Contents

Preamble

The Summary should not be read in isolation, but in the context of relevant chapters of the report as a whole.

Introduction

This report was instigated by the discovery by Mrs Elaine Isaacs in April 2000 that the brain of her late husband, Mr Cyril Isaacs, had been removed during the post mortem examination carried out at Prestwich mortuary on 27 February 1987.

Mr Isaacs' brain was removed without the knowledge or consent of Mrs Isaacs and in clear breach of the requirements of the Human Tissue Act, 1961.

Mr Isaacs' brain and many others were retained as part of an arrangement that had started in 1985 when the Coroner for the North Manchester district, Mr North, had agreed to a proposal that his office staff should identify, from among the deaths reported to the Coroner, those where the brain might be suitable for research at Manchester University. Mrs Joyce Langan, the senior member of the Coroner's office staff, had ascertained that Mr North had agreed to the proposal before any brains were retained for research.

This research programme was jointly undertaken by staff of the Departments of Psychiatry and Physiology. The initial team comprised Dr Bill Deakin, now Professor Deakin, in the Department of Psychiatry, and Dr Alan Cross and Dr Paul Slater in the Department of Physiology. For the avoidance of doubt, the programme organised by Dr Deakin, Dr Cross and Dr Slater is referred to as the 'Joint Programme' to distinguish it from other research programmes in Manchester University which were in progress at the same time.

It is important to note that there was in Manchester a separate research programme in the Cerebral Function Unit (CFU), which is part of the Department of Neurology, that also collected brains from the same mortuaries as the joint programme. The CFU's research programme had the full support and knowledge of the relatives and approval from the Ethics Committees who had been provided with comprehensive details of the research. The Cerebral Function Unit's research continued during the same time period as the joint programme.

The existence of more than one programme created confusion in some mortuaries.

Discovery of the retention of Mr Isaacs' brain

When Mrs Isaacs discovered her late husband's brain had been retained, without her knowledge, she was dismayed and incensed as the religious beliefs of her husband and family, as Orthodox Jews, required burial of her husband's body in a complete state. At the time of her husband's death, Mrs Isaacs had drawn attention to the requirements of her husband's faith and her own objections to any post mortem examination of her husband's body. The objections of the family had been recognised to the extent that the time of the post mortem had been rescheduled to enable Mr Isaacs' funeral to take place on the day after his death.

Mrs Isaacs had been reassured that contact would be made with her husband's general practitioner, which she assumed would avoid a post mortem because of her husband's treatment for mental disorders in the weeks prior to his death. The possibility that any part of her husband's body would be retained at the post mortem did not enter her mind.

When she discovered the truth, Mrs Isaacs immediately began investigating the circumstances and drew attention to what had happened to her Member of Parliament, Mr Ivan Lewis MP, who in turn raised the matter with Mr Alan Milburn, Secretary of State for Health.

Mr Milburn requested the Chief Medical Officer, Professor Sir Liam Donaldson, to meet Mrs Isaacs. Following a meeting on 4 May 2001 between Sir Liam, Mrs Isaacs, her son, Dr Austin Isaacs, Mr Lewis and officials of the Department of Health and the Home Office, Mr Milburn decided that an independent investigation should be undertaken. It was against this background that I was asked to undertake an investigation with the following Terms of Reference:

'H.M. Inspector of Anatomy has been asked to carry out an independent investigation with the following Terms of Reference:

1. To investigate and document the procedures and circumstances which led to the removal and retention of organs of the late Cyril Mark Isaacs during the autopsy performed at Prestwich Mortuary on 27 February 1987;

2. To investigate what subsequently happened to the organs removed and retained;

3. To review whether similar removals of organs occurred at other public mortuaries after deaths outside hospitals;

4. To examine these events in the light of clinical and ethical policies, relevant legislation, religious beliefs, and the expectations and rights of relatives;

5. To report conclusions and recommendations to the Secretary of State for Health.'

The initial phase of the investigation

From my early enquiries in Manchester University, Prestwich Hospital and the Coroner's Office for the North Manchester coronial district, it became clear that the retention of Mr Isaacs' brain was not an isolated incident, but part of a larger system for the collection of brains for the joint programme. The brain books of the joint programme show that a total of at least 311 brains were obtained between November 1985 and April 1997. There is evidence in the brain books that other brains were collected in addition to those identified as part of the joint programme.

Of the brains collected, the large majority (230) were obtained from Coroners' cases. Most of these cases were sudden deaths in the community and a minority, deaths in hospital reported to the Coroner.

Approximately 25 per cent of all the brains collected were from hospital in-patient deaths without the involvement of the Coroner.

For in-patient deaths in both categories, there was no evidence, from the limited number of case records available, that consent had been obtained from the relatives. The collection of brains from patients who died in the long-stay wards of mental hospitals was encouraged. The brains of patients with mental handicap, as it was then described, were also included in the programme.

Why were brains collected?

The joint team planned to investigate the neurochemistry of the brains of those suffering from various disorders, including Alzheimer's disease and schizophrenia. Newly developed techniques were used to compare the results of investigations of abnormal brains with those of people who had died with no neurological or psychiatric diseases. It was the comparison with 'normal' brains that necessitated the collection of 'normal' brains as controls.

Brains from Coroners' cases

The large majority of the 'normal' brains were obtained from post mortems carried out for Coroners, while the brains of patients with diseases were collected both from Coroners' post mortems and from hospital post mortems on patients from mental hospitals.

Sources of brains

Prestwich hospital mortuary

The arrangements for obtaining brains from Prestwich mortuary were made through Dr Deakin's contacts with the consultant psychiatrists at Prestwich hospital and after Dr Slater's discussions with the North Manchester Coroner's office in Rochdale.

In the initial two years, 1985-1987, the large majority of the brains (44 of 58) were collected from Prestwich mortuary and identified for the joint programme through the arrangements with the North Manchester district Coroner's office in Rochdale. Mrs Joyce Langan, who was then the senior member of the Coroner's office staff, believed these arrangements had the Coroner's approval.

The identification of brains through the North Manchester Coroner's office began in November 1985 after a number of telephone calls had been received in the Coroner's office. Mrs Langan's clear recollection is that she had not identified any cases for the joint programme until Mr North had indicated his agreement. Later, on an unrecorded date but probably in 1986, when Dr Slater was in Rochdale to collect a brain from the public mortuary, he visited the Coroner's office. Mr North was not there at the time, so Dr Slater left a letter which Mrs Langan placed on Mr North's desk.

In May 1987 the joint programme ceased receiving brains from all the mortuaries that had been involved in providing brains prior to that date. No further brains were received by the joint programme for the next ten months. This temporary ending of brain referrals occurred seven weeks after the inquest into Mr Isaacs' death and after Mrs Isaacs had written three letters to Mr North to question the verdict of suicide. This may have been pure coincidence, but none of those involved at the time has been able to give a convincing explanation that the two events were not related.

Both Dr Slater and Professor Deakin have stated that they were unaware that Mrs Isaacs had begun correspondence with the Coroner in 1987.

Only nine further brains were collected between August 1988 and September 1989 when post mortems at Prestwich mortuary ceased.

Bury, Oldham and Rochdale mortuaries

The arrangement for identification of suitable cases through the North Manchester Coroner's office was not confined to Prestwich mortuary. After the interval when no brains were collected in 1987/88, the arrangement involving the North Manchester district Coroner's office resumed and was extended to identify suitable cases from Coroner's post mortems at mortuaries in Bury, Oldham and Rochdale. The arrangement to identify cases from these mortuaries continued until Mrs Langan retired in 1996.

North Manchester General Hospital (NMGH) mortuary

At NMGH a different arrangement was in place to identify brains for the joint programme. The collection of brains from NMGH mortuary followed Dr Deakin's approach to consultants, psychiatrists and pathologists at the hospital and a letter from Dr Deakin to Mr Peter Leatherbarrow, the mortician at the hospital, following approval of an application to the Ethics Committee responsible for NMGH, dated 17 July 1986. This application does not mention Coroner's cases.

Mr Leatherbarrow was uneasy and took the letter to the Senior Consultant Pathologist, Dr Glyn Brown, who was aware of the Ethics Committee clearance and reassured Mr Leatherbarrow that the supply of brains to the joint programme was in order.

Only three brains were collected from NMGH before collection was suspended in May 1987. When collection resumed in 1988, the NMGH mortuary was the main source of brains for the programme and over the next four years provided more than 130 brains, two-thirds of which were from Coroner's cases.

The system depended on the mortician, Mr Leatherbarrow, identifying cases where the brain might be suitable for the joint programme.

North Manchester General Hospital is in the jurisdiction of the Central Manchester Coroner, Mr Leonard Gorodkin. The Coroner and his office were unaware of these arrangements as the post mortem reports submitted to them did not refer to brain retention.

Warrington General Hospital mortuary

The third largest source of brains was the mortuary of Warrington General Hospital. While in terms of numbers this mortuary provided only 23 brains, these included 15 Coroner's cases. Many of these, and the eight hospital cases, were from patients in Winwick, a nearby mental hospital.

The arrangement to collect brains of patients who died in Winwick Hospital, Warrington, was made following Dr Deakin's approach to consultant psychiatrists at the hospital. The basis on which brains were obtained in this coronial district is less clear. In 1989 a newly appointed Coroner's Officer questioned the retention of brains for research. He was reassured by a member of the Coroner's office staff that retention was in order.

Other mortuaries

Small numbers of brains were obtained from four other mortuaries. These, with two exceptions, were all from hospital post mortems.

Proposed enlargement of the programme

In March 1995 an attempt was made to enlarge the programme and a draft letter prepared for local pathologists. The draft letter refers to discussions with local Coroners about access to tissue from Coroners' cases in terms that suggested the contact with Coroners was a new initiative. This disregards the fact that, by 1995, more than two-thirds of all the brains collected for the programme had been obtained from Coroners' cases.

Following advice from local pathologists that Coroners' cases would require consent of the relatives, a meeting was set up with Mr Gorodkin.

Ethics Committee clearance

Brain collection for the joint programme started in November 1985, before any Ethics Committee had considered the research proposals of the programme. On 15 January 1986 the Salford Ethics Committee, which had the responsibility for considering research at Prestwich Hospital, was the first Ethics Committee to consider an application from the joint programme.

The application referred only to the collection of brains from in-patients for which the relatives had given ante mortem consent, and the importance of relating post mortem findings to the patient's mental health condition in life was emphasised.

The North Manchester Ethics Committee (NMEC) considered a different application in July 1986. While the application to the Salford Ethics Committee did not mention the collection of 'control' brains, the application to the NMEC did mention this. However, the application to the NMEC did not mention that the majority of the brains already collected had come from Coroners' cases or that it was intended to continue this arrangement.

The application to the NMEC and to the other Ethics Committees stated 'We will need to look at the deceased patient's notes at some stage after collecting each patient's brain'. For the brains of 'control' cases, this would require access to the patient's medical records.

When the joint team needed to obtain information about Coroners' cases where no in-patient notes were available, the team sent a letter to the deceased's general practitioner. This letter is notable for two features. First, the letter states:

'These studies have Ethical Committee approval'.

However, the Salford EC and the NMEC had not been informed that the 'controls' would be mainly Coroners' cases and that approaches would be made to general practitioners of Coroners' cases. The Salford EC was never informed of the collection of brains from Coroner's cases or from other deaths in the community.

The second misleading feature of the letter refers to 'brain samples' when in fact the whole brain had been retained in most cases. The letter left general practitioners with the impression that the studies met the existing Ethical Committee guidelines.

Apart from the protocol dated 17 July 1986 and a single letter, there are no papers available about the consideration given by the South Manchester Ethics Committee (SMEC). The surviving letter, dated 21 November 1986, suggests that consideration by the SMEC took place after consideration by the Salford and North Manchester Ethics Committees. The unsigned letter asks the South Manchester Ethics Committee Secretary for comments on a draft letter to GPs. The draft letter is not attached. However, Professor Deakin states that the draft letter was approved by the SMEC.

No papers are available to indicate what response was given by the South Manchester Ethics Committee regarding the draft intended for GPs. There is no indication that similar letters were sent to the NMEC. The Salford Ethics Committee certainly did not receive a similar letter as this would have been recorded in the minutes where no reference to it can be found.

The General Medical Council in its Guidance issued to all practitioners in August 1983 had advised that the fact of death did not absolve the general practitioner from keeping medical and personal information confidential, but that information may be disclosed for a medical research project 'which has been approved by a recognised Ethical Committee'.

The reference to Ethics Committee approval in the joint team's letter, which at best is economical with the truth, would have led some general practitioners to disclose information about their deceased patient in circumstances that no Ethics Committee had been asked to consider.

Between 1989 and 1991 further Ethics Committees were approached with the protocol that had been sent to the NMEC in 1986. No additional information was provided. The Committees were reassured that the application had approval from the Ethics Committees of Salford, North and South Manchester. By the time these Committees were approached, the research team would have been aware that two-thirds of the brains they had collected had been obtained from Coroners' cases. There was no mention of this in the protocol.

In 1991 the Department of Health issued new guidance to Ethics Committees which required them to consider all research in NHS hospitals on the recently dead. No action was taken by the joint research team to inform the various Ethics Committees of changes to their protocols following the 1991 circular, or to keep the Committees informed of the progress of their studies. Had reports been made, the Committees should have been informed of the dependence of the research programme on brains obtained from Coroners' cases.

Why were brains collected without the knowledge of relatives?

At the mortuaries at Prestwich, Rochdale, Oldham and Bury the pathologists and morticians believed they were following the Coroner's instructions as the Coroner's office staff had initiated the process and informed the joint programme of the availability of each brain. The Coroner's Officers in this district were also aware that the instruction had originated from the Coroner's office. The staff did not question the collection of brains, authorised by the Coroner.

The morticians at Prestwich, Bury, Rochdale and NMGH were well aware that in hospital cases the consent of the relatives was required. In Coroners' post mortems, however, the morticians believed that consent of the relatives was not needed, as the Coroner's authority was all that was required. At the mortuary at NMGH the pathologists and the mortician had been further reassured by the documentation provided by the joint research team which indicated the research had been approved by the Ethics Committee.

These mortuaries had since 1982 been collecting brains with consent from the relatives for the research programme of the Cerebral Function Unit. The CFU research had Ethics Committee approval, as it involved assessment of the patients in life and study of the brain after death if the relatives agreed.

Not all the CFU patients had a post mortem examination and for those that did not, the morticians were asked to remove the brain without the supervision of a pathologist. The morticians meticulously checked each patient's notes to ensure a consent form had been completed before they removed the brain.

Fees to morticians

Morticians in the 1980s were accustomed to receiving fees. These had been paid since the 1960s for the National Pituitary Collection Programme. They also received fees from pathologists for each Coroner's post mortem with which they assisted. Fees to morticians had previously been paid for brains supplied to the Anatomy Department of Manchester University.

From the start of the joint programme, morticians were offered a fee for each brain collected. Dr Deakin wrote to Mr Leatherbarrow at NMGH in 1986 suggesting up to two brains per week might be provided: 'We can arrange payment of £10 per brain before tax, which is deducted at source'.

Although the offer of a fee is not in itself remarkable, the level set was interpreted by at least one mortician (at another hospital) as an inducement to encourage provision of a regular supply of brains.

It is notable that no fee was paid for brains collected for the Cerebral Function Unit research programme, although the removal of brains involved the mortician in additional work. On occasion, morticians were asked to attend the mortuary in the middle of the night to remove brains for the CFU programme.

The morticians' employers were unaware of the fee arrangements which, in one instance, paid the mortician over £400 in a period of 12 months.

How did Prestwich mortuary become involved?

From the early 1970s, Dr Bird in the Cambridge brain bank was actively collecting brains of patients with Huntington's disease. For this pioneering programme, Dr Bird had the enthusiastic support of the relatives of patients with this progressive, incurable disease. Through these relatives, pathologists throughout the country became aware of the programme, and Dr Bird was offered brains, with consent, from many parts of the country.

In 1972 Dr Rockley, a Consultant Psychiatrist at Prestwich Hospital, who had heard about this research, wrote to Dr Bird. Following from this contact, in April 1973 the first brain from a patient with Huntington's disease was referred by the pathologist at Prestwich Hospital to the Cambridge brain bank.

Over the next 13 years the brains of 28 patients were referred from Prestwich mortuary to the Cambridge brain bank. The first referrals were brains of patients with Huntington's disease that were sent, with consent and the full support of relatives. Later, brains of patients with schizophrenia were also referred by pathologists. In patients whose deaths had been reported to the Coroner, the referral of the brain was made by the pathologist without reference to the North Manchester Coroner's office.

By 1985 the pattern of referral by pathologists between Prestwich mortuary and the Cambridge brain bank was well established and only brains that matched the specification set out in protocols distributed by the Cambridge brain bank were referred to the bank. No 'normal' brains were referred from Prestwich mortuary to the Cambridge brain bank.

The case notes of the last case referred from Prestwich mortuary to the Cambridge brain bank include a note giving the telephone number of the North Manchester Coroner's office and Mrs Langan's name as the contact point for further details, but the staff of the Coroner's office were not involved in the referral to Cambridge.

Dr Deakin, Dr Cross and Dr Slater visited Prestwich Hospital and mortuary in 1985. Dr Deakin suggests the date was either 19 or 22 April, although this date is unconfirmed. The team travelled in Dr Deakin's Vauxhall car. The visit was to meet the consultant psychiatrists at the hospital and explain the research programme to them. The team also visited the mortuary. They did not meet Dr Farrand, the pathologist who undertook most of the Coroner's post mortems at Prestwich in the late 1980s, but did see the mortician Mr Walkden. The visit is remembered by others at Prestwich Hospital.

How did the Coroner's office become involved?

I have been unable to discover when in 1985 the first contact was made between the joint research team and the North Manchester Coroner's office in Rochdale. There are no extant documents. The Coroner's office has been searched but no trace of any letters or other written evidence of the arrangement has been found.

It is clear, however, from the recollections of Dr Slater and Mrs Langan that there were a series of telephone calls between them initiated by Dr Slater.

Both Mrs Langan and Dr Slater remember these calls but not the dates. During these telephone calls Dr Slater asked Mrs Langan about the possibility of brains being obtained for the joint programme, with the agreement of the Coroner. Dr Slater did not speak to the Coroner.

Mrs Langan's recollection is that the calls were made before any Coroner's cases were identified to the research programme. Mrs Langan remembers that the phone calls were followed some time later by a visit from Dr Slater to the Coroner's office in Rochdale. Mr North was not in the office. Mrs Langan remembers that Dr Slater left a letter, which she had typed for Dr Slater, for Mr North's consideration.

The date of Dr Slater's visit remains uncertain but is remembered by other members of the office staff.

Mrs Langan states that, in keeping with the procedures in the Coroner's office at the time, she and other members of the Coroner's office staff would have taken no action without the agreement of the Coroner. She assures me that no cases were identified to the joint programme until Mr North had indicated that he agreed to the proposals Dr Slater had made in his telephone calls.

Dr Slater's recollections of the telephone calls and of details of his visit to the Coroner's office are less definite. Dr Slater remembers he left a letter for Mr North after his visit to the Coroner's office, but states that he never received a reply. Dr Slater is certain his visit was not in 1985 but later, perhaps as late as 1988. Dr Slater is clear that brains had already been identified by the Coroner's office before his visit to the office in Rochdale. The entries in the first of the brain books serve to confirm this.

In the absence of any contemporaneous data, I cannot be sure when the arrangement began or of the date of Dr Slater's visit to the Coroner's office. The available information suggests this was probably in 1986.

What is clear is that from the start of the joint programme on 1 November 1985 there was a steady flow of referrals to the programme from the Coroner's office.

The Coroners

Mr Bryan North - North Manchester (1978-1994)

None of the post mortem reports submitted to Mr North makes any reference to retention of the brain. However, the fact that brains were being retained was well known by all members of his office staff.

Mr North assures me that he did not know. He has provided me with copies of letters he wrote before and after Mr Isaacs' brain was retained in 1987. These letters spell out in clear terms the requirements of the law and state that the consent of the relatives must be obtained if the brain is to be retained for research purposes.

I find it hard to believe that Mr North was completely unaware of the activities of his staff over a ten-year period from 1985-1994.

Mr North resigned as Coroner in June 1994 on the grounds of ill health and his deputy, Mr Barrie Williams, filled the post on an interim basis until formally appointed in 1995.

Mr Leonard Gorodkin - Central Manchester (from 1978)

Although the largest number of brains was obtained for the programme from Coroner's cases in NMGH, I am satisfied that Mr Gorodkin and his staff were completely unaware of what was happening. Mr Gorodkin had made his position on organ retention clear to his pathologists and staff for many years. Mr Gorodkin has only authorised the retention of any organ for examination in order to establish the cause of death. If any organ is required for any other purpose, there would have to be consent of the next of kin.

I have examined more than 50 of the 100 Coroner's cases from NMGH submitted to Mr Gorodkin and, with a single exception, there was no mention that brains had been retained for research purposes. In view of the number of post mortem reports received, Mr Gorodkin relied on his office staff to scrutinise these and alert him to unexpected particulars.

The first occasion Mr Gorodkin could have become aware of the joint programme was during the meeting held at Professor Deakin's request on 26 June 1995.

The late Mr Hibbert - Cheshire (1988-1992)

Mr Hibbert's office staff were aware that brains were collected for research at Manchester University. When questioned by the new Coroner's Officer in 1989, they had reassured him that the brain could be retained. There is nothing to suggest Mr Hibbert was aware that brains were going to Manchester University for unconsented research. I have examined all the post mortem reports provided by the Coroner's office of the cases from Warrington General Hospital. None includes any reference to retention of the brain.

Mr Barrie Williams - North Manchester (from 1995)

After Mr Williams was appointed Coroner, the identification of suitable cases to the joint programme was a well established routine in the office, but by 1995 the number of brains identified in the Coroner's office was small compared with earlier years. Mr Williams assures me that he was totally unaware of the long-standing arrangements. Nothing was said to me by any of his staff to the contrary.

Pathologists

Examination of the post mortem reports provided for the Coroners in Manchester, North Manchester and Cheshire districts showed that, with two exceptions, these contained no mention of retention of the brains. This finding came initially as a surprise to me, as the removal of a major organ for research or for diagnostic purposes would appear to be a significant feature of the examination.

Discussion with Dr Farrand, who had carried out the post mortem on Mr Isaacs, and with other pathologists in the Manchester area, indicated that this omission did not surprise them. The removal of brains and other organs was so frequent in the 1980s that it was not a matter of comment or discussion among pathologists at the time.

There are a number of explanations for this lack of reference to organ retention.

First, before the Human Tissue Act in 1961, pathologists had been used to removing organs at post mortems that appeared to be of interest for research or teaching purposes. This practice had continued during the 1960s, little influenced by the Human Tissue Act.

Second, pathologists carrying out post mortems were trained by their seniors and followed their example and the practices of earlier years set by their seniors.

Third, some pathologists were reportedly asked by Coroners not to distress relatives by referring in their post mortem reports specifically to the retention of organs. There is nothing in writing to confirm that such instructions were given, but avoidance of distress of the relatives was so frequently mentioned that I am satisfied some Coroners did ask pathologists to refrain from mentioning organ and tissue retention in their post mortem reports.

Fourth, it is noteworthy that Schedule 10 of the Coroners Rules, which sets out the format for the post mortem examination report, refers obliquely to organ or tissue retention. The schedule does not require a list of organs and tissues that have been retained.

The Guidelines for Post Mortem Reports, issued by the Royal College of Pathologists in August 1993, recommend that the post mortem report should indicate whether material has been taken for histology and what other material has been saved. The College's 1993 Guidelines were based on best practice during previous years.

While brain retention was not overtly reported to the Coroners in and near Manchester, the practice was no different from that in other parts of the country. Brains were very widely retained after Coroners' post mortems both for diagnosis and for use in research without any reference to retention being made in the post mortem reports sent to Coroners.

Morticians and Coroner's Officers

The morticians who put aside brains from Coroners' cases for the joint programme in North Manchester were under the impression that the instructions had come from the Coroner. At least one of the morticians became concerned that the relatives were in ignorance, but believed the Coroner's authority was sufficient.

For similar reasons, the Coroner's Officers in the North Manchester district were misled. However, a newly appointed Coroner's Officer in the Cheshire district questioned the retention of a brain on the first occasion he became aware of the system. The Coroner's Officer was wrongly reassured.

In the Central Manchester district the position of the mortician, Mr Leatherbarrow, has already been described. The Coroner's Officers and staff of Mr Gorodkin's office were unaware of the large number of brains that were being collected for research.

NHS authorities

All the mortuaries that provided brains for the programmes were in NHS hospitals with the exception of the Rochdale public mortuary. Hospital cases were referred to Rochdale mortuary as no post mortems were carried out at Birch Hill Hospital during the period in question.

The NHS authorities were unaware of the collection of brains for research from Coroners' cases, including those of deaths among inpatients that had been reported to the Coroner for other reasons.

What happened to the brains collected in the joint programme?

Most of the brains collected were used for the joint research programme. During the research procedures, the brain substance and structure were lost, so that at the end of the procedure there was no residue for disposal.

Some brains that were collected were not used in the research programme, as investigations of the deceased's medical history showed that they had not suffered from the neuropsychiatric disease for which their brain had been obtained, or, in the case of 'controls', that the medical history was unavailable or indicated some previous mental illness. Brains unsuitable for use in the research programme and brain tissues not used for research were disposed of by incineration as clinical waste.

A small number of brains unsuitable for study in the joint programme were transferred to research teams in other locations. On three occasions samples of brain were provided for research carried out with pharmaceutical companies.

In no cases were the brains returned to the family for burial.

What happened to Mr Isaacs' brain?

This investigation started with the retention of Mr Isaacs' brain; it is therefore important to record my findings of what happened in his particular case.

The brain books of the joint programme indicate that Mr Isaacs' brain was not used for research as Dr Rosenberg, Mr Isaacs' general practitioner, did not provide any information about Mr Isaacs' previous health.

Two members of the research team recalled that a number of brains were disposed of in approximately 1993. Their conclusion was that Mr Isaacs' brain had been disposed of at that date. There is, however, no written evidence of this.

It was important to ensure that Mr Isaacs' brain had not been transferred for research, either to another research team in Manchester or to teams in other parts of the country that had received a small number of brains collected by the joint programme.

The records of other brain collections in Manchester were checked. There is no record in any of these to suggest Mr Isaacs' brain was transferred.

There are also references in the joint programme brain books to seven other locations or individuals who might have received Mr Isaacs' brain. These were all visited and their records checked. There is no record of Mr Isaacs' brain being transferred elsewhere.

Other research records in Manchester University were examined to see if any other organs of Mr Isaacs had been retained. Nothing was found in any of these checks to suggest that any of Mr Isaacs' other organs were transferred elsewhere. This point confirms the recollections of Dr Farrand, the pathologist, and Mr Walkden, the mortician, who were present at the post mortem examination.

My conclusion is that Mr Isaacs' brain was disposed of after it was decided that it could not be used in the research programme. None of his other organs was retained for research.

The wider scope of the investigation

In the next phase it was necessary to investigate whether brains had been collected in other locations for research without the knowledge of the relatives. The Census of retained organs carried out by the Chief Medical Officer in 2000 had shown that brain retention was widespread in the years 1970-1999.

In view of the large number of NHS hospitals that had reported collections of brains during the Census, it was decided to focus the investigation on the universities and NHS Trusts that had had some contact with the joint programme in Manchester, as indicated by entries in the brain books. Within the time scale of the investigation, it was simply not possible to visit every location that had reported a collection of retained brains in the CMO's Census.

Different types of brain collections and brain archives

The wider phase of the investigation showed there are three types of collection that include brains from Coroners' cases, unknown to the relatives.

Brains specifically collected for research

These collections are few in number and are distinguished from the other collections by the fact that the brains were obtained solely for research. There was no prior intention to carry out any diagnostic procedure or to inform the Coroner of the results of the research investigations. Many of the brains obtained from the joint programme in Manchester were in this category, as were some of the brains collected by the brain bank in Cambridge.

Brains initially collected for diagnostic purposes, but later used for research

These collections include by far the largest number of brains held in the centres that I have investigated. The brains were referred for histological examination from hospital and Coroners' post mortems. Once the histological examination had been concluded the brains were set aside, but at a later date were used in research studies. Some of these studies had a direct relevance to the disease or condition from which the deceased had suffered, but this was not necessarily always so.

A diagnostic report would have been made available to the referring doctor in the case of a hospital post mortem, or to the Coroner as appropriate, but the results of the research investigation would not be sent to the referring doctor or to the Coroner.

Accumulations of brains

The third type of brain collection are those where brains initially referred for diagnosis are set aside once the diagnostic process is completed. Over time, more and more brains have accumulated without any research or other use being intended.

Some accumulations have occurred simply because neither the Coroner nor the pathologists gave instructions regarding disposal of these brains.

In practice, many brain collections include brains from the latter two categories. However, the important difference between the first category and the other two is that the sole reason for retaining the brain was for research (or, in some locations, for teaching use).

Did research on brains take place elsewhere without the knowledge of the relatives?

As a direct result of the findings in Manchester, it was necessary to follow up the brains transferred from Prestwich mortuary to the Cambridge brain bank to see if there was a link to the North Manchester Coroner's office. I am satisfied that the Coroner's office was not involved in the referral of brains to Cambridge.

Other brain collections that had a direct link to the joint team were at the Clinical Research Centre at Northwick Park (now closed), Oxford, St George's Hospital in London and the Corsellis collection, now held at the West London NHS Mental Health Trust.

During the investigation I was approached by relatives who believed that organs had been retained during Coroners' post mortems in other locations, including Nottingham and London.

A series of visits demonstrated that research on brains retained in the first two categories described above was frequently undertaken, but the circumstances of these studies varied widely.

The responses to the questionnaires from centres that held brain collections and archives but which I have not visited, show that the retention of brains from Coroners' cases was very widespread. In only four locations were any attempts made to obtain consent from the relatives, and these were sporadic.

The Cambridge brain bank

This brain bank was one of the first in the world to be set up, and started as a result of the interest of Dr E D Bird in researching the brains of patients with Huntington's disease. This programme, which began in 1970, had the enthusiastic support of the relatives who encouraged other relatives to contact Dr Bird whenever the death of a patient with Huntington's disease occurred.

Dr Bird's programme took place within a research unit supported by the Medical Research Council (MRC). The programme evolved so that in 1985 the MRC awarded a major programme grant for the banking of brains and brain tissues. The brain bank was expected to supply other researchers with suitable samples.

In 1987 the main purpose of the Cambridge brain bank changed after Cambridge was one of the centres chosen to carry through a large scale prospective study of ageing, including the dementias of old age. Before this study began, a research nurse had been appointed by the brain bank for a local epidemiological study of dementia which had also been funded by the MRC. One of the main tasks of the research nurse was to make contact with the relatives during a patient's illness and, when a patient died, to request consent for study of the brain.

The current research programme of the Cambridge brain bank takes place with the full knowledge and consent of the relatives.

This, however, has not always been the case. From the late 1970s, many brains were collected from Coroner's post mortems carried out at the mortuary at Addenbrooke's Hospital without the knowledge of the relatives. A simple system was in use to identify brains that would be of interest to the brain bank, either as index or 'control' cases.

The senior technician in the brain bank would visit the mortuary early each morning to review the list of post mortems for the day. The technician would then report to the person in charge of the brain bank who, in turn, would ask the pathologist to retain the brain of any case of interest to the