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Earl Howe: My Lords, all the amendments in this group fall under the same broad heading but adopt a slightly different approacha dual approach. Amendment No. 1, so ably moved by the noble Baroness, extends the principle of anonymisation in relation to research, in Clause 1(9), to education and training relating to research. But in so doing it exempts such education and training from the need for patients' consent. Amendment No. 67 does the same thing with regard to education and training relating to research using the results of DNA analysis.
Amendments Nos. 6, 8 and 66 adopt a more radical approach, by proposing that all education and training in these areas should be exempt from the consent requirements. Those are two different approaches, which are not necessarily mutually inconsistent. I will come to what I believe that the Government should do.
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I shall not repeat everything that the noble Baroness said, but I will say something about genetics, about which I have been briefed quite extensively. As all of us are aware, genetics is a rapidly advancing science. Because it is advancing so quickly, we frequently find that technological advances are rapidly translated across to service provision. As a result, it is difficultif not impossiblein that field to distinguish between education and training relating to human health and that relating to research. I put that to the Minister as an additional argument from the real world.
As the noble Baroness said, in every other field, the distinction that the Government are trying to draw is well nigh impossible. What, in practice, is the distinction between training someone for diagnostic work and training someone for research work, when the techniques are the same in both? How can one separate those two types of training in a laboratory? It is meaningless to do so but, apparently, the Government believe that one type of training does not require consent and the other does.
The Government have acknowledged the difficulty and pointlessness of trying to draw rigid dividing lines between the definitions in Schedule 1. They are right about that. The same applies here: one simply does not find situations in educational settings in which only researchers are being trained or only clinicians who diagnose and treat patients. The reality of life is that a lot of people are gathered in one place, listening to the same teacher but learning different skills. Someone studying to be a clinical academic doctor will need clinical, research and teaching skills at the same time to do the job. Those things go together and reinforce each other. Why pretend that convenient dividing lines can be drawn between each activity? If tissue can be used without a patient's consent for education and training in diagnostic work, what harm do the Government perceive will be done to that patient by not obtaining his consent to use the same tissue for education and training in research?
Of the two approaches in the amendments, I can see no case for not embracing the second and more radical, to which the noble Lord, Lord Turnberg, has put his name. The arguments are clear-cut. If, however, the Government are willing to move some distance but not all the way, I, for one, would be willing to compromise by settling for Amendments Nos. 1 and 67 and thus avoid a Division. The practical effect of those amendments, even if it is not the legal effect, would be that any human tissue from living donors used for education and training of any kind would need to be anonymised. If the Minister is willing to compromise on that basis, the House should swallow hard and not pursue the more radical option.
Baroness Finlay of Llandaff: My Lords, I shall not repeat the arguments made so well by the noble Lords who have spoken, but, having put my name to the amendments, I must emphasise that it is important for everyone to understand that today's research technique is tomorrow's routine practice. Without good training in research and research techniques, the
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clinicians of tomorrow will be far less effective. They will not understand the fundamentals of the practice that they will enact.
We are not talking about taking new or additional specimens; we are talking about using redundant tissue that would otherwise be discarded to allow training in research techniques. That comes down to things such as fixation techniques, staining techniques and refining the ability of clinicians, who can then link their research expertise directly to the clinical scenario. They will probably use such techniques as routine throughout their career and will also have an understanding on which to make further advances in techniques.
It is also the beginning of quality control. The Government have recognised the importance of quality control but, unless we improve the way in which we do things, we will not have better quality in the long term. The quality control of today will, in five years' time, seem ridiculously outdated. We must be able to develop more refined techniques that are more cost-effective and have greater accuracy, so that we decrease false negatives and false positives in results. The development of such techniques comes under the category of research.
It is important to remind the House that all those in higher specialist training are required to have some time in research, the reason being that there has been much evidence over the years that clinicians who are not trained in research techniques are, in the long term, less effective than those who have had adequate training. It is now a statutory part of their training. It is against that background that I strongly support all the amendments.
Lord Jenkin of Roding: My Lords, like my noble friend Lord Howe, I have had a good deal of helpful briefing. I am impressed by the wide range of the organisations that have taken the view that a wholly artificial distinction has been written into the Bill. They include the Academy of Medical Sciences and the Association of Medical Research Charities, which includes such important bodies as the Wellcome Foundation, Cancer Research UK, the Medical Research Council and various others.
I was particularly impressed by a note that I received from the Council of Heads of Medical Schools. It made some strong points, and I shall refer briefly to them. The council simply said that it was impossible, in practice, to separate training for research from training for diagnosis. The council considers the matter from the point of view of the role of the pathologist. Anyone who has watched any of the recent television programmes will appreciate how enormously important pathology is in developing research and training, as well as in chasing murderers.
Pathology is the hidden science at the heart of modern medicine. It is vital to the diagnosis and clinical management of disease. Pathologists are central to the delivery of quality clinical care in the
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NHS, and their work underlies much of the work that must be done subsequently by surgeons and other specialists.
"It is part of every doctor's role to advance medical knowledge through research and this is especially true in pathology. The techniques which pathologists use in the diagnosis of disease are also those which are used in research, and consequently it is simply not possible to make a distinction between training for research and training for diagnosis".
The council gave me some examples. I shall not weary the House with them this afternoon, as I am not sure that I understand them entirely. It took the example of cancer treatments. The work that is done to decide the appropriate treatment for a patient's cancer and the work that is done to enable research to go forward into the appropriate treatment for a patient's cancer is, the council says, indivisible. That is why it argues, as I argue, that there is a wholly artificial distinction in the Bill.
When most of the major medical research bodies, including the Medical Research Council, a public body, join forces to say that the Government have got it wrong, the House should take note. Reluctantly, I would go along with my noble friend's suggested compromise. I would like to go the whole way and say that the distinction drawn in the Bill and in the first schedule is quite unrealistic and cannot be sustained, but I will listen to what the Minister has to say.
In Grand Committee, when we had heard the Minister advance his arguments for making this distinction no less than three times, his argument was absolutely no more convincing the third time than it had been on either of the other two. He may do better today but, somehow, I doubt it.
Lord Turnberg: My Lords, in speaking to these amendments, I shall speak also to Amendment No. 8. I am sorry to return to the matter of education and training and to add to the burden of my noble friend the Minister on this issue. But I do so only because this is such a vital issue. I speak here from the point of view not so much of researchers but of the rest of us, whose future health is so dependent on good research being carried out but which is threatened by this part of the Bill.
I declare my interests as vice-president of the Academy of Medical Sciences and, perhaps more importantly, as adviser to the Association of Medical Research Charities whose member charities are largely made up of patients and their carers and cover a wide range of disease categories. I shall not repeat the arguments so ably made by others in Grand Committee and today. But I want to make one of two points that I hope might persuade my noble friend.
I can best illustrate the problem by describing the case of a young pathologist in training being taught how to distinguish various diseases by examining small sections under the microscope and going on to reach a diagnosis. They will also need to train in research techniquesfor example, new types of tissue stains or
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tests that will enhance the understanding of diseasewhich they are likely to use in their future career. Those novel research techniques are all part of the training for a forward-looking pathologist who will be expected to have an active, inquiring future.
We really cannot afford to have pathologists who will be stuck in the time warp of today's technologies for the next 30 or more years. They must be capable of understanding and applying new research to their future work, to say nothing of those who want to go on to an academic career.
That type of training in research techniques will not necessarily be of direct relevance to the patients with whom they are dealingeven though, inevitably, pathologists in training will know who they are or, more importantly, who they werebecause they may be untraceable for one reason or another. For that reason, pathologists in training are very likely to know the identity of the patients from whom tissue has been taken. After all, they have been making the diagnoses.
It is because of that that I have some difficulty with parts of Amendments Nos. 1 and 67 where it is suggested that research trainees should not know the identity of the patients. I fear that that will not be practicable in the circumstances that I have described.
It has been suggested that a line has to be drawn somewhere between research and education and that if training in research is allowable without consent as other training is, that will open the door to others who may want to do research without consent. But that cannot be so. Nowadays, no clinical research can be carried out without ethics committee approval. One cannot get a research grant or publish the results without ethics committee approval. Ethics committees are unlikely to give approval for research without consent or anonymisation.
So the distinction between research and training for research is much clearer than that between training for research and training for professional purposes. I do not accept that that would open this door, but it would remove a high hurdle placed in the way of a pathologist in traininga confused pathologist in training. The effect of such confusion is that he or she would be discouraged from training in pathology at a time when we are desperately short of pathologists and, equally importantly, will inhibit anyone from entering an academic career when we are losing just these academic clinicians we need to take forward the Government's strategy on research and development.
We have more than enough reasons to be worried about the fall in numbers of young doctors willing to enter academic careers without adding an additional unnecessary burden. If it is said, "Oh yes, but we have to protect patients' rights", I agree with that. It is vital that we do so. But I fail to see how putting all education and training, which everyone agrees is essential, into Part 2 of this schedule will in any way conflict with that principle. It just does not make sense.
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I hope that I can persuade my noble friend to take this away and consider it further. I know that he has earned admiration and respect for his support for the needs of clinical research. I hope that he will continue to respond to those needs.
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