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The Investigation of Events that followed the death of Cyril Mark Isaacs
(rule)

CHAPTER 44

Legislation on the use of bodies, organs and tissues; Coroners' post mortems;
procedures and alternatives

Introduction

This is the first of three chapters that address the fourth of my Terms of Reference. This chapter discusses the use of organs and tissues from hospital and Coroners' post mortems for research and teaching in the light of current legislation, and the findings made during this investigation. Alternatives to post mortems in some types of Coroners' case are considered.
The investigation of sudden, unexpected and violent deaths
There are three enduring reasons for the proper investigation of all deaths that occur suddenly after accidents or in unexpected and suspicious circumstances. These are:

-  to discover the cause of death in sudden and unexpected deaths;

-  to detect evidence of foul play;

-  to identify avoidable factors and prevent the same circumstances recurring.

The responsibility to investigate such deaths and the powers to do so are now exercised by Coroners in the 136 districts in England. In practice, deaths are reported to Coroners by doctors, the police, the Registrars of Births and Deaths, and occasionally by relatives.
A legal framework for the investigation of unexpected deaths will always be necessary. At present, within each district the Coroner has the absolute right, subject only to intervention by the High Court, to decide whether a post mortem should be undertaken in any death reported to him.
Home Office review
In 2001 the Home Office set up a fundamental review of all aspects of the role of Coroners and coronial services. The Terms of Reference of the review are at Annex 7.
As future arrangements for the investigation of deaths that are currently reported to Coroners and proposals for a medical auditor service are central to the work of the Coroner Services Review, these subjects are not discussed in this report. Some other subjects overlap with the review and these are noted accordingly where they occur in this chapter.
Background to retention of organs and tissues
Historically, the use of bodies and body parts for medical teaching and research was controversial because of the emphasis then given by Judeo-Christian religions on the importance of the body remaining intact.
Before the Anatomy Act of 1832 it was only lawful to dissect the bodies of criminals executed for murder, but not for other capital crimes. As a result, the 'trade' of body snatching was developed to satisfy the requirements of medical schools to teach anatomy.
Rather than rob graves, Burke and Hare resorted to murder to provide bodies for the Edinburgh Medical School. The Anatomy Act was the direct result of their crimes. It became law after the execution of Burke, whose body was given to the Edinburgh Medical School for dissection.
The 1832 Act survived virtually unchanged until 1984 when it was replaced by the present Act.
There was in the 1832 Act an important principle that was carried forward into the Human Tissue Act 1961 and to the revision of the Anatomy Act in 1984, that if the relatives objected the body could not be used for the purposes permitted by the Act.
Anatomy Act 1832: objections by relatives
Section VII of the 1832 Anatomy Act permitted anatomical examination of those who had expressed this wish in life 'unless the surviving Husband or Wife, or any known Relative of the deceased Person, shall require the Body to be interred without such examination'. Put simply, any relative was given the legal right to object to the use of a body for anatomical dissection.
The Human Tissue Act 1961
This Act was intended to regulate the retention of body parts from post mortems which had not previously been specifically regulated, provided the relatives had no objections.
In this context the Human Tissue Act, Clause 1(2), refers to the person in possession of the body 'having made such reasonable enquiry as may be practicable, he has no reason to believe -

(a) that the deceased had expressed an objection to his body being so dealt with after his death, and had not withdrawn it; or

(b) that the surviving spouse or any surviving relative of the deceased objects to the body being so dealt with.'

Similar wording is contained in Section 4(3)(b) of the 1984 Anatomy Act.
Both the Human Tissue Act and the Anatomy Act clearly intend that the views of the relatives should be sought. When the relatives object, the Acts are clear that these objections should prevail over the intended use of the body or organ or tissue.
Differences between the Anatomy Act and the Human Tissue Act
An important feature of the 1984 Anatomy Act was the introduction of regulations. These require detailed record keeping not only of all bodies and body parts held under the Act but also of the names and addresses of the relative or executor who has authorised the donation of the body and/or the retention of body parts.
The Human Tissue Act does not require any records to be kept.
Whereas the 1832 Anatomy Act included criminal penalties for non-compliance that have been maintained in the 1984 Anatomy Act, the Human Tissue Act does not include any penalties.
The 'lack of objection' by the relatives was intended as an important safeguard. Had the Human Tissue Act required record keeping and included penalties for non-compliance it is unlikely that brain retention on the scale discovered during this investigation would have occurred.
Organ and tissue retention in hospital and Coroners' cases
For the reasons discussed in Chapter 43, the requirement of relatives' consent to a hospital post mortem has been ineffective in preventing organ and tissue retention without the knowledge of the relatives. Few relatives when asked to consent to a post mortem knew that organ and tissue retention might result from their agreement.
In a Coroner's post mortem, the Coroners Rules should have prevented retention of organs and tissues for teaching and research that had no bearing on the cause of death.
Coroners Act and Rules
As described in earlier chapters, the Coroners Rules derive their authority from the Coroners Act 1988, and Rule 9 states:
'A person making a post-mortem examination shall make provisions, so far as possible, for the preservation of material which in his opinion bears upon the cause of death for such a period as the coroner thinks fit'.
To comply with the Human Tissue Act the relatives should have been asked if they had objections to further retention and to the use of organs or tissues for research or teaching, once the Coroner had no further need to retain the 'material'.
This rarely happened. Retention continued, as many pathologists were not given directions about disposal. Coroners report that they had left further retention to the discretion of the pathologists. Pathologists and Coroners had relied on 'common sense' with the result that brains, other organs and tissues from Coroners' post mortems accumulated in pathology departments, Chapter 7.
It is no surprise that these accumulations of brains and other organs were later used for teaching or research, Chapter 34.
Had Rule 9 been observed, these accumulations would not have been available for research after the Coroner had no further need of the 'material'.
Alternatively, the relatives could have been asked whether they were content for the 'material' to be donated for research or teaching. This is what now happens in an increasing number of places.
Consent forms for hospital post mortems
The inadequacies of hospital consent forms for post mortem have already been discussed. The forms used in the past did not give the relatives the information they needed to make an informed decision.
Many members of the public are also now much better informed of their rights.
For the future, the legal imperative for retention of body parts (including brains) after hospital post mortems is clear - the relatives must give their consent. The alternative phraseology, that the relatives 'have no objection', does not satisfy the anxieties that relatives have expressed. Their trust in the present arrangements has been undermined.
The Department of Health is consulting on new forms that will rectify this deficiency and provide relatives with the information they need to make an informed choice on hospital post mortems and the retention of organs and tissues.
Refusals of hospital post mortems and threats to report deaths to Coroners
During the course of this investigation I was told by relatives of their experiences of pressure from doctors exerted on them to agree to a hospital post mortem. When these relatives refused they were told the death would be reported to the Coroner. In one case the relatives had already been given the death certificate, but had the presence of mind to speak immediately to the Coroner and explain what had transpired. When the death was later reported to him, the Coroner refused to order a post mortem.
While this incident is outside my Terms of Reference, the use of threats by doctors to report a death to the Coroner to force relatives to consent to a hospital post mortem is a form of duress and totally unacceptable.
Deaths reported to the Coroner and frequency of post mortems
The next sections of this chapter overlap to an extent with the Review of Coroner Services.
In England and Wales in 2001 over 200,000 deaths were reported to the Coroner. Post mortem examinations were undertaken in over 120,000 cases.
In England and Wales the overall Coroners' post mortem rate amounted to 23 per cent of all deaths, whereas in Scotland the post mortem rate on the instructions of the Procurator Fiscal was 15 per cent and in Northern Ireland nine per cent.
Are Coroners' post mortems always necessary?
The above differences in post mortem rates pose the question whether all Coroners' post mortems are really necessary. Several Coroners questioned the need for, and value of, post mortems in many of the deaths reported to them, as the examination added little information to that available from other sources. While all cases reported should be considered on their individual circumstances, Coroners identified the following categories of death where a post mortem may not be needed in every case.
Deaths in those with known life threatening disease.
A category of 'natural' deaths currently reported to the Coroner are those where the deceased is known to have life threatening disease such as advanced cancer or severe heart disease. If the deceased had not seen a doctor in the last 14 days of his life, the doctor is not permitted to sign a death certificate. The 14 day time limit is arbitrary, but when the doctor knows that death was inevitable, the need for a Coroner's post mortem and the value of the examination is questionable.
Deaths from some types of accident
The circumstances of all deaths from accidents require investigation. Where injuries from an accident are incompatible with life, such as decapitation, the purpose and value of the post mortem examination can be difficult to justify.
The internal examination is of little help to the Coroner in determining how the deceased met his death. On the other hand, toxicology texts for alcohol and/or drugs may contribute vital information.
Extreme old age
The need for a post mortem examination in centenarians was questioned during the course of this investigation, but some Coroners consider a post mortem may still be necessary in extreme old age where there is no known pre-existing disease.
Alternatives to post mortem
There remain a substantial number of mainly sudden deaths reported to the Coroner that do not fall within the above categories. In these deaths, some means of identifying the cause is still required. During the investigation the following options were identified by Coroners and others.
Magnetic Resonance Imaging as an alternative to post mortem
While all sudden deaths require investigation, many will be due to natural causes such as a stroke or heart attack. A post mortem has hitherto been regarded as the only way to establish why the deceased died.
A preliminary trial carried out in Manchester compared the results of Magnetic Resonance Imaging (MRI) in cases of sudden death with the findings of conventional post mortems. This technique is already used extensively for imaging of the interior of the body for diagnostic purposes. Following that study, the Coroner for Central Manchester will now accept a cause of death identified through MRI when the findings are clear-cut. Where no cause of death can be found on the MRI scan, a post mortem examination will follow.
Other Coroners have been willing to accept a cause of death identified by this technique. However, MRI is successful in only a proportion of cases. The use of the technique does not guarantee that a post mortem will be avoided. All Coroners who have accepted a cause of death based on MRI emphasise that there must be certainty that the cause of death has been established.
MRI has been used by the Jewish faith community in Manchester and by others who, for reasons discussed in the next chapter, object in principle to interference with the body after death. Coroners who will accept MRI all emphasise that the option of this technique is open to all relatives who will meet the costs in order to avoid a post mortem examination, and is not confined to particular faith groups.
The potential of MRI as an alternative to post mortem requires further evaluation. The costs are substantial and current availability is very limited.
A limited post mortem
Many relatives do not understand why it is necessary to conduct a full post mortem when an obvious cause can be found from a limited examination. In practice, the main objection is to the opening of the skull to examine the brain when the cause of death has been identified in the chest or abdomen. The relatives argue that the post mortem examination should end once a cause of death has been found.
Coroners who contributed to this investigation generally agreed with this argument. Some had given instructions that the skull should not be opened without their consent when a cause of death had been found in the chest or abdomen.
The concept of a limited post mortem could be extended further.
Toxicology
Coroners often referred to toxicology as 'an under-used resource'. The findings from specific tests for drugs and other toxic substances are reported by Coroners to be more informative than post mortem examination in some cases.
The importance of toxicology as an adjunct but not an alternative to post mortem has been emphasised in the First Report of the Shipman Inquiry.
A different approach to the investigation of sudden death
Several Coroners expressed concern at the number of post mortem examinations which did not add significantly to the information already known about the patient's medical condition before death. There were often cases where no doctor was willing to sign the death certificate as the deceased had not recently been seen.
A Coroner who is concerned about the proportion of post mortems that yield little additional information to what is already known about the medical condition of the deceased but which cause much distress to the relatives, commented to me that:

- a careful description of the scene and circumstances of a death,

- a meticulous external examination of the body, and

- toxicology testing as appropriate

could provide a sufficient basis to establish that the cause of death was not 'unnatural' .
These are matters that are under consideration by the Review of Coroners Services and the Shipman Inquiry, but such an approach would only be relevant to deaths of those known to have pre-existing life threatening diseases.
Deaths in suspicious circumstances
It must be emphasised that deaths with any unusual or suspicious features will always require a post mortem, as will some other categories of death reported to Coroners, for example those due to industrial diseases.
Retention of organs and tissues after a Coroner's post mortem
In all post mortems undertaken for the Coroner there will be some where the pathologist is unable to determine the cause of death from the naked eye findings and histological examination will be necessary. The pathologist must be able to retain organs and tissues, including the brain, in these cases.
When organs or tissues are retained it is essential that the relatives are told what has been retained and why retention is necessary. With this information the relatives can decide whether:

-  to delay the funeral so that the organs and tissues can be returned to the body before burial or cremation;

- to dispose of the retained organ or tissue separately when the Coroner's investigations are complete;

- to donate the retained parts to the hospital or other institution for medical teaching or research.

Under Rule 9, the retention of 'material' remains in force until the Coroner decides further retention is not required. Retention can be extended provided the relatives have no objections, but to comply with the Human Tissue Act they must be asked.
There is an important exception where criminal and/or civil actions may follow. The Crown Prosecution Service has provided guidance on circumstances when retention may be justified in criminal cases. The legal considerations when civil proceedings may follow are beyond the scope of this investigation.

An alternative to brain retention in Coroners' cases

For the reasons described in Chapter 7, it is normally impossible to carry out histological examination of the brain in less than four to six weeks while the brain is 'fixed'. In other parts of the world, notably New Zealand, the use of microwaves has been attempted to expedite fixation to allow the brain to be reunited with the body within 48 hours of the post mortem examination.
The acceptability of this technique has not been explored among those who object to organ retention. There is, however, a substantial practical objection, as many neuropathologists describe the resulting histological examination as 'unsatisfactory'.
Organ transplantation
The possibility of organ transplantation when the deceased carried an organ donor card adds a further urgent dimension to the removal of major organs for life-saving procedures to benefit others. In natural deaths that are not reported to the Coroner, the relatives, where they are readily contactable, can give consent to organ removal for transplantation.
Many deaths where organ donation might follow need to be reported to the Coroner. In these circumstances organ removal for transplantation is at the Coroner's discretion, provided the relatives also agree. During this investigation, Coroners who mentioned transplantation stated that they would normally agree to organ removal for transplantation provided this did not impede their pathologist's ability to determine the cause of death.
Audit of Coroners' post mortems
The review of Coroner services is considering how these services should in future be subject to audit and quality assurance.

This investigation has shown that there are no current checks on the standard of Coroners' post mortems and no independent quality assessment of other aspects of the service. These findings reinforce the provisional conclusions of the Coroner Services Review that audit and quality assurance should be built into any new arrangements.

Responsibility for Coroners' post mortems carried out in NHS mortuaries
One crucial finding from this investigation is the uncertainty over who is responsible for the conduct of staff involved in post mortems undertaken for Coroners in NHS hospital mortuaries. While the pathologist undertakes the post mortem on the instructions of the Coroner, the other staff are NHS employees.
In the incident in the Medico Legal Centre at Sheffield, reported in Chapter 36, the City Council investigated what had happened as the Council were responsible for the premises and mortuary staff involved but not for the pathologist.
There is no similar clarity of responsibility where Coroners' post mortems are carried out in NHS hospital mortuaries. In an NHS mortuary the body of the deceased will be under the jurisdiction of the Coroner, but the mortuary staff will be employees of the NHS and the Coroner will pay the pathologist.
While there may be a fee paid to the NHS Trust for each post mortem (or an annual contract between the Coroner and the NHS Trust for use of the mortuary), the practical consequences cause confusion.
Many Coroners reported that they did not regard themselves as responsible for the actions of NHS employed staff when the latter were assisting the pathologist with a Coroner's post mortem, while Trusts considered the Coroner was responsible for bodies that were under his control.
Coroners who were legally rather than medically qualified stated they could not be held responsible for the actions of NHS mortuary staff or supervise what happened in the mortuary to ensure that organs and tissues were not inappropriately removed.
Put simply, the issue is 'who should police the mortuary' to check that organs and tissues are not retained after Coroners' post mortems, except when retention is authorised by the Coroner and/or with the consent of the relatives?
The responsibility for the conduct of Coroners' post mortems in NHS mortuaries is further confused when examinations of hospital and Coroners' cases are undertaken at the same time or in random order.
Summary
The Home Office has established a fundamental Review of Coroner Services.
Post mortem examinations will always be required to identify the cause of death when this is unknown. This responsibility rests with the Coroner.
Hospital post mortems can only proceed with the consent of the relatives, but the Human Tissue Act requires that organs and tissues are only retained when the relatives have no objection.
It must never be assumed that the relatives have no objections. Some inquires must be made on this point.
In a Coroner's case, Rule 9 of the Coroners Rules authorises retention of 'material' where this is relevant to the cause of death.
When the Coroner decides the 'material' is no longer needed, organs and tissues can only be further retained so long as the relatives have no objection. There is exception when criminal proceedings may follow.
The continued retention of organs and tissues for civil proceedings requires clarification.
A large proportion of Coroners' post mortems are carried out where the circumstances of the death may not need a 'routine' post mortem. Alternatives to post mortem examination should be considered in such cases.
For other unexplained deaths, the potential of Magnetic Resonance Imaging requires further evaluation.
The use of a 'limited post mortem' should be explored where there are personal or religious objections to post mortem.