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Ms Rosie Winterton: I beg to move amendment No. 108, in page 2, line 32, at end insert—
'(6A) Subsection (1)(d) does not apply to the storage of relevant material for use for the purpose of research in connection with disorders, or the functioning, of the human body if—
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(a) the material has come from the body of a living person, and
(b) the research falls within subsection (6C).
(6B) Subsection (1)(f) does not apply to the use of relevant material for the purpose of research in connection with disorders, or the functioning, of the human body if—
(a) the material has come from the body of a living person, and
(b) the research falls within subsection (6C).
(6C) Research falls within this subsection if—
(a) it is ethically approved in accordance with regulations made by the Secretary of State, and
(b) it is to be, or is, carried out in circumstances such that the person carrying it out is not in possession, and not likely to come into possession, of information from which the person from whose body the material has come can be identified.'.
Madam Deputy Speaker: With this it will be convenient to discuss the following:
Government amendments Nos. 109, 67, 19, 20, 110 to 112, 21.
Amendment No. 17, in page 36, line 8 [schedule 1], after 'training', insert
'to which paragraph 13 does not apply'.
Amendment No. 15, in page 36, line 20, after 'Research', insert
'to which paragraph 13 does not apply'.
Government amendments Nos. 22, 23, 68.
Amendment No. 18, in page 36, line 28, at end insert—
'13 Education, training or research with local research ethical committee approval, carried out using relevant material not otherwise needed after completion of treatment or investigation for which the patient's consent was obtained in writing or by tacit consent for the removal of the sample of relevant material.'.
Government amendments Nos. 69, 24, 70, 113.
Ms Winterton: These three sets of amendments are grouped together because they deal with the use of so-called residual or remnant tissue—that is, tissue removed lawfully from living patients in the course of diagnosis or surgical intervention.
I shall speak first to Government amendments Nos. 108 to 113, which deal with research use of residual tissue.We discussed the matter extensively in Committee. Following the Committee stage, the Government received many direct representations from academic researchers. Hon. Members may also have noticed that there was a campaign in the news media by the same stakeholders. The research community said that obtaining consent to use tissue removed for medical treatment and diagnosis from living patients—so-called residual or remnant tissue—would be so onerous and costly that it would stifle research. I met a number of the stakeholders from the research and academic communities and have considered various options for dealing with the matter.
The Government are clear that they do not wish to impose excessive burdens on those who process the many diagnostic and clinical samples of blood, urine
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and tissue taken in the NHS. Obtaining consent in relation to all such samples to make them available for research would be a disproportionate burden. However, there is a need to maintain scrutiny and control over the research use to which such samples are put. We therefore propose to amend the Bill to allow research using material from living patients to go ahead without consent, but with safeguards.
The first safeguard will be that the research must be ethically approved in accordance with regulations made by the Secretary of State, which we expect will provide for approval by a research ethics committee. The second safeguard is that the researcher must not possess information as to the identity of the person from whom the tissue came; in other words, the research must be anonymised. We believe that these safeguards will maintain the essential principles of the Bill and provide appropriate controls, while allowing medical researchers the access to human tissue that they need.
Dr. Evan Harris: I have raised this issue with the Minister before: does she propose that the anonymisation should be irreversible—in other words, that someone could never find out who the tissue belonged to—or does she propose that a third party, but not the researcher, could if necessary find out where the sample came from? In what circumstances does she believe that the anonymity could be broken, if it could be?
Ms Winterton: Anonymisation does not mean that the patient and the tissue would be permanently unlinked. Further information could be sought from the records, but the researcher should not get identifying information, and the ethics committees would be able to consider what arrangements were appropriate in each case.
Dr. Harris: I understand that point and I am satisfied about it. Further information could be obtained, but not identifying information. But what about the circumstance in which something that might be of interest to the person concerned or to their benefit is found in the research, or perhaps something is found that is prognostically significant but to their disbenefit? Would that information be able to flow back, and if so, is that true anonymisation? Should there be consent for that? Some people may not want to know, and if they are never asked for consent to the use of their anonymised tissue, they may be burdened with information that they never wanted to have.
Ms Winterton: That is an issue that I would expect the research ethics committee to consider before any research started. It is likely that the research ethics committee would say that in order to be able to use any information that came from the research, consent would have to be sought from the individual. Research ethics committees would have to consider the matter when granting permission for research in the first place.
I shall now move on to the set of amendments dealing with the use of residual tissue for medical education and training. In Committee the Government were made aware of similar concerns about the provisions on
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consent to the use of residual human tissue for education and training. The Bill as drafted provides that the use of tissue from living patients for on-the-job training in pathology laboratories, for example, should not require consent, as it is considered part and parcel of the diagnostic and care process. However, use of tissue from living patients for education in more formal settings does require consent.
In Committee hon. Members raised the issue of the practical difficulty for teachers of distinguishing between those two types of education and training. That led us to reconsider the issue. In the second set of amendments we now propose to allow all education and training using tissue from living patients that relates to human health and to disorders and functioning of the human body to be carried out without consent. That means that references to education and training would be moved from part 1 to part 2 of schedule 1. Consequential amendments relate to clause 8 and schedule 5.
Use of residual human tissue for education and training in research techniques, which is a more easily distinguished topic, will remain subject to consent. Members of the academic, teaching and research communities have indicated that they are satisfied that this approach will allow them access to the tissue that they need for research and education.
Dr. Harris: Perhaps I have not understood the architecture of the Bill, as amended. If the education and training in research techniques were done on anonymised tissue, subject to the approval of a research ethics committee, would it be exempt from the requirement for consent, as the research is, or does the wording mean that while doing the research on anonymised tissue, one could not teach post-doctoral or postgraduate students how to do that research, because that would constitute a part 1, schedule 1 purpose?
8 pm
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