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The Investigation of Events that followed the death of Cyril Mark Isaacs
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CHAPTER 12

Prestwich mortuary

Application to the Salford Ethics Committee, January 1986

Introduction

This chapter describes the research protocol submitted to Salford Ethics Committee (SEC) that was considered on 15 January 1986, and the chronology of the brains obtained from Prestwich mortuary.
Sources of information
The chapter is based on documents provided by Professor Deakin and the minutes and papers of the SEC.
Background
Following the 1974 NHS reorganisation, Prestwich Hospital became part of Salford Area Health Authority. The SEC had responsibility for consideration of research projects that affected patients in Prestwich Hospital. (The designation Salford Ethics Committee changed in 1991 to Salford Local Research Ethics Committee (LREC)). For consistency, the earlier name is used throughout the rest of this chapter.
In 1987 Circular HC(77)28 was the most recent advice to the NHS on the 'Removal of Human Tissue at Post Mortem Examination', Chapter 6.
Discussions and correspondence preceding the application to Salford EC
Dr Som Soni, consultant psychiatrist at Prestwich Hospital, had carried out research and clinical reviews of long-stay patients in Prestwich Hospital. His findings offered a unique opportunity to relate clinical features to post mortem changes.
Discussions in the spring of 1985 with Dr Soni and other clinical colleagues at Prestwich Hospital had indicated that the joint team would, in principle, be able to obtain the brains of patients who died in Prestwich Hospital with neuropsychiatric diseases. These discussions had been on the understanding that consent would be obtained from the relatives. As Chapter 8 documented, the Cerebral Function Unit was already obtaining brains from Prestwich hospital on the same basis.
Dr Soni wrote to Dr Deakin on 31 July 1985 enclosing: 'copies of the literature on getting consents for post mortem studies. Perhaps you would like to go through this and decide on a protocol, which we can then get printed for our patients at Prestwich Hospital'.
Dr Deakin replied on 2 October 1985: 'I enclose a draft submission to the Prestwich Ethical Committee. Do you think there might be some mileage in meeting groups of relatives ward by ward to speed things up?'
The version of the protocol submitted to the SEC is no longer available. Annex 31 is a copy of the draft enclosed with Dr Deakin's letter. (Two pages are unfortunately missing from this document).
The title of the project was: 'Brain Research in Schizophrenia and Tardive Dyskinesia'.
This includes a section headed 'Request for Brain Tissue': 'The consent for postmortem will be obtained in advance from the patient (if possible) and his relatives. It is not an easy matter to make a request of this nature, but is vital if progress in understanding and treating schizophrenia is to be made. It is important that relatives of patients with schizophrenia are involved in this decision; we must safeguard any wishes that patients may have but may not be able to express. Where possible, the decision will be discussed with patients and their relatives. Such requests have been successfully made in areas of research on other illnesses such as multiple sclerosis and Parkinsonism. A standard form has been prepared based on the forms used by the Multiple Sclerosis Society of Great Britain and by the Parkinsonism Research Group (copies of form and related documents enclosed)'.
As this research focussed on hospital inpatients with a diagnosis of schizophrenia, the draft protocol did not mention control cases or refer to collection of brains from Coroners' post mortems.
The SEC meeting and minutes
The application was considered by the SEC on 15 January 1986, as project number 8608. The title of the proposal had not changed from the draft.
The relevant minute reads: 'Brain research in schizophrenia and tardive dyskinesia'
'Dr Deakin and Dr Soni attended the meeting. The protocol explained that a programme of research has been set up, at Manchester University, to investigate brains of schizophrenic patients with a view to elucidating the abnormalities of biochemistry relevant to the illness. Researchers at the university are now able to study the chemistry of brain cells in remarkable detail. Very careful records have been kept at Prestwich Hospital of all patients but especially those with schizophrenia, (done in connection with a separate study on tardive dyskinesia, in progress since 1981). The records include not only detailed treatment profiles but also a chronological change in the clinical picture. These records should enable them to determine which brain systems are involved in schizophrenia but correlating the postmortem findings with the antemortem clinical pictures. It may also delineate the reasons why some patients develop dyskinesia and not others. This study is a long term project which will involve continuing clinical documentation on long stay patients at present resident in Prestwich Hospital. This will involve not only assessment of clinical parameters of schizophrenia but also documentation of psychological and psychometric tests on the population. When any of these patients die from any cause, the brain will be retrieved at postmortem as soon after death as possible. This will then be subjected to the research procedures at Manchester University. The consent for postmortem will be obtained in advance from the patient (if possible) and his relatives. Informed written consent will be obtained on a special form submitted with the protocol'.
The SEC: 'had no ethical objection to the study'.
Features of the SEC's minute
The minute refers to patients with schizophrenia but there is no mention of Alzheimer's disease.
The retention of brains from 'normal' controls and from cases of sudden death reported to the Coroner are not mentioned.
SEC minutes after January 1986
There are no further references in the minutes of SEC to research applications using brain tissue from Dr Deakin jointly with Dr Soni. The SEC did not receive any progress reports and no changes to the protocol were notified to the Committee(1). The SEC did not receive any proposals from Dr Slater. Dr Soni submitted applications to the Committee on other matters until the 1990s.

Chronology of brains obtained from Prestwich mortuary 1985-1989

The Cerebral Function Unit had been collecting brains, with the knowledge and consent of the relatives, from Prestwich mortuary before the joint programme started.
The first brain for the joint programme was obtained from Prestwich mortuary on 1 November 1985. This mortuary was the source of 43 of the 58 brains obtained before brain collection was suspended in May 1987.
When brain collection recommenced in February 1988, the main source of brains was the mortuary at North Manchester General Hospital, Chapter 13. Five brains were obtained from Coroner's cases at Prestwich mortuary between April 1988 and 18 July 1989 when the last brain was received. Three of these were from in-patients with neuropsychiatric diseases whose deaths had been reported to the Coroner, and the other two from sudden deaths in the community.
Post mortem examinations at Prestwich mortuary ended in August 1989. After that date, further brains were obtained from in-patients who died in Prestwich Hospital but the post mortems were carried out at Bury mortuary(2).
Analysis of all brains from Prestwich mortuary
Fifty-three brains were obtained through Prestwich mortuary between 1985 and 1989.
Thirty-four brains, including Mr Isaacs', were obtained from Coroner's autopsies into cases of sudden death in the community. (These deaths can be easily distinguished as they are listed in the Mortuary Register of 'Police Outside Deaths'). Twenty-one are categorised in the brain books as 'controls'.
Eleven brains were obtained from post mortems on in-patients at Prestwich Hospital whose deaths were reported to the Coroner. Most of these patients had some pre-existing neuropsychiatric disease.
Seven brains were obtained from post mortems on hospital cases without any involvement of the Coroner. In five of these, the brain was initially retained for the Cerebral Function Unit. Parts of these five brains were later transferred to the joint programme by Professor Mann.
The last brain collected from Prestwich was obtained on 18 July 1989.
Brain collection in relation to Ethics Committee consideration
Five brains recorded as part of the joint programme were obtained prior to 15 January 1986 when the SEC considered the protocol submitted by Dr Deakin and Dr Soni. These five were all Coroner's cases, including one in-patient whose death had been reported to the Coroner. In addition, there were 15 other brains collected before January 1986 which are not included in the list of brains collected for the joint programme. These brains were obtained for research without reference to any Ethical Committee.
Dr Slater, in commenting on the collection of brains prior to consideration by the SEC, has stated:
 'It is a fact that in making grant applications in the UK one can be in an impossible situation. No project would ever get funded if there is doubt about securing the material, brain samples in this case, or if no pilot study has been made. I have already said that brain 'collection' was entirely random. Thus no brain samples and no pilot study equals no funding and no research on serious diseases. This is even more true today'.
Summary
A research protocol was submitted to the SEC and considered by the Committee on 15 January 1986.
The protocol referred to studies of the brains of patients with neuropsychiatric conditions.
The patient and/or the relatives were to be asked to give consent to brain retention.
The protocol did not refer to collection of 'control' brains or brains from Coroner's cases.
Five brains were obtained before the SEC had considered the protocol and a further 15 brains were collected that were recorded in the brain books but not considered a part of the joint programme.
Although these brains were collected for research, no Ethical Committee had been consulted.
Thirty-four brains were from sudden deaths in the community of which 21 are categorised as controls.
Eleven of the brains from Coroner's cases were from in-patients with neuropsychiatric diseases.
Seven brains were obtained from hospital post mortems, of which five were initially collected for the CFU programme.
Prestwich mortuary provided 43 of the 58 brains obtained for the joint programme before collection was suspended in May 1987.
After brain collection resumed, nine more brains were collected before post mortems at the mortuary ended in August 1989.
References
1  SEC minutes 1986-1996.
2  Data provided by Mental Health Services of Salford NHS Trust.



 
       
 

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