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Interim Report: Removal and retention of human material
Part III: The background: law and relevant guidelines
B. Relevant guidelines
- We have already indicated earlier that the reference here to guidelines is intended to refer to the pronouncements of such bodies as the Royal College of Pathologists and government departments. They appear to have at least two aims: to seek to explain or make clear the law, and to seek to urge or prescribe best practice. They culminate in the long-awaited publication by the Royal College of Pathologists of its updated Guidelines for the retention of tissues and organs at post-mortem examination in March 2000. We refer to the various guidelines and, in particular, those of the Royal College of Pathologists, at greater length in Annex B and do not attempt any detailed commentary here. Rather, we confine ourselves to some general observations.
- We state at the outset that, in any guidelines, certain ethical principles need to be set out. They must inform the guidance offered, whatever body or organisation may issue them. Equally, they must inform the law and those who interpret the law. We set out later our views on the relevant guiding principles.
- Perhaps the most significant comment about guidance in the past is
the low priority which, historically, has been given to the concerns
of the family and particularly parents. We are aware that the various
guidelines are intended to be of general application and not just concerned
with post-mortems on children. But, that said, the particular position
of parents who have just lost a child should always have been clear
to all as warranting special and sensitive attention. The fact was that,
as Professor Anderson put it in evidence, it was only recently that
it was realised that the needs of the parents ought to be addressed:
[73]
'Q. When you began to study retained hearts and became aware of their retention, do you know what, if any, reference was made to the relatives of the dead person from whom the heart came?
A. I think that in many ways this is the one thing that this entire Inquiry has brought to our attention: the fact that we presumed much too much when we made our collections. I mean, I first worked with hearts at Alder Hey Children's Hospital, with the Institute of Child Health there, where they have a wonderful collection of hearts. I do not know how the hearts were collected and I am not exactly sure what questions were asked at that time. When I then came to the Royal Brompton and started to build up my own collection of hearts, because I was not a pathologist - and I am not trying to deflect the decision-making in any way here - but because I was not a pathologist, the pathologist would remove the organs at autopsy, for which we had received consent, so unless it was a Coroner's case and we presumed that the consent given for the autopsy permitted us then to retain the organs, we never asked the question: had the parents been asked if it was appropriate for us to retain the organs? We presumed that appropriate permission had been given. But I think we were wrong in that respect. I do not think we asked the question. I think we should have asked the question... But I do not think that we explained to the parents that we were going to retain the hearts. I think we should have done. I think we were wrong to presume that we had that right...'
- Professor Green [74]
told the Inquiry: [75]
'My generation were, therefore, taught by those who had always themselves been taught that there was no property in a dead body and the general lesson that was drilled into me as a medical student was: be courteous, be polite, explain that you are asking for permission for this autopsy because it will help others, both in learning and in the treatment of disease, but do not go into any more detail; it will upset the relatives and they will be distressed and they might refuse consent...it was felt that if organs were to be retained, relatives should not be further distressed by being presented with a list of organs that might be retained.'
- The reasons offered are well-meaning: a desire to protect parents from the realities of post-mortem examination; a desire not to intrude further on the parents' grief. But these reasons are also, to a degree, self-serving to the profession. Pathologists and clinicians regarded post-mortems and all that followed to be an important activity, particularly in a teaching hospital. Therefore, the presumption was that they should be carried out and human material retained. Parents need not be involved. They might, after all, say no if they were told 'too much'. And, in any event, they would be pleased to know that research and education were being enhanced, if they ever found out. Their consent should be sought, because this was believed to be a legal requirement, but it need only be consent in form rather than in substance.
- With this historical perspective in mind, we turn to the most recent developments. In March 2000, in advance of his report to Ministers, the Chief Medical Officer for England [the CMO] issued interim Guidance [76] to chief executives of NHS Trusts in the light of new guidance from the Royal College of Pathologists which we consider shortly. He stated that he 'would be grateful if you [the Chief Executive] would ensure that this is put in place immediately'.
- The interim Guidance goes much wider than post-mortems on children. It does, however, embrace principles which are of particular relevance in the context of our report. The Guidance states at the outset, for example, that standards in the area 'should improve immediately and become more transparent, particularly communication with the bereaved and obtaining their "consent"'.
- While recognising its interim nature, we welcome this Guidance as an indication of the direction which both principle and practice should follow in the future. We particularly draw attention to the range of information which bereaved parents should be offered, such as what a Coroner's post-mortem may entail; the relationship (in terms of timing) between a post-mortem and funeral arrangements; whether any human material might be retained and, if so, where and why; and the arrangements for disposal of any human material which have been retained.
- The Guidance goes on to require chief executives of Trusts to ensure that clinicians 'follow best practice', and refers in this context to the Royal College of Pathologists' Guidelines published on the same day. In the light of the reservations we express about these Guidelines, we expect that 'best practice' will require further restatement in due course, not least in the light of recommendations we make.
- Then, as we have seen, new guidelines were published by the Royal College of Pathologists. We welcome them as much for their existence as for what they say. They represent a clear recognition by the professional group perhaps most closely concerned with the matters we have been discussing that the future cannot be like the past. They recognise the pre-eminent importance of respect for the parents and family, of the need for agreement except when not required by the current law, and of the need to make that agreement properly informed.
- We recognise that the College saw its brief as being to produce new guidelines. They cannot, of course, make new law. At the same time, they could have proposed that their changes be put into statutory form, on the ground that professional guidelines were not sufficiently binding. After all, previous guidelines have not been conspicuously well-observed. The College chose not to do so. It is a matter of considerable concern whether guidelines, on their own, issued by the very professional body seen by some as having lost trust, will suffice to recapture this trust. We doubt it. For this reason, in our recommendations in Part IV, we argue that, if guidelines were to be used, rather than new law, they would have to come from government, taking account of the views of the public as well as the professionals, and be backed by government.
- We set out in Annex B a detailed description of the Royal College of Pathologists' Guidelines. We confine ourselves here to making a number of general points.
- We welcome the clear recognition in para 1(4) that '...the public and patients no longer wish important decisions to be taken by professional staff on their behalf, but expect a full informed partnership in all such decisions. Relatives therefore need to be given information by people they trust, so that they can understand the implications of decisions and be assured that due account is taken of their wishes.' We also welcome and endorse the recommendation in para 8(1) that 'Medical schools and hospitals must provide training for medical, and other appropriate personnel...in requesting and obtaining agreement for post-mortem examinations and in dealing with relatives' concerns about tissue and organ retention.'
- On the matter of language, the Guidelines are not entirely satisfactory. Two of the issues we identified at the outset as giving rise to confusion, the meaning of 'tissue' and the difference between consent and objection, remain problematical. As regards 'tissue', there is no definition in the Guidelines, but they refer at different points to 'tissue and organs' and 'tissue, organs and body fluids', and 'organs' are referred to in such a way as to include parts of organs. In Annex A to the Guidelines, which is the Information Leaflet intended for relatives, there is a glossary of terms which includes definitions of 'tissue', organ(s) and body parts. In the model form for recording agreement to a hospital post-mortem, at Annex B to the Guidelines, a whole range of expressions are used at different points without the relationship between them being made clear, including 'tissue samples', 'fluids', 'whole organs', 'organs', 'tissue'. Any distinction between 'tissue' and 'tissue sample' and between 'whole organ' and 'organ' is not specified, and neither parts of organs nor body parts are mentioned. In Annex C to the Guidelines, referring to a model form after a Coroner's post-mortem, 'tissue or [sic] organs' are referred to, with tissue immediately translated into 'tissue samples', to be followed in another section of the form with the words, 'tissue, fluids or organs'. No further explanation is offered. The net result is that while all the possible varieties of human material are described at some point in the various documents produced by the College, unless the forms which they propose are read with the leaflet and some explanation given of both, the average relative will still be less than well informed as to what is being agreed to.
- As regards consent and objection, the Guidelines are unsatisfactory. The underlying reason seems to be that the College, while stating at the outset that the Guidelines are not concerned just with the law but with 'the ethical and emotional concerns of bereaved relatives' (para 1.1), feel themselves trapped by the law. For that reason, they decide not to use the word 'consent' (para 1.4, footnote 3), since the Human Tissue Act 1961 does not require consent, only the lack of objection. Instead, they opt for perhaps the worst of all possible worlds by using a third word, 'agreement'. The immediate response is that, if the Guidelines are really concerned with ethics, it is entirely proper for the College to impose a higher duty on pathologists than that required by the law and, thus, use the word 'consent', if that is what they want to say. The language of the 1961 Act is not relevant. Further, the introduction of a third word is unlikely to aid clarity. 'Agreement' is described as being intended 'to infer that a relative does not object' (footnote 3). How this would be translated into the conversation between a distressed relative and a healthcare professional is unclear, but it is likely to be converted into the language of consent, if only to avoid having to establish a negative. If this is so, 'consent' should have been used from the start, since that is really what the College intends to say. But, the confusion does not end there. The Information Leaflet throws in the towel and describes the hospital post-mortem as 'the consented post-mortem', even though it then reverts to the language of 'agreement'. The model forms recommended by the College, however, only use the words 'agreement' and 'agree'. We suggest that it is just this sort of imprecision and vacillation which undermines trust and creates tension. For this reason, we use the word 'consent' throughout our recommendations.
- We turn now to ask what assistance we can find in the Guidelines concerning the crucially important and difficult question of what should be done with human material at the conclusion of a Coroner's post-mortem. Para 3.5 appears to make it clear that to retain 'tissues and organs' for purposes not within the remit of the Coroner's post-mortem, the 'agreement' of the relatives should be obtained. Further, in para 3.5 (b), the Guidelines require coroners to advise relatives of material retained for the purposes of the Coroner's post-mortem, and when and how the material will be released. This would appear to provide a seamless system, such that retained material is to be returned to relatives or dealt with at their direction, unless they agree to its use for other purposes. This position is reinforced by the model form in Annex B to the Guidelines. It specifically details arrangements for the disposal of 'tissue or organs' once the Coroner's post-mortem is concluded, subject to the option of agreeing to the use of the human material for therapeutic purposes or for medical education or research. There is, however, one problem. In para 3.6, the Guidelines contemplate the situation in which the pathologist discovers something, for example a genetic condition, wholly unconnected with the cause of death but warranting further examination in the best interests of the family. In such circumstances, the guidance given is that the material should be taken and stored, unless reasons for objection, for example on religious grounds, were already known. There should not, however, be any tests carried out until agreement is obtained and, if not given, the material should be returned to the body. While this may be a desirable and defensible proposal in the abstract, it comes at a time of failing trust, when any exception to a rule is seen as swallowing the rule. Also, it appears to be contrary to the law, which provides that material may be preserved only for the purpose of establishing cause of death. If, therefore, it is thought to be a desirable practice, and we see the possible good effects it could bring, it can only be allowed for if consent is gained to do this before the Coroner's post-mortem is begun.
- The apparently seamless system just described is subject to a further problem contained in para 6.3. By this para, the responsibility for 'tissues' is said to revert to the pathologist, once the Coroner's post-mortem is concluded. It is immediately acknowledged, in keeping with what has just been said, that further use or disposal is subject to relatives' wishes. But, it then goes on to state that 'a reasonable compromise is to archive the processed tissue blocks and histological sections, and to retain unprocessed tissue for the same period as biopsy and surgically-resected tissues unless relatives have expressed wishes to the contrary'. It is not clear what, or why, 'compromise' is called for. In addition, 'biopsy and surgically-resected tissues' have not previously been mentioned, nor has any period of time for their retention. This lack of clarity, particularly when the language of 'compromise' is used, is likely to add to rather than reduce trust and is, to that extent, counterproductive.
- We make one final point. The information in the proposed Information
Leaflet is helpful not least because it is detailed and specific. But,
by being so, we recognise that it will be painful to some parents, already
reeling from the loss of their child, while other parents will find
it of assistance. We cannot square this particular circle. There is
a price to be paid for being informed. We can only seek reassurance
in the knowledge that those trained in the area of bereavement understand
these difficulties. We observe that the case for their involvement in
supporting parents from the start is reinforced.
European Convention on Human Rights and Biomedicine [77]
- This Convention was produced by the Council of Europe in 1997. It has not yet been ratified by the UK. We notice and endorse the commitment to respect for the dignity and integrity of humans which is the central focus of the Convention. We regard the principle set out in Article 2, that 'the interests and welfare of the human being shall prevail over the sole interest of society or science', as a central ethical principle which should guide practice in the future, both as regards the issues discussed in this Report and more generally. Equally, while not specifically addressed to the issues of concern to us, we endorse as a guiding principle the central importance given to information and consent. We would wish to see this principle applied as much to the situation of parents asked to consent to the removal and retention of human material from their deceased child for the purpose of medical education and research, as to the care and treatment of the living. We notice and draw attention to the fact that the view we express concerning the proper approach to human material initially removed at post-mortem pursuant to Rule 9 of the 1984 Rules is entirely in keeping with Article 19. This Article sets out a rule consistent with the general principle of consent (in Article 5), that parts of the body which have been removed during an intervention for a specified purpose must not be stored or used for a different purpose unless the general conditions governing information and consent have been observed.
- In the flow charts which follow we describe in diagrammatic form
the processes involved in Coroners' post-mortems (Figure 1), hospital
post-mortems (Figure 2) and the removal and retention of human material
(Figure 3).
Figure 1: The process leading to a Coroner's post-mortem and inquest following a death in hospital
European Convention on Human Rights and Biomedicine
Footnotes
73 T45 p. 101-3 [Return to text]
74 See Appendix [Return to text]
75 T42, p. 56 [Return to text]
76 'Organ Retention: Interim Guidance on Post-mortem examination', Department of Health 23 March 2000 [Return to text]
77 See further discussion in Annex B [Return to text]