BRI Interim Report: Part IIB

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Interim Report: Removal and retention of human material

Part II: Evidence

B. The Bristol story

The paediatric post-mortem practice at Bristol
The role of parents at the time of post-mortems
Parents discover the extent of retention
The ethical propriety of practices at Bristol
The lawfulness of practices at Bristol
Conclusion

Here we set out the salient points in the account of what happened at Bristol. There is a fuller account in Annex A.
The paediatric post-mortem practice at Bristol
Before and during the period of the Inquiry's terms of reference, human material was routinely removed from the bodies of children who had died while undergoing paediatric cardiac surgery:
- as part of a hospital post-mortem;
- as part of a Coroner's post-mortem to establish the cause of death; and
- during the course of the Coroner's post-mortem, but not to establish the cause of death.
In all three circumstances, human material, once taken, was frequently retained. On the evidence available thus far to the Inquiry, 265 post-mortems were carried out on children who underwent paediatric cardiac surgery between 1984 and 1995, of which 45 were hospital post-mortems and 220 were coroners' post-mortems. [21] Professor Berry, the paediatric pathologist who performed all the post-mortems on paediatric cardiac surgery patients at the Bristol Royal Hospital for Sick Children (BRHSC) [22] during the Inquiry's terms of reference, until the appointment of Dr Michael Ashworth [23] in 1993, assumed, initially at least, that once the coroner's post-mortem to establish the cause of death was concluded, the retention of human material was not contentious. He regarded it as justified both legally and ethically. In his evidence to the Inquiry, he said that 'it is a generally held view that if tissue has been legally and properly retained during the course of a coroner's post-mortem examination, then it may be further retained for the legitimate processes such as medical audit, clinico-pathological review, and so on'. [24]
We consider later whether such an assumption was valid (see Annex B). But, as regards the practices set out in the first two points of paragraph 36, Professor Berry grew increasingly concerned. As regards the hospital post-mortem, his concern lay in the quality of the consent given by the parents, although it will be recalled that consent is not required by law. He regarded it as insufficiently informed. He said: 'It has become clear that there is a great range in what parents understand about the post-mortem examination, and this challenges us to increase the public's general knowledge about what post-mortem involves, and the contribution of post-mortem examination to health care.' [25]
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As regards the taking and retaining of human material at a coroner's post-mortem for a purpose other than to establish cause of death, from about 1990-91 Professor Berry viewed this as unauthorised. He said: 'In about 1990-91, I became concerned that legal justification was insufficient for the retention [meaning, it appears, the taking and then keeping] of some tissue. These concerns arose from speaking to parents, and from occasional cases widely publicised in the press. At about this time I wrote a departmental code of practice for the retention of tissue at post-mortem... also at this time I raised this issue with our paediatric cardiologists and cardiac surgeons, and reminded them that hearts could only be retained [meaning, it appears, removed and preserved] for diagnosis under the Coroners Rules, and that I thought they should be telling parents that hearts were generally kept.' [26] However, from 1993, it was Dr Ashworth, not Professor Berry, who performed the vast majority of post-mortems on paediatric cardiac surgery patients. Dr Ashworth appeared less troubled by questions of the legality or otherwise of taking what he referred to as tissue during a Coroner's post-mortem examination for purposes other than to establish cause of death and keeping it afterwards. He thought that this was 'not illegal'. [27]
Professor Berry expressed his concerns in a letter dated 6 August 1992 which he sent to the Bristol cardiologists and cardiac surgeons. He said, in relation to Coroners' post-mortems: 'In future, we will not be able to retain the heart unless there is a signed statement in the notes from one of the doctors looking after the child that they have satisfied themselves that the parents of the child do not object to the retention of tissue [sic] during the course of the Coroner's post-mortem examination.' [28] In particular, he was anxious to point out the limits of what he thought could be done in the course of a Coroner's post-mortem and to urge that more specific consent (presumably for taking and keeping human material for purposes other than establishing cause of death) be obtained from parents. The response of the cardiac surgeons was unenthusiastic. Mr Dhasmana [29] admitted that 'lately there has been some oversight on my part to discuss the matter with parents and relatives and therefore consent was not taken by my junior staff'. [30] Mr Wisheart [31] said he understood that the Coroner, in fact, granted them greater licence than Professor Berry was suggesting. [32] In other words, while he acknowledged the letter, he neither accepted the basis of Professor Berry's position nor agreed to vary his conduct.
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The role of parents at the time of post-mortems
It was normal practice when a child died after undergoing paediatric cardiac surgery for there to be a Coroner's post-mortem or a hospital post-mortem. Parents would be told that a Coroner's post-mortem was to be carried out or asked to 'consent' to a hospital post-mortem. Parents expressed considerable dissatisfaction as to the timing and manner of the approaches made by medical staff. There was also criticism that the task of approaching the parents was often left to junior staff. After all, it was accepted at the time, perhaps more in the breach than the observance, that the breaking of bad news and consequent discussions should ordinarily be carried out by the consultant in charge of the patient. In 1991, a Joint Working Party of the Royal College of Pathologists, the Royal College of Physicians of London and the Royal College of Surgeons of England stated that 'great care should be taken in obtaining permission for [a hospital post-mortem]. The responsibility lies with the consultant in charge of the case'. [33] In its consultation paper in 1999, the Royal College of Pathologists emphasised this point, stating 'the most senior doctor who knew the relative best during the patient's last illness should obtain consent to the hospital post-mortem examination'. [34] In their final guidelines, the College refers (para 5.6), in the case of a child, to 'a senior member of the clinical team'. Ordinarily, it is assumed this should be a consultant. In Bristol, there is evidence that the consultant surgeons spoke to the parents about post-mortems but found this difficult. For instance, Mr Dhasmana recalled that 'this used to be a most difficult period...I was always emotional during this meeting and the only way I could really just, you know, express it was just quickly get to the point'. [35] Certainly, none had received any training in bereavement counselling or in breaking bad news as recognised by Mr Dhasmana. [36] But then, neither had the junior doctors received any such training, whether as part of their formal education or at the behest of the consultants. Mr Ross [37] gave evidence that it was common practice throughout the NHS for consent to a hospital post-mortem to be obtained by junior medical staff. [38]
Parents found themselves asked to discuss the signing of papers at a time, very soon after the death of their child, when many were clearly and understandably unable to comprehend what was being put to them. For example, Mrs Linda Burton, mother of David, recalled that 'we had literally come out of ITU and got back into this family room, I mean a matter of minutes, five minutes at the outside, and there was this junior doctor suggesting that we should agree to a post-mortem. This had never been raised with us.' [39] The fact that it was a post-mortem which was being discussed, with its additional emotional implications, only served to exacerbate the likelihood of this inability to comprehend. As Leading Counsel to the Inquiry said, [40] it is clear on the evidence before the Inquiry that consent to post-mortem, where required, was taken in nearly every case, but parents' recollections of giving 'consent' may be faulty and this 'may suggest that the process was carried out at a time when inevitably concerns and thoughts and feelings were elsewhere, making it difficult to comprehend everything that was happening.' [41]
A number of parents who gave evidence (written and oral) were adamant that, notwithstanding Professor Berry's evidence that consent was always asked for and given for hospital post-mortems, they had not signed consent forms. It is not surprising that, in the majority of cases, parents cannot recall giving consent, as none was sought or given; 220 of the 265 post-mortems were coroners' post-mortems for which consent and, hence, a signed consent form is not required. In relation to the 45 hospital post-mortems, the Inquiry has verified that in all but three cases parents' written consent was given; there was no suggestion in these three cases that consent was not obtained. In a further case, whilst the consent form was missing, the parent recalls giving consent.
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It is crucial to understand that this gulf between perception and reality may illustrate a number of things which are not mutually exclusive. First, it cannot serve to justify any criticism of the parents. Their beliefs were genuinely held. Second, their anger at what has happened may cause them to paint a picture which is uniformly critical as regards their dealings with the UBHT. Third, the subject matter and the context in which the forms for a hospital post-mortem were signed or a Coroner's post-mortem examination was discussed were such as almost to guarantee that little or nothing would be remembered. Finally, the forms for hospital post-mortems were sufficiently vague and employed such unfamiliar terms that they were not understood or remembered. Indeed, it is extremely doubtful that the language used in the forms made sufficiently clear to parents (i) what a post-mortem entailed; (ii) the circumstances, if any, under which tissue might be removed and retained; (iii) the removing and retaining of it; and (iv) what was meant by 'tissue'.
To take two examples: while the pathologists and clinicians understood the word 'tissue' to refer to anything from whole organs to slides and frozen sections, the very great majority of parents had no appreciation of this. Second, the word 'retention' was used by Professor Knight in his 1985 article. He stated, in relation to a Coroner's post-mortem, that 'the retention of tissue for teaching and research is not covered by the Coroner's permission and the Coroner cannot grant such permission, as it is not within his remit to do so'. On one reading, this can be said to refer to the keeping or holding back for these purposes of tissue already removed. An alternative meaning is that, when Professor Knight refers to retention, he only means the initial removal and is not referring to any subsequent retention and use, once the tissue has been removed under Rule 9 of the 1984 Rules and the post-mortem is concluded. Professor Berry appeared to interpret the word retention in this latter way.
Indeed the term 'retention' can have an even greater variety of meanings. Ruth Richardson, a historian of medicine, in her comments on the Royal College of Pathologists' 1999 draft guidelines, [42] identified the following as being encompassed within the term 'retention':
- removal of a part of someone's body for examination at post-mortem;
- holding on to it for testing in the immediate aftermath of death;
- storage in the case of criminal/civil proceedings;
- archiving for legal reasons;
- archiving for medical research;
- use long/short term for teaching purposes;
- use for museum exhibition; and
- use for personal research.
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Parents discover the extent of retention
There was a great deal of shock among parents when they learned first that their children's hearts and, later, other organs and human material had been removed and stored rather than returned to the bodies. It cannot be known whether the degree of anger and outrage was greater than it might otherwise have been because of the surrounding circumstances. After all, most of the parents involved were already convinced that the UBHT was, as they saw it, the author of their misfortune in having been responsible for the deaths of their children. Furthermore, given that the heart has special significance, as well as having been the seat of their children's disease, taking and keeping the hearts was particularly hard to accept. The fact that Bristol was already a 'story' meant that as soon as it was known to the press, the reporting of the removal and retention of human material was inevitably couched in sensational terms. No account was taken of the fact that this was a widespread national practice of longstanding, whatever the shortcomings in information and understanding, and that Bristol was not exceptional.
The story began with the discovery by Mrs Helen Rickard in April 1996 that her daughter Samantha's heart had been retained at the UBHT, following the post-mortem occasioned by her death after cardiac surgery. In March 1996, after watching a television programme called Dispatches about paediatric cardiac surgery in Bristol, Mrs Rickard contacted the hospital and obtained her daughter's medical records. From the records she discovered that her daughter's heart had been retained at post-mortem. Mrs Rickard then obtained the permission of the Coroner to take possession of the heart. Mrs Rickard met Professor Berry and Mr Ian Barrington [43] on 8 May 1996 and took the heart.
In due course, the Executive Committee of the Bristol Heart Children Action Group (BHCAG) became aware of the issue. [44] They began discussions with the UBHT, with a view to discovering the scale of retention of human material from those who had died after paediatric cardiac surgery and how they should proceed in terms of appraising their members. The UBHT management had hoped to complete the identification process and then write to parents who had approached the UBHT, via the BHCAG, to appraise them of the situation and ask them what action, if any, they wished UBHT to take. The key feature of this approach was that parents would receive individual letters and would not learn of the issue from the media. Responses were expected to range from a request to return the heart or other human material for disposal, to a desire not to be involved. But the Executive Committee of the BHCAG was made aware that the story, hitherto not public knowledge, was about to appear in the press. Anxious to avoid the very accusation from their members that they, as parents, had levelled against UBHT (namely the withholding of information) they decided to call a press conference in February 1999 to inform the public of the retained hearts. (At that point, it was thought that only hearts had been retained.) Mr Ross, when informed of the BHCAG's press conference, contacted the Bristol Surgeons Support Group (BSSG) [45] 'to give them an opportunity to contact their own members before the news became public'. [46]
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The original letters were not sent: fresh letters were drafted and sent out by the UBHT management to respond to queries from parents who telephoned or approached UBHT through the BHCAG. [47] These letters sought the consent of parents to receiving details about whether organs were retained. Subsequent letters were prepared to confirm that organs had or had not been retained, together with a further letter seeking instructions for the return or disposal of the organs. Parents who thought that they had buried their child and were perhaps coming to terms with their grief, suddenly had to face the agonising question whether they wished to know if their child's heart (and, later, other human material) had been retained; and if they decided to find out and the answer was that it had been, what they would do. Would they want to reclaim it; could they bury or cremate it? These were the painful and unwelcome questions with which they had to deal.
The scale of the retention of human material in Bristol gradually began to emerge. Professor Berry and Mr Barrington took the lead in establishing the true position. Many weeks were spent tracking down human material and identifying the parents of the children from whom it had been removed. In this period Professor Berry 'took personal responsibility for identifying and collating the data in the Pathology Department in his own department' and later assisted with the data from the BRI Pathology Department. Mr Barrington and his staff were 'asked by the Trust to undertake the role of receiving and responding to parents' enquiries'. [48]
Thereafter, events played themselves out, as parents dealt with the UBHT. The UBHT had 231 enquiries from parents about retained human material, particularly organs. Of these, 219 made follow-up enquiries and in 140 cases organs had been retained. Inevitably, in such a large, labour-intensive, retrospective examination of records, mistakes (albeit few) were made. These caused considerable additional distress to parents. It would be wrong, however, to criticise UBHT or its staff who were clearly doing their best to proceed as quickly and yet as sensitively as possible.
Some members of BHCAG, through their lawyers, were moved to direct strong criticism at UBHT, specifically Professor Berry, Mr Ross and Mr Barrington. Professor Berry, in particular, was accused of acting unethically and unlawfully. These accusations need to be addressed.
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The ethical propriety of practices at Bristol
As regards the ethical propriety of what was done at the UBHT, ethics has historically been given more than one meaning. Ethics is seen now as the application of rigorous moral analysis, with a view, for example, to identifying proper standards of conduct in any particular context. Our context is the practice of health care. Until relatively recently, however, ethics was a term more commonly used to describe those standards which, from time to time, a particular professional group judged to be proper. In our case, the professional group involved is the medical profession. The taking and use of human material had attracted little ethical analysis in the first sense until the mid-late 1990s when bodies such as the Nuffield Council on Bioethics and the Working Party of the Royal College of Pathologists looked at issues such as retention, and subsequent use, of human material. [49] Thus, in fairness, in the context of the time, we should here concentrate on professional guidance and practice.
The practice at Bristol appeared to accord with that adopted generally in England and Wales. It was only over the period of our terms of reference that the general notion of a greater involvement of patients in their medical care along with the principle of informed consent gradually developed. As early as 1992, Professor Berry appears to have recognised that this development had implications for the conduct of post-mortems. He took the view that in respect of a Coroner's post-mortem, consent would need to be sought for the retention of any human material, initially taken to establish the cause of death beyond the conclusion of the examination and once the coroner had discharged his duty. It was for this reason that he wrote to medical staff at the UBHT on 6 August 1992, stating that 'in future we will not be able to retain the heart [after a Coroner's post-mortem] unless there is a signed statement in the notes from one of the doctors looking after the child that they have satisfied themselves that the parents of the child do not object to the retention of tissue [sic] during the course of the Coroner's post-mortem.' [50] The wording of the letter is, however, ambiguous. The 'retention of tissue during the course of the Coroner's post-mortem' could refer to the initial taking and subsequent retention, for purposes other than to establish the cause of death. Alternatively, the words could refer to retention once the Coroner's duty was discharged. We have given the words the latter meaning. It will be evident, however, that this uncertainty of meaning runs through the story as a constant theme.
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It may be argued that Professor Berry did not go far enough, and that his department continued to be involved in the removal and retention of human material without the real awareness of parents. But that is to be guilty of a failing which this Inquiry must always be alert to guard against: commenting on the past from the perspective of the present. By the standards of his profession at the time, whatever view may be taken of those standards, Professor Berry was not behaving improperly. Indeed, Dr Ashworth told us that commentators such as Professor Knight were 'lone voices ... The pathological opinion ... was that it was not an issue.' [51] We may regret that those standards were the product of a small group of professionals talking to themselves. We may agree that they reflected a degree of professional arrogance. We may lament that they displayed a lack of interest in, or paternalism towards, the views and feelings of parents. But that was how things were. That was the culture of the times. We should also recognise that it is no more easy for professionals than parents to have to talk about the death of a child for whom they have been caring. As Mr Wisheart explained: 'It [seeking explicit permission to retain a child's heart] added to the difficulty' of talking to parents when their child had died, 'certainly for the parents, and I guess for myself as well, to be honest...' [52]
The task we have is a task for the future. It is to ensure that parents are respected and that medical care is developed, not least through the appropriate use of post-mortems. This is no easy task, given the inevitable and understandable breakdown in trust which currently prevails between parents and professionals. It is made no easier by mistaking the language of shame and blame for the language of accountability. Of course, blame has a proper role where there is personal misconduct. But where, as here, it was a system which was responsible, and a system which needs to be changed, blaming any individual is not only unfair and unhelpful; it is positively counter-productive.
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The lawfulness of practices at Bristol
As regards the lawfulness of the practices adopted in Bristol, the overall impression from the evidence before the Inquiry is that, while the law was recognised as having some relevance, it was not clearly understood. This is hardly surprising. Pathologists are not lawyers and there was a distinct lack of authoritative legal expertise. As regards the specific issues which concern us, there was and remains little by way of guidance. It is no wonder that a kind of professional folklore developed which served the role of the real law. Again, we may regret this state of affairs. We may express amazement that in an area as sensitive as this, the importance of the place of law was not immediately recognised and the law changed or clarified, if found to be wanting. But, at the time, the prevailing practice suited the interests of those within the system. Those who might have complained did not do so for the simplest of reasons: they did not know what was going on.
There are a variety of possible explanations for this state of affairs. The law is complex and obscure. Practice had developed over decades which suited the interests and needs of those involved: the medical professionals. Coroners, in effect, operate fiefdoms. They exercise considerable discretion and display little uniformity of practice as regards, for example, the proper disposal of human material removed for the purposes of a coroner's post-mortem, once the cause of death has been established. Pathologists and clinicians largely held the view, if they ever gave their mind to it, that the law was something remote, far removed from the realities of their daily practice.
There was nothing to suggest that the practice of those at Bristol was different from that of other centres. Thus, any claim that they acted unlawfully, is, in effect, a claim that the general practice relating to certain aspects of the taking and use of human material was unlawful. That said, the legal maxim communis error non facit legem (a practice may be common but still unlawful) means that those at Bristol cannot rely on the behaviour of others. What they can, perhaps, legitimately say to those who may claim that they behaved unlawfully, is that it is harsh in retrospect to judge them in this way, when they did no more than follow accepted practice.
This, of course, assumes that those in Bristol did behave unlawfully and such a conclusion is by no means straightforward. To repeat, the law is obscure. Moreover, there have been few attempts to state or clarify the law in legal writings, and no rulings from the courts on a number of the central issues of contention. We need look no further than to notice that two well-researched submissions, one commissioned from our experts, the other put in by the legal team representing BHCAG, take opposing positions on an issue of central importance: the status of human material in the possession of the pathologist after the conclusion of a Coroner's post-mortem. On one view, it is open to the pathologist to use the tissue for such purposes as research or education. On another view, the human material must be returned to the parents. [53]
We set out later in Part III, with some hesitation, what we regard as the true state of the law. We believe that our description of the law is accurate (although we are not the final arbiters). We also believe that, given its uncertainty and complexity, failure in the past to follow what we set out as the law should not, on that basis alone, attract criticism now.
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Conclusion
We conclude our account of the evidence from Bristol with an eye to the future. We have seen that many benefits to healthcare can accrue to patients and, in our case, sick children from post-mortems and subsequent access to human material when, sadly, a child has died. Yet for these benefits to be sustained in the future, it is crucial that parents must not be excluded. They must be respected, at this time of all times, and their permission sought to a hospital post-mortem and to the retention of human material subsequent to a hospital post-mortem and Coroner's post-mortem. The information they are given should be clear and comprehensible. Furthermore, the means of informing them and seeking their views must be sensitive and supportive. We feel certain that if an atmosphere of trust can be rekindled, many parents will want to contribute. We can also hope that, despite the current anger and anguish felt by parents, ways may be found whereby existing archives of human material, which could hold the prospect of help for future children, can remain in existence.
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Footnotes

21 We note that other post-mortems for other conditions were performed in this period and human material retained from these examinations, but these do not fall within the remit of this Inquiry's terms of reference [Return to text]

22 See Appendix [Return to text]

23 See Appendix [Return to text]

24 T55 p. 75-7 [Return to text]

25 WIT 0204 0050-51 [Return to text]

26 UBHT 0308 0219 [Return to text]

27 T54 p. 74 [Return to text]

28 UBHT 0308 0018 [Return to text]

29 See Appendix [Return to text]

30 UBHT 0308 0017 [Return to text]

31 See Appendix [Return to text]

32 T41 p. 116 [Return to text]

33 WIT 0054 0944. We accept that in certain circumstances the consultant may be unavailable. In such a case we take the view that the task of seeking permission should be undertaken by a senior member of the clinical team, and not left to a junior, a view endorsed by the Royal College of Pathologists in their recent guidelines [Return to text]

34 RCPath 0001 0072 [Return to text]

35 T87 p. 97-8 [Return to text]

36 WIT 0084 0106 [Return to text]

37 See Appendix [Return to text]

38 T37 p. 27 [Return to text]

39 T5 p. 43 [Return to text]

40 See Appendix [Return to text]

41 T55, p. 7 [Return to text]

42 'Tissue Retention - an outsider's view', Bulletin of the Royal College of Pathologists (forthcoming, summer 2000) [Return to text]

43 See Appendix [Return to text]

44 See Appendix [Return to text]

45 See Appendix [Return to text]