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Schedule 1
Ms Rosie Winterton: I beg to move, That this House agrees with the Lords in the said amendment.
Madam Deputy Speaker: With this we may discuss Lords amendments Nos. 57, 60 and 61.
Ms Winterton: On several occasions, arguments have been advanced to the Government, from both within and outside the House, suggesting that the Bill as drafted would have an adverse impact on the training of doctors and researchers. The difficulty related to the question of whether consent should be needed for the storage and use in training related to research of residual tissue samples following diagnostic or clinical procedures. We have listened long and hard to all the points that were made and recognised that there is some force behind the arguments.
Following debate in the other place, several Opposition amendments were passed to clause 1, schedule 1 and schedule 5. Those all had the intention of allowing use of residual tissue for research education and training without any consent, or with certain safeguards. Taken together, however, those amendments would have been unworkable. Therefore, we tabled Lords amendments Nos. 57, 60 and 61, which, when taken with Lords amendment No. 56, achieve a similar but more consistent and clear effect.
The amendments remove education and training in research techniques from part 1 of schedule 1, allowing that purpose to be subsumed within education and training in human health, so that it will be lawful to store and to use tissue from the living for both those purposes without consent under part 2 of schedule 1. Amendments to schedule 5 will similarly allow DNA analysis for education and training in research techniques without consent.
We chose that route to allow education and training in research techniques without consent, rather than the alternative option proposed in Opposition amendments of tissue anonymisation, for reasons of simplicity and clarity. We initially took the view that the use of residual samples for that purpose was too far removed from the original reason for taking the sample—for diagnosis or treatment—for the material to be used without consent. Unlike training in clinical and diagnostic procedures, training in research techniques is not part of what patients would ordinarily regard as part of the package of receiving treatment. That is why we felt that consent would be needed or, as a minimum, some other protection, such as anonymisation.
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We heard many arguments relating to the potential difficulty of distinguishing between education and training in research and that required for clinical practice, because the processes themselves are often the same. Moreover, we recognise that the training of doctors must include research training, and training activities will often include both clinical and research trainees. We therefore considered it best to save further confusion by aligning the two—clinical and research training—under the general heading of "Education or training relating to human health" in paragraph 9 of schedule 1.
Dr. Evan Harris: Can the Minister confirm that even though the Bill no longer specifies that education or training relating to research should be considered as education or training relating to human health, rather than research, it is her expectation that it should be understood to be so considered by those operating within the Act, and indeed by the courts in the event of any challenge?
Ms Winterton: Yes, I can certainly confirm that.
I must emphasise one point: this will not provide a back door to the use in research of tissue without consent. For example, this will not permit people to undertake such research without consent simply by involving a research trainee. That is not the idea at all.
Training and education in research techniques are clearly distinct from carrying out research. Research is concerned with creating new knowledge by addressing clearly defined questions with systematic and rigorous methods. Training, on the other hand, is more about showing medical students or technical trainees how to use equipment or about showing them research methods. So research, and training and education in relation to research, are distinct activities.
Dr. Murrison: Can the Minister confirm that a research ethics committee would clearly be bound by the Act, so no confusion is possible between research and treatment activities?
Ms Winterton: Yes, I can certainly confirm that.
While storing and using tissue for training purposes will now fall under part 2 of schedule 1, and may be done without consent, storing and using tissue for research itself will remain under part 1 of the schedule, requiring consent or, alternatively, anonymisation and, as the hon. Gentleman said, ethical approval for the project concerned, whether or not a research trainee is taking part. Of course, a trainee will often observe properly approved research, but that does not make it a training activity.
We can imagine a situation in which a research project is being carried out and a research trainee is also being taught. The researcher is examining tissue for the project and then demonstrating the technique to the trainee. Clearly, both activities—each for a different purpose—are taking place: one is research, the other is training. The training purpose does not require consent, but the research purpose still requires consent or REC approval with anonymisation. Satisfying the requirements for one activity does not obviate the need to satisfy the requirements for the other.
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We have listened very carefully to the debate on this issue and I believe that we have come up with a solution that is pragmatic, in that it enables appropriate training to take place without undue restrictions, while ensuring that the door is not opened to research being conducted without proper approval. I hope that Members will welcome these amendments, which fully meet the concerns expressed in previous debates in this House and in the other place. I urge Members to accept them.
Dr. Murrison: Along with the amendments relating to clause 7, Lords amendment No. 56 is probably the most crucial that we have considered today. It is fairly straightforward, in that it removes from schedule 1 the reference to
In so doing, it addresses many of the concerns expressed to us by the research community. I know that it must have been very difficult for the Minister to allow this amendment. The Bill is about consent, and the amendment rows back slightly from that; however, in our view it is a pragmatic solution that should allow the research community to proceed relatively unhindered with the important work that it does on our behalf, while retaining the Bill's original purpose. So to that extent, we of course welcome the amendment.
Residual tissue was a hotly contested issue in Committee and the general public have a clear view on the difference between the handling of organs from a corpse for such purposes and residual tissue taken from operations—in other words, tissue taken from somebody who is alive. Emotionally, the two are profoundly different, and we have finally managed to get a Bill that adequately reflects that difference. Of course, several months ago that was not the case. The two were closely allied, even though the popular perception and feeling was that they were quite different. The original Bill was out of line with popular sentiment in that regard, and given that it stemmed from the Kennedy, Redfern and Isaacs inquiry, I found that rather surprising. But we got there eventually, although it has been a hard slog. Given that the Bill is not partisan but very technical, it is a great pity that it was not subjected to pre-legislative scrutiny. The issues that this amendment and others have dealt with could have been sorted out by discussing them with the relevant expert organisations, but we will simply have to live with that in the months and years ahead.
We can all think of problematic situations—they have been described to us at great length—in which this amendment will help. We can perhaps envisage the law being broken every day in every medical school throughout the country, with one side of a lecture theatre learning how to treat patients and the other learning about research techniques, fundamentally the same instruction being given and the poor lecturer in the middle, trying to wade his way through the legislation to make sure that he is steering a proper course and not transgressing the law in any way. This problem is particularly relevant to cytology. Noble Lords discussed cytology in another place in defence of their amendments, the substance of which was eventually accepted by Ministers. We clearly need to train people in histopathology and cytology, which involve staining. Many stains are used in the course of therapeutics, but many others are research tools. Both can now be dealt
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with at the same time during the instruction of those who are learning how to treat patients and those who are learning research techniques.
It would make no sense at all to retain the Bill as originally drafted, as it would cause major disruption to medical schools. I believe that the amendments help to get around most of the problems. To that extent, they are extremely welcome and I am very pleased to see them. I am just sorry that we could not have reached this point sooner.
The downside, of course, has been an element of confusion in the minds of many who work in this field—pathologists, researchers, people in the NHS and in research generally—and they may be left wondering what is going on. I very much hope that any such confusion will be short-lived and that they will be able to get on with their work in the certain knowledge that they will not be transgressing when they carry out activities that most of us would regard, in a common sense way, as perfectly reasonable.
I share the Minister's hope that the amendment will not prove to be a back door to research without consent. I come back to the original tenet of the Bill, stemming from the tragedies at Alder Hey and the Bristol royal infirmary, that consent must be at the heart of everything that we do. I hope that neither this amendment nor any others will degrade or detract from that original intention. Indeed, I am sure that they will not.
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