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Interim Report: Removal and retention of human material
Annex B: Law and Guidelines
Part II: The hospital post-mortem examination
The purpose of the hospital post-mortem examination
The 1961 Act
The pathologist in the hospital post-mortem examination
Removal of tissue pursuant to the 1961 Act
The 1984 Act
The 1989 Act
Common law
Notifying the result of the hospital post-mortem
- Professor MacSween summarised the functions of the hospital post-mortem
examination as providing: a check on the accuracy of diagnosis and certification
of death, a form of medical audit of medical competence in both hospital
and community care, an essential part in the training of medical students
and junior doctors, and a deterrent to homicide.
'Many developments in orthopaedic and cardiac surgery, to name but two specialisms, have followed detailed study of post-operative specimens removed in the autopsy room and studied jointly by the pathologists and by the treating clinical team'. [68]
- Professor Green told the Inquiry of the importance of the hospital post-mortem in the recognition of new diseases; the assessment of the success of surgical techniques; as a source of information for relatives; for the teaching of medical students; and as a source of human tissue and organs for the treatment of the living.
- The use of the post-mortem examination in clinical audit was stressed in 'The Autopsy and Audit.' [69]
- Professor Green referred the Inquiry to The Royal College of Pathologists' consultation paper 'Guidelines for the retention of tissues at post-mortem examination' [70] noting the continued importance of the post-mortem examination and subsequent review of the outcome as 'the gold standard against which new techniques are assessed'. In his view 'the importance of the clinico-pathological conference cannot be over-emphasised when all the doctors in the team and the pathologist who carried out the autopsy are together.' [71]
- The Inquiry heard from Professor Berry that as a hospital pathologist
he regarded it as one of his duties:
'to assist clinicians investigating deaths, both individually and as part of audit.' He 'contributed to the cardiac surgery clinico-pathological meetings, presenting post-mortem findings to the cardiac surgeons, cardiologists and others'.
The 1961 Act
- The 1961 Act provides the statutory basis for the hospital post-mortem examination.
- Section 1, 1961 Act is not concerned with post-mortems but with the
removal of parts of bodies for certain specified purposes. It is section
2, 1961 Act which is concerned with post-mortems. Section 2(2) provides:
'...no post-mortem which is not directed or requested by the Coroner or any other competent legal authority shall be carried out without the authority of the person lawfully in possession of the body...'
- Section 2(2) provides that where a post-mortem is not directed or requested by a Coroner or other competent legal authority, it is the person lawfully in possession of the body who may authorise the post-mortem. The giving of that authority is governed by the same provisions as regulate the removal of parts of bodies under section 1, with any necessary modifications. We set out the material text of section 1 in due course. In essence, authority may only be given if the person lawfully in possession of the body has made 'such reasonable enquiry as may be practicable' and has no reason to believe that the deceased expressed an objection which was not withdrawn prior to death, nor any reason to believe that the surviving spouse or any surviving relative objects (section 1[2]). Authority cannot be given without the Coroner's consent where there is reason to believe that an inquest or post-mortem may be required by the Coroner (section 1[5]).
- Thus, whenever the expression 'hospital post-mortem' is used to describe a procedure which is concerned, not with a post-mortem examination, but only with removal of human material for purposes of medical education or research (and therefore a procedure governed by section 1, not section 2, 1961 Act), that expression is used loosely and incorrectly.
- Authority for the use of parts of the body for therapeutic, medical
education or research purposes is governed by section 1(2) which provides:
'...the person lawfully in possession of the body of a deceased person may authorise the removal of any part from the body for use for the said purposes [i.e. therapeutic purposes, medical education or research] if, 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.'
- Where the body of the deceased is lying in a hospital (or nursing home or other institution), the necessary authority for post-mortem (under section 2) or removal of parts for therapeutic, medical education or research purposes (under section 1) may be given, on behalf of the person having the control and management of the institution, by any officer or person designated for the purpose by that person. [72]
- Section 1(7) implies, as the note in Halsbury's Statutes volume 28 indicates, that in the case of a death in a hospital, the manager thereof is in lawful possession. However, the phrase 'person lawfully in possession' is not defined in the 1961 Act.
- The person who may give the authority must make reasonable enquiries to discover whether there is any objection from the surviving spouse or any surviving relative (or from the deceased himself prior to death) to removal under section 1(2) of any part from the body for the specified purposes (therapeutic, education and research). There is no obligation to obtain consent, therefore, before the removal under section 1, 1961 Act can be authorised. Where his reasonable enquiries do not reveal an objection, the person in lawful possession of the body may proceed to authorise a removal without the need to obtain any consent. [73]
- Notwithstanding that the 1961 Act does not, in terms, require consent,
the 'form of consent' for hospital post-mortem appended to 'The Autopsy
and Audit' [74]
does employ the language of 'consent' in relation to the hospital post-mortem.
It provides:
'I understand that the examination is carried out:
a) to verify the cause of death [section 2(2)] and to study the effects of treatment [section 1(2)], which may involve the retention of tissue for laboratory study;
b) to remove amounts of tissue for the treatment of other patients and for medical education and research [section 1(2)].'
- The advice accompanying this form [75]
is that it should be adhered to, but that it might also be helpful for
the person giving the consent to be provided with an explanation couched
in simpler language, thus:
'...If you give permission it will allow us to carry out a careful internal examination which may reveal new information and, therefore, benefit future patients...It also allows us to remove tissue for laboratory investigations which are not possible during life...'
- The amount of information to be provided to parents by clinicians seeking their 'lack of objection' to a hospital post-mortem and/or to the removal and retention of tissue consequent on the post-mortem, is not prescribed by statute, nor has it been considered by the courts.
- We consider here, by analogy, what level of information is required for consent to treatment of a living patient to be valid, or 'real'. Whether the analogy is appropriate is considered in the main body of our report.
- The prevailing view following the decision in Bolam v Friern HMC [76] in 1957 was that, to obtain a properly informed or 'real' consent, the law required the clinician to inform the patient (or parent, in the case of a young child) of those matters which a responsible body of doctors would regard as appropriate, i.e. the so-called 'Bolam test'.
- The amount of information to be provided to a patient was then considered in 1981 by Bristow J in Chatterton v Gerson. [77] He held that 'once the patient is informed in broad terms of the nature of the procedure which is intended...that consent is real'.
- In 1984 the Court of Appeal in Sidaway v Bethlem Royal Hospital Governors [78] approved Chatterton. However, the decision in the House of Lords [79] marked the beginnings of a movement away from this paternalistic legal standard which took account only of the views of doctors. Although they confirmed that the duty to inform was governed by the Bolam test, their Lordships applied a gloss to the test. Lord Bridge stated that the doctor's duty must 'primarily be a matter of clinical judgement' [80] thus indicating that there comes a point when the doctor should take into account what the patient may wish, or have a right, to know.
- However, in 1988 the Court of Appeal in Gold v Haringey Health Authority [81] reverted to the Bolam test without gloss.
- In 1997, the House of Lords in Bolitho v City and Hackney Health Authority [82] held that the court, not the doctor, was the final arbiter. The court must be satisfied that exponents of the responsible body of opinion can demonstrate that the opinion has a logical basis. However, this case was concerned with the standard to be applied to the quality of care rather than the duty to inform (as in Bolam) and there was some doubt whether this decision affects the duty to disclose.
- In 1999, in Pearce v United Bristol Healthcare NHS Trust [83] the Court of Appeal synthesised the decisions in Sidaway and Bolitho in determining the standard of disclosure. Lord Woolf MR held 'if there is a significant risk which would affect the judgment of a reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course he or she should adopt.'
- The extent of the reasonable enquiries required by the 1961 Act is
unclear. The memorandum sent by the Ministry of Health to hospital authorities
in advance of the 1961 Act coming into effect advised:
'The nearest relative available should be asked if he objects or if he has reason to believe that any other relative would object...The word 'relatives' is not defined in the Act and the minister considers that it should be interpreted in the widest sense, to include those who claim a quite distant relationship to the deceased.' [84]
- What enquiries are reasonable or practicable may depend on the circumstances, including perhaps, the urgency with which a body part is needed (the Act has in mind organ transplants), and the nature of the relationship between the deceased and the people who may be considered 'any surviving relative of the deceased'. There is no indication as to whether this definition relates exclusively to blood relatives or includes relatives by marriage, and there is no express limit on proximity of the relation. [85]
- In relation to the Coroner's inquest, the 1984 Rules are specific in Rule 19 (and 20[2]) in identifying certain classes of relative, and the Practice Notes for Coroners give guidance [86] on the exercise of the discretion to notify anyone with a proper interest in the inquest under Rule 20(2)(h), by reference to the principles set out in R v South London Coroner ex parte Driscoll. [87] It may extend to the classes of relative beyond those of a parent or child to, for example, siblings of the deceased (but only in the absence of any parent, spouse or child), or even perhaps, but less likely, the partner of the deceased, especially if that partner is acknowledged as the other parent of a child of the deceased.
- Where lack of objection to a hospital post-mortem examination or
to removal under section 1(2) is confirmed, then a hospital post-mortem
or, as the case may be, removal under section 1(2), may lawfully be
authorised. Such procedures are sometimes referred to as 'consent' post-mortems
although, as noted above, procedures which are concerned only with removal
of parts pursuant to section 1 and not with establishing the cause of
death are strictly not post-mortems at all. The proper ambit of what
exactly is 'consented to' and whether this accords with the understanding
of the person giving consent must be considered. This we do below.
The pathologist in the hospital post-mortem examination
- The 1961 Act gives no guidance as to the choice of pathologist in
a hospital post-mortem examination, save that by section 2(2) it must
be carried out by or in accordance with the instructions of a fully
registered medical practitioner.
Removal of tissue pursuant to the 1961 Act
- Section 1(1) provides for the removal (and use) at the request of the deceased. Provided the deceased's directions were given in writing or orally in the presence of two witnesses during his last illness, then unless he has reason to believe the request was withdrawn, the person lawfully in possession of the body may authorise the removal of body parts in accordance with the request. [88]
- Section 1(2) provides for the removal and use of body parts, in the absence of any request by the deceased.
- Thus, removal of tissue for purposes unrelated to establishing the cause of death would require specific authority under section 1, 1961 Act.
- Section 1, 1961 Act, provides for the removal (and use) of parts
of a body for therapeutic purposes or for purposes of medical education
or research. Provided that the terms of the Act are complied with, any
part of the body may be removed.
The 1984 Act
- The provisions of the 1984 Act provide an alternative framework for the removal, retention, use and disposal of human tissue in certain circumstances. The long title of the 1984 Act is 'An Act to make provision about the use of bodies of deceased persons, and parts of such bodies, for anatomical examination and about the possession and disposal of bodies of deceased persons, and parts of such bodies, authorised to be used for anatomical examination, and for connected purposes'.
- By section 1(4), 1984 Act, nothing in that Act applies to anything done for the purposes of a post-mortem examination requested or required or directed to be made by a competent legal authority or carried out for the purpose of establishing or confirming the causes of death or of investigating the existence or nature of abnormal conditions. By section 1(5), if a part of a body is authorised under section 1, 1961 Act to be removed for the purposes of medical education or research, then that section of the 1961 Act applies to the removal and use of the part, and not the 1984 Act, but the 1984 Act may apply as regards the body after the removal of the part pursuant to section 1, 1961 Act.
- The 1984 Act and the Regulations made under it [89] provide for and regulate the use of bodies for anatomical examination.
- An anatomical examination is defined [90] as 'the examination by dissection of a body for purposes of teaching or studying, or researching into, morphology; and where parts of a body are separated in the course of its anatomical examination, such examination includes the examination by dissection of the parts for those purposes'.
- Given that examination involves removal of tissue, the 1984 Act therefore makes removal of tissue lawful, for the purposes covered by the 1984 Act.
- The circumstances under which the examination can be carried out are that if the deceased requested that his body be so used, either in writing at any time or orally in the presence of two or more witnesses during his last illness, and the person lawfully in possession of the body after death has no reason to believe that the request has been withdrawn, then that person may authorise the use of the body for anatomical examination. [91]
- By section 4(3), of the 1984 Act the person lawfully in possession
of the body may authorise it to be used for anatomical examination:
'if having made such reasonable inquiry as may be practicable, he has no reason to believe -
that the deceased, either in writing at any time or orally in the presence of two or more witnesses during his last illness, had expressed an objection to his body being so used after his death, and had not withdrawn it, or
that the surviving spouse or any surviving relative of the deceased objects to the body being so used.'
- As with the 1961 Act, authority for an anatomical examination under the 1984 Act cannot be given (except with the coroner's consent) if there is reason to believe that a Coroner's post-mortem or inquest will be held, [92] and in the case of a body lying in a hospital (nursing home or other institution), authority for the examination may be given on behalf of the person having the control or management of the institution by someone designated by him. [93]
- As with the 1961 Act [94] the extent of the enquiries the person lawfully in possession must make to ascertain any objection before authorising an examination is not specified in the legislation, beyond requiring that the extent of the enquiry be such as is practicable and the nature of it is reasonable.
- Unlike the 1961 Act, the 1984 Act regulates the period for which authority under the Act subsists, [95] provides for inspection and licensing, and for control of possession of the body or part of the body after examination. [96] Both the person carrying out the examination and the premises on which the examination takes place must be licensed by the Secretary of State (sections 3 and 7), and are subject to inspection by HM Inspectors of Anatomy (sections 9-10).
- Where a body has been subject to anatomical examination, the person
with the licence is under a duty to ensure that the disposal of the
body shall, as far as practicable, be in accordance with the wishes
of the deceased, and that separated parts of the body (other than those
parts which are held in possession by virtue of sections 5 and 6 of
the 1984 Act) are, so far as practicable, disposed of with the body.
[97]
The 1989 Act
- The 1989 Act creates a prohibition on commercial dealings in organs
removed for the purposes of transplantation and extends to organs removed
from the dead.
Common law
- The authors of the Nuffield Council report [98] considered whether there might be a residual power at common law to remove and retain tissue for uses not covered by statute if the use could be justified as being for the public good.
- The archiving or banking of retained tissue (unless falling within
the terms education, teaching or research), or the removal of tissue
with the intention of exploiting it commercially through, for example,
sale of it or constituent elements of it, uses which arguably do not
fall within the wording of the statutes considered above, would be covered
by such a common-law power.
Notifying the result of the hospital post-mortem
- There is no statutory requirement for the results of the hospital post-mortem examination to be given to relatives. Guidance given in 'The Autopsy and Audit' [99] states that it is important to communicate the result of the post-mortem to relatives, whether this is done by the consultant in charge of the case, or his delegate, or the family's general practitioner, and that a copy of the final post-mortem report should be sent to the general practitioner. The guidance suggests that it is not appropriate for the pathologist to speak directly to relatives without the prior knowledge of the consultant in charge of the case.
The purpose of the hospital post-mortem examination
Footnotes
68 WIT 54/31 para 3.2 [Return to text]
69 Report of the Joint Working Party of the Royal College of Pathologists, the Royal College of Physicians of London and the Royal College of Surgeons of England (August 1991) WIT 54/936-960 and RCPath 54/936-960 [Return to text]
70 (June 1999) RCPath 1-87 [Return to text]
71 T42, p. 41-43 [Return to text]
72 Sections 1(7), 2(2). Section 1(7) appears to contemplate a formal process of designation. Evidence of this taking place in practice is lacking [Return to text]
73 See DHSS Circular HC (77) 28 para 3, WIT 43/119 [Return to text]
74 WIT 54/936-960 at 960 [Return to text]
75 WIT 54/958 [Return to text]
76 Bolam v Friern Hospital Management Committee [1957] 1 WLR 582 [Return to text]
77 [1981] QB 432 [Return to text]
78 [1984] QB 493 [Return to text]
79 [1985] AC 871 [Return to text]
80 900 [Return to text]
81 [1988] QB 481 [Return to text]
82 [1998] AC 232 [Return to text]
83 [1999] PIQR P53 (C A) at P59 [Return to text]
84 Health Memorandum (61) 98 (21 September 1961) WIT 43/115 [Return to text]
85 For further discussion see Skegg 'Human Tissue Act 1961'(1976) 16 Medicine, Science and Law 193, 197; and Dworkin 'The Law Relating to Organ Transplantation in England' (1970) 33 MLR 353, 364-5 [Return to text]
86 Para 5.1, WIT 39/7 [Return to text]
87 (1993) 159 J.P. 45, D.C.; Independent, November 22, 1993 [Return to text]
88 Section 1(1) and 1(3) [Return to text]
89 Anatomy Regulations 1988 SI 1988/44 and Anatomy (Amendment) Regulations 1988 SI 1988/198 [Return to text]
90 Section 1(1), 1984 Act [Return to text]
91 Section 4(1) and (2), 1984 Act [Return to text]
92 Section 4(5), 1984 Act [Return to text]
93 Section 4(9), 1984 Act [Return to text]
94 See paras 74-76 [Return to text]
95 By section 4(10) the period is three years, beginning with the date of death or such other period as the Secretary of State may specify [Return to text]
96 Sections 5 and 6, 1984 Act [Return to text]
97 Regulation 4(1)(e), Anatomy Regulations 1988 SI 1988/44 [Return to text]
98 See para 5 [Return to text]
99 Para 3.4, WIT 54/948. [Return to text]