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The Investigation of Events that followed the death of Cyril Mark Isaacs
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| This chapter describes the statutes, circulars and other official guidance that were relevant to organ and tissue retention in the late 1980s. | |
| In the late 1980s the legislation that bore directly on the retention of body parts from post mortem examinations were the Human Tissue Act, 1961, and the Coroners Rules, 1984. (The Corneal Tissue Act (1986) deals only with the removal of eyes.) | Appendix 2 |
| The Human Tissue Act, 1961 | |
| This Act applies to all bodies and made provision for the removal of body parts for medical purposes. | |
| Before this Act, only the Anatomy Act of 1832 and the Corneal Grafting Act of 1952 had specifically regulated the use of bodies or body parts for medical purposes, research and teaching. | |
| The Human Tissue Act gives authority to 'the person lawfully in possession of the body' to consent to the use of a body or parts of the body for therapeutic purposes or for medical education or research. The reference in the Act to 'any part of a body' clearly implies that the part in question will be separated from the body and retained. | |
| Importantly, this consent was subject to the requirement that the deceased in life had expressed 'no objection' and that the surviving relatives did not object. | |
| The authority to give consent did not extend to bodies that might be subject to the jurisdiction of the Coroner. In these cases Section 1(5) requires the prior consent of the Coroner. | |
| The key point of Section 1 of the Human Tissue Act is that the person in possession of a body must first make reasonable enquiries to make sure there are no objections. This cannot be assumed. | |
| Section 1 is relevant to this report as it refers to bodies lying in hospitals or other institutions. While a body is in a hospital 'the person having the control and management' has the authority to consent to removal of body parts 'if, having made such reasonable enquiry as may be practicable, he has no reason to believe - | |
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| The Human Tissue Act repealed the Corneal Grafting Act (1952). This Act had permitted the removal of the eyes of deceased persons subject to very similar authority and consent requirements. The Corneal Grafting Act required that there was 'no objection' from the deceased or surviving relatives. | |
| The Coroners Rules (1984) | |
| The Rules are a Statutory Instrument, deriving their authority from Sections 26 and 27 of the Coroners (Amendment) Act 1926. | |
| Rules 7, 9, 10 and 12 are relevant to the issues described in this report. Rule 7 sets out who should be notified that a post mortem is to take place, Rules 9 and 12 relate to the preservation of material (body parts), and Rule 10 to the post mortem report to the Coroner. | |
| Rule 7 'Coroner to notify persons of post mortem to be made' | |
| 7(1) requires the Coroner to notify a number of persons of the time and place of a post mortem that he has ordered, '..unless it is impracticable to notify any such persons or bodies or to do so would cause the examination to be unduly delayed'. | |
| 7(2) lists the persons to be notified and includes, 'any relative of the deceased who has notified the coroner of his desire to attend, or be represented, at the post- mortem examination' and 'the deceased's regular medical attendant'. | |
| Rule 9 'Preservation of material' | |
| 9 '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'. | |
| Rule 10 'Report on post-mortem' | |
| 10(1) 'The person making a post-mortem examination shall report to the coroner in the form set out in Schedule 2 or in a form to the like effect'. | |
| 10(2) 'Unless authorised by the coroner, the person making a post-mortem examination shall not supply a copy of his report to any person other than the coroner'. | |
| Rule12 'Preservation of material' | |
| 12 'A person making a special examination shall make provision, so far as possible, for the preservation of the material submitted to him for examination for such period as the coroner thinks fit'. | |
| Guidance to the NHS | |
| HM(61)98 Human Tissue Act, 1961 | |
| This Ministry of Health memorandum was distributed to the NHS in England and Wales on 21 September 1961. Its purpose was to describe 'the effect of the Human Tissue Act, 1961, on the law relating to the use of parts of bodies for therapeutic purposes, medical education or research, and to post-mortem examinations…' | |
| Paragraphs 5, 8 and 10 are relevant to this report. The memorandum is at Appendix 3. |
Appendix 3 |
| Paragraph 5 draws attention to the authority vested in the person in control of the body while it is in a hospital or other institution to give consent to removal of tissue so long as the body is in the hospital: 'Where the deceased person has not requested that his body or a part or parts of it be used, the Act empowers the person lawfully in possession of the body to authorise the removal of any parts, for use for the purposes specified in the Act'. | |
| Paragraph 8 emphasises the need for the relatives to be consulted about the use of body parts by the person lawfully in possession of the body: 'The nearest relative available should be asked if he objects or has reason to believe that any other relative would object.' | |
| Paragraph 10 requires the consent of relatives to a post mortem: 'Even if the deceased has expressed a wish that there should be a post-mortem examination on his body, the examination may not be authorised if there are objections from relatives… The coroner's consent must be obtained if there is reason to believe that he may require an inquest or post-mortem examination'. | |
| One purpose of this memorandum was to reassure NHS hospitals that it remained lawful under the Human Tissue Act to remove eyes for corneal transplantation despite the repeal of the Corneal Grafting Act provided there were no objections expressed by the relatives. Appendix II of the Memorandum addresses the Enucleation Storage and Transport of Eyes. | |
| HSC(IS)156 Guidance circular to NHS Authorities: Human Tissue Act, 1961 | |
| This circular was issued in June 1975 to clarify the uncertainty that had arisen over the interpretation in HM(61)98 over who is 'the person lawfully in possession of the body'. The circular reinforces the advice in HM(61)98. Paragraphs 6, 11, 12 are relevant. |
Appendix 4 |
| Paragraph 6 states: 'If a person dies in hospital, the person lawfully in possession of the body, at least until the executors or relatives ask for the body to be handed to them, is the Area Health Authority or the Board of Governors responsible for the hospital'. | |
Paragraph 11 reinforces the need for the person in possession of the body to ensure the relatives do not object to removal of tissue: 'A person lawfully in possession of the body of a patient who has not requested that his body or parts of it be used may only authorise removal of parts if, having made such reasonable enquiry as may be practicable, he has no reason to believe that the donor would have objected or that the surviving spouse or any surviving relative objects to the body or the specified part being so dealt with. Specific consent is not necessary, merely a lack of objection'. |
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| Paragraph 12 emphasises that the retention of parts of the body removed with the authority of the person in possession at the time the removal took place continues to be lawful after the body is returned to the relatives: | |
| 'In cases where the Health Authority is the person lawfully in possession of the body, and an authorisation under Section 1 (of the Human Tissue Act) has been given, the relatives or executors may subsequently ask that the body be handed over to them; but this action does not revoke the authorisation which continues to be legally effective'. | |
| The circular includes paragraphs on kidney transplantation, corneal grafting and human materials used in treatment, diagnosis or monitoring of therapy. | |
| HC(77)28 Removal of human tissue at post mortem examination - Human Tissue Act 1961 | |
| This circular was issued in August 1977. The first paragraph sets out its purpose to facilitate 'the removal of human organs and tissue, eg pituitary glands, during post mortem examination for subsequent use for the treatment of other patients and for medical education and research'. The same paragraph comments 'It would be tragic if insufficient pituitary glands became available, since it is at present impossible to synthesise human growth hormones'. | Appendix 5 |
| Paragraph 3 repeats the advice previously given in HSC(IS)156 with regard to the 'person lawfully in possession of the body'. Health Authorities were asked to designate officers to undertake their responsibilities in this respect. The same paragraph states: 'Specific consent is not required by the Act'. | |
| Collection of pituitary glands | |
| To set the context of HC(77)28, a short account of the pituitary collection programme is included at the end of this chapter. | |
| DA(82)9 The national pituitary collection and treatment with human growth hormone | |
| This circular letter, dated 11 May 1982, to District Administrators drew attention to a shortage of the number of pituitary glands becoming available for the growth hormone treatment programme. In substance, the letter repeated the advice in HSC(IS)156, that Health Authorities should designate officers for ensuring that the necessary enquiries were made for authorising the removal of organs or tissue. | Appendix 6 |
| Other circulars on related matters | |
HN(83)3/HN(FP)(83)4 Introduction of brain death check list |
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| This circular was issued with a revised code of practice on the removal of cadaveric organs for transplantation, and the introduction of a check list for diagnosis of brain death. The circular did not alter the advice on tissue removal that was not related to transplantation. | |
| Home Office newsletter to Coroners 1989 | |
| The Home Office newsletter to Coroners included the following paragraph: 'Post mortem examinations: We still receive representations from MPs and members of the public about the fact of post mortem examinations or their extent. Invariably our reply is that the post mortem examinations are required only to establish the precise cause of death, that they are not requested or granted gratuitously and are limited in extent to that necessary for the purpose. 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'(1). | |
The pituitary collection programme |
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| This programme was started in the 1950s as a research project supported by the Medical Research Council. The initial objective was to discover if the height of children who were very short for their age could be increased by treatment with growth hormone. Growth hormone is a complex of molecules produced naturally in the pituitary gland which is attached to the underside of the brain, deep inside the skull. | |
| The research project was successful and this prompted an increased demand for growth hormone so that the treatment could be provided for more short-of-stature children. Until synthetic growth hormone was successfully manufactured, the only source of the hormone was by extraction from the pituitaries obtained at post mortem. | |
| As only minute amounts of growth hormone could be extracted from each pituitary gland, very large numbers of glands were required. Between the start of the programme and its discontinuation in 1985, small glass jars containing acetone were to be found in mortuaries across the country. The pituitary glands were collected in these jars until a sufficient number had accumulated. The full jars were then sent centrally for extraction and purification of growth hormone. | |
| It was the intention of HC(77)28 to increase the number of pituitaries collected. In practice, the glands were usually removed by the morticians at the end of post mortem examination. To encourage the collection of pituitaries, a small payment was made for each gland by the Medical Research Council. | |
| This was initially one shilling and six pence for each gland but had increased to twenty new pence by 1980. | |
| The Medical Research Council continued the growth hormone research programme, with the backing of the Department of Health and Social Security (DHSS), until 1980 when the DHSS took over responsibility for its management. A letter dated 25 April 1980 was sent to all NHS hospitals in England to explain the transfer arrangements and encourage the continued collection of pituitary glands. |
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| With the transfer of responsibility from the MRC to the DHSS the payment per gland to NHS morticians was discontinued. Instead, the work involved in retaining pituitaries was consolidated into a new Whitley salary scale. This payment change did not apply to morticians working in Local Authority mortuaries who continued for a period to receive payment for each gland. | |
| The pituitary collection programme continued until 1985 when treatment with growth hormone obtained from pituitaries ceased following the discovery that Creutzefelt Jacob Disease (CJD) had been unwittingly transmitted to some of the children who had been treated with growth hormone. | |
| Fortunately, a synthetic form of growth hormone became available within a few months of this discovery. | |
| Summary | |
| In the late 1980s the Human Tissue Act and Coroners Rules were the relevant legislation. Guidance circulars from the Ministry of Health and DHSS provided further advice. | |
| The National Pituitary Collection Programme encouraged the collection of pituitary glands at post mortem. | |
| References | |
| 1. Home Office newsletter to Coroners, August 1989. | |