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Interim Report: Removal and retention of human material

Part I: Introduction

Background
Problems of language and definitions
Post-mortem examination - the two types
Consent and objection
'Removal' and 'retention'
Periods of time during which human material may need to be retained for the purpose of a post-mortem
Statistical context

  1. This is an Interim Report. It is published in advance of the Inquiry's Final Report so that it can be taken into account by the Chief Medical Officer for England. He is currently undertaking an investigation into organ and tissue retention in England to consider what the issues are and what needs to be done in the longer term. He will be making a final report to Ministers in September following which comprehensive advice will be issued to the NHS. We commend our views to him.

    Background

  2. We concentrate on parents[1] and their children, since they are the central concern of our Inquiry. The terms of reference of this Inquiry require us to consider the paediatric cardiac service provided at the Bristol Royal Infirmary[2] from 1984-1995. Where a child died after surgery, the treatment of the child's body after death, and treatment of the child's parents, clearly fall to be considered as part of our examination of that service. Further, it soon became evident to us that this was an issue of great and grave concern.
  3. The Inquiry took evidence on this issue, both written and oral, from parents of children who had undergone post-mortem examinations following paediatric cardiac surgery at Bristol, from clinicians and other professionals directly involved in that process in Bristol; and from Royal Colleges, the Coroners' Society, the Home Office and the Department of Health in relation to the national framework within which that process took place.[3]
  4. The issue of concern was that, without the realisation of parents, tissue had, over a long period of time, been systematically taken at or after post-mortems on children who had died following paediatric cardiac surgery at Bristol. The tissue had been removed and retained by the pathologists at the UBH/T[4] and used for a variety of purposes, including audit, medical education or research, or had simply been stored.

     

  5. When the practice of tissue retention came to light in Bristol, there was, both in Bristol and elsewhere, an outcry from parents. They sought information about whether tissue had been removed from their children. Once informed, some asked for organs and tissue to be returned for burial. In response, an extensive search was carried out in Bristol to discover what tissue had been removed, and once removed, what had become of it. Parents were notified and, if they wished it, their child's tissue was returned to them. Not surprisingly, given the scale of the exercise and the time period covered, mistakes were made about whether in fact tissue had or had not been removed and retained. Some parents were misinformed, only later to learn the real circumstances.[5] The additional pain and distress is a cause of the greatest concern.
  6. The press and other media gave considerable publicity to the evidence of Professor Anderson[6] in September 1999 in which he described the various collections of tissue which existed around the country. As a consequence, parents whose children had died in hospital (not necessarily as a consequence of paediatric cardiac surgery), sought information from the hospitals named by Professor Anderson.[7]
  7. In late 1999, the Secretary of State asked the Chief Medical Officer of England to prepare an inventory of centres where tissue was held and of the tissue retained and to review current practice with a view to making recommendations.

    Problems of language and definitions

    Tissue

  8. There is no definition of 'organ' or 'tissue' in the relevant statutes. The word 'tissue' has come to be understood by some as a generic term including not only small sections of tissue but whole organs and parts of organs. This is not, however, how the term tissue is understood in everyday language. Indeed, most people would not regard organs as being properly described as tissue. Herein lies one of the many barriers to communication and understanding which are at the root of the problem we are examining.
  9. Black's Medical Dictionary defines tissue as: 'The simple elements from which the various parts and organs are found to be built... It is customary to divide the tissues into five groups: epithelial tissues, connective tissues, muscular tissues, nervous tissues and wandering corpuscles of the blood and lymph' and defines organ as:'A collection of different tissues that form a distinct structure in the body with a particular function or functions... [for example] the kidneys, brain and heart.'
  10. The report of the Nuffield Council on Bioethics, Human Tissue Ethical and Legal Issues, [8] took the term tissue to include: 'Organs, parts of organs, cells and tissue, sub-cellular structures and cell products, blood...'.
  11. To avoid the confusions associated with all other suggested definitions we will adopt in this report our own general term, 'human material', which includes not only tissue in its various forms, organs and parts of organs but extends also to any other material such as amputated limbs. We emphasise that the term 'human material' is not a legal term. (Thus, we do not use it in Annex B, where we discuss the relevant law.)

     

    Post-mortem examination - the two types

  12. When a person dies in hospital, the attending doctor completes a medical certificate of cause of death. The certificate is then taken, by parents in the case of a child, to the Registrar so as to register the death.
  13. As a matter of law, a Registrar is obliged to refer to the Coroner deaths which fall into a number of categories, including those where the cause of death appears to be unknown, or which appear to have occurred during an operation. In practice, in many such cases it is the doctor who contacts the Coroner's office directly. The Coroner may decide to order a post-mortem, or he may consider that there is sufficient information for a death certificate to be issued. The purpose of carrying out a Coroner's post-mortem is limited in law to establishing the cause of death of the deceased. This is considered in full in Annex B.
  14. There is another kind of post-mortem, known as a hospital or a consent post-mortem. The rationale, authority and legal framework for this type of post-mortem is entirely different from that for a Coroner's post-mortem. A hospital post-mortem arises for a number of reasons, one primary reason being where it would be beneficial to medical care to study the cause of death in greater detail. Such an examination may also be carried out with a view to obtaining human material for the purposes of medical education or research. Although this is often referred to as a post-mortem examination, strictly speaking it is not a post-mortem at all, but a procedure aimed at removing and retaining human material. The legal framework is not the Coroners Act 1988 (the 1988 Act) but the Human Tissue Act 1961 (the 1961 Act).
  15. It follows that a Coroner's post-mortem should not serve as a vehicle for a number of other medical or scientific purposes, however worthy or beneficial these may be. But, given that when a post-mortem is not requested or directed by the Coroner, the hospital must make enquiries as to whether parents object to a so-called hospital or consent post-mortem, and that such a process is inevitably distressing, it can be understood how hospitals and clinicians might wish to resort to Coroners' post-mortems for purposes which can only properly be authorised through recourse to hospital post-mortems (broadly defined).
  16. We emphasise again that the focus of this report is parents and their children. In the context of post-mortems, the law is broadly no different as between children and adults. Thus our analysis and recommendations should be applied to all post-mortems, except wherever the law prescribes otherwise.

     

    Consent and objection

  17. If a post-mortem is requested or directed by the Coroner, he is not required by law to seek the consent, or respect the objection, of parents. In the case of a hospital post-mortem, however, the central feature of the statutory framework is that it may not be authorised if any relative objects to its taking place. The Human Tissue Act does not require that consent be given; it merely requires that there be no objection. In practice, even before the Human Tissue Act was passed, parents and relatives were commonly asked for their consent.
  18. In Bristol, as we shall see, when Coroners' post-mortems were carried out on the authority of the Coroner, parents were not advised of, far less asked for their views on, the fact that the pathologist might take or retain human material, nor of the uses to which the human material might be put. [9]
  19. Equally, in Bristol, when hospital post-mortems were carried out, although asked whether they gave their consent, parents signed forms which were not explicit as to what might be done.

     

    'Removal' and 'retention'

  20. We take the term 'removal' to mean the short-term removal of human material from the body, and subsequent reuniting of that tissue with the body prior to its burial or cremation.
  21. We take the term 'retention' to mean that tissue is removed from and not immediately thereafter reunited with the body, either being retained in the short term (for further tests to be carried out), or retained in the long term (for example for educational or research purposes).
  22. Coroners work to a set of rules called the Coroners Rules, made under statute. A Rule of particular relevance to the issue of retention is 'Rule 9'. It states that '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 period as the coroner thinks fit.'
  23. As we set out, during the course of the evidence taken by the Inquiry, it became apparent that these terms were not uniformly applied, nor indeed understood, by professionals let alone parents.

     

    Periods of time during which human material may need to be retained for the purpose of a post-mortem

  24. Human material may need to be removed for examination. This is important for parents, not least as regards the timing of the burial or cremation of their child. Historically, it has been necessary for a pathologist to keep at least some human material for days or even weeks so as to allow a proper scientific examination. Over time, and particularly over the last decade, the scientific procedures available to pathologists have allowed many of these time periods to be significantly shortened.

     

    Statistical context

  25. The Office for National Statistics supplied the following data to the Inquiry in April 2000:

    Table One:
    Deaths and post-mortems, England and Wales 1984, 1990, 1995 and 1998, All ages

     

     

    Total deaths

    Total post-mortems:

    Of which
    Hospital
    deaths [1]

    Hospital post-mortems:

       

    Coroner's

    Not at
    request of
    Coroner [2]

    Total

    Coroner's

    Not at
    request of
    Coroner [2]

    1984

    566,881

    138,071

    20,833

    343,467

    55,746

    19,367

    1990

    564,846

    130,443

    11,636

    357,767

    55,860

    11,199

    1995

    569,683

    124,231

    n/a

    309,481

    55,977

    n/a

    1998

    555,015

    121,584

    3,524

    304,350

    55,929

    3,335

    n/a = Not available

    Notes

    1 Hospital deaths for 1984 and 1990 are an aggregate of two institutional categories: NHS (non-psychiatric) and non-NHS (non-psychiatric). For 1995 and 1998 the figures are an aggregate of general hospitals, sanatoria, geriatric hospitals or units, chronic sick hospitals, maternity hospitals, military hospitals and multi-function sites.

    2 A post-mortem not at the request of a Coroner is a post-mortem performed by a certified medical practitioner usually at a hospital but not always. These are the best available data nationally on hospital post-mortems.

    Source - ONS: The ONS does not routinely publish all of the data above. It does publish some data relating to death certification by cause of death but not by place of death.

     

    Table Two:
    Deaths and post-mortems, England and Wales 1995 and 1998, ages 0-16

     

     

    Total deaths

    Total post-mortems:

    Of which
    Hospital
    deaths [1]

    Hospital post-mortems:

       

    Coroner's

    Not at
    request of
    Coroner [2]

    Total

    Coroner's

    Not at
    request of
    Coroner [2]

    1995

    6,086

    1,881

    n/a

    4,931

    1,156

    n/a

    1998

    5,622

    1,645

    422

    4,656

    1,122

    416

    n/a = Not available

    Notes

    1 Figures not available for earlier years in this format.

    2 A post-mortem not at the request of a Coroner is a post-mortem performed by a certified medical practitioner usually at a hospital but not always. These are the best available data nationally on hospital post-mortems.

    Source - ONS: The ONS does not routinely publish all of the data above. It does publish some data relating to death certification by cause of death but not by place of death.

    The significant points to note from tables are:

    • For the population as a whole, many more Coroners' post-mortems are performed than hospital post-mortems following deaths in hospital. In 1998, approximately18 per cent of hospital deaths were followed by a coroner's post-mortem, and1 per cent were followed by a hospital post-mortem.
    • The number of hospital post-mortems has declined dramatically since the early 1980s for all deaths, as well as for deaths in hospital, whereas the number of Coroners' post-mortems has remained fairly constant. Between 1984 and 1998 the number of hospital post-mortems following a death in hospital fell by 83 per cent.
    • While national data on deaths of children aged 16 and under is only available for recent years, the overall patterns apply - that many more Coroners' post-mortems than hospital post-mortems take place.
    • It is notable that a high proportion of children who die, do so in hospital, approximately 80 per cent, compared with just over 50 per cent for the population as a whole.

     

Footnotes

1 Whilst we refer in this Interim Report to 'parents', we do not seek to resolve here wider questions of the exercise of parental responsibility, but refer to the general law [Return to text]

2 See Appendix for the description of the Bristol Royal Infirmary, UBHT and UBH [Return to text]

3 A list of witnesses appears in the Appendix [Return to text]

4 See Glossary in the Appendix [Return to text]

5 See Annex A for full details [Return to text]

6 See Appendix [Return to text]

7 Professor Anderson, in his evidence, said that major collections were held at Alder Hey Children's Hospital, Royal Brompton Hospital, Great Ormond Street Hospital for Sick Children, Birmingham Children's Hospital, Leeds General Infirmary, and The Freeman Hospital Newcastle, Southampton General Hospital and the Royal Manchester Children's Hospital [Pendlebury]. (see T45 p. 104-106) [Return to text]

8 April 1995 [Return to text]

9 Rule 9, Coroners Rules 1984 (The 1984 Rules), requires a pathologist conducting a coroner's post-mortem to make arrangements for preserving 'material', ie, human material, which in his opinion bears upon the cause of death. See Annex B for a full discussion [Return to text]

 


Published by the Bristol Royal Infirmary Inquiry, July 2001
Crown Copyright 2001