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Contents > Annex B
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Interim Report: Removal and retention of human material
Annex B: Law and Guidelines
Part I: The Coroner and the Coroner's post-mortem examination
Reporting and registering a death
Involvement of the Coroner
The Coroner
The Coroner's power to act
The
Coroner's post-mortem examination
The Coroner's inquest
The Coroner's post-mortem examination and inquest:
authority and consent
Information for relatives about the Coroner's
post-mortem examination and inquest
The pathologist in the Coroner's post-mortem
examination
Removal of tissue at a Coroner's post-mortem
Retention of tissue removed at the Coroner's
post-mortem examination
Use of tissue removed at the Coroner's post-mortem
examination
Disposal of tissue removed or retained at the
Coroner's post-mortem examination pursuant to Rule 9
Reporting and registering a death
- Any death in England and Wales must be reported to the Registrar
of Births Marriages and Deaths [the 'Registrar'] for the sub-district
in which the death occurred, for entry in the register [section 15,
Births and Deaths Registration Act 1953 [the '1953 Act'] and Regulation
41 of the Registration of Births and Deaths Regulations 1987 [the '1987
Regulations']. [19]
Before a death can be registered and the body disposed of, there must
either be a medical certificate of cause of death from a doctor, or
a certificate from a Coroner after his investigations are completed.
- Under sections 16 and 17 of the 1953 Act it is the duty of a 'qualified
informant' to give relevant details to the Registrar concerning a death.
Failure to do so is a criminal offence. The Inquiry heard from Mr Clifford
[20] that
the expression 'qualified informant' applied to a senior member of hospital
administration staff in relation to a death in hospital. It also applies
to a relative of the deceased who has knowledge of any of the particulars
required to be registered concerning the death. [21]
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Involvement of the Coroner
- The Registrar is the only person with a statutory duty to report
a death to the Coroner. Regulation 41(1) of the 1987 Regulations provides:
'Where the relevant Registrar is informed of the death of any person
he shall, subject to paragraph (2), report the death to the Coroner
on an approved form if the death is one:
a) where the deceased was not attended during his last illness by
a registered medical practitioner;
b) in respect of which the Registrar has been unable to obtain a
duly completed certificate of cause of death or has received a certificate
from which it appears that the deceased was not seen by the certifying
medical practitioner after death or within 14 days before death;
c) the cause of which appears to be unknown;
d) which the Registrar has reason to believe to have been unnatural
or to have been caused by violence or neglect or abortion or to have
been attended by suspicious circumstances;
e) which appears to the Registrar to have occurred during an operation
or before recovery from the effect of an anaesthetic;
f) which appears to the Registrar from the contents of any medical
certificate of cause of death to have been due to an industrial disease
or industrial poisoning.'
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- Regulation 41(1)(e) is interpreted in Jervis on Coroners,
para 5-27, [22]
as applying to deaths which occur during an operation or within 24 hours
of the operation or full recovery from the anaesthetic, or to a death
where there is reasonable cause to believe that it was related to the
operation or anaesthesia. In practice, when deciding whether to report
to the coroner under Regulation 41(1)(e) Jervis, para 5-32, suggests
various questions to assist Registrars and medical practitioners:
'(i) Was the death due to disease or injury for which the surgery
was being performed, and would death have occurred at the time it
did without surgical intervention?
(ii) Was there any other disease process in the patient which pre-disposed
to a fatal outcome of surgical intervention, and was this disease
process taken into account by the doctors before surgery was begun?
(iii) Was death caused by a disease process unrelated to that for
which surgery was performed and was this considered by the doctors
before the operation?
(iv) Was the surgical intervention urgent, life-saving or merely
elective for the purpose of improving the quality of the patient's
life? Was the condition of the patient for surgery and anaesthetic
assessed in relation to these motives for performing the operation?
and
(v) Was there any evidence of accidental error or negligent technique
in the surgical or anaesthetic procedure?'
- There is no specific statutory requirement for members of the public
to inform the Coroner of deaths.
- There is a common law duty on every person who is at the place of
death or nearby at the time it takes place, to give immediate notice
to the Coroner or to his officer or to the appropriate officer of police
of circumstances which may lead to the holding of an inquest.
[23]
- The only statutory duty, in this context, imposed on a doctor is
pursuant to section 22 of the 1953 Act, which requires a certificate
of the cause of death to be sent to the Registrar by the doctor attending
the person in his last illness. [24]
- Notwithstanding the position under statute, the Inquiry heard from
Mr Clifford that, in practice, deaths are commonly reported to the Coroner
by a doctor or other member of hospital staff where they have reason
to believe that an inquest is likely to be necessary.
- In 1996, and therefore outside the period being considered by the
Inquiry, in R v HM Coroner for Wiltshire ex parte Clegg
[25] the
High Court criticised the lack of guidance given to NHS staff as to
providing information to coroners. The Chief Medical Officer's Update
20/98 subsequently issued to all doctors advised:
'The Select Committee on Public Administration earlier this year
stressed the need for clinicians to disclose all relevant information
to the Coroner to ensure a fully informed decision on cause of death.
Whilst there is no specific duty on clinicians to do this, all those
who have information which could help Coroners' inquiries should disclose
it voluntarily and not only when requested. The GMC [General Medical
Council] has updated, and the UKCC [United Kingdom Central Council
for Nursing, Midwifery and Health Visiting] will shortly be publishing,
amended professional guidance emphasising the need to inform the Coroner.'
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The Coroner
- The Coroner is an independent judicial officer. Only a barrister,
solicitor or legally qualified medical practitioner of not less than
five years' standing in his profession may be appointed [section 2(1),
1988 Act]. He is required to appoint a deputy and may appoint an assistant
deputy [section 6(1)]. These officers are not employees or officers
of local government and are independent of local government, although
the 'relevant council' appoints them, remunerates them and provides
their premises. Their appointment and powers are regulated by the 1988
Act and the 1984 Rules.
- The Home Office is responsible for the law in relation to Coroners
and has a role in setting standards of practice for Coroners by issuing
circulars and newsletters, although these have no statutory underpinning.
Neither the Home Office nor any other government department has any
statutory responsibility for setting educational or training standards
for Coroners, although the Home Office has, since 1984, provided study
opportunities for them. [26]
- The Inquiry heard from Mr Burgess [27]
as to the role of the Coroners' Society. Most Coroners, deputy and assistant
Coroners are members of the Society, which issued guidance in the form
of practice notes for Coroners for the first time in 1998, after the
period under consideration by the Inquiry. [28]
- There is no statutory requirement for Coroners to undergo training
or achieve particular qualifications other than those required by section
2(1).
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The Coroner's power to act
- The Coroner cannot act unless and until the provisions of section
8(1), 1988 Act are satisfied, namely:
'that he is informed that the body of a person is lying within his
district and there is reasonable cause to suspect that the deceased:
a) has died a violent or an unnatural death; or
b) has died a sudden death of which the cause is unknown; or
c) has died in prison or in such a place or in such circumstances
as to require an inquest under any other Act.'
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The Coroner's post-mortem examination
- If, after initial consideration, the Coroner concludes that section
8(1) does not apply and that a post-mortem examination and inquest are
unnecessary, he will complete Form 100A [29]
setting out the cause of death as certified by the deceased's doctor.
- If the Coroner after initial enquiries considers there is reasonable
cause to suspect that the circumstances in section 8(1)(a) or (c) may
have occurred, then he must proceed to hold an inquest. He will usually
order a post-mortem examination for evidential purposes under section
20, 1988 Act.
- If, on initial enquiries, the Coroner considers the cause of death
to be unknown (section 8(1)(b), 1988 Act), he will direct a post-mortem
examination under section 19(1), 1988 Act if he is of the opinion that
it may prove an inquest to be unnecessary to establish the cause of
death. If, once a post-mortem examination has been carried out under
section 19(1), the Coroner is satisfied that an inquest is not necessary,
he sends Form 100B [30]
to the Registrar stating the cause of death disclosed by the post-mortem
report.
- By section 20, 1988 Act, once Coroners have decided to hold an inquest,
they are authorised to request any legally qualified medical practitioner,
[31] ordinarily
a pathologist, to make a post-mortem examination and report the result
in writing to the coroner. By section 20, the Coroner may also direct
that a post-mortem be carried out and evidence be given before the Coroner
as to how the deceased came by his death.
- Importantly, the pathologist acts as agent of the Coroner
[32] and
his remit is limited to the purposes of the Coroner's enquiries.
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The Coroner's inquest
- The purpose of the Coroner's inquest is prescribed by section 11(5),
1988 Act, namely to determine, as far as can be proved, who the deceased
was, [33]
and how, when and where he came by his death. The written inquisition
must set out these particulars. [34]
After an inquest has been held, the Coroner must, within five days after
the finding of the inquest, send to the Registrar a certificate setting
out the information prescribed by section 11(7), 1988 Act.
[35]
- Mr Clifford and Mr Burgess both stressed the limited purpose of the
Coroner's inquest as set out in section 11(5), and referred to the Coroners'
Society's 'Practice Notes for Coroners 1998' issued after the period
with which the Inquiry is directly concerned which state, at paragraph
3.6:
'You will also need to keep in mind the limited purpose of the Coroners
inquest, as clearly stated in section 11(5) Coroners Act and Regulations
36 and 42 Coroners Rules.'
- The 1984 Rules [36]
provide:
'36. (1) The proceedings and evidence at an inquest shall be directed
solely to ascertain the following matters, namely -
a) who the deceased was;
b) how, when and where the deceased came by his death;
c) the particulars for the time being required by the Registration
Acts to be registered concerning the death.
Neither the Coroner nor the jury shall express any opinion on any
other matters.'
'42. No verdict shall be framed in such a way as to appear to determine
any question of -
a) criminal liability on the part of a named person, or
b) civil liability.'
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- The overall purpose of the inquest was previously considered by the
Broderick Committee [37]
to be:
a) to determine the medical cause of death;
b) to allay rumours or suspicions;
c) to draw attention to the existence of circumstances which, if
unremedied, might lead to further deaths;
d) to advance medical knowledge;
e) to preserve the legal interest of the deceased's family, heirs
or other interested parties.
- This approach was, some years later and within the period of the
Inquiry's terms of reference, noted with approval by Simon Brown LJ
in R v HM Coroner for Western District of East Sussex ex parte Homberg.
[38]
- Once an inquest is concluded and the verdict returned, it is clear
that the Coroner has no further powers in relation to the death and
is functus officio (without any further lawful authority having
discharged the duties of his office). In so far as a pathologist, in
conducting a post-mortem examination, does so on behalf of the Coroner,
and thus as the Coroner's agent, the pathologist's authority as regards
any further dealing with the body (or anything removed from it) will
terminate when the Coroner becomes functus officio.
[39] It is
not as clear that the completion of Form A and Form B also has the effect
of rendering the Coroner functus officio, as the Coroner has
not, at the stage of completing either Form, constituted himself into
a Coroner's Court, but, as regards the position of the pathologist,
in a Form A case there is no post-mortem and in a Form B case, once
that form has been completed, the pathologist would not have continued
authority qua agent of the Coroner to retain or use tissue removed
at post-mortem.
- A number of witnesses expressed a view before the Inquiry as to whether
the Coroner's Court is an appropriate forum for audit or identifying
local or national trends in mortality. This issue will be addressed
in that part of the Inquiry's final report concerned with Audit.
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The Coroner's post-mortem examination and inquest: authority and
consent
- There is no statutory requirement for the Coroner or his officers
to obtain consent from any natural or legal person before holding an
inquest or directing a post-mortem examination or special examination,
[40] and
these may therefore be conducted notwithstanding lack of consent or
even despite objections from relatives.
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Information for relatives about the Coroner's post-mortem examination
and inquest
- Although there is no requirement for the Coroner to seek consent
from relatives, there are provisions for certain people and bodies to
be notified of the date and time of a proposed post-mortem
[41] unless
it is impracticable to do so or would cause the examination to be unduly
delayed. [42]
Those to be notified include 'any relative of the deceased who has notified
the Coroner of his desire to attend, or be represented at, the post-mortem
examination'. [43]
The Coroner has a discretionary power to notify any other person whom
he is not under a duty to notify. [44]
- The Inquiry heard from Mr Clifford [45]
that no Home Office guidance had been issued as to how Coroners might
or should exercise their judgement under these provisions.
- However, the 'Practice Notes for Coroners', issued after the
period under inquiry, advise [46]
that 'relatives and family of the deceased person should be given appropriate
information' about a proposed post-mortem and, more generally, 'Before
making any decision which will affect other people, you must give all
the relevant interested persons an opportunity to comment on the situation
concerned.' [47]
- The report of a Coroner's post-mortem examination or special examination
is delivered to the Coroner and may not be disclosed to any other person
without his consent. [48]
Once received, the Coroner must supply a copy of the post-mortem report
(on payment of a fee) to any person who, in the opinion of the Coroner,
is a 'properly interested person', [49]
but there is no statutory requirement for relatives to be provided
with a copy of the post-mortem report or notification of the result
of the inquest.
- The 'Practice Notes for Coroners' advise: 'The relatives and
family of the deceased person...should be told the result of the examination
as soon as practicable, and in writing, if they request it...It might
be appropriate to offer to forward the result and a copy of the pathologist's
report of the examination to their nominated medical attendant so that
this can be explained to them.' [50]
- The Coroner is required (by Rules 19, 20 and 33, 1984 Rules) to notify
certain people of the arrangements for any inquest.
[51]
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The pathologist in the Coroner's post-mortem examination
- Rule 6(1)(a), 1984 Rules requires the Coroner, wherever possible,
to instruct a pathologist with suitable qualifications and experience
who has access to laboratory facilities.
- The 1984 Rules and 1988 Act do not prevent the Coroner's post-mortem
examination being performed at the hospital where the death occurred.
Rather, Rule 11(3) requires that if the death occurred in a hospital
possessing adequately equipped premises, the post-mortem should be carried
out there (provided the hospital authority consents) unless the Coroner
decides otherwise.
- Under Rule 6(1)(c), Coroners should not direct or request a pathologist
on the staff of, or associated with, the hospital to carry out the post-mortem
if the pathologist does not wish to; or if the conduct of any member
of the hospital staff is likely to be called into question; or if so
requested by any relative of the deceased. However, a pathologist at
the hospital may still be directed or requested to carry out the post-mortem,
notwithstanding the aforementioned considerations, where an examination
would be unduly delayed if it were necessary to seek a different pathologist
with suitable qualifications and experience.
- Thus, as regards the pathologist, the 1984 Rules place the onus on
him to decline the Coroner's request or direction.
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- The 'Practice Notes for Coroners' [52]
(which, as noted above, were issued after the period under inquiry)
provide that:
'The Coroner should recognise that under the provisions of [Rule
6 of the 1984 Rules] the pathologist may wish to excuse himself from
such examination. The responsibility lies initially with the pathologist
to recognise any conflict of interest although if there seems to the
Coroner that there is or may be such a conflict, then he should either
instruct an alternate pathologist or seek confirmation from the pathologist
as to whether there is any conflict preventing his making the examination.'
- However, the guidance given in 'The Autopsy and Audit'
[53] is that
where the death occurred in a hospital 'Wherever possible, permission
should be obtained from the Coroner' to have a post-mortem examination
performed in the hospital where the death occurred, so as to provide
the consultants concerned in the case, who have the right to attend,
with a better opportunity to attend the examination as part of the audit
process.
- In certain specified circumstances the selection of the pathologist
will be subject to further criteria. [54]
- In practice, barring the circumstances envisaged by Rule 6(1)(c ),
the hospital pathologist's role in a Coroner's post-mortem is to investigate
the cause of death following surgery or other treatment, and report
to the Coroner. The pathologist's powers are dependent on, and subordinate
to, those of the Coroner. The position of the pathologist once his principal,
the Coroner, has no further proper interest in the death, will be considered
below.
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Removal of tissue at a Coroner's post-mortem
- The pathologist conducting a Coroner's post-mortem or special examination
is under a duty, so far as possible, to remove from the body, and to
make arrangements for preserving, 'material' which in his opinion bears
upon the cause of death. Such arrangements for preservation must be
kept in place for such period as the Coroner thinks fit.
[55] The
Coroner has no power to direct or permit the removal and or preservation
of any other 'material'. So it follows that his agent, the pathologist,
has no power, qua agent of the Coroner, to do so either.
- In 1985 Professor Bernard Knight, [56]
in his paper 'Legal Considerations in the Retention of Post-mortem
Material', expressed the view that the retention of tissue for teaching
and research was not covered by the Coroner's authority, and authority
for such purposes could not be granted by the Coroner.
[57]
- Likewise the Coroners' Society [58]
takes the view that the Coroner can only ever authorise those acting
through him to make examinations to further his own enquiry, and cannot
authorise removal or retention or use of tissue other than for the limited
purpose of the Coroner's enquiry.
- Home Office guidance was issued in August 1989 [59]
on the use of tissue retained at the Coroner's post-mortem:
'You will wish to remind your pathologist that Ministers are concerned
that tissue and organs should not be taken for teaching or research
purposes from Coroners' post-mortem examination cases.'
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Retention of tissue removed at the Coroner's post-mortem examination
- As noted above, material removed during a Coroner's post-mortem pursuant
to Rule 9, 1984 Rules must be preserved for such period as the coroner
thinks fit. But once the Coroner has become functus officio,
it is not clear what legal powers and obligations are possessed by the
pathologist, who is often in physical possession of the Rule 9 material.
This issue is explored more fully below.
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Use of tissue removed at the Coroner's post-mortem examination
- The Inquiry heard from Professor Green [60]
that the prevailing view in his profession was that where material had
been removed for the purposes of Rule 9, once that purpose had been
exhausted'...the material which is left over..., once the Coroner has
discharged his function and he is functus officio, that piece
of tissue is in effect the property of the pathologist and the department
which has processed it. It has had something done to it and therefore
it is perfectly licit to use [it] for research purposes; it is perfectly
licit to use that organ for teaching purposes, museum purposes.'
- Guidelines produced by the Royal College of Physicians in 1990
[61] advised
on the use of 'discarded tissue'. 'The anonymous use for research of
tissues genuinely discarded in the course of medical treatment, and
of tissues removed at surgery or at autopsy, is a traditional and ethically
acceptable practice that does not need consent from patients or relatives...
although there may be legal constraints.' This guidance could refer
to material removed pursuant to Rule 9 or to material otherwise removed.
The legal constraints are not analysed further in the guidelines, although
they are more obvious with regard to material removed pursuant to Rule
9. It is not clear whether the Royal College of Physicians intended
the word 'tissue' to have the meaning it has been given in this Report,
or to have a more limited meaning (for example, tissue 'blocks' kept
for slides and histopathological study).
- The 1996 update of that guidance [62]
advised: 'The use for research of anonymous tissues genuinely discarded
in the course of medical treatment ... and of tissues removed at surgery
or at autopsy, is a traditional and ethically acceptable practice, that
we suggest does not need consent from patients or relatives...There
may be legal constraints and it remains unclear to whom such samples
belong in terms of beneficial ownership.' The concept of 'beneficial
ownership' is not analysed further in the guidance. The use of the world
'samples' may suggest that the Royal College of Physicians did not have
in mind the retention of whole organs.
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Disposal of tissue removed or retained at the Coroner's post-mortem
examination pursuant to Rule 9
- As to the disposal of tissue which has been retained pursuant to
Rule 9, Mr Clifford told the Inquiry that the Home Office had issued
no guidance on the length of time tissue removed in the course of a
Coroner's post-mortem should be retained. [63]
Clearly the length of time for which it is necessary to retain tissue
is related to the purpose of retention, i.e. establishing cause of death,
but may be extended for example until police enquiries or criminal proceedings
in relation to the death are concluded.
- Professor MacSween [64]
told the Inquiry that there is no clarity about the issue of how long
tissue should be kept and what its ultimate disposal should be, and
that the practice of individual Coroners varies widely. Professor Green
[65] said
that, in practice, Coroners do not order a pathologist or a pathology
department to dispose of tissue. 'The Coroner's view is, "I no
longer have any interest in this case; it is now up to you what to do
with it...They can tell you for how long you can keep it, but they tend
not to tell you that you must dispose of it, or there is no disposal
order. You are ordered to keep it, but disposal is left to the discretion
of the pathologist".'
- Mr Burgess commented that, in cases where a Coroner's post-mortem
examination was carried out, there would not normally be a referral
back to the Coroner before tissue retained by the pathologist was disposed
of. 'The Coroner will expect the pathologist to clear out his laboratory
periodically, but on occasions it has come to my knowledge at least
that that has not happened.' [66]
- As is more fully explained at paragraph 152 below, we consider that
the better view of the law at present is that, in relation to human
material initially lawfully retained under Rule 9, once the Coroner
becomes functus officio, the pathologist, while being the person
in actual (and lawful) possession, may not be the person with the best
claim to the human material. The effect of the cessation of the Coroner's
power to override the right to possession of the next of kin, is that
this right reverts to them, in order for them to perform their duty
to dispose of the human material. They thus have a right of possession
attendant upon a duty to dispose. If those with the power to call for
possession from the pathologist do not exercise this right, then the
pathologist, it seems, has the power himself to dispose of the human
material. This is what happened in Dobson. [67]
However, it would not appear that the pathologist has a duty to dispose
of the human material.
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Footnotes
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