term "no connection with R" is extremely broad and difficult to interpret. I take the point made by my noble friend Lord Turnberg and shall return to it with an example in a minute. It is not only difficult to interpret the term consistently and satisfactorily in legislation, which would cause problems, but it might also have the perverse effect of excluding a range of individuals who would be appropriate consultees for the people involved.

The second reason is that it is important that researchers are clear about what they have to do to comply with the Bill and about all the safeguards that we have built into it. Not only that, but the Bill runs alongside the clinical trials regulations which govern research into new medicines and have been in force for some time. The wide scope of the Bill and the narrower scope of the regulations and the complex relationships between different health organisations and care organisations, which are involved in research provisions for the first time, must be aligned. It is far better to use statutory guidelines.

The third point is again about the safeguards. The safeguards are not only those contained in the Bill and bound by it. In Clause 32 we have the requirement that the researcher must take steps to identify someone who cares for the person, except in a professional capacity, and who is willing to be consulted about the person's participation in an approved research project.

If that is not possible because carers are genuinely unwilling or unable to do this—there may be such cases—or the person has no eligible carers, the researcher must nominate a third party unconnected with the research who is willing to act as a consultee. That person must be identified in accordance with statutory guidance to be issued by the Secretary of State and the National Assembly for Wales.
 
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One thing I should say to the noble Baroness, which I may not have said on Report, is that if it is not possible to identify a suitable consultee, the assumption must always be that the person is not enrolled on the project. In any event, Clause 31(7) requires that the arrangements regarding consultation with a carer or a third party have to be acceptable to the research ethics committee. We had a long discussion at both stages of the Bill about how scrupulous the RECs are in carrying out their range of duties.

The term "connected" is very wide. Putting it in the Bill would make it extremely difficult to interpret. In the broad sense, what precisely is meant by having "no connection"? As the noble Lord, Lord Turnberg, said, it could be interpreted as someone with no professional or financial connection by virtue of working in the same organisation or same professional groups or belonging to the same professional society. But it could also extend to living in the same street, having a passing acquaintance or worshiping in the same church.

I appreciate that the noble Baroness said that she wanted to make the provision watertight, but the phrase does not do that. It is simply too broad. If researchers do not know how to interpret it, they will be confused and err on the side of caution. They may not feel able to approach someone they know and respect, perhaps a professional or social contact, who would be a suitable person. That may have the opposite effect to the one that is intended.

Let us say that a researcher with strong religious beliefs is involved in research with elderly patients with dementia, looking at the development of dementia in relation to brain development, using CAT scans. The researcher may know that the hospital's visiting chaplain has been appointed to the panel of third-party consultees and that he occasionally leads services. However, some of the potential research participants may have been the chaplain's parishioners. He may know of their previous wishes and feelings. Let us say that the researcher decides to ask the chaplain whether he would be willing to be nominated to the REC as the third-party consultee for any relative or unpaid carer who is willing to be consulted. Under the amendment, he would not be able to do so. The chaplain could not be said to have "no connection" to the researcher. The Bill, as it stands, would allow him to do it. We have to be careful of that type of case. Interpretation is the first problem.

The second problem is that we have to ensure that researchers are clear about what they have to do in relation to the Bill and to the related clinical trial regulations. We have to be pragmatic and sensible. The statutory guidance procedures allow us to align and to create a simple and effective mechanism that is well understood by researchers as we cannot actually go into the detail.

We have looked at the clinical trials model as a basis for the Bill. It is constructed in a narrower way which reflects the more limited scope of medicines trials. The regulations broadly say that if a "legal representative" cannot be found among P's next of kin, then the researcher must identify,
 
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That definition has been drawn much more narrowly. The person should not work for the researcher or sponsor, or be supervised by the researcher. It does not say that the person cannot know or otherwise be connected with them. So, we cannot use that model because it is too narrow.

I shall explain why we need flexible regulations. We will prepare and consult. The noble Baroness asked about consultation, which is extremely important. We will consult on guidance on the interpretation of third-party consultees under Clause 32(3) and on the legal representation under Schedule 1 to the clinical trials regulations. That is the only way to align the different legal requirements into a single system of appropriately trained independent persons who can advise on enrolling people under the statutory frameworks. Its inclusion in regulations enables us to bring those two sets of requirements together in a fit and proper way that helps everybody involved.

4.45 p.m.

The Bill also covers a wider range of health and social care research. We cannot simply require that the consultee be appointed by the healthcare provider; we must take into account the fact that some people involved in research projects may be in a care home funded by a local authority or cared for at home. We want the researcher to have the flexibility to use the appropriate third-party consultee, nominated by either his employer—for example, a trust or university—or another organisation, acting on behalf of the relevant local authority. Again, we are looking at the flexibility offered by statutory guidance and regulations.

We will have to look at those complex issues in more detail in the statutory guidance. The noble Baroness, Lady Knight, asked about that guidance. I am very happy to give her as much detail as we have available and certainly to keep in touch as the implementation programme progresses. I assure the House that the statutory guidance will say that the care organisations involved, whether trusts or local authorities, should work with the relevant research ethics committee to establish a suitable panel of people who can act as third-party consultees. That panel will be the responsibility of each trust or social care organisation and will be governed by the research governance framework. It will be set within a proper framework.

We have yet to decide on remuneration; it depends on who will be the employing party. Payment or other expenses will be part of the overheads charged to researchers or sponsors, so it will be built into the research programme.

The noble Baroness asked what sort of people would be involved. They could be existing employees, such as other clinical staff not connected with the trial, or social workers. I take the point about social workers' time pressures, but in this context we might be looking at hospital-based social workers, who may have other sorts of responsibilities and would take an
 
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interest in these issues. So the picture may not be so gloomy. There might also be non-executive members of the trust board and hospital chaplains. There will be a role for the independent mental capacity advocate. The REC will also have a role in ensuring that training is available.

I imagine that the training will include the sort of information and advice that is available to research ethics committee staff—the context of research, how it is managed and the social factors regarding the people coming forward.

The noble Baroness asked about the timescale for guidance. It will be issued after we have amended the clinical trials regulations. We aim to consult towards the end of the year. There is usually a three-month consultation period, in which we will ensure the noble Baroness is involved.

The third point is that all that will be backed up by the code of practice. It is extremely important that the safety and security guidance for researchers be made clear. There will be more information in the code of practice. Taking the advice of the noble Earl, Lord Howe, we amended the Bill on Report to require researchers also to have regard to the code of practice. It emphasises the statutory guidance from the appropriate authority under Clause 32(3) and will highlight the role of the research ethics committee.

I hope that noble Lords will understand that clinical researchers are also bound by a very strict research governance framework for health and social care; for example, the professional codes of the General Medical Council. They contain general safeguards against conflicts of interest and other forms of professional misconduct.

Those three points—interpretation, what we need to achieve to bring our provisions into line with each other for safety and security in the way that research is conducted across a very complex set of relationships and agencies, and the wider safety framework—will, I hope, reassure the noble Baroness, particularly in the light of what I have said about the detail that will be in the statutory guidance and the code of practice.

In response to the question asked by the noble Lord, Lord Alton, we will be pleased to put the letter of 24 March in the Library. I was very pleased that he was pleased that we had met some of his concerns. With those assurances, I hope that the noble Baroness will not be too disappointed and will feel that she can withdraw her amendment.


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