|Human Tissue Bill
Dr. Murrison: This is a useful discussion. It is important to get such matters on the record by way of exploring the issues, as my hon. Friend the Member for South Cambridgeshire said. Does the Under-Secretary agree that, although the fact that the tragedies at Alder Hey led to the Bill should be a thread running through it, there is a big difference between what went on at Alder Hey and what might go on in an operation, for example, in which material would be regarded by most people as residual, as waste? The two need to be clearly distinguished. Many of the representations made to us have been along the lines of, ''We as academics are not clear that politicians have clearly distinguished the two.''
Dr. Ladyman: I entirely agree that there is a different order of magnitude in the bigger picture, but I put to the hon. Gentleman that those involved in many of the tragedies that have occurred, including Alder Hey, did not think that they were behaving badly. The tragedies occurred because people thought that they were working within the guidelines and, indeed, that what they were doing was for the best. However, it is not acceptable to have benign intentions if one's actions turn out to be malign.
I agree that there is a difference in the order of magnitude between the use of a bit of residual material that was taken for diagnostic purposes anyway, and the retention of organs. I keep that in proportion in my mind, and I am speaking not only as a Member of Parliament but as a scientist who has done such work. There is a difference, but the principle remains the same. If we are to have a Bill based on the firm principle that people must have consented or understood why the material was collected and what it would be used for, that principle must run through the entire legislation—as a golden thread that is not broken at any point.
The amendments would break that golden thread. The hon. Member for South Cambridgeshire introduced them by saying, ''The research community believes that''. That was also implicit in what the hon. Member for Westbury said. In fact, whereas the research community is alive to the
Column Number: 067practical issues and the difference in the order of magnitude between events that happened in the past and what we are talking about now, I believe that, when it discusses the ethics of these principles, it does not disagree with what is in the Bill.
I shall highlight the view of the General Medical Council as an example. Page 12 of its guidance, which is entitled ''Research: the Role and Responsibilities of Doctors'', states:
The General Medical Council believes that the extra material that is collected should not be treated outwith the needs agreed to when consent for its use was given.
Dr. Harris: I do not disagree with the Under-Secretary. Consent must be very clear, and I have come to that conclusion from my work on research ethics committees. However, there is a question over whether the GMC is more representative of the research community than the Medical Research Council, which says in its briefing that the terms, by which it means appropriate consent,
Even if I agree with the Under-Secretary, he still has more persuading to do with what is perhaps the elite body of the medical research community.
Dr. Ladyman: I am not entirely sure I agree with the hon. Gentleman. It is not necessary to trouble the family of the deceased again if initial consent is sought in broad enough terms. If there were some purpose for retaining residual material, it would be necessary to obtain the family's consent only for one or more uses of the material as defined in schedule 1. Thereafter, it would not be necessary to return for more specific consent.
The GMC guidelines are not the only template; the position on consent is also set out in the Department of Health's reference guide and in the British Medical Association's guidelines. The BMA, the GMC and other research groups, including the National Translational Cancer Research Network, have clearly stated that they support the Bill's clarification of the position on consent and that best practice will rest on clear statutory advice.
I entirely understand why the hon. Gentleman has tabled the amendments; it is so that we can debate the matter and clearly state the position on the record. I would be surprised if he wished to pursue them any further. When considering the Bill we must maintain the fundamental principle that people are entitled to consultation about the use of materials, and that scientists—no matter how well meaning, and no matter how difficult it may appear to them to overcome the practicalities of the issue—accept the principle.
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The vast majority of scientists accept and understand why we believe that the best way forward is to create a statutory framework in the Bill and for the Human Tissue Authority to establish best-practice guidelines that can change as ethical and moral positions change and science changes, so that actions can be refined. That is better than trying to spell out everything in detail in the legislation. The right way forward is a statutory framework with a golden thread running through it stating that people have the right to be consulted about the use of material from their own bodies, which is backed up by best-practice guidelines established in co-operation with the professionals.
Dr. Harris: I do not necessarily disagree with the Under-Secretary, but is he satisfied that that will provide the autonomy that people need to be able to decide what sort of research they are prepared their tissue to be used for? Some people may have ethical objections to certain types of research, and he should give some thought to what a consent form should look like if he is relying on generic research to reassure the likes of the MRC.
Dr. Ladyman: The hon. Gentleman is tempting me into trying to write the best-practice guidance. The whole point of what we are trying to do is not to write that guidance, which will follow as a result of the involvement of professionals who will do their best to help to put it together. We are here today because we are trying to rebuild the public's confidence in the collection of material for medical purposes. Many people no longer quite trust clinicians to do what they say that are going to do with material. Many people who will be consulted about the use of material from their loved ones or from their own bodies are unsure about giving the go-ahead in case their child's organs end up in a bottle on a shelf to be used by someone for undisclosed purposes in a year's time. We are trying to rebuild people's confidence in the system, but we will not do so if we undermine the Bill's principle that they should be consulted.
Members of the research community may foresee practical difficulties with consultation, but they must come to terms with the fact that if they want the public's trust and confidence, and if they want to be able to obtain material freely, they must put more effort into ensuring that everyone has the confidence in the system that we want them to have, so that organs and material are freely donated. I should add that best practice is already well defined and that people are working well.
I hope that Opposition Members accept my arguments and that the hon. Member for South Cambridgeshire is prepared to withdraw the amendment.
Mr. Lansley: On the subject of enduring consent, we will have an opportunity to discuss just how effective the consent proceedings for transplantation can be made. From what the Under-Secretary has said, there seems to be no value in trying to intrude a further definition of consent rather than considering at a later stage the issues relating to the organ donor card or the registry. I therefore entirely accept what the Under-Secretary has had to say, and will move on.
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On the subject of residual tissue, the Under-Secretary is right that there is quite a strong acceptance of the principle of consent among members of the research community—certainly those to whom I have spoken. They are, however, very worried about the practicalities, and we will have to try to deal with that worry in the codes of practice. The Under-Secretary is right to say that we are trying to rebuild confidence in the system, but the reason why some of availability of material has been prejudiced is only partly to do with a reduction in relatives' consent. It probably has more to do with the concerns when encountering patients of people in the research community and clinicians about expanded consent procedures and the practical difficulties of obtaining consent, especially for very large numbers of tissue samples.
Again, we must be clear, as must the research community, about what consent means for the purposes of the schedule. It needs to be explained to people that different uses may be made over time of the residual material for education, training and research. They can support future research if they consent to it, but the process must be quick and easy. If it is not, we may have many audits of the sort that I illustrated this morning from reports that were sent to me. As those audits demonstrated, a large proportion of samples may simply not have their boxes ticked, which may severely prejudice their representative nature and the archives that otherwise might be established. That is because clinicians who have contact with patients do not see the point of the process and they have a consent procedure that they regard as excessive.
We have fixed on debating residual tissue because, as previously discussed, we are dealing not with the absence of consent, but with consent to treatment and what that implies. The Under-Secretary is right, in the formal sense, that if one looks at any issue, it always seems unreasonable to say that one has a research purpose or further training or educational opportunity in mind and that consent should not be taken in that instance for such a purpose. It is possible for consent to be taken in any of those instances, and it should be taken, but a problem arises when the aggregate number of required consents so overwhelms the front-line GPs and hospital junior doctors that they simply stop having the conversations. Evidence from the audits is that as many as two thirds of cases are returned without the conversation having taken place. There is no answer to that problem, other than to establish the principle in the legislation and to be aware that there must be scope for sensitivity in the codes of practice.
This is an important discussion, to which we may return, but I do not want to depart from the principle to which the Under-Secretary adhered, as it is the basis on which we have supported the Bill. I want to encourage us to continue to consider precisely how the codes of practice will enable consent to be given in a practical way for the benefit of research. I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
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