|Human Tissue Bill
Dr. Harris: I am happy to accept the Minister's point and I do not intend to press new clause 2. However, I should like the Minister to consider the case that I cited. I accept that that case is not in new clause 2, but if it were to include part 2 issues only, a post mortem would be required to state whether relatives saw any problem with quality assurance, clinical audit or education and training that were incidental to the medical treatment and diagnosis. If the new clause were to include part 2, rather than part 1, would the Minister revise her thinking?
Ms Winterton: There has to be flexibility in the approach taken by the person dealing with bereaved relatives at any particular time. If there were no clear, prior guidance from the patient, it would not be appropriate to move on to ask for consent. We feel that it is right for those who are dealing with bereaved relatives to be able to make a judgment on what it is possible to ask at a particular time.
Dr. Harris: I understand and have accepted that point in respect of everything in this group except the issue of part 2 purposes such as clinical audit and quality assurance, which I maintain are part and parcel of port mortem examinations. Clause 1 states that the default position, if permission were given only for establishing the cause of death, is that the material cannot be used for clinical audit or quality assurance purposes; nor can any medical students or junior doctors watch the examination because specific consent is needed for those part 2 purposes.
Does the Minister think that under the relatively narrow circumstances of hospital post mortem requests, it might be worth while asking that question and ensuring that it is always asked? Otherwise, pathology laboratories will never know, or they will have half their specimens based on the data provided for by the hon. Member for South Cambridgeshire, on which they cannot carry out full work.
Ms Winterton: The point is that clinical audit, for example, does not require consent. Schedule 1 sets out that those are areas for which consent is not normally required in the same sense as public health monitoring or on-the-job training. It is set out clearly that consent is not required for those purposes.
Dr. Harris: That is except in clause 1(1)(e) and (g), which refer to storage and use
Ms Winterton: We will return to that matter. The obvious difference is what can be used in terms of clinical audit for living patients and from the deceased. There is an issue about the need for consent where someone is deceased. If the material had been taken before they died, it would be possible for it to be used; if it were taken from a deceased person, there would be restrictions on its use.
The hon. Gentlemen may be trying to tease out an assurance that issues of the use of tissue and organs for research and transplantation will be addressed on every possible occasion so that the opportunities for donation are maximised. That is a laudable aim, but this is not the way to achieve it. The consequence of that approach would be that both patients and bereaved relatives were obliged to specify all manner of detail that they might not wish to consider. Doctors would have to ask whether they thought that appropriate. Those approaching bereaved relatives have to be aware of the difficulties that people face in some of those circumstances.
One of the main purposes of the Bill and of the consent provisions is to ensure a proper and positive engagement between medicine, science, patients and the public. We want to ensure that the use of tissue is based squarely on consent. We know that patients, as I have said, overwhelmingly will consent to the use of tissue for research. That is why it is right that they should be asked; current GMC guidelines state that we must not place obligations on patients. We must work with the trust and confidence that we build. It is by means of good practice, not statute, that we should consider when and how we seek such consent.
The hon. Member for South Cambridgeshire asked about generic consent; for example, if blood were taken and an individual stated that they were happy for research to be carried out, that sample could be kept for a length of time. We must distinguish between research that will lead, in general terms, to a particular scientific development and research that will affect an individual. For example, research might lead to the discovery that an individual has a particular disorder that might occur later in life. The use of samples for those purposes is a different scenario. That must be considered in the context of medical ethics committees, which look closely at what research is undertaken and how research material should be collected.
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Dr. Doug Naysmith (Bristol, North-West) (Lab/Co-op): I know of an archive that is kept for ovarian cancer purposes, which goes back 50 years. Permission for that was given for generic research purposes. How will what the Minister is saying affect the use of tissues that were given over a long period? There are now research purposes that were not thought of 50 years ago, through which useful information can be gained. How will the new proposals affect that? As a result of the Bill's preparation, people have been jumpy recently about what can and cannot be done with, for example, cell lines or tissue samples.
Ms Winterton: The Bill makes it clear that it will be lawful to use existing holdings. There is guidance on the circumstances in which some of those holdings should be used and whether, in some cases, they should be returned. The subject is delicate because some existing holdings are traceable to individuals and any dealings must be sensitive. We are aware that existing holdings contain a lot of valuable archive evidence that can be used for research. We want to clarify that that evidence can be used where appropriate and right, as long as it would not cause distress.
It is important to distinguish between the two areas that I was outlining. A person can specify that they are happy for blood, for example, to be used and stored for medical research. However, we must be aware that if research has an effect on an individual, medical research committees and those that commission research must ensure that people are fully aware of the use to which the research might be put.
Mr. Lansley: The Minister agrees with the points made by Opposition Members; it is important, when consent is given, to be clear about the particular scheduled purpose for which that consent has been obtained. She is referring to the difference between paragraph 7 of schedule 1, which refers to research
Clearly, we must be able to distinguish between those purposes. To return to the Bill, if it is the Minister's intention that that should be so, and given that it is not required to be the case in the Billone could, in theory, give consent for all scheduled purposes in one ticked box, without distinguishing between the purposeshow does she propose that it should be done? Will it be done through codes of practice from the Human Tissue AuthorityI do not think that the codes of practice allow thator through the general principles that have been set out in relation to the remit of the authority? Which is it to be?
Ms Winterton: It will be a mixture of the two. We are building on what is already in guidance regarding how consent should be obtained. We are not altering the position as it stands in respect of what is allowed under best practice. In certain areas, it will be important to
Column Number: 21make a distinction. What is, in effect, generic consent can be used in relation to medical research, but there is not always complete anonymity.
In respect of public health monitoring, something might be anonymised. Particular types of research might relate to the individual but not necessarily affect the individual if something was found out from a sample that could have an effect on their life. Knowing the condition of the person, one would wonder whether they should be informed of it. There is a distinction, and the ethics committees will be brought in to ensure that any research follows the most relevant way of gathering the materials.
Dr. Naysmith: What my hon. Friend the Minister is saying makes a lot of sense. There is the question of best practice and in many hospital laboratories and so on best practice is followed well. What really needs to be answered is how that best practice is to be promulgated after the Bill has been put into effect. At the moment, there are problems with certain ethics committees perhaps interpreting their role too rigorously or not rigorously enough. We must ensure that best practice, if that is what we are to depend on, is promulgated and that we know what it means.
Ms Winterton: My hon. Friend is right, and we would expect the Human Tissue Authority to take action on that issue.
Under clause 56(1) to (3), ''anatomical examination'' refers only to examination by dissection of bodies or parts removed from a body after death. Parts of a body removed during life may well be examined or used after the person dies. That could be done under other scheduled purposes, but it would not be defined under the Bill as anatomical examination. I hope that that clarifies the position for hon. Members.
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