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Baroness Neuberger: My Lords, I thank the Minister for his reassurance and clarification. I am not sure that I completely agree with him, but, meanwhile, I shall read Hansard once again and decide whether I need to come back to this matter at a later stage. For now, I beg leave to withdraw the amendment.
The noble Lord said: My Lords, when this matter was debated in Committee, the Minister was reluctant to include in the Bill the phrase "generic and enduring" in relation to "consent", although he gave some welcome reassurance that that was what the Government meant by "consent". However, that is where the problem lies. My fear is that research ethics committees, which will be examining research
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proposals, will be left with the difficulty of interpreting what is meant by "consent" when they already have some difficulties with it.
I can perhaps best illustrate the problem by describing the situation of patients who have biopsies taken for diagnostic purposes or who have tumours or other diseased organs removed. Their consent is sought at the time for research to be performed on the removed parts. It is rare for such consent to be withheld and it is usually presumed by the patients at least that they are giving consent for all types of research to be undertaken then and at any time in the future. Some patients may wish to give limited consent; only for certain types of research and only for a limited time. That is entirely reasonable and acceptable. However, most patients could not care less.
Unfortunately, research ethics committees may not interpret the consent that is given in the same way. Whenever they receive a request for permission to undertake a new piece of research on the same tissue at some future date, even if it differs from the original research only marginally, they may demand that further, new consent is required from the patients. That is likely to be the position that the committees adopt as they lean over backwards towards what they see as being their responsibility. However, obtaining renewed consent at that stage may be quite impossible or, at least, impracticable because patients may have moved or died in the interim or be untraceable. Those who can be traced are likely to be surprised by a renewed request for a consent which they felt they had already given.
There seem to be three arguments against inserting "generic" and "enduring" in the Bill. First, some suggest that it would open up an opportunity for malicious research on tissues against the patient's best interests, However, any new research or even minor changes in the original research for which consent was given requires renewed approval by a research ethics committee. Therefore, considerable safeguards are in place, to say nothing of the duties of confidentiality and the penalties for misbehaviour that are envisaged in the Bill.
Secondly, it is suggested that inserting qualifying adjectives in a Bill closes off different interpretations and reduces flexibility. However, the words "generic" and "enduring" do the opposite of narrowing the definition of consent; they broaden its meaning.
Finally, if it is suggested that it is unnecessary to include those words, the clearer guidance that they would give to ethics committees and the HTA would remove an area of confusion that would continue to bedevil them and the researchers who seek their approval. I beg to move.
Baroness Finlay of Llandaff: My Lords, I support the amendment to which I have added my name. Perhaps I may remind the House that the Minister helpfully said in Committee that where a patient has
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given clear consent for the use of tissue for research purposes, that consent would be continuing and generic and would endure. That is so important that it should be stated in the Bill. It would ensure that case series could be studied; that genetics research could proceed unimpeded by the need to try to trace everyone every time; that clinicians and staff, particularly those with continuing professional education, could carry on with their understanding of research; and importantly, that patients who wished to contribute to the common good could do so without being pestered by requests for different consents on their surgically excised tumour or blood sample. It would also ensure that all healthcare organisations had in place straightforward and failsafe procedures to ensure that, when such consent is not given, the specimen would be discarded after the diagnostic process and the patient knew that he would not be contacted again even if some new information came to light. That is patient choice.
If a patient has given general and enduring consent and then changes his mind, he simply goes back to inform the trust, which has to act. The Minister's letter helpfully clarified some of those matters, but we suggest that the amendment would preserve patient choice and prevent patients and healthcare researchers being burdened with cumbersome re-consenting processes which would simply be time-consuming and maybe burdensome to a patient who says, "I just want to be rid of this tumour. You can do what you like with it. I want it to be used for the common good. I never want to hear about it or be reminded of it again". The amendment would make it clear that the Bill allows patients to do that, but it would also make it clear that if a patient did not wish to consent, the trust must take appropriate action.
Baroness Hayman: My Lords, I have been in the Minister's situation and therefore I know the arguments that are rehearsed against adding to the Bill adjectives of the kind suggested by the amendment of my noble friend Lord Turnberg. However, there are two good arguments for so doing in this case.
As has been said by other noble Lords, the effect of the Bill as it stands is that consent would be generic and enduring. The Minister made that absolutely and helpfully clear in Grand Committee. The difficult question we now face is whether we think that that being recorded in Hansard will be sufficient to obviate the problems not only for research ethics committees, as were outlined by my noble friend, but also, I would suggest, for patients. There is an advantage in patients understanding that giving a single consent relates not only to a small piece of researchperhaps on breast cancer if they have had a breast tumour removedbut could have different applications in future, having been stored in a tissue bank.
Including these words in the Bill would simplify and clarify the situation without acting as a deterrent and requiring people to return on several occasions to give
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different consent. It would also help the research community and make the nature of the consent more transparent to patients.
Baroness O'Neill of Bengarve: My Lords, I understand the Minister's reservation about adjectivesoften they are not helpfulbut we are not operating in a vacuum. We are operating in an area in which a number of international conventions or agreements are highly relevant to prospective research. Where specific consent is sought, for example, for a clinical trial which may put people at risk, they must consent to particular intervention.
Here we are discussing retrospective research. The tissue has already been removed and the question is whether the patient shall be bothered again and again for specific consent. At an earlier stage in another place, a misleading degree of emphasis was put on specific consent. I am pleased that the understanding now is that that adjective is not intended and I hope that we can make that clear on the face of the Bill.
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