|Previous Section||Back to Table of Contents||Lords Hansard Home Page|
Baroness Neuberger: My Lords, I am grateful to the Minister for his assurance that the legislation has no intention of damaging education and training for research. However, unless he is prepared to accept at least the spirit, if not necessarily the letter, of some of the amendments, many of us around the Houseas we have heard in the course of debatewill have real concerns that nevertheless education and training for research will be seriously compromised. For that reason, I remain convinced that we need to press hard on the amendments.
I assure the Minister that many of us in this HouseI would argue probably all of usare as concerned as he is and as the Government are that the whole area of research should be consent based. I declare an interest as I was formerly a member of the GMC and chaired the consent working group for that body. I was also formerly a member of the Medical Research Council and the BMA's ethics committee. I am as concerned as the Minister is that everything should be consent based. But I believe that he mistakes the issue with regard to ordinary education and training in a clinical setting, when people cross over in their techniques in between looking at what happens in terms of human health and what happens in terms of training people, as to what they might do were they to conduct a research project at a later date.
25 Oct 2004 : Column 1078
This legislation, as it stands, does not allow us to deal with that matter. It will certainly concern a large number of researchers and clinical instructors who will worry that they might be about to commit a criminal offence. Of course the public values education and training for research. As the noble Baroness, Lady Hayman, so powerfully put it, the issue is not as easy as saying that one lot is research and one lot education and training for human health. The public values what researchers do, as we know from the support that it gives to the various medical and health research charities.
The Minister has not convinced me or, I believe, many of the other noble Lords who have put their names either to this amendment or to the others. We have listened to arguments around the House from people who are themselves clinicians with experience, people from the voluntary sector and patient advocates. I am sorry that he has not accepted the spirit of these amendments and I would now like to test the opinion of the House.
"( ) Nothing in subsection 9(b) shall prevent a person, for the purpose of carrying out or facilitating research as referred to in subsections (7) and (8), from taking such action in relation to relevant material as may be necessary to ensure that the person from whose body the material has come may not be identified."
The noble Earl said: My Lords, there is concern in certain quarters of the scientific research community that the wording of the Bill as it stands would have an unintended and regrettable consequence. Clause 1(9) sets out the conditions under which research using tissue from living donors may be carried out without consent. The second of those conditions is, to paraphrase subsection (9)(b), that the tissue must be anonymised so that the researcher does not know, and is not likely to find out, whose tissue it is.
The unintended consequence that I mentioned is that under the Bill the process of anonymisation itself would be rendered illegal; that is the concern. To anonymise a piece of human tissue involves starting off with material that has identifiers attached to itthe name of the person, hospital number and so onand then converting it into material which does not have identifiers on it. The name and other identifiers are removed and replaced with a code to which the researcher does not have access. This is what is normally referred to as "linked anonymisation". Where that process takes place for the purposes of obtaining samples for research, the fear is that it would be caught by Clause 1(9).
There are analogies here with the processing of information as regulated under the Data Protection Act and the Health and Social Care Act. Under the latter Act researchers are required to apply to the Patient Information Advisory Group before anonymising data sets. However, unlike the processing of information, slides and blood samples cannot easily be de-identified outside the laboratory setting where
25 Oct 2004 : Column 1081
appropriate facilities for refrigeration of samples are available. For the small-scale research project, the only staff who may be able to undertake that will be those supervised by or under the authority of the person carrying out the research. For the purposes of the clause, the "person carrying it out" surely must mean all members of a research team involved in a particular project.
The practical ways of getting round the problem are all fairly burdensome. One could employ an independent agent off-site, but that poses obvious logistical difficulties. One could set up Chinese walls in the laboratory and appoint someone to carry out the process of de-identification who is not involved in the research in question. However, in a small laboratory there may not be enough people to enable that separation of functions to take place. One could have a system whereby the name of the patient was removed but another kind of patient identifier was retained. Even that would mean that case-series analysis would be unlawful without consent.
How does the Bill as worded not create an impossible trap for those researchers working in a small laboratory who discover that the requirement to anonymise tissue samples prevents them, in practice, carrying out research projects? I beg to move.
|Next Section||Back to Table of Contents||Lords Hansard Home Page|