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"(1A) If the Authority is satisfied
(a) that relevant material has come from the body of a living person,
(b) that it is desirable in the interests of another person (including a future person) that the material be used for the purpose of obtaining scientific or medical information about the person from whose body the material has come ("the donor"),
(c) that reasonable efforts have been made to get the donor to decide whether to consent to the use of the material for that purpose,
(d) that there is no reason to believe
(i) that the donor has died,
(ii) that a decision of the donor to refuse to consent to the use of the material for that purpose is in force, or
(iii) that the donor lacks capacity to consent to the use of the material for that purpose, and
(e) that the donor has been given notice of the application for the exercise of the power conferred by this subsection,
it may direct that subsection (2) apply to the material for the benefit of the other person."
I have already warmly welcomed the changes made to subsection (1) and the fact that the Government have reconsidered the question of whether the HTA, rather than the High Court, should be the point of referral in cases in which there is a need to use tissue from living donors for the benefit of another person but the donor cannot be traced. With these amendments, we seek to persuade the Government that they should take the process one stage further to what I believe is a logical conclusion.
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If I were to sum up what the Bill says about research on tissue, it would be, "Obtain consent. If you can't obtain consent and the tissue is from a living person, anonymise. If you can't do either of those things, go to the High Court under the provisions of Clause 7(3)". That is a simplified analysis but, I hope, a correct one. The issue in contention is whether, instead of the High Court, the Human Tissue Authority would act as an equally appropriate and capable gatekeeper on research proposals if consent is impossible or, for one reason or another, it is not feasible to anonymise.
I urge the Minister to think again about that. A few minutes ago, I said that since Grand Committee I had changed my mind on the matter of whether it should be the High Court or the Human Tissue Authority. The Minister, who has also changed her mind, gave very convincing reasons why. I have done so for a number of reasons, one being that I have been convinced that the need to use this mechanism will not be rare. If we look at the experience of the Patient Information Advisory Group, in a typical 12-month periodJune 2002-03applications for research where consent could not be obtained or conducted anonymously numbered some 58.
We can imagine severalI suggest quite probablescenarios. The first is where consent has been obtained from a patient, but it is unclear whether the consent is sufficiently broad to cover the research in question. Another scenario might be where it is unclear whether consent has been obtained, say, because of a failure in record keeping. We can imagine a situation where a patient has died of a rare condition without either giving or withholding consent and has no friends or relatives who might consent on his or her behalf; or, let us suppose, a patient with a rare condition cannot be traced but the inclusion of his or her tissue in a research project is of importance to the development of treatments for that condition and it is impossible to anonymise the tissue because the patient is known to all of the researchers working in the particular field. It might happen that a piece of research is well under way and is being done on anonymised samples. During the course of the research, say, the principal investigator discovers that he recognises some of the tissue samples as belonging to former patients of his. It is impossible to locate those individuals in order to obtain consent, but the research cannot continue without further authority. There may well be justification for allowing the research to continue if the risks to the individual are judged by a suitable third party to be minimal and that confidentiality is assured and the benefits of completing the research are potentially very high.
Against that background, I question whether the High Court is the most appropriate mechanism to deal with those types of application. The burden of going to the High Court seems excessive and unsuitable for that type of application and likely to deter researchers from undertaking research. Even if the applicant does not need to go to a court, he or she will no doubt need legal representation to make an application and, almost certainly, the support of expert evidenceall of which
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researchers in the academic and public sector are ill-placed to afford. The High Court mechanism will also, by its nature, have a considerable deterrent effect.
I do not believe that the Government have produced a good argument to show why those matters are necessarily best decided by judges rather than by a body of individuals with relevant experience and expertise working alongside lay members. Indeed, one has to ask what the Human Tissue Authority is for if it is not to adjudicate this type of case.
I took note of what the noble Baroness said about the previous group of amendments where she rightly pointed out that it might be overly burdensome to insist that the High Court should be the arbiter in those cases. I agree with that.
So, for all those reasons, I hope that the noble Baroness will reconsider the provisions in Clause 7(3). I am aware that they are the provisions that are of most concern to the research and scientific community in the context of this clause, although I am sure that they will be very grateful for the changes that we have made to the earlier part. I beg to move.
Lord Jenkin of Roding: My Lords, I support my noble friend. This subsection would give the Government power to make regulations either for the High Court or for the Human Tissue Authoritywe would prefer the HTA. My point on that is that this is not the final word. When the Government draft their regulations and consult on them, there will be another opportunity, if necessary, to circumscribe the circumstances in which the Human Tissue Authority can give the necessary consent.
As my noble friend has said, if one is setting up a body such as the Human Tissue Authority, it would be desirable that any of these what one might call relatively normal circumstancesthey may be infrequent but they are not wholly exceptionalbe considered by the authority rather than putting everyone to the expense and trouble of taking a case to the High Court.
Baroness Neuberger: My Lords, the noble Earl, Lord Howe, and the noble Lord, Lord Jenkin, have made a very good and persuasive case. In support of this amendment, it is worth saying that it would be proper here for the Human Tissue Authority to make those decisions, precisely as it was when we were discussing Amendment No. 75. It was the proper use of the High Court when we were talking about a case where we were going against the principle. Here, it seems that the Human Tissue Authority ought to be allowed to be the body that makes those decisions. I support the amendment.
Baroness Finlay of Llandaff: My Lords, one very small point in favour of having the Human Tissue Authority is that the stages before a decision is made when there is potentially a dialogue that may go on between those who want to conduct a study and the authority may be extremely informative in ensuring that the research community really understand how
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the Bill is to be implemented. The guidance will also be able to evolve with time as different research techniques and scenarios arise.
I am not saying in any way that the authority would water down the Bill. I think quite the converse: it may be very rigorous. But by having a dialogue with the research community, there will be a much better uniformity of standard and better understanding than trying to have local reinterpretation of a one-off High Court judgment by other researchers who are not quite sure what to do. The advantage of the authority, I hope, is that it will be approachable and able to discuss and provide guidance at a stage that perhaps would remove the need for some formal decision to then be taken.
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