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Baroness Andrews: I am very grateful to noble Lords for bringing forward what I know are concerns of distinguished medical bodies. We are sympathetic to these concerns and are grateful to have the opportunity to clarify matters and to tell noble Lords what our intent will be. It is also good that they have welcomed the research clauses of the Bill. We look forward to debating them in due course.
In the meantime, two amendments have been tabled. The amendment of my noble friend Lord Turnberg simply deletes the words "at the material time" and the noble Earl, Lord Howe, has tabled an amendment to the same clause, Clause 2(1), that would provide that the Secretary of State can specify in regulations the meaning of "at the material time". I have been asked to assist in reducing confusion and to give some indication that we are dealing with the problem that researchers are anticipating.
The main problem is establishing whether consent to participating in research that is given while a person has capacity to do so survives loss of capacity or whether the consent ceases to be valid when capacity is lost. Noble Lords have rightly drawn attention to the kinds of research projects that might have begun before the Bill and will be ongoing when the legislation comes into force but which are not adversely affected by its provisions for research. There is, of course, a huge number of major trials involving many people where this situation might occur.
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I understand that the term "at the material time" applies when the act that would be unlawful without consentfor example, taking bloodis done. So the material time is the time of the act; in this case, carried out in the context of research. I understand that it will be difficult and, in some cases, impossible for existing and ongoing projects to meet the requirements of Clause 31, which covers approval. In some cases, especially in long-term projects, consent to use and retain samples and data is given by participants in advance for research that is conducted over many years and that may well continue beyond the onset of loss of capacity.
We are concerned to achieve a smooth transition from the current practice to that in the Bill. If, for example, an ongoing research project has already been approved and the participants have consented in advance, we do not want the project to be brought to an untimely or unintentional stop because of the formulation of the Bill. Indeed, it could be detrimental to a project if a participant could no longer take part because he lacked capacity. However, it would be burdensome, possibly excessively so, to put the whole project through an additional set of safeguards required by the Bill if there is a risk that there is one participant who might lose capacity during the project. We have to get the balance right. We do not want to be unfair and move the goalposts in that way. So, in looking for the best of both worlds, we need to ensure that research is not subject to excessive interference, while simultaneously ensuring that we protect the rights and dignity of individuals.
We intend to clarify whether consent given in advance to an ongoing or long-term research project continues to be valid when the person loses capacity. We need to be absolutely sure that adequate safeguards are in place to protect individuals who may lose capacity. Of course, under Clause 33, there is a very important raft of safeguards concerning the withdrawal of people wishing to leave a research project.
We also need to be sure that any changes we make are the right ones. Making changes to key Clause 2, which provides a definition of people who lack capacity, would have implications for the whole of the Bill. Simply deleting the words, "at the material time", as my noble friend proposes, would undermine the Bill's time-specific approach to capacity, which we need to keep. I am sure that Members of the Committee would not want us to do that.
I suggest that we take this away and look at how we might bring forward an amendment that expresses the notion of continuing consent in those circumstances. We will certainly consult widely with the bodies that have made their concerns known. I also take the noble Lord's point about guidance, which we will think about. With those assurances, I hope that the noble Lord will be able to withdraw his amendment.
Lord Turnberg: I am most grateful for that very full explanation and the willingness of my noble friend the Minister to look at this issue again. Of course, I am delighted to withdraw my amendment.
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The noble Baroness said: The amendments in this group relate to communication. Currently, all clauses concerning communication relate to ensuring that no one is considered to lack capacity simply because he lacks the relevant communication support. Throughout the Bill, it is not clear whether people will still require communication support to participate in decision-making processes and to express their wishes and feelings. It is difficult to see how, in practice, the best interests of a person will be assessed if that lack of support is not there.
The amendments refer to communication in different forms, including orally and visually, which is extremely important. We have spent a lot of time today talking about expressions of wishes in writing. There are quite a number of people who for different reasons are very capable of expressing their wishes, but who cannot write. There is also the additional issue of people who have to use specialist means of communicationfor example, Makatonor people with learning disabilities receiving information in forms of Easy Read.
As I was preparing for today, I heard an excellent example of how things might go wrong. It was about a lady who had had a stroke. While collecting her pension, she could not remember her PIN number and could not write. In her dealings with the bank, with the assistance of an advocate, a bank employee said, "Well, why don't you make your husband your power of attorney?". The lady concerned has a perfect ability to think and knows what she wants to do. She just cannot write. For the purposes of this Bill, that was a fortuitous example.
Much of this Bill, and whether it will work, depends wholly on communication and appropriate means of communication being available at all times. Ultimately, the question is why we should seek to put this in the Bill rather than in the code of practice, which, not surprisingly, has an extensive section on communication. There are two reasons for that. First, people who have caring responsibilities for people with very profound learning disabilities and very limited communication have expressed powerfully what that is like and how long it takes to understand what is meant by a person who has no speech.
The second reason concerns resources and can be expressed in two ways. Communication of that type and the time that it takes necessarily involves resources. There is a cost for the types of communication that are being suggested becoming best practice. In our minds, there is a question about whether something that exists in a code of practice will command enough authority.
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Beyond a code of practice, there is the requirement for all sorts of different organisationsperhaps those that have not ever really had to deal with this sort of issue beforeto begin to develop good practice. I am not sure that lawyers and solicitors, for example, routinely have had to engage in this. For all those reasons, we believe that these amendments should be considered in depth. I beg to move.
Baroness Finlay of Llandaff: Briefly, I would like to stress the point made by the noble Baroness, Lady Barker, about the need to have a very wide range of ways of helping people to communicate, which involves communication aids and relevant professionals, such as speech and language therapists. Like the noble Baroness, I have a concern that if there is not something in the BillI accept that the wording of the amendments may not be quite right and that there is some duplication in the wordingthere will not be the lever when it comes to the rationing debate to say that the provision of assistance to communicate must become a higher priority in the delivery of healthcare services.
Part of the reason why that will not happen is the way budgets are controlled, which tends to be in silos. The provision of communication aids in speech and language therapy will be in one silo and will be quite separate from other services available to people who lack capacity. Therefore, they may become a lower priority, particularly because there are only one or two speech or language therapists attached to a service.
In addition, the pieces of equipment can appear to be quite an expensive outlay. It is a pity that the health economists are not doing a slightly more imaginative model because good communication could, if properly costed, prove to be cost-effective because we would be taking good decisions more quickly.
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