Clause 30 - Research
Mental Capacity Bill
3:45 pm
Mr Tim Boswell (Shadow Minister, Home Affairs; Daventry, Conservative)
Welcome back to the Chair, Mr. Cran.
I am deeply relieved that the officials agree with their Minister, even if my hon. Friend the Member for Tiverton and Honiton had a little disagreement with me. It was about procedure rather than substance, because we all want to get on with discussing the Bournewood gap, but not in relation to these
particular amendments. However, some of the issues about consent, safeguards and the necessary process are as germane to the clauses that we are discussing as they were to that matter.
The Minister will know that these clauses are new clauses in the sense that they have come in since the Joint Committee's report, in response to its recommendation that research issues should be handled, rather than being clauses that have been resurrected from past mental health Bills because of concerns that were expressed at the time. Nevertheless, as I said on Second Reading, some of the issues of principles here give me the greatest difficulty that I have about the Bill. I remain to be convinced whether I can accept them and, if so, in what form.
The group of amendments is rather general, so I will start by setting one or two general points in context. Let us think about what has been done in the name of research, even through the necessary procedures that are internal to the control of that research such as research ethics committees, which have stretched the doctrine of necessity to its limit.
People can well imagine a situation in which somebody's loved grandparent has a stroke, is lying in hospital and a doctor comes along and asks the grandchild whether they can carry out tests on that person. That would be a distressing situation for everyone. There is probably a degree of moral encouragement to do that, because it may be good for granny—it could be argued on those grounds. Even if granny could not benefit, because she was by now past it, perhaps somebody else, or somebody else's granny, might benefit. That is not an unworthy set of human suggestions. We would probably have to say that, in the absence of legislation of this kind, there is no framework to regulate that kind of thing, and some undesirable things have happened. That leads me to observe that the work of research ethics committees—in relation to this and other types of research, and whether carried out on human subjects with consent, animals or whatever—is an important safeguard.
Those of us who have had explained the procedures, the external validation and the protocols that have to be found know that there is no question but that it is taken extremely seriously. I would not wish to signal that people are in some way getting up to wilful malpractice or resorting to practices of which we would be ashamed in principle. That is one important safeguard. The second is set out in the Helsinki convention—the Minister may be more au fait with that than many of us on the Committee. It provides a broad framework within which the issue should be addressed. I take comfort from that, although I warn the Minister that there is a bit of a sucker punch to come in a moment.
I consulted with the Disability Rights Commission on the matter only yesterday because of something that was drawn to my attention. It is only fair to quote what was said on the general point. That was:
''Generally however, the DRC believes that the Government has encompassed the Helsinki convention on research within the Bill and we think this is reasonably sound.''
That is a fair endorsement, and I am sure that the Minister would want the measures to be endorsed. It was also observed to me recently, when I took advice on the matter, that such processes are going on all over Europe. I asked the expert I was consulting whether we were ahead or behind, and the answer was ''probably ahead''.
The civilised world is, as it were, looking at this. There are concerns, and they need to be addressed. There is also an explicit safeguard in the Bill that is already explicit in the practice of research ethics scrutiny in this country. That is entirely proper. Let me say, before anybody gets the wrong idea, that the research should be specific to the person involved. There is no question of taking persons lacking mental capacity, exploiting their lack of mental capacity, and then saying—sadly all members of the Committee can imagine analogies—that these are Untermenschen, people whom we can now use to find out something else that we want to know. That has been done too many times in the last century, and we do not want to see anything like it. I would be the last person to suggest either that it is encompassed in current practice in Britain or in most other countries, or that it would be in any sense facilitated by this Bill. It is absolutely outside it. It has happened in western, democratic countries, as the Minister will know, but we have no time for it. Equally, we should not excite or alarm people into suggesting that it is now taking place.
Having said that, there are some matters of concern in the clauses. The Minister was silent during the exchanges that we had with her counterpart, the Under-Secretary of State for Constitutional Affairs, the hon. Member for Tottenham, in relation to principles and best interests, which we have discussed extensively. One assurance that I received from him was that the principles of clause 1 inform the whole Bill. He gave some explanation as to how they would be taken into account. If one considers clause 30, it is difficult to argue that the principle of best interests, which kicks in when a person lacks mental capacity, is in any way waived by it. The principle of best interests must continue in this clause; it cannot be taken out.
There is an argument involving clause 31, which amendment No. 44 addresses by deleting subsection (4)(b). Subsection (4)(a) states that the objectives of the research might be to
''have the potential to benefit P without imposing on P a burden that is disproportionate to the potential benefit''.
That is perfectly reasonable, and consistent with the best interests principle. However, paragraph (b), which is disjunctive to paragraph (a) as it is related to it by an ''or'' rather than an ''and'', states that the research might
''be intended to provide knowledge of the causes or treatment of, or of the care of persons affected by, the same or a similar condition.''
Therefore, it would be specific to the condition that the person had, but might not be to their benefit. This must be reconciled with the principles in clause 1. It goes to the heart of a lot of concerns. We cannot waive the best interests principle.
I turn to my second point—I warned the Minister of a sucker punch to come. I consulted the Disability Rights Commission because of submissions I received from the I Decide coalition and other interested parties in relation to the Disability Discrimination Act 1995. As the Minister knows, I could weary the Committee talking about that, but I have no intention of doing so. However, if under clause 30 we were to produce, even unwittingly, a regime that in terms of consenting to research is less protective of the interests of those who are disabled because they lack mental capacity than it is of persons with capacity—in other words, if we were to open a gap so that persons who lacked capacity could be made subject to procedures that they would not necessarily experience if they had capacity—we would have a problem, in terms of both disability legislation and the European convention, with discrimination issues. We must not get into that position.
I gave the Minister formal notice that I wanted to raise the matter that my third point addresses. I have not researched this as much as I should, but I am anxious that any regime we adopt be congruent with the Human Tissue Bill, which is being considered in another place. Above all, we cannot have a situation in which living persons who lack mental capacity, albeit they have a decision maker on their behalf, have to undergo more intrusive procedures than might be permitted on cadavers with the consent of the dead person's family or otherwise. The level of safeguards must be at least equivalent, if not higher.
I want to explain the biggest concern I had when I initially read these clauses. Lot of debates about donor cards have arisen as a result of private Member's legislation introduced by the hon. Member for Oxford, West and Abingdon (Dr. Harris). I carry a donor card; I suspect that many Committee members do, too. It is an advance decision of a kind. Many of us would probably be prepared to acknowledge that having a presumed consent to donation would be very convenient and might be in the best interests of medical research and the availability of organs. However, we are holding back from that on the principle of informed consent. We do not feel that it should be presumed that an adult has given consent simply because they have not not given consent. There is a danger when a person lacks capacity and they are not in a position any longer to make their own decision; nobody should be able to take a decision on their behalf that fails to meet the best interests principle.
I hope I have made clear the sort of groundwork from which I approach this matter and the areas in which I have genuine concerns. They have been mirrored in many of the representations made to us.
Amendment No. 41 is the easiest proposal and the Minister might say that it is redundant, but it would provide that research would be all right if it conformed to an advance decision made while P had capacity to permit the carrying out of research on P. In other words, it would extend the earlier provisions on advance decisions to include research, a principle that is not objectionable. Amendment No. 42 would
leave out subsection (3) and amendment No. 43 subsection (5), both of which relate to clinical trials regulations. Not all of us are expert on the clinical trials regulations specified under the Bill. We do not know exactly how they work, whether the safeguards are similar and whether the principles that I have set out, including the best interests principle, operate in the same way across those regulations. If they do not, there could be a difficulty.
Amendment No. 44 would strike out the alternative test. Under clause 31(4)(a), the research must have the ''potential to benefit P''. The alternative test under clause 31(4)(b) is that the research must provide general knowledge of the subject. I am not caricaturing the provision or suggesting that it is way beyond the pale; it is about people researching into Alzheimer's on an Alzheimer's subject, but it is arguable whether that is in the person's best interests. I wish to bring two other considerations to the Committee's attention, the first of which is urgency.