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Interim Report: Removal and retention of human material
Part III: The background: law and relevant guidelines
A. The law
The Coroner's post-mortem
The hospital post-mortem
- Our concern is with the carrying out of post-mortems and the removal, retention, use and disposal of tissue during or after post-mortems. We do not see it as helpful here to set out a detailed account of all the relevant law. This can be found in Annex B. Our purpose here is to note the principal salient features of the legal landscape. The hope is that by doing so, the various strands of the law, and the various gaps in the law, can be exposed. In doing this, we have no doubt that the complexity and obscurity of the current law will be manifest to all. Equally, we have no doubt that there will be general agreement that this state of affairs is regrettable, and in need of attention.
- The law as it stands does not distinguish between post-mortems on children and adults and, apart from certain legal issues in relation to parents and parental responsibility, we see no reason for any change in that situation. The arguments and recommendations outlined here refer, therefore, to deceased children and their parents, but unless specifically stated, can be taken to apply across the board.
- In the introduction, we identified the two types of post-mortem,
Coroner's and hospital, and identified a number of problems of language
and definition. These should be borne in mind when reading what follows.
The Coroner's post-mortem
- The large majority of post-mortems carried out in Bristol during the Inquiry's terms of reference were, as we have seen, Coroners' post-mortems.
- The conduct of Coroners' post-mortems is regulated by the 1988 Act and the 1984 Rules. We set out in Annex B the circumstances under which a Coroner's post-mortem may take place, the principal purpose of the Coroner's post-mortem (to establish the cause of death) and who may carry it out. Here we concentrate on those legal issues which are of particular importance regarding the removal, retention, use and disposal of human material.
- The Coroner does not need the consent of the parents before requesting or directing a post-mortem. Indeed, the Coroner has the legal authority to proceed with a post-mortem in circumstances where he considers this will assist him in determining the cause of death, even if the parents object. The justification is one of public interest: to ensure that wherever doubt may exist, the cause of death is established through a formal judicial process. At the same time, however, there is nothing in the law to prevent the Coroner from receiving, or even seeking out, the views of parents and giving effect to them, to the extent that doing so is compatible with carrying out his duty. [54]
- The Coroner's post-mortem is ordinarily carried out by a pathologist, although the law does not insist on this. (The law requires that the post-mortem be carried out by a 'legally qualified medical practitioner' [55] and requires the Coroner, wherever possible, to instruct a pathologist with suitable qualifications and experience who has access to laboratory facilities. [56])
- The pathologist, when working under the Coroner's instructions, acts as the Coroner's agent. While conducting the Coroner's post-mortem, the pathologist is an independent agent. Thus, any powers and authority which the pathologist has are derived from and, importantly therefore, no greater than the Coroner's. In practice in the case of hospital deaths, the pathologists who carry out Coroners' post-mortems for the Coroner are mainly hospital pathologists. The Inquiry heard from Mr Burgess [57] that no Coroner has his own mortuary. In many counties, including Surrey for which he is currently the Coroner, the Coroner is entirely reliant on hospitals to provide mortuaries for post-mortems. Indeed, the 1988 Act and 1984 Rules do not prevent the Coroner's post-mortem being performed at the same hospital where the death occurred. Rather, the 1984 Rules [58] require that, if the death occurred in a hospital possessing adequately equipped premises, the post-mortem should be carried out there (provided the hospital authority consents) unless the Coroner decides otherwise.
- The pathologist may carry out whatever procedures on the body he deems necessary to meet the obligation of establishing cause of death. What he, in fact, does is determined by the standards of practice at the time, since he is bound to exercise due skill, and this includes taking account of relevant medical and scientific developments. Thus, the pathologist may remove a wide range of human material, from whole organs to small tissue samples. Once removed, the human material may be investigated and then returned to the body. Alternatively, it may be retained for such a period as allows the pathologist properly to examine it. This is the import of Rule 9 which provides for the preservation of material which bears on the cause of death. There does not appear to be any legal requirement on the Coroner to explain this process to parents, whatever may be ethically desirable.
- Any removal and subsequent keeping of tissue by the pathologist is as the agent of the Coroner and, thus, is legally justified only to the extent that it serves to enable the pathologist to establish cause of death. It follows that the Coroner cannot give authority for the removal and retention of human material for any other purpose, for example research or education, under the 1988 Act. If it is to be lawful, it must be authorised on some other legal basis. That legal basis is the 1961 Act.
- The 1961 Act provides in section 1(2) that the person lawfully in possession of the body can authorise the taking of parts of the body for therapeutic purposes, medical education or research.
- Here we encounter the first of many problems. Who is lawfully in possession of the body? Clearly during the currency of the Coroner's post-mortem, it is the Coroner, but we have seen that his authority extends only as far as establishing the cause of death. So, he cannot give authority under the 1961 Act. We have to look elsewhere for proper authorisation. The 1961 Act can be read as providing that, by virtue of section 1(7), the hospital is in lawful possession of the body. Thus, the hospital is in lawful possession before the body comes under the Coroner's jurisdiction. During the Coroner's post-mortem, the body is in the lawful possession of the Coroner through his agent the pathologist. However, once the Coroner's post-mortem is concluded, we have taken the view, outlined fully in Annex B, that, while the pathologist may have actual and lawful possession, he must cede lawful possession to the parents if requested to do so. [59]
- The importance of this issue lies in the fact that, by section 1(2), the person lawfully in possession of the body can authorise that the body may be used for the purposes set out in section 1(1) of the 1961 Act only if, having made such reasonable enquiry as may be practicable, he has no reason to believe that the deceased had expressed an objection to his body being so dealt with after his death, and had not withdrawn it; or that the surviving spouse or any surviving relative of the deceased objects to the body being so dealt with.
- The effect of our view as set out in the previous paragraph, appears to be that the hospital must have made such reasonable enquiry as may be practicable before surrendering the body to the Coroner. Failure to do so would, on this reasoning, mean that any subsequent use made of the human material, other than for the purposes of the Coroner's post-mortem, would be unauthorised.
- But, this conclusion is not free from difficulty. The position may be reasonably clear that any taking and retaining of human material, during the course of the Coroner's post-mortem, for purposes other than to establish cause of death, is unauthorised. There is disagreement, however, on other matters. It has been argued that once the Coroner's post-mortem is concluded, human material which has been previously retained for the purpose of establishing cause of death, becomes the property of the pathologist and, thus, the hospital. On this view, it could thereafter be used for any number of purposes, provided they did not offend some sense of public decency. [60] There is some plausible legal argument to support this view, but for it to be right, it depends on whether the human material has been worked on and in consequence has acquired different attributes. We remark in passing that the legal position should not rest on such arcane distinctions. Furthermore, if this is the law, its ignoring of the need to have regard to and respect the views of parents makes it unacceptable. A fuller consideration of this issue is in Annex B.
- Alternatively, it has been argued [61] that, once the Coroner's post-mortem is concluded, all human material reverts to the lawful possession of the parents. On this view, the pathologist has a duty to comply with the parents' request that the human material be returned to them. We tend to agree with this approach but emphasise that this Inquiry is not the arbiter of the law.
- We have seen that the person in lawful possession of the body must at some point have made such reasonable enquiry as may be practicable to determine whether the parents (as 'any relatives') object to human material being used for the purposes specified in the 1961 Act. It is clear that the law does not require the parents' consent, but only an attempt to establish their lack of objection. While this may be thought to be a distinction without a difference, it is of some importance. To ask parents at a time of such emotional strain whether they object may subtly disempower them. The onus is on the parents to object, rather than on the hospital to seek consent. Again, the law seems out of sympathy with the needs and feelings of parents. They may well wish to give consent. Many may hope that something good might come out of their tragedy. But the law is not sensitive to this.
- We turn now to note not so much what the law provides, but what the law is silent on. First, at the conclusion of the Coroner's post-mortem, there does not appear to be any legal requirement placed on the Coroner to indicate what the pathologist should do with human material retained for the purpose of the Coroner's post-mortem. In other words, the law is silent about the transitional point when human material moves from being in the Coroner's lawful possession to ceasing to be so. It is this lacuna which gives rise to the problems we aired earlier. One solution could be to require some positive act of release by the Coroner, but this could only work if it was also stated to whom the human material must be released. [62]
- A second matter not covered by the law is any obligation on the part of the Coroner and, through him, the pathologist to liaise with parents, both before and after the Coroner's post-mortem.
- The 1984 Rules provide for certain people to be notified of the date and time of a proposed post-mortem [63] (unless it is impracticable to notify them or to do so would cause the examination to be unduly delayed [64]). These people include 'any relative of the deceased who has notified the Coroner of his desire to attend, or be represented at, the post-mortem examination.' [65] It should be noted that the onus is on the relative to notify the Coroner of a desire to attend; there is no duty on the Coroner to indicate that a relative may attend or be represented. The Coroner also has a discretionary power to notify any other person [66] . The Inquiry heard from Mr Clifford [67] that no Home Office guidance had been issued as to how Coroners might or should exercise their judgement under these provisions.
- The Coroners' Society, in their Practice Notes for Coroners issued in 1998, advise [68] that 'relatives and family of the deceased person should be given appropriate information' about a proposed post-mortem and, more generally, 'Before making any decision which will affect other people, you [the Coroner] must give all the relevant interested persons an opportunity to comment on the situation concerned.' [69] But this is advice only and, thus, it is a matter of discretion for the particular Coroner.
- There is no statutory requirement for parents to be provided with a copy of the post-mortem report (or notification of the result of an inquest) although the Practice Notes for Coroners advise: 'The relatives and family of the deceased person... should be told the result of the examination as soon as practicable, and in writing, if they request it...It might be appropriate to offer to forward the result and a copy of the pathologist's report of the examination to their nominated medical attendant so that this can be explained to them.' [70] Again, it may be noted that the onus is placed on the relatives and family to request the result.
- There is a real sense in parents of exclusion, of being caught up in a system in which they play no role and have no say, when it is their child who has just died. This is perhaps exacerbated by the involvement of the Coroner or his officer, as these are people not previously involved with the family and whose role may be unclear to the parents.
- There can be no real justification for not placing the Coroner under a positive duty to inform the parents about the purpose of the Coroner's post-mortem and what it entails, and about whether an inquest will be held and what it entails.
- Finally, there is no legal obligation on the Coroner or pathologist
to discuss the timing of the post-mortem, and to discuss whether human
material might need to be retained for a period of time. The length
of time for which human material may be retained will be important to
parents, not least as they might wish to postpone the burial or cremation
of their child's body until the material can be reunited with the body.
Currently they depend for this information on the goodwill of the particular
Coroner or pathologist.
The hospital post-mortem
- As we have seen earlier, this form of post-mortem is governed by section 2(2) of the 1961 Act. We have seen and commented on the fact that the consent of parents to the post-mortem is not required, but rather that reasonable enquiry is made to ascertain whether they object. Notwithstanding this, hospital post-mortems are commonly referred to as 'consent' or 'permission' post-mortems.
- In the following paragraphs, we concentrate on areas in which the law is either undeveloped or simply silent. We have seen that the person in lawful possession of the body must, 'having made such reasonable enquiry as may be practicable,' have 'no reason to believe' that '...any surviving relative of the deceased objects' to the body being used for the purposes contemplated by the 1961 Act. The question is: to what extent, in establishing a lack of objection, must the hospital as the 'person in lawful possession of the body' have regard to the evolving law relating to consent?
- In the context of the practice of medicine, the law on consent has developed somewhat since the beginning of the period of our terms of reference. The prevailing law was that, to obtain a properly informed or 'real' consent and thus comply with the legal duty imposed by the law of negligence, the law required the clinician to inform the patient (or parent, in the case of a young child) of those matters which a responsible body of doctors would regard as appropriate: the so called 'Bolam test'. [71] Over time, there began to be a movement away from this paternalistic legal standard which took account only of the views of doctors. We consider this development in further detail in Annex B.
- To answer the question just posed relating to consent, we must proceed in stages. The first matter to be resolved is whether this law relating to consent applies at all. It has developed in the context of exchanges between doctors and patients. At the point at which a post-mortem is being discussed, the child patient has sadly died. Treatment and, thus, consent to treatment, is no longer being discussed. This could lead to the conclusion that the law relating to consent does not apply. Counter-arguments exist. The discussion of the post-mortem is sufficiently closely related in time and context to the care of the child that it could be said that the law remains the same. Additionally, or alternatively, the parents in their grief and distress could, perhaps, be said to have become patients and so the duty is owed to them in their own right. We do not purport to resolve these questions here. Rather, we draw attention to the uncertainty of the law and to the fact that there is no authoritative answer whether in case law or statute. Further, we say nothing about what might be right from an ethical point of view. Our concern here is solely with the law.
- The second question for us is whether the statutory reference to a lack of objection in the 1961 Act, if it engages the law relating to consent at all, imposes on the hospital the same positive duty to impart information as it does if consent to treatment is being sought. Another way of posing the question is whether there is a law of informed refusal or objection which co-exists with the law of consent and which is co-extensive with it. Again, arguments may be mounted, for example, that the reason for establishing a lack of objection is out of respect for the relatives, and that if the relatives are not properly informed, that respect is undermined. There is, however, no definitive answer.
- The third question is, even if the law relating to consent applies and it extends to include a duty to obtain an informed refusal, what, in concrete terms, would be required of the clinician in dealing with the parents? Again, putting aside what might be called for ethically, the answer is that, for the whole of the period covered by the Inquiry's terms of reference, the duty would consist of passing on that information which a responsible body of medical opinion would regard as appropriate. This, in turn, means following the accepted medical practice and if there is more than one practice, following any of them which was not on its face self-evidently unreasonable (and even this gloss of unreasonableness is only relatively recently recognised). [72] It follows that the law is, at most, silent and, at least, uncertain in those very areas about which parents express most concern: their lack of any real understanding of what the hospital post-mortem was for, what it could entail, what 'tissue' could mean, that 'tissue' might be retained, perhaps indefinitely, that 'tissue' could be put to a variety of uses, and, perhaps most important of all, that as a consequence they would be burying or cremating their child's body incomplete. This conclusion only has to be stated to be seen to be indefensible.
- We turn now to a number of other areas in which the law is relevant but less than clear. The first relates to the uses to which human material may be put. We assume, for the sake of argument, that an appropriately informed absence of objection to the use of human material has been established. As we have seen, section 1(1) of the 1961 Act specifies certain uses which may be authorised, namely for therapeutic purposes and for the purpose of medical education and research. A number of uses to which human material has been put in the past are not referred to, for example the storage of human material in a bank or archive, or its exploitation for commercial purposes. On one view, such uses are, therefore, unauthorised. Alternatively, it may be argued that they are justified by analogy, in so far as archiving, for example, is sufficiently similar to education as to be within the ambit of the statute. Further, where the argument by analogy breaks down, there is an argument, albeit not strong, that, quite apart from the 1961 Act, the common law permits the uses of human material, except in circumstances where that use would offend public decency. That there is no clear law on this matter demonstrates again the inadequacy of the current law.
- Another area of concern is the length of time for which human material, assuming its retention is lawful, may be retained. Under one statutory system regulating the use of human material, the Anatomy Act 1984 (the 1984 Act), the material may only initially be retained for a limited period of time, and only subsequently either for the purpose of decent disposal or provided that statutory conditions are satisfied (see Annex B). There is no such provision in the 1961 Act.
- Lastly, there is the vexed question of whether human material 'belongs' to anyone, and, if so, when and to whom. We set out in Annex B the background to the 'no property' rule, that the body, on death, does not become property and cannot, therefore, belong to anyone. We also describe the circumstances in which human material may become property: broadly, when work has been expended on it such that it has acquired different attributes. This has led the few commentators and the even fewer legal cases to reflect on such apparently arbitrary questions on whether, for example, the process of fixing human material, such as a heart in paraffin in order to aid examination by the pathologist, is sufficient to make it property and, therefore, be susceptible to 'belonging' to someone.
- It is no hyperbole to describe the law in this particular area as both obscure and arcane. Yet, legal issues, ranging from the status of human material archives to the claim of parents to the return of such material taken from a child, depend for their solution on this law. Thus, while there is no shortage of views, there is no semblance of certainty. It is for this reason that in our recommendations which follow, we offer as one option a scheme of prior consents. By this scheme, modelled on the Human Fertilisation and Embryology Act 1990, all dealings with human material after death, other than in relation to the Coroner's post-mortem strictly defined, would be the subject of prior agreement by the parents. A default position would come into play at each stage if the circumstances which were contemplated when the consent was given no longer prevail. That default position would indicate what should then happen to the human material. The significance of this approach is that it would obviate the need to determine such vexed questions as whether human material can belong to someone and, if so, when.
Footnotes
54 See the discussion of the 'Practice Notes for Coroners' in Annex B. Coroners are encouraged to inform families and to give them and others affected by a decision an opportunity to comment on the situation concerned [Return to text]
55 Sections 19 and 20, 1988 Act; this would appear to mean a registered medical practitioner, and not a medical practitioner with a legal qualification [Return to text]
56 Rule 6(1)(a) [Return to text]
57 See Appendix [Return to text]
58 Rule 11(3) [Return to text]
59 We reiterate here that we recognise that there are wider questions as to the exercise of parental responsibility. We do not resolve them here but refer instead to the general law [Return to text]
60 See, for example, Doodeward v Spence [1908] 6 CLR 406, R v Gibson, R v Sylveire [1990] QB 619 considered further in Annex B [Return to text]
61 By lawyers for the BHCAG, in their Submission to the Inquiry, SUB 0001 0001 [Return to text]
62 See Recommendations [Return to text]
63 Rule 7, 1984 Rules [Return to text]
64 By Rule 5, 1984 Rules delay in the holding of a post-mortem is to be avoided [Return to text]
65 Rule 7(2)(a), 1984 Rules [Return to text]
66 Rule 7(4), 1984 Rules [Return to text]
67 See Appendix and WIT 43/8 at para 36 [Return to text]
68 Practice Notes for Coroners, Appendix A para 4, WIT 39/14 [Return to text]
69 Practice Notes for Coroners, Note 3.2, WIT 39/6 [Return to text]
70 Para 6.1, WIT 39/8 [Return to text]
71 Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 [Return to text]
72 To the extent that the written consent forms used in Bristol from 1987 reflected practice generally throughout the country, on this analysis it would be difficult to conclude that there was any breach of legal duty [Return to text]