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The Investigation of Events that followed the death of Cyril Mark Isaacs
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| This chapter first summarises the consent procedures that were planned at the start of the joint programme, and second, compares the plan with the consents that were obtained from relatives. The chapter follows from the descriptions in previous chapters, and draws on the recollections of morticians and other staff involved at the time. | |
| The joint research team's approach to consent | |
| The research applications submitted to the NWRHA and the Medical Research Council, Chapters 9 and 11, state that the consent of the relatives would be obtained for brain retention. | |
| Obtaining the consent of the relatives is clearly stated in the applications to Ethics Committees, Chapters 12 to 16. For example, the protocol dated 17 July 1986: 'After a patient has died the Psychiatrists who have been looking after the patient will seek permission from the nearest relative to remove the brain tissue at post-mortem. This is already in operation at Prestwich Hospital and has been approved by the ethical committee. A standard post mortem consent form will be used'. | |
| Pre-mortem consent from relatives of patients in hospital | |
| Early in the programme, Dr Deakin had discussed with consultants at Prestwich Hospital the possibility of obtaining consent from the relatives in advance of the patient's death. | |
| Experience showed, however, that while pre-mortem consent may be realistic in patients with Alzheimer's disease, it was then an unsatisfactory procedure in those with schizophrenia. The patient's prognosis and life span in Alzheimer's disease is more predictable towards the end of life, whereas a patient with schizophrenia may live for many years. A premature request to the relatives about brain retention could all too easily give offence. For this reason, the idea of obtaining pre-mortem consent in schizophrenia was not pursued. | |
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Consent to post mortem after the death of a hospital in-patient |
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| Dr Deakin's letters and information provided to Ethics Committees written between 1986 and 1990 emphasise the importance of approaching the relatives for their agreement to brain retention: 'We should like to obtain post-mortem brains from patients in Prestwich Hospital. To lessen the distress caused by making this request of the next of kin at the time of death, we should like to discuss this with relatives before the patient's death'. | |
Other contemporary letters further illustrate this approach. In a letter to the Chairman of the North Manchester Ethics Committee on 27 June 1986, Dr Deakin wrote: 'I think the only ethical difficulty is asking patients relatives routinely for permission to remove post-mortem brain material. This obviously needs to be handled tactfully and the request would be made by the doctor involved in the care of the patient who in most cases will already know the relatives. It is of course entirely at the descretion (sic) of the medical firm whether an approach to the relatives is made and should they feel it inappropriate such a request would not be made'. |
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| 'Would it be possible for you to draw the approval of this research to the attention of particularly the medical staff so that when an in patient dies a request for a post mortem examination is made of the relatives. It is of course entirely at the discresion (sic) of the medical firm whether they approach the relatives and no doubt some times they would feel it appropriate to make such a request'. | |
| 'This, at first sight, seems a difficult request to make. However, I have found that relatives are generally pleased to hear of the research effort and are only too willing to cooperate'. | |
Patients with no known relatives |
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| In the context of hospital patients who had no relatives, Dr Deakin wrote to Dr Braude on 13 February 1990, Chapter 14: 'Often chronic inpatients don't have next of kin, in which case there is no difficulty. | |
| There should be local consent forms, perhaps your secretary could get in touch with the pathology department or the administrator at the Victoria Road Hospital'. | |
| There is no mention of seeking the agreement of the person designated by the hospital's manager required by HC(77)28, Chapter 5. | |
| Coroners' cases |
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| The arrangements described above were planned with hospital cases in mind. In the event, as Chapter 16 shows, the joint programme received many more brains from Coroners' cases than from consented hospital post mortems. | |
| On 11 June 2001 Professor Deakin wrote retrospectively on the reasons why consent was not asked from the relatives of Coroners' cases: 'The purpose of not informing the relatives was to avoid causing distress. At the time, what went on in post mortem rooms was not felt to be a matter that public sensibilities could tolerate. The consequence - to keep things within the profession - is of course completely unacceptable by modern standards of openness and of public and religious involvement'. | |
| On the collection of brains of Coroners' cases as controls, Professor Deakin wrote to me on 6 March 2002: 'I have written and explained to you previously about control brains. We did not think that Ethics Committee permission was required since Coroners and Pathologists were more than willing to supply tissues of all kinds from Coroners' post mortems…We did not think that the Coroner system would yield significant numbers of brains in people with Schizophrenia and that hospital post mortems would be necessary. It seemed to me therefore essential to have Ethics Committee permission to make such a difficult and possibly stressful request of a bereaved relative'. | |
| Coroners' cases - lack of consent by relatives for sudden deaths in the community | |
| When a case of sudden death occurs in the community there is an important procedural objection to any approach to the relatives about organ retention between death and the post mortem. In this interval any such approach would require the Coroner's agreement. Until the post mortem examination has established the cause of death, Coroners will not sanction any such request to the relatives (except for organ donation for transplantation when the deceased had carried an organ donor card). Mr North's letter to Professor Yates in July 1985 illustrates the point. | |
| During the course of this investigation, a number of Coroners were asked if they would have allowed a research team to speak to the relatives about brain retention before the post mortem. All replied that they would not have agreed. | |
| It is clear that in cases of sudden death in the community, none of the relatives was asked to consent to brain retention or whether they had any objections to retention. This applied irrespective of the mortuary to which the body had been taken. | |
| Coroners' cases - deaths in hospital | |
| For the same reasons, Coroners would also have refused any approach to relatives about brain retention of patients whose deaths had been referred to them from Prestwich, North Manchester General or any other hospital. | |
| Some of these in-patients with psychiatric disorders were in long-stay wards. These patients could have been assessed for the joint programme in the way set out in the research protocols, and consent forms signed by the relatives. While this may have happened for some patients with Alzheimer's disease, for the reasons already given it is much less likely that a consent form would have been requested or completed for patients with schizophrenia. If a consent form had been signed, it would have been placed in the patient's notes. None of the hospital case records of patients with schizophrenia was available for me to check. | |
| Hospital deaths not reported to the Coroner | |
| Any consent forms for post mortem and/or brain removal should have been placed with the patient's hospital notes. Very few sets of hospital case records survive. The following paragraphs summarise what was found in these notes. | |
| Prestwich Hospital |
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| There were seven deaths in this category, of which six were patients of the Cerebral Function Unit. One set of notes is available and this contains a consent form for brain removal properly signed and dated by the relatives(1). | |
| North Manchester General Hospital | |
| There were 32 hospital deaths. Two sets of records are available(2). In one a consent form was found. This is the standard 'post mortem declaration form' with the following wording: | |
| 'I understand that this examination is carried out: | |
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| However, in the set of notes found, item 'b' as above had not been signed by the relative but this exclusion had not been respected. The brain had still been retained for research. | |
| Warrington General Hospital |
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| There is little information available about the eight brains of hospital cases which include two brain-only removals. Most were, or had been, in-patients in Winwick Hospital. As these were hospital post mortems, it is likely that the standard hospital post mortem consent form was used. | |
| Bury and Rochdale mortuaries |
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| There is no information available on the four hospital post mortems from these mortuaries. | |
| Brain removal from patients in the Cerebral Function Unit research programme | |
| Chapter 8 records that all patients in the Cerebral Function Unit's programme were seen and assessed in life. | |
| One practical feature of the CFU programme not discussed in Chapter 8 serves to confirm that the consent of the relatives was obtained before the brain was removed. | |
| Mr Walkden explained that at Prestwich many of the brains for the CFU's programme were from 'brain only' removals. These did not involve the attendance of a pathologist. In 'brain only' cases the mortician removed the brain as soon as practicable after death, and in some cases in the middle of the night. | |
| As brain removal was unsupervised, Mr Walkden would always check the consent form himself before he started the procedure. Professor Mann independently confirmed this. If the form was missing the brain removal would have to wait until the signed consent form arrived. | |
| Similar checks were made by morticians at other hospitals from which Professor Mann had collected brains. | |
Summary |
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| From contemporaneous documents it is clear that the joint research team recognised that consent by the relatives was necessary for hospital cases. | |
| For Coroners' cases, it appears the team believed the Coroner could authorise brain retention, but at NMGH which provided the largest number of brains the Coroner was not asked, and his agreement appears to have been assumed by the pathologists who allowed the mortician to remove the brain. | |
| As it turned out, the large majority of the brains obtained for the programme were from Coroners' cases and not from hospital post mortems. | |
| No attempt was made to approach the relatives for consent in Coroners' cases. | |
| Few hospital case records are now available, so it is no longer possible to check how frequently consent forms had been completed by the relatives | |
| In one hospital case where the brain was retained at NMGH, the consent form shows that the relatives had not authorised removal of tissue for teaching or research. | |
| In 'brain only' examination, before brains were removed for the CFU programme the morticians who undertook the removal were careful to check the consent form, as they were undertaking the procedure without the supervision of a pathologist. | |
| The comment that 'often chronic inpatients do not have a next of kin, in which case there is no difficulty' disregards the responsibility placed on the Chief Executive or Hospital Secretary by HC(77)28. | |
| Professor Deakin's retrospective observations that 'we did not think the Coroners system would yield significant numbers of brains with schizophrenia and that hospital post mortems would be necessary' do not match the facts as recorded in the brain books. These show that most brains from cases of schizophrenia were obtained from Coroners' post mortems. | |
References |
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| 1 Case record at Prestwich Hospital. | |
| 2 Case records at NMG Hospital. |