With this it will be convenient to discuss the following:
Amendment No. 93, in
schedule 1, page 37, line 21, at end insert
'other than such research conducted using residual tissue'.
Amendment No. 94, in
schedule 1, page 37, line 26, at end insert 'or using residual tissue'.
Amendment No. 95, in
schedule 1, page 37, line 28, at end add—
'13 Research in connection with disorders, or the functioning, of the human body using residual tissues'.
Amendment No. 86, in
clause 24, page 15, line 20, leave out '(8)' and insert '(8C)'.
Amendment No. 99, in
clause 24, page 15, line 23, at end insert—
'(3A) The Standards required to be laid down by subsection (1) may include provision that the use of residual tissue not normally requiring consent for purposes under part 2 of Schedule 1 may require the approval of an appropriately constituted research ethics committee.'.
Amendment No. 87, in
clause 24, page 16, line 3, at end insert—
'(8A) The standards required to be laid down by subsection (1) shall include provision to secure that consent indicates for which scheduled purposes consent has been obtained.
(8B) The standards required to be laid down by subsection (1) may provide that residual tissue may be retained for scheduled purposes under paragraphs 3, 5 or 7 of Schedule 1 without consent or pursuant to a consent to treatment entered into by the person concerned.
(8C) The standards required to be laid down by subsection (1) may provide that consent for the scheduled purpose of transplantation may be given by means of an enduring consent.'.
Amendment No. 88, in
clause 24, page 16, line 3, at end insert—
'(8D) For the purposes of this Act—
''residual tissue'' means relevant material obtained, in the course of, and consequent upon, a course of diagnosis or treatment, following consent of the person concerned to treatment; and
''enduring consent'' means a consent given by the person concerned which is obtained prior to any treatment and which is not specific to the circumstances of any diagnosis or course of treatment of that person while he is alive, or to the circumstances of his death.'.
Amendment No. 96, in
clause 47, page 29, line 26, at end insert—
'(e) purposes of research in connection with disorders, or the functioning, of the human body using residual tissues.'.
Some of the amendments in the group have slightly different purposes to amendment No. 92, which I will explain. The purpose of amendments Nos. 92, 93, 94 and 95 is to transfer activity using residual tissue in relation to two schedule purposes in part 1, education and training, and research, to part 2. We tabled those four amendments because part 1 deals with education and training other than that conducted using residual tissue, and research other than research conducted using residual tissue; by extension we have added the use of residual tissue to paragraph 10, and we have added a new paragraph 13 to provide that research using residual tissue would not normally require consent.
We want to debate this point because it is clear to many in the medical research and scientific community that, following the tragedies at Alder Hey and Bristol, the issues that have given rise to some of the strongest concerns about the current legislation have arisen in relation to the retention of organs and tissues of those who have died. That is not to say that concern has not been expressed about tissues retained from living persons, but they have tended to be of a lesser nature.
The question that has emerged from the medical research community, which it is proper for us to discuss, is whether, although there are differences between living persons and deceased persons, the balance of the Bill is wrong, in that, as we heard in our debate on the previous group of amendments, so many tissue samples are being, or will be, retained from living persons in the course of treatment that if consent were required it would be excessive and burdensome to the research community.
The amendments are designed to explore that issue in relation to the two purposes of research and education and training—not to the general purposes of part 1. There are safeguards in the amendments, because although consent would not normally be required, amendment No. 86, a technical amendment,
would allow standards laid down to be included in the code of practice. Amendment No. 87, to clause 24, would add a range of standards that need to be laid down, one of which relates to residual tissues. It would require, in proposed new subsection (8B):
''The standards required to be laid down by subsection (1)''—
the standards in the codes of practice of the Human Tissue Authority—
''may provide that residual tissue may be retained for scheduled purposes under paragraphs 3, 5 or 7 of Schedule 1 without consent or pursuant to a consent to treatment entered into by the person concerned.''
Clause 24(3) allows the authority to set out the exceptions to those standards. Amendment No. 99 would provide that the standards will also require that the use of residual tissue, which would not normally require consent, may none the less
''require the approval of an appropriately constituted research ethics committee.''
I shall summarise the structure that we are suggesting. Residual tissue can be used for education, training and research purposes, and for the obtaining of scientific information. Residual tissue is defined in amendment No. 88 as
''relevant material obtained, in the course of, and consequent upon, a course of diagnosis or treatment, following consent of the person concerned to treatment''.
It clearly relates to a living person consenting to treatment. It does not impact on deceased persons, other than where they have died subsequent to that consent. The tissue can be used for specific purposes, but can be used only with the consent of a properly constituted research ethics committee. I think we are getting to the point where we shall at least have a structure—which could be put into legislation—designed to reflect some good practice now.
I would have thought that this sort of use would require the permission of a research ethics committee, and what the hon. Gentleman is doing in amendment No. 99 is saying that ''Standards . . . may include provision'', and those in turn may require the approval of a research ethics committee. If use of this sort of material requires the permission of a research ethics committee—perhaps he would consider circumstances where it would not, and where consent would not be sought, because it was not research envisaged at the outset of the treatment—is that really necessary, and might it actually put in statute a rather weaker provision?
I do not think that the provision would be weaker, because the whole structure of the codes of practice is permissive, in the sense that they allow the Human Tissue Authority to determine what the practice should be. The codes of practice will state that, under some circumstances, the use of residual tissue will require consent, so it would not necessarily follow that the codes of practice would therefore require the approval of a research ethics committee, although that would probably happen under those circumstances as well.
There is a structure here. There is a point of principle here—are we committed to explicit consent as a basis for the use of residual tissues arising from
treatment? The research community is saying that that is a very burdensome requirement. We have to weigh up whether the demands of consent from living persons following treatment are such that we are not willing to consider that there may be a place for residual tissue—with the consent of research ethics committees—being treated as an exception to that principle. It is a question that we need to consider. I am not saying that we should necessarily reach that conclusion, but we should show the research community that we have considered it. I freely confess that there may be technical problems with the amendments, but the issue needs to be thought about—whether residual tissues arising from treatment, particularly if they are small amounts and directly consequent upon that treatment, should be, necessarily, the subject of explicit consent.
That is the first question that I do not want us to lose sight of, but there are others, and amendments Nos. 87 and 88 are not confined to that question. I ask the Committee to think about those two amendments separately. We discussed earlier, on the first group of amendments, the extent to which consent should be taken for specific, scheduled purposes. Amendment No. 87 would introduce a further standard to be laid down in the codes of practice by the Human Tissue Authority, to the effect that provision to secure consent
''should indicate for which scheduled purposes consent has been obtained.''
That is less rigid than putting the structure into the Bill, but clearly directs the Human Tissue Authority towards avoiding generic consent for a range of purposes without spelling out which purposes are intended.
Amendments Nos. 87 and 88 also add a further question—it is merely a question. Can consent for the purpose of transplantation be given by means of ''an enduring consent''? An enduring consent is defined under amendment No. 88 as
''a consent given by the person concerned which is obtained prior to any treatment and which is not specific to the circumstances of any diagnosis or course of treatment of that person while he is alive, or to the circumstances of his death.''
Can we be assured that, if explicit consent is required, consent for the purposes of transplantation will not be dependent on any of the circumstances giving rise to the person's death or any of the treatments or diagnoses that he might have received before his death? Will consent at an early stage, unrelated to subsequent events, be regarded as consent that carries through to the scheduled purpose being implemented after death?
To make it easier for me to respond properly to the hon. Gentleman, will he clarify exactly what he means? It seems that he is describing a donor card signed before a person becomes ill. Such an example is not related to the other provisions, but I might have misunderstood his amendment.
The Under-Secretary is right—it is unrelated to the discussion about the other amendments. Amendment No. 88 is in the group
because it follows on from amendment No. 87, which refers to residual tissue. An organ donor card could be an enduring consent, but we must be clear when we are legislating about a structure of consent and resting on common law consent. The Under-Secretary's understanding is that consent given that is unrelated to subsequent circumstances can be regarded as explicit consent in subsequent circumstances. I think that the hon. Member for Oxford, West and Abingdon has tabled amendments about whether an organ donor card can be regarded as consent for such purposes. My answer is yes, it can and that it can be regarded as enduring consent. However, we must be aware that practice is not as simple as that. Often it is regarded as conditional consent—conditional on the absence of objections from the next of kin.
Is the hon. Gentleman asking whether the carrying of a donor card gives consent for uses of the person's body beyond that necessary for transplantation? If that is not what the hon. Gentleman is getting at, is he suggesting that, if a person's body were used for transplant purposes, some parts of it may also be considered to be residual tissue from that process? I am struggling with why such matters should be referred to in the clause.
I meant neither of those arguments. It might have been unhelpful of me, but I grouped together in one amendment three standards that the code of practice should cover, so the matter rides on the coat tails of residual tissue, but is unrelated to it as an argument. The amendment is not about the use for scheduled purposes other than transplantation. I want make sure that there is a strengthened understanding that there is a form of consent that is not subject to subsequent changes of circumstances, nor, by implication, to being overridden by the objections of others, because the consent was given in an enduring form.
This intriguing group of amendments was moved thoughtfully by the hon. Member for South Cambridgeshire. I hope that he can satisfy me on a couple of issues. Proposed new subsection (8A) in amendment No. 87 is an interesting way in which to deal with the issue that we discussed under the first group of amendments. Before he was pressed by the Under-Secretary to give an example of enduring consent, I thought that he was talking about whether, for example, a consent taken at the time of the taking of cord blood, which is then frozen for a long time, would endure—in other words, there would be no need to return to the patient or the patient's parents for further consent to use that blood for transplantation or, indeed, for the freezing of bone marrow stem cells, which could be stored for a time and not used acutely.
That is what I thought the hon. Gentleman meant. Even if he did not, I should nevertheless like the Under-Secretary, if this is an appropriate time, to say whether the material in question is considered residual tissue—although I notice that the amendment to a certain extent defines residual tissue. Is the hon. Member for South Cambridgeshire saying that,
under the amendment, subsequent advice from the Human Tissue Authority would cause a donor card to constitute enduring consent, and that the next of kin could not countermand that consent?
Technically, no, that is not my argument. We would entrench into the codes of practice the concept of a form of consent that would be unrelated to subsequent changes of circumstance and which would be distinguished from any other kind of explicit consent. Once that strengthened form of consent had been created, the assumption about the views of the family that the hon. Gentleman described might be written into the codes of practice, but not necessarily so.
As we know from the Second Reading debate, that is a contentious issue. However, I am pretty sure that there are amendments to clause 3 that deal with the problem from my perspective, so I shall leave the issue to one side.
I thought that the hon. Gentleman's reference to enduring consent was also an attempt to address conditional consent, whereby, although people have given consent, or their next of kin has given it after death, for their tissue to be used, they want to set conditions on who can receive it. That might be touched on by his question.
The third issue is the one that the hon. Gentleman started with, which is the idea that there need to be standards on the use of residual issue for research purposes. He did not give a ''for instance'', but he might be referring to a group of patients who have had tumours resected: such tissues are often stored for all sorts of reasons, permission for which is usually granted as part of the written consent for the operation. If research is being conducted on those tumours, consent might be sought for work that does not involve anonymisation of the samples, because researchers might want to compare the findings with other characteristics of the patients: for instance, if a certain antibody or antigen is found, one can, on examination of the case records, ask whether it was a factor in the history.
Is the hon. Gentleman suggesting that consent would generally have to be sought if, for example, samples that were patient-identified were to be used for new research conducted years after they had been taken? That is a reasonable question and I hope that the Under-Secretary can clarify the issue. I assume that a research ethics committee would be involved in such work—indeed, one would have to be. If so, I question the need for the extra protection that the hon. Gentleman proposes. Perhaps the understanding is that, for a new research project years later, there would be no need to obtain further consent from those patients, who may not still be alive. That is an interesting area to pursue, since we are dealing with tissue from living sources. Will the Under-Secretary clarify that?
These are not my amendments, but I ask the Under-Secretary to expand on what he believes the role of research ethics committees to be. They are otherwise not mentioned in the Bill; perhaps he regards them as temporary bodies. However, overlaps with research
ethics committees may become relevant as we discuss other elements of the Bill, particularly those referring to the Human Tissue Authority. Early guidance on the role of research ethics committees would be appreciated.
Let me first deal with enduring consent for transplants. I shall deal with the topic briefly because I am sure that we will return to it in detail later. I confirm what I said on Second Reading: that the carrying of a donor card, or other indication of one's views, is an enduring consent to organs being used in transplantation. That consent applies either until it is withdrawn by the person who gave it, or until the consent is put into effect on death.
However, nothing in life is that simple. As my hon. Friend the Minister explained extensively on Second Reading, even if someone has expressed their wishes and clearly consented to their organs being used for transplantation, it is necessary to consult relatives when the organs have to be collected—for example, when screening the donor's recent behaviour to ensure that no diseases have been contracted that may pass to the recipient of an organ. If relatives are not prepared to give that information, it may not be possible to use the organs even though the person has given their consent.
Clinicians involved in such decisions are encouraged to be sensitive to the needs of everybody affected by the tragedy of a death. Therefore, if a close relative is deeply distressed by the idea of organs being used for transplantation, even though the individual had consented, the clinician may not feel it appropriate to use those organs. That said, one's donor card is a clear indication of one's views, and would, under the terms of the Act, be considered an enduring consent for organs to be used for transplantation. Someone would not be able to override that consent on technical grounds or because they wanted to impose their moral position; one's expressed wish would have to be clearly dominant in the minds of clinicians. I hope that we do not need to discuss the issue in further detail now, because we will do so later.
Let me deal with the concept of residual tissue. I understand why people working in laboratories and scientists carrying out diagnostic procedures might regard leftover material as waste and of no value to the person who donated it, and why they might therefore believe that they are entitled to impose their view of what it is used for ahead of what might be the view of the individual who provided the material. However, to do that would be fundamentally wrong and against the principles of the Bill. The principles of the Bill are that we all own our bodies, we are entitled to determine how material from our bodies is used, and we should have consented to the use made of that material. If we consented to the use of material from our bodies for diagnostic purposes, it should be used for those purposes, and it should not be assumed that the bit that is left over may be used for any other purpose.
That requires people to be careful when seeking consent for the use of material. If we think that residual material, as it is called in the amendments, may be used for purposes other than diagnostic procedures, it is necessary to consult the person
providing the material and to ask them to consent to its use for that purpose. What that means should be explained to the person.
Depending on the type of material, how much material is involved and the likelihood of its being used, the giving of consent may need to be a more detailed process or may be a fairly routine, simple process. A line may simply have to be added to the form that people have to sign to consent to the diagnostic procedure, saying, ''I also consent to any residual material being used for research or education purposes.'' So long as people know that that line is there when they sign the form and they understand what it means, that is perfectly acceptable, but the principle must be that they will know and be consulted. The fact that a bit too much material has been taken by accident is not an excuse for not seeking consent in the first place, and this group of amendments would fly in the face of that principle.
This is a useful discussion. It is important to get such matters on the record by way of exploring the issues, as my hon. Friend the Member for South Cambridgeshire said. Does the Under-Secretary agree that, although the fact that the tragedies at Alder Hey led to the Bill should be a thread running through it, there is a big difference between what went on at Alder Hey and what might go on in an operation, for example, in which material would be regarded by most people as residual, as waste? The two need to be clearly distinguished. Many of the representations made to us have been along the lines of, ''We as academics are not clear that politicians have clearly distinguished the two.''
I entirely agree that there is a different order of magnitude in the bigger picture, but I put to the hon. Gentleman that those involved in many of the tragedies that have occurred, including Alder Hey, did not think that they were behaving badly. The tragedies occurred because people thought that they were working within the guidelines and, indeed, that what they were doing was for the best. However, it is not acceptable to have benign intentions if one's actions turn out to be malign.
I agree that there is a difference in the order of magnitude between the use of a bit of residual material that was taken for diagnostic purposes anyway, and the retention of organs. I keep that in proportion in my mind, and I am speaking not only as a Member of Parliament but as a scientist who has done such work. There is a difference, but the principle remains the same. If we are to have a Bill based on the firm principle that people must have consented or understood why the material was collected and what it would be used for, that principle must run through the entire legislation—as a golden thread that is not broken at any point.
The amendments would break that golden thread. The hon. Member for South Cambridgeshire introduced them by saying, ''The research community believes that''. That was also implicit in what the hon. Member for Westbury said. In fact, whereas the research community is alive to the
practical issues and the difference in the order of magnitude between events that happened in the past and what we are talking about now, I believe that, when it discusses the ethics of these principles, it does not disagree with what is in the Bill.
I shall highlight the view of the General Medical Council as an example. Page 12 of its guidance, which is entitled ''Research: the Role and Responsibilities of Doctors'', states:
''Samples of body fluids, tissues and organs can form a valuable archive for research purposes. You must obtain appropriate consent or authorisation before taking or retaining organs, tissues or body fluids, from patients or volunteers, for research purposes. This applies whether the material is obtained solely for research purposes or retained following a clinical or surgical treatment.''
The General Medical Council believes that the extra material that is collected should not be treated outwith the needs agreed to when consent for its use was given.
I do not disagree with the Under-Secretary. Consent must be very clear, and I have come to that conclusion from my work on research ethics committees. However, there is a question over whether the GMC is more representative of the research community than the Medical Research Council, which says in its briefing that the terms, by which it means appropriate consent,
''should be sufficiently broad to allow for use of tissue for new and unforeseen projects, with ethical approval, without having to trouble patients or relatives again for further consent.''
Even if I agree with the Under-Secretary, he still has more persuading to do with what is perhaps the elite body of the medical research community.
I am not entirely sure I agree with the hon. Gentleman. It is not necessary to trouble the family of the deceased again if initial consent is sought in broad enough terms. If there were some purpose for retaining residual material, it would be necessary to obtain the family's consent only for one or more uses of the material as defined in schedule 1. Thereafter, it would not be necessary to return for more specific consent.
The GMC guidelines are not the only template; the position on consent is also set out in the Department of Health's reference guide and in the British Medical Association's guidelines. The BMA, the GMC and other research groups, including the National Translational Cancer Research Network, have clearly stated that they support the Bill's clarification of the position on consent and that best practice will rest on clear statutory advice.
I entirely understand why the hon. Gentleman has tabled the amendments; it is so that we can debate the matter and clearly state the position on the record. I would be surprised if he wished to pursue them any further. When considering the Bill we must maintain the fundamental principle that people are entitled to consultation about the use of materials, and that scientists—no matter how well meaning, and no matter how difficult it may appear to them to overcome the practicalities of the issue—accept the principle.
The vast majority of scientists accept and understand why we believe that the best way forward is to create a statutory framework in the Bill and for the Human Tissue Authority to establish best-practice guidelines that can change as ethical and moral positions change and science changes, so that actions can be refined. That is better than trying to spell out everything in detail in the legislation. The right way forward is a statutory framework with a golden thread running through it stating that people have the right to be consulted about the use of material from their own bodies, which is backed up by best-practice guidelines established in co-operation with the professionals.
I do not necessarily disagree with the Under-Secretary, but is he satisfied that that will provide the autonomy that people need to be able to decide what sort of research they are prepared their tissue to be used for? Some people may have ethical objections to certain types of research, and he should give some thought to what a consent form should look like if he is relying on generic research to reassure the likes of the MRC.
The hon. Gentleman is tempting me into trying to write the best-practice guidance. The whole point of what we are trying to do is not to write that guidance, which will follow as a result of the involvement of professionals who will do their best to help to put it together. We are here today because we are trying to rebuild the public's confidence in the collection of material for medical purposes. Many people no longer quite trust clinicians to do what they say that are going to do with material. Many people who will be consulted about the use of material from their loved ones or from their own bodies are unsure about giving the go-ahead in case their child's organs end up in a bottle on a shelf to be used by someone for undisclosed purposes in a year's time. We are trying to rebuild people's confidence in the system, but we will not do so if we undermine the Bill's principle that they should be consulted.
Members of the research community may foresee practical difficulties with consultation, but they must come to terms with the fact that if they want the public's trust and confidence, and if they want to be able to obtain material freely, they must put more effort into ensuring that everyone has the confidence in the system that we want them to have, so that organs and material are freely donated. I should add that best practice is already well defined and that people are working well.
On the subject of enduring consent, we will have an opportunity to discuss just how effective the consent proceedings for transplantation can be made. From what the Under-Secretary has said, there seems to be no value in trying to intrude a further definition of consent rather than considering at a later stage the issues relating to the organ donor card or the registry. I therefore entirely accept what the Under-Secretary has had to say, and will move on.
On the subject of residual tissue, the Under-Secretary is right that there is quite a strong acceptance of the principle of consent among members of the research community—certainly those to whom I have spoken. They are, however, very worried about the practicalities, and we will have to try to deal with that worry in the codes of practice. The Under-Secretary is right to say that we are trying to rebuild confidence in the system, but the reason why some of availability of material has been prejudiced is only partly to do with a reduction in relatives' consent. It probably has more to do with the concerns when encountering patients of people in the research community and clinicians about expanded consent procedures and the practical difficulties of obtaining consent, especially for very large numbers of tissue samples.
Again, we must be clear, as must the research community, about what consent means for the purposes of the schedule. It needs to be explained to people that different uses may be made over time of the residual material for education, training and research. They can support future research if they consent to it, but the process must be quick and easy. If it is not, we may have many audits of the sort that I illustrated this morning from reports that were sent to me. As those audits demonstrated, a large proportion of samples may simply not have their boxes ticked, which may severely prejudice their representative nature and the archives that otherwise might be established. That is because clinicians who have contact with patients do not see the point of the process and they have a consent procedure that they regard as excessive.
We have fixed on debating residual tissue because, as previously discussed, we are dealing not with the absence of consent, but with consent to treatment and what that implies. The Under-Secretary is right, in the formal sense, that if one looks at any issue, it always seems unreasonable to say that one has a research purpose or further training or educational opportunity in mind and that consent should not be taken in that instance for such a purpose. It is possible for consent to be taken in any of those instances, and it should be taken, but a problem arises when the aggregate number of required consents so overwhelms the front-line GPs and hospital junior doctors that they simply stop having the conversations. Evidence from the audits is that as many as two thirds of cases are returned without the conversation having taken place. There is no answer to that problem, other than to establish the principle in the legislation and to be aware that there must be scope for sensitivity in the codes of practice.
This is an important discussion, to which we may return, but I do not want to depart from the principle to which the Under-Secretary adhered, as it is the basis on which we have supported the Bill. I want to encourage us to continue to consider precisely how the codes of practice will enable consent to be given in a practical way for the benefit of research. I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
I beg to move amendment No. 77, in
schedule 1, page 37, line 22, at beginning insert
'Organ or tissue donation for the purpose of'.
This is a minor amendment, designed to probe the use of the word ''transplantation'' in the list of purposes in schedule 1. I have discussed the amendment with others since I tabled it, and I can foresee some of the Under-Secretary's arguments. It is important to note that, at the time of consent, although transplantation may be intended, it will not necessarily take place. If the word ''transplantation'' is used, there may be an expectation that if tissues—or, more likely, organs—are taken, transplantation should take place. There may be disappointment and a feeling that something that was expected to happen has not done so.
The question of the purpose of transplantation covers everything that must be done on the way, but there is an argument for making schedule 1 more explicit to aid those who are considering the issue. We are talking about what consent is required for organ or tissue donation for the purpose of transplantation and not as the end point. Another question concerns how much of what is covered by ''transplantation'' will be part of the remit of the Human Tissue Authority, which we can deal with later.
We are struggling with some definitions. We struggled with the terms ''inherent'' and ''incidental'', and I would now like some clarification of the term ''transplantation''. There is some confusion about the involvement of the Human Tissue Authority in that regard. Clause 56, which deals with general interpretation, includes transfusion in the definition of transplantation, but clause 11(5) excludes it from the authority's remit. That seems to be a bit of a disconnect, and I seek the Under-Secretary's clarification.
I am grateful to the hon. Member for Oxford, West and Abingdon for clarifying the purpose behind the amendment, but I am not persuaded that it is necessary.
The term ''transplantation'' is defined in clause 56(4). It is used to describe the process involved in fulfilling a purpose, rather than a specific action that is carried out as part of that process. Transplantation means removing the organ from the donor body—with all the activity that that requires—transporting the organ, storing it during transportation and re-implanting it into the body that receives it. That is a whole process.
Someone who consented to a loved one's organs being used to save someone else's life, only to find that they could not be used for that purpose, may well be very upset. The clinicians would have to be aware of such emotionally difficult situations and would have to give appropriate counselling and advice. It needs to be made clear in the guidance and in the way in which people are consulted when their consent is sought for transplantation that something might go wrong during the process and that the final act might not take place. However, we do not need to deal with that in the Bill, because we clearly define transplantation as a process,
or a series of steps, rather than as a single act that must be carried out.
I hope that that is sufficient clarification and that the hon. Gentleman will withdraw the amendment.
With this it will be convenient to discuss the following:
Amendment No. 82, in
schedule 1, page 37, line 28, at end add—
'13 Research activities where relevant material is anonymised and untraceable.'.
We can be brief. I would be hard put to distinguish between public health monitoring and epidemiological research, but I suspect that it is possible to do so. One might say that monitoring relates to the current prevalence of disease in the population, whereas epidemiological research relates to the likely effects on the population of future and communicable diseases. The two things are highly complementary and might, indeed, overlap to an enormous extent, but, in some cases, monitoring may not constitute research. It was certainly the Under-Secretary's intention to include epidemiological studies in paragraph 11, on scheduled purposes.
The purpose of the amendment is to explore, for the sake of completeness, whether the lack of reference to epidemiological studies is really an omission.
I am delighted that amendment No. 82 was selected with amendment No. 97; they go together in seeking to probe whether the purposes set out in paragraph 11 to schedule 1 are clear and sufficiently wide.
Public health monitoring is not the same as research for the purposes of supporting or improving public health. Public health monitoring means monitoring of the health of the public or of public health issues, but it can be argued that other approaches could be taken. For instance, such monitoring might not monitor public health directly but instead monitor the prevalence of a pathogen or an underlying condition that may not be apparent in a diagnosis; it may have an impact on public health but not be directly related to public health. It may help to hear how the Under-Secretary defends the existing wording, as I would not need to give exemplars.
Of more relevance is the question of whether public health monitoring is being used as a shorthand for research that is epidemiological and involves either anonymised and unlinkable or anonymised and potentially linkable samples. Some of the paperwork that I have seen on the Bill implies that paragraph 11 would allow prevalence testing on anonymised samples. It is not clear whether that can be done without consent on tissues from the living because it is
anonymised, or because someone has deemed it to be related to public health.
It could be argued that in respect of tissues from living people—we would not have to deal with the question of whether consent was required—it might be satisfactory to state that if the testing were anonymised and not linkable to the originator of the material, it could have no impact on the individual who had donated it. So long as it was deemed by a research ethics committee to be worth doing—doing so may even be pressing, and not only for reasons of public health—it would not otherwise require consent.
I am not sure that I agree with that, for the same reasons that I gave for agreeing strongly with the Under-Secretary that people have a right over what is done to tissue from their bodies. However, by restricting the provision to public health monitoring, he appears to be of the view that in some circumstances testing can be done when it is monitoring to do with the public health. That is not necessarily specified under paragraph 11, and I would be grateful if he would clarify his thinking. Such practice would not be traceable under certain circumstances. I imagine that his view is that, perhaps when needed to protect the public health, the source of the material may need to be traced, either for the person's own benefit or for the benefit of others. We need clarification.
Let us consider tissue that comes from the living; one example is that of tumours. A treatment may become available that requires the collection of tissue as soon as possible—prospectively, the information might not be so helpful—in order to determine whether there is an antigen on the surface of the tumour. That could be done from de-linked, anonymised tissue that is otherwise available. One would hope that there are two circumstances. One is that there is specific consent for research under paragraph 7 of part 1. I would be grateful if the Under-Secretary said that, where such consent does not exist, someone wishing to do such anonymised and unlinked research would not be allowed to do so, and that that is the intention of the Bill. A number of us have received representations to the effect that, if that is the case, it should be made clear now, so that people are aware of it and researchers can be aware of it when thinking how they will handle the introduction of this measure.
Epidemiology is the study of the causes, distribution and control of disease in populations. The Government's view is that public health monitoring is a sufficiently wide definition to include use for epidemiological purposes. Therefore, the amendment tabled by the hon. Member for South Cambridgeshire is unnecessary. We would include in that definition the study of material for things such as the spread of HIV, CJD, severe acute respiratory syndrome—SARS—and so on.
As far as the amendment tabled by the hon. Member for Oxford, West and Abingdon is concerned, the fact that the material is subsequently anonymised does not mean that it was anonymised
when it was collected from somebody in the first place. The golden thread—that people are entitled to be consulted about what the material that they are providing should be used for—again applies. People should be consulted about the fact that material might be used for the sorts of purposes that he outlined. Even if it is subsequently anonymised, it would not be appropriate to use it for a purpose beyond those set out in part 2 of schedule 1—those not requiring consent.
The Under-Secretary said that he considers public health monitoring to include epidemiological studies. There may be one such study that seeks to examine tissue typing on those sorts of samples. That is similar to the sort of research that I described as that usually carried out on so-called residual tissues that are anonymised and unlinked. If he is saying that public health monitoring includes epidemiology, he is running the risk of going further than he would wish to—judged on his strong view, which I share, about the need to ensure that people have control over the type of research that is done with their material, even if it is anonymised.
The answer to the hon. Gentleman's question is this: part 2 sets outs the purposes for which consent is not normally required, and they include public health monitoring. Within public health monitoring, we include epidemiological activities. Therefore, if material is being used for that purpose—specifically for the public weal—it will not require an additional consent. If the proposed research goes beyond that, clearly it should have had consent in the first place. The fact that the material has subsequently been anonymised is irrelevant to the process. I hope that that is a sufficient explanation for the hon. Gentleman.
We can explore the issue later; it is not something that we need to tackle now. I want to take advice on whether the Under-Secretary's definition of epidemiology might be considered by people who take his and my view on research to be too wide. There is a series of studies that might be described as epidemiological that are not related to public health but are carried out in respect of what he called the
public weal. Ultimately, a huge number of research projects might come under that category. However, he has been as clear as he can be at the moment, and I am prepared to think about the matter at a later stage.
The hon. Member for Oxford, West and Abingdon has teased out an interesting issue, but one on which it might be wise to reflect rather than debate further at this point. Nevertheless, there is clearly a danger of epidemiological research stretching widely into categories of research that ought to come under part 1 rather than part 2. We need to see where the boundaries between the two might lie. We may have an opportunity later to discuss that in relation to the codes of practice. I am happy that the Under-Secretary intends that public health monitoring should include the epidemiological studies that we have in mind. On that basis, I beg to ask leave to withdraw the amendment.
Amendment, by leave, withdrawn.
Question proposed, That this schedule be the First schedule to the Bill.
I should like to ask one brief question about ''purposes normally requiring consent''. The second purpose listed is ''Determining the cause of death''. My understanding is that a coroner could require, without consent, to determine the cause of death. I want to be sure that that part of the schedule would not override what the coroner can ask.
A coroner certainly can so require; the Bill does not interfere with the rights of coroners. The schedule is to do with examples such as hospital post mortems, which would not normally require a coroner's intervention.
Question put and agreed to.
Schedule 1 agreed to.
Further consideration adjourned.—[Joan Ryan.]
Adjourned accordingly at six minutes past Five o'clock till Thursday 29 January at ten past Nine o'clock.