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

RECOMMENDATIONS

Introduction
This chapter sets out the action and recommendations that in my view should follow from my findings. It is important to remember that this investigation followed the chance discovery by Mrs Elaine Isaacs in April 2000 that the brain of her late husband had been retained for research in February 1987.
Had Mrs Isaacs not come across the letter sent to Mr Isaacs' general practitioner by the joint research team, she would never have known that her husband's brain had been retained, and the widespread retention of brains, and other organs, from Coroners' post mortems might have remained undisclosed.
Most of the brains from Coroners' cases in the 1980s and 1990s were initially held for entirely proper diagnostic investigation into the cause of death. A very much smaller number were retained specifically for research or teaching. The feature that unifies both these categories is that very few relatives were aware of the practice and I found no evidence that any were asked for their consent for later research or teaching use. In this way the requirements of the Human Tissue Act were consistently disregarded.
I have not investigated the extent to which relatives who signed consent forms for hospital post mortems were aware of the possibility of organ retention and that research or teaching use might follow. Among the limited number of consent forms that I have examined, few specifically mention organ retention. It appears the assumption was made that a signed post mortem consent form also indicated agreement to organ and tissue retention. It will never be known how many relatives were aware that organs might be retained from hospital post mortems without their knowledge.

Parallel investigations and policy reviews

Two major Government initiatives and the Shipman Public Inquiry have been in progress since my investigation began. These each have areas of common interest with the events I describe in this report:

The Retained Organs Commission (ROC) was established as a Special Health Authority by the Secretary of State for Health in April 2001 in the aftermath of the Redfern Report. The ROC's Terms of Reference are at Annex 6.



Annex 6
 

The Home Office Fundamental Review of Death Certification and Coroner Services in England, Wales and Northern Ireland was announced on 23 March 2001. The Terms of Reference for the Review are at Annex 7.



Annex 7
 

The Shipman Public Inquiry, chaired by Dame Janet Smith, was announced on 31 January 2001. The Terms of Reference are at Annex 8.


Annex 8
The recommendations set out below follow from the Terms of Reference I was given and the findings made during this investigation. I have endeavoured to take account of the consultation papers and interim reports of these important bodies and my recommendations are not intended to anticipate or detract from the recommendations of their work.
In particular, the first report of the Shipman Inquiry has illustrated the vital importance of evidence that can be obtained from retained organs, tissues and other post mortem specimens.


The objectives of these recommendations

My recommendations have four objectives:
1.  The primary and overriding objective must be the introduction of legal, administrative, ethical and other requirements designed to ensure that organs and tissues retained from Coroners' post mortems will not be retained for or used in research or teaching without the knowledge and consent of the relatives.
2.   The second objective is to restore public confidence in post mortem procedures and practices to enable organs and tissues to be used in research that cannot be undertaken during life, to improve treatment and care for the benefit of future generations but only with the full and proper consent of relatives.
3.  Third, to ensure that the objections of those who do not agree to post mortem examinations or organ retention are recognised and, in respect of Coroners' post mortems, to facilitate religious observances to the extent that these are compatible with the Coroner's investigations.
4.   To clarify those features of the current Rules and procedures that have created uncertainty.
The recommendations below are intended to restore public confidence that organs and tissues will not be used in research or for teaching without the knowledge and consent of relatives. To achieve these objectives a series of changes are needed to administrative and other procedures in professional and employment practices and to the law.

I. To prevent unauthorised organ and tissue retention

 

Review of relevant law relating to unauthorised removal of organs and tissues

The unauthorised removal and retention of organs and tissues from Coroners' post mortems for research, without the knowledge or agreement of the relatives, is the central issue of my investigation. The Human Tissue Act refers simply to 'lack of objection' rather than 'consent' but retention of organs and tissues for research without the knowledge and consent of the relatives must never be permitted to recur.
The most certain way to ensure there is no recurrence of unlawful organ and tissue retention is through a change to strengthen the law. The Department of Health has recently issued a consultation document on possible changes to the Human Tissue Act and the Anatomy Act.
The Shipman Inquiry has issued a discussion paper 'Developing a new system for death certification'.
The Home Office Fundamental Review of Coroners Services has conducted a separate consultation which outlines alternative arrangements for certifying death and for possible changes in Coroners' services.
The Retained Organs Commission is considering many issues that bear on the retention of organs and tissues.
From their interim reports and consultation documents, these inquiries and reviews are likely to recommend changes in the law that will affect post mortem procedures and practice.

Human Tissue Act
In my view there are serious weaknesses in the Human Tissue Act. Unlike the Anatomy Act, there are no record-keeping requirements in the Human Tissue Act and no penalties for those who disregard its provisions.
The lack of penalties is a serious weakness. In my opinion, when the opportunity arises to amend or replace the Human Tissue Act, the following changes are needed:
Recommendation 1a
  • the retention of organs and tissues from post mortems, without legally defined and valid consent, should be made an offence;

 1b
  • there should be appropriate penalties for unauthorised retention in the legislation;

 1c
  • the term 'lack of objection' should be replaced by 'with consent of'.
Until the law can be changed, there are other steps that will deter anyone who might be tempted to retain organs and tissues without proper consent. Therefore, unauthorised organ and tissue retention should become:
Recommendation 2
  • a disciplinary offence within the Terms and Conditions of Service for (i) local authority staff working in public mortuaries and (ii) NHS staff working in hospital mortuaries;
Recommendation 3
  • the General Medical Council should specify in professional guidance to medical practitioners that unauthorised organ and tissue retention will be subject to professional discipline.
Retention of 'material' under Coroners Rules 9 and 12
  • These sections of the Coroners Rules have caused confusion to Coroners, pathologists and researchers.
Recommendation 4
To resolve this confusion, the Rules need to be revised or clear guidance provided to clarify the legality of organ and tissue retention in the following circumstances:

(a) when criminal legal action will or is likely to follow completion of the Coroner's action;

(b) when civil legal action may follow after the Coroner's action has ended;

(c) in the absence of instructions from the Coroner, for how long the pathologist may hold the retained material before it is disposed of in accordance with the instructions of relatives.

II. To ensure that consent for retention is properly obtained

Consent forms and retention of organs and tissues
The relatives' consent is not required for a Coroner's post mortem. However, the possibility of organ or, more probably, tissue retention should be explained and the reasons for this. This already happens in many districts.
The relatives should be asked for their wishes regarding disposal of any retained tissues; one option might be to delay the cremation or funeral until the retained tissues can be returned to the body. This should always be explained.
Recommendation 5
  
  • The relatives should be routinely asked for their wishes for disposal of any organs or tissues retained from a Coroner's post mortem and systems put in place to ensure that these wishes are carried out.
Recommendation 6
  • Organ and tissue retention forms, similar to those already in use in many districts, should be introduced everywhere.
Recommendation 7
  • All post mortem reports should include full and accurate details of all organs, tissues and other tissue samples retained.
Recommendation 8
  • Relatives, unless they decline, should be informed about what samples have been retained.
Recommendation 9
  • Relatives should be given the opportunity to indicate whether eventual disposal of retained tissues should be (a) a delayed cremation or funeral to allow the tissues to be returned to the body; (b) returned to them after disposal of the body; (c) undertaken by the hospital; (d) donated for medical research.
In respect of hospital post mortems:
Recommendation 10
  • Post mortem consent forms should have separate sections seeking (a) consent to the examination and (b) additional consent for organ and tissue retention. Relatives must know that they can refuse consent to the examination and they can separately consent to the post mortem but not to retention, if that is their wish.
Recommendation 11
  • Relatives must never be pressured to agree to a hospital post mortem under the threat that if they do not agree the death will be reported to the Coroner.
III. To ensure relatives are fully and properly informed when decisions are taken
Information and support for relatives following deaths reported to Coroners
The sudden death of a relative is among the most stressful of life's experiences and the closer the relative the greater the distress. The same usually holds true for the relatives of those whose deaths are reported to the Coroner for other reasons.
Many who are suddenly bereaved are 'in shock' in the days that immediately follow. More ready access is needed to the advice, support and counselling that is available for the relatives of those who die in NHS hospitals. In the community, similar help is provided by many voluntary organisations and faith groups, but many relatives do not know to whom to turn.
Recommendation 12
  • Information about 'what will happen next' during the Coroner's investigations should always be explained fully and with sympathy. The relatives should be told of their rights.
Recommendation 13
  • When there is likely to be a Coroner's post mortem, the reasons for the examination should be explained unless the relatives do not wish to be given details.
Recommendation 14
  • When for the Coroner's purposes a formal statement is needed, there should be no pressure on a relative for its urgent completion or duress over the contents. While 'in shock', erroneous information may too easily be included.
Recommendation 15
  • As many relatives do not, at first, take in details of what is explained to them a written summary should be provided.
Recommendation 16
  • Support from NHS and voluntary sector bereavement services should be made more accessible to relatives of those whose deaths are reported to Coroners, particularly after sudden death. The range and availability of such local services should be more widely advertised.
 Research and teaching use of retained organs and tissues
When the relatives are asked for consent to organ or tissue retention for diagnosis it must not, as in the past, be assumed that consent extends to research or teaching. In a hospital post mortem, when the relatives consent to diagnostic organ or tissue retention, separate consent is needed for research or teaching use. The same principle applies to consented research on organs and tissues from Coroners' post mortems.
The nature of the research should be explained. If organs or tissues are retained for research that has not yet been planned, this must be explained. Blanket consent for any research is not enough. In particular, if genetic or other research which may affect other members of the family is planned, the relatives should be asked specifically about this.
If there will be tissues for disposal at the end of the research, the relatives should be informed and asked about their instructions for disposal.
Recommendation 17
  • Consent forms for research or teaching use should be specific to the purpose and investigation for which the organs or tissues have been retained.
Recommendation 18
  • Genetic or other research that could affect other family members must be carefully explained before consent is requested.
IV. Role of NHS Trusts in organ and tissue retention
There are particular problems about consent where a person dies in the NHS without known relatives or next of kin. Guidance circulars place on NHS authorities 'in possession of the body' the authority to consent to a post mortem and to organ and tissue retention after the death of a patient without known relatives.
It is not axiomatic that all those who die in NHS hospitals and have no next of kin would agree to their organs being retained for research. This is particularly relevant to patients who have been long-stay residents in hospital care.
Recommendation 19
  • An independent authority should be given the responsibility for deciding whether a hospital post mortem and/or organ retention for research should follow the death in hospital of a person who has no known relatives or next of kin.
Coroners' post mortems in NHS mortuaries

There is confusion in some locations over who is responsible for the inappropriate actions of NHS mortuary staff when a post mortem is carried out in an NHS mortuary.

Recommendation 20
  • The confusion over who is responsible for the conduct of NHS staff during Coroners' post mortems in NHS mortuaries should be resolved urgently.
V. Ethical approval and supervision of research on retained organs and tissues
Ethics Committees, organisations that fund research, Universities and other bodies that host research should all have procedures in place to ensure that all the projects they facilitate have received appropriate ethical approval.
Ethics Committees
There must now be no lingering doubts about the importance of Ethics Committee approval for research on retained organs and tissues. All such research, including the use of archived material, should be considered by a properly constituted Ethics Committee.
Ethics Committees should ensure that changes to research protocols are notified to them and that progress reports on research reach them by the due date.
Recommendation 21
  • Ethics Committees should give particular attention to the consent forms that are proposed for any research using retained organs and tissues.
Research funding organisations
Research funding organisations have rightly requested information about the ethical approval of research applications submitted to them for funding. However, the ethics approval quoted in support of some research applications investigated had been given for a different project.
Recommendation 22
  • Organisations that provide funds for research on retained organs and tissues should include in their procedures steps to check that the ethical approval quoted relates directly to the research that is under consideration.
Recommendation 23
  • In complex areas of research on retained organs and tissues, research funding organisations should consider establishing their own Ethics Review Committees.
Universities and organisations that host post mortem research
Universities and other institutions that host research on retained organs and tissues on their premises should be aware of the special sensitivities of this research.
Recommendation 24
  • Universities and other institutions should establish their own Ethics Committees which must be notified of all external grant support and Ethics Committee approvals obtained by their staff.
VI. Staff training
There are limited training opportunities for staff in Coroners' offices and also for mortuary staff. Many staff learn their duties through in-service experience without prior structured training. Coroners' Officers, staff of Coroners' offices and public mortuaries meet bereaved people at a time of great stress.
Recommendation 25
  • Staff in Coroners' offices, Coroners' Officers, morticians and other staff involved in Coroners' post mortems should be given training better to assist and help the relatives and to explain the reasons for a Coroner's post mortem.
Recommendation 26
  • Guidelines should be developed on all aspects of public mortuary practice and for NHS mortuaries where Coroners' post mortems are carried out.
Recommendation 27
  • Systems for the audit and quality assurance of Coroners' post mortems are required, and similarly for the procedures and practices in public mortuaries.
VII. Recognition of the views of those who oppose post mortem examinations and organ retention
While the majority of the community may not hold firm views on post mortems and organ retention, there are some who regard these procedures as abhorrent and incompatible with their sincerely held beliefs. When a death is reported to a Coroner it is important that the sincerely held beliefs of the deceased or his relatives are rapidly identified. To acknowledge and, where possible, respect those who hold these beliefs:
Recommendation 28
  • enquiries should be routinely made about the religion of the deceased, which should be stated in the papers that accompany each body to the mortuary and/or included in the information obtained by the Coroner's Officer;
Recommendation 29
  • in the interval between death and burial or cremation, religious ceremonies and rituals that do not interfere with the Coroner's investigation should be permitted;
Recommendation 30
  • a post mortem should not be carried out routinely where the cause of death can be established without one. Also, a limited post mortem procedure will be more acceptable than a full procedure to some faith communities;
Recommendation 31
  • alternative methods for establishing the cause of death, such as Magnetic Resonance Imaging, require further evaluation to see if these will provide an alternative to post mortem examinations in a proportion of sudden deaths;
Recommendation 32
  • use of toxicology may identify the cause of death in some cases and avoid the need for a post mortem examination;
Recommendation 33
  • as the retention of organs and tissues poses major religious difficulties for some faith communities, these procedures should be avoided if possible.
Return of retained organs to faith communities
There are collections of retained organs which are known to include those of persons of the Jewish or Muslim faith. In some locations there are simple ways of identifying persons from these faith communities, either from the Mortuary Registers or by other means.
Recommendation 34
  •   In locations where retained organs and tissues from those of the Jewish or Muslim faiths are known to exist and can be identified, these organs should be returned to the religious authorities for burial, even when their return has not been requested by the relatives of the deceased.


 
       
 

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