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Interim Report: Removal and retention of human material
Part IV: Recommendations
Option 1 - A Code of Practice
(a) Coroners' post-mortems
(b) Hospital post-mortems
- To command respect, any code of practice must be seen to be enforceable
and enforced. We recommend that the duty to comply with the recommendations
which follow be incorporated into the employment contract of clinicians
[81] (and into the 1984 Rules,
as set out in paragraph 122). Breach of them would give rise to possible
disciplinary action by both the employer and the regulatory body in
the case of clinicians, and judicial review in the case of Coroners.
[82] (Recommendation 7)
(a) Coroners' post-mortems
- No matter what the circumstances are which give rise to the need for a Coroner's post-mortem, whether the death to be investigated occurs in hospital or elsewhere, parents should be given information about the Coroner's proposed post-mortem, why it is necessary and what it entails. Even though the law does not require that they consent, parents should nonetheless be told what requests they can make of the Coroner concerning what may be done to the body. (Recommendation 8)
- Currently, consent need not be sought in the case of a Coroner's post-mortem. Where the parents object, having been informed that a Coroner's post-mortem is contemplated, the Coroner should provide them with an explanation as to why he thinks a post-mortem is necessary. [83] (Recommendation 9)
- In the case of a death in hospital which gives rise to a Coroner's post-mortem, information about the Coroner's post-mortem should be given to the parents by a designated person within the hospital who has received all necessary and appropriate training. [84] (Recommendation 10)
- Meetings concerning the Coroner's post-mortem, including its timing, should be conducted with proper regard for the circumstances of the parents. There should be a designated area with appropriate privacy. The parents should be offered support. If the parents agree, their GP should be contacted with a view to further care and counselling. (Recommendation 11)
- Parents should be given information about the Coroner's post-mortem in a permanent form which they can take away. They should also be given the name and telephone number of the hospital's designated person. (Recommendation 12)
- As hospitals develop websites, a domain should be created concerned with 'bereavement' in which all the relevant information concerning post-mortems can be set out in an appropriate manner. (Recommendation 13)
- Coroners should advise parents about post-mortems and inquests, informing them about such matters as the date, time and place. (Recommendation 14)
- The Coroner's post-mortem report should be sent to any consultant who has been involved in the care of the child during his last illness. [85] (Recommendation 15)
- The Coroner's post-mortem report should be sent to the patient's GP. This report should indicate whether any human material has been retained and, if so, what. (Recommendation 16)
- The pathologist [86] who is to conduct the Coroner's post-mortem should, in consultation with the Coroner, discuss with the parents the timing of burial or cremation so that any human material removed can, wherever possible, be reunited with the body for burial or cremation, if they have not consented to its being used for other purposes. (Recommendation 17)
- The Coroner, on requesting or directing a post-mortem, should stipulate that the pathologist carrying out the post-mortem may remove and retain human material from the body only for the purpose of establishing cause of death. Human material may not be removed, or, once removed, retained or used for any other purpose, except with the consent of the parents. [87] (Recommendation 18)
- The Coroner should require the pathologist conducting the Coroner's post-mortem to notify him when it has been concluded and to indicate whether, and if so, what human material has been retained separate from the body. (Recommendation 19)
- The Coroner's post-mortem should be understood as having been concluded when the pathologist indicates his findings on the cause of death to the Coroner. (Recommendation 20)
- On being notified of the conclusion of the post-mortem, if the Coroner decides not to hold an Inquest, he should require the body to be released to the parents for burial or cremation, if this has not already taken place, subject to any prior consent of the parents that human material may be used for other specified purposes, or subject to the needs of public health. Where the Coroner decides to hold an Inquest, the body should be released to the parents as soon as possible and, in any event, not later than the conclusion of the Inquest (save in exceptional circumstances). To avoid any doubt, the Coroner should stipulate to the pathologist that he has no independent right to retain, use or dispose of human material once the Coroner's post-mortem is concluded, except on the authority of the Coroner in, for example, criminal cases, or with the consent of the parents. (Recommendation 21)
- Subject again to any prior consent, human material which has been removed should, wherever possible, be reunited with the body before release to the parents, except when the Coroner, having taken the advice of the pathologist, orders that its continued retention is required for the furtherance of legal process. Where it is not possible to reunite the material with the body, the Coroner, unless there is reason to do otherwise, should order that it be disposed of after consultation with the parents. (Recommendation 22)
- Parents should be asked, either at the time that they are informed of the Coroner's post-mortem, or subsequently, whether, on the conclusion of the Coroner's post-mortem, they consent to the retention of human material removed from their child and the use of that human material for certain specified purposes. (Recommendation 23)
- In requesting parents' consent, the meaning of human material should be made clear: that it includes organs, parts of organs and tissue in various forms, such as frozen sections and samples fixed in paraffin. (Recommendation 24)
- The purposes for which human material is to be kept should be set out and explained; for example, audit, education, research, display [88] or archiving. [89] In the case of use in any programme of research, application to and approval by the relevant Ethics Committee should be required. (Recommendation 25)
- Obtaining parents' consent should be seen as a process, and not just the signing of a form. As part of that process, parents should be allowed proper time to reflect and be informed that they may change their minds until such time as they sign a form indicating their consent. (Recommendation 26)
- As part of that process, parents should have access to:
- advice (see designated person); and
- information which is comprehensible, accessible, and in a form which allows it to be taken home if desired. (Recommendation 27)
- The information to which the parent is entitled should include:
- what human material it is proposed to retain: there should be an option to refuse consent for the retention of any material and the option of a list allowing the parents to give or withhold consent as regards each type of human material;
- what may be done to the human material;
- whether, if the human material was wanted for a limited period of time, the timing of the burial or cremation could be arranged so that the human material was reunited with the body;
- the uses to which the human material could be put: there would follow a list as above, with the parents having the option of withholding consent to any particular use;
- the length of time for which human material would be retained, with the parents having the option of attaching a time limit;
- the arrangements which the parents could make for the human material after use, where relevant, ie when the human material was not to be placed in an archive or museum (Options include: reuniting the material with the body; disposal by the hospital; or separate burial or cremation.); and
- the arrangements to safeguard confidentiality. (Recommendation 28)
- There should be a formal, open system whereby the pathologist records
the consent given, what was consented to, what human material was removed
and retained, what was done to it and how it was disposed of. (Recommendation
29)
(b) Hospital post-mortems [90]
- Notwithstanding the fact that the law does not require consent for a hospital post-mortem but merely that an attempt is made to ascertain whether there is objection, consent should be sought before undertaking a hospital post-mortem. (Recommendation 30)
- Consent should be sought by the consultant in charge of the care of the deceased or by a senior member of the clinical team. [91] (Recommendation 31)
- A third person, for example a registered nurse, should be present when the consultant seeks consent. (Recommendation 32)
- Consultants should receive training in 'breaking bad news' and in seeking consent for a hospital post-mortem. (Recommendation 33)
- Application to and approval by the hospital's Ethics Committee should be required in all cases in which consent for a hospital post-mortem is sought for the purpose of carrying out a research programme on human material, or when a research programme is contemplated after consent to a hospital post-mortem was given for other purposes. (Recommendation 34)
- Meetings concerning the hospital post-mortem, including its timing, should be conducted with proper regard for the circumstances of the parents. There should be a designated area and with appropriate privacy. The parents should be offered support. If the parents agree, their GP should be contacted with a view to further care and counselling. (Recommendation 35)
- Parents should be given information about the hospital post-mortem in a permanent form which they can take away. They should also be given the name and telephone number of the hospital's designated person. (Recommendation 36)
- The hospital post-mortem report should be sent to any consultant who has been involved in the care of the child during his last illness. (Recommendation 37)
- The hospital post-mortem report should be sent to the patient's GP. This report should indicate whether any human material has been retained and, if so, what. (Recommendation 38)
- The pathologist who is to conduct the hospital post-mortem should discuss with the parents the timing of burial or cremation so that any human material removed can, wherever possible, be reunited with the body for burial or cremation, if they have not consented to its being used for other purposes. (Recommendation 39)
- When consent to a hospital post-mortem is requested, parents should be asked whether they consent to the retention of human material removed from their child and the use of that human material for certain specified purposes. (Recommendation 40)
- In requesting parents' consent, the meaning of human material should be made clear: that it includes organs, parts of organs and tissue in various forms, such as frozen sections and samples fixed in paraffin. (Recommendation 41)
- The purposes for which human material is to be kept should be set out and explained; for example, audit, education, research, display or archiving. In the case of use in any programme of research, application to and approval by the relevant Ethics Committee should be required. (Recommendation 42)
- Obtaining parents' consent should be seen as a process, and not just the signing of a form. As part of that process, parents should be allowed proper time to reflect and be informed that they may change their minds until such time as they sign a form indicating their consent. (Recommendation 43)
- As part of that process, parents should have access to:
- advice (see designated person); and
- information which is comprehensible, accessible, and in a form which allows it to be taken home if desired. (Recommendation 44)
- The information to which the parent is entitled should include:
- what human material it is proposed to retain: there should be an option to refuse consent for the retention of any material and the option of a list allowing the parents to give or withhold consent as regards each type of human material;
- what may be done to the human material;
- whether, if the human material was wanted for a limited period of time, the timing of the burial or cremation could be arranged so that the human material was reunited with the body;
- the uses to which the human material could be put: there would follow a list as above, with the parents having the option of withholding consent to any particular use;
- the length of time for which human material would be retained, with the parents having the option of attaching a time limit;
- the arrangements which the parents could make for the human material after use, where relevant, ie when the human material was not to be placed in an archive or museum (Options include: reuniting the material with the body; disposal by the hospital; or separate burial or cremation.); and
- the arrangements to safeguard confidentiality. (Recommendation 45)
- The parents should be told the reason for making the request to carry out a hospital post-mortem. (Recommendation 46)
- The parents should be told that they may refuse consent. (Recommendation 47)
- The parents should be told, if it is intended to do so, that, as part of the hospital post-mortem, human material may be removed from the body. (Recommendation 48)
- Consent should be recorded and the record retained in the child's medical records. The form used to record consent should include such matters as who obtained consent, the date and the witness. (Recommendation 49)
- The pathologist should keep a formal record of who gave consent, what the consent related to, what human material was removed and retained, what was done to the human material and how it was disposed of. (Recommendation 50)
- The pathologist and the hospital should periodically take stock of human material retained by them and make the results known in an annual report to the hospital's Trust Board. (Recommendation 51)
Footnotes
81 Consultants and other hospital doctors [Return to text]
82 Non-compliance could also constitute professional misconduct on the part of the coroner. The Lord Chancellor has powers of removal under section 3(4) of the 1988 Act in the case of 'inability or misbehaviour in the discharge of his duty' [Return to text]
83 We would wish to go further
and recommend that, in the absence of good evidence justifying the post-mortem,
the Coroner should be required to give good reason why a Coroner's post-mortem
is called for. We notice in their recent Discussion Paper Coroners:
A Review 1999, that the New Zealand Law Commission refer to Section
8 of the N.Z. Coroners Act 1988. This section requires that, in deciding
whether or not to authorise a post-mortem, the Coroner must consider:
'e) The desirability of minimising the causing of distress to persons
who, by reason of their ethnic origins, social attitudes or customs, or
spiritual beliefs, customarily require bodies to be available to family
members as soon as is possible after death; and
f) the desirability of minimising the causing of offence to persons who,
by reason of their ethnic origins, social attitudes or customs, or spiritual
beliefs, find the post-mortem examination of bodies offensive'
We see the value of such a provision. We recognise, however, that any
such provision could have wider implications for the conduct of inquests,
which take us beyond our remit here. Thus, we confine ourselves here to
urging this wider recommendation as part of any broader review of the
powers and duties of Coroners [Return to text]
84 Since consent is not required for the conduct of a Coroner's post-mortem we do not here refer exclusively to the consultant in charge of the child's care, but rather to a designated person whose responsibilities may go wider [Return to text]
85 We note that a similar recommendation was made by the Allitt Inquiry, para 7.8(1), 'Report of the Independent Inquiry Relating to Deaths and Injuries on the Children's ward at Grantham and Kesteven General Hospital during the period February-April 1991' [Return to text]
86 We note the Allitt Inquiry recommendation 7.8(3) that paediatric pathology services should be engaged in every case in which the death of a child is unexpected or clinically unaccountable [Return to text]
87 There may, in exceptional cases, be a need to retain tissue, for example, in cases of Escherichia coli 0157, meningococcal meningitis and other infectious diseases where it is important for public health reasons to act quickly to identify a pathogen [Return to text]
88 The term 'display' refers to use of human material at a conference or meeting. It does not include any activity which would offend public sensitivity [Return to text]
89 It is not clear whether parents may consent to uses not otherwise contemplated by the relevant law: the 1961 Act and the 1984 Act. Archiving in a museum collection and display, for example, at a conference, are not specifically referred to in these Acts and audit is covered only to the extent that it could qualify as 'education'. We regard these uses as broadly within the spirit of the law and acceptable, provided that there is consent from the parents and proper respect is shown to the human material [Return to text]
90 We use the term hospital post-mortem in its wider sense, to include post-mortem examination and the removal of human material for therapeutic purposes, medical education or research [Return to text]
91 We notice that the CMO, in his Interim Guidance, suggests that consent be obtained by a designated individual, rather than the consultant in charge. We do not agree; we reiterate our view that it must ordinarily be the consultant who should seek consent from the parents, and in the absence of the consultant, a senior member of the clinical team [Return to text]