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Interim Report: Removal and retention of human material
Annex B: Law and Guidelines
Part V: Other law and guidelines
The Human Rights Act 1998
Patient's Charter rights and standards
Nuffield Council on Bioethics
Consensus statement of recommended policies for
uses of human tissue in research education and quality control
Retention and storage of pathological records
and archives
Human tissue and biological samples for use in
research
The European Convention on Human Rights and Biomedicine
Introduction
The general philosophy of the Convention
Removal of human material
The draft Protocol to the Convention
'Organ' and 'tissue'
Royal College of Pathologists Guidelines for
the retention of tissues and organs
- The Human Rights Act 1998 obtained the Royal Assent 9 November 1998 and will come into force on 2 October 2000.
- It will require that, so far as possible, all legislation, past and future is read and given effect in a way compatible with the European Convention on Human Rights and Fundamental Freedoms [ECHR]. [133]
- The Act will provide for courts to make a declaration of incompatibility where legislation is found to be incompatible with an ECHR right. [134]
- The Act will require case law of the European Court of Human Rights 'to be taken into account', [135] although strictly it will not have the status of binding precedent.
- The Act will require that where public authorities such as NHS trusts, or other NHS bodies, do not act compatibly with the ECHR their actions are to be considered 'unlawful'. [136] The 'victim' of such an 'unlawful' act will be able to bring proceedings against the authority. [137]
- A deceased child would not be a 'victim' acquiring a posthumous cause of action under the Act in relation to matters occurring at his post-mortem examination. Thus the estate or parents will have no cause of action on the child's behalf and would have to show that they themselves were 'victims' of the action of the relevant Health Service organisation in order to bring themselves within the ambit of the Act.
- Cameron McKenna's submission [138] considered various possible circumstances in which a Health Authority might be found in breach of Article 8 [139] of the ECHR in removing, retaining or using tissue, and the possible impact of Article 13. [140]
- Article 8 has been interpreted as protecting the individual against
arbitrary interference by public authorities in his private or family
life. [141]
The concept of 'family life' has been construed broadly, although the
question of whether the removal, retention and use of tissue from a
deceased member of a family can be an interference with family life
has not yet been determined. Assuming it were, Cameron McKenna suggest
that the following may be considered acts incompatible with Article
8:
the 'no property' rule and the apparent lack of effective sanction for 'wrongful' removal of tissue;
a failure properly to comply with the provisions of section 1(2), 1961 Act in seeking lack of objections from relatives;
where tissue lawfully removed, for example for the purposes of Rule 9, 1984 Rules, is subsequently retained by the pathologist for an unauthorised use when relatives are not given the opportunity to object;
the use of retained tissue, which may affect a relative's own health, for example, for genetic research (the use of the tissue will not, of course, affect a relative's health, but the information derived from it could).
- Article 13 is not incorporated directly into the Act, since the Act
itself is intended to establish a scheme whereby effective remedies
for breaches of ECHR are provided. To the extent that domestic law does
not provide, for example, an effective remedy against unauthorised use
of tissue, Article 13 could be relied upon before the Strasbourg court
in proceedings against the UK brought by a person who could demonstrate
that a Convention right of theirs had been violated.
Patient's Charter rights and standards
- The Patient's Charter [142] was launched in October 1991 and took effect on 1 April 1992. It identified ten guaranteed National Charter Rights to care in the NHS. It is important to recall that these are not statutory rights recognised by law. Seven of the charter rights were expressed to be already well established, and three were introduced by the Charter. It also introduced nine National Charter Standards for the NHS to achieve in key areas, and required local health authorities to set their own Local Charter Standards from 1 April 1992.
- 'The Patient's Charter & You', [143] published by the Department of Health in January 1995, provided a new expanded and updated Charter introducing further standards. This document defined charter rights as 'Rights - which all patients will receive all the time', and expectations as 'standards of service which the NHS is aiming to achieve. Exceptional circumstances may sometimes prevent these standards being met.'
- Two charter rights identified in the Patient's Charter in 1991 as
already being 'well established' were:
'to be given a clear explanation of any treatment proposed, including any risks and any alternatives, before you decide whether you will agree to the treatment',
and
'to choose whether or not you wish to take part in medical research or medical student training'.
- A National Charter standard of service is:
'Respect for privacy, dignity and religious and cultural beliefs. The Charter standard is that all health services should make provision so that proper personal consideration is shown to you, for example by ensuring that your privacy, dignity and religious and cultural beliefs are respected. Practical arrangements should include meals to suit all dietary requirements, and private rooms for confidential discussions with relatives.'
- The right to choose whether or not to take part in medical research or medical student training, and the right to the respect of your privacy, dignity and religious and cultural beliefs were reiterated in 'The Patient's Charter & You'.
- It may be said to be consistent with the spirit if not the strict letter of the Charter that a parent of a deceased child has a right under the Charter to be given a clear explanation of a proposed hospital post-mortem examination, and to decide whether their child's body or tissue may be used in medical research.
- Further, the right to respect for religious views can be said to
require the person seeking to obtain consent (or, strictly, ascertaining
that there is a lack of objection) for the removal, retention and use
of organs or tissue, to ascertain whether the parents have any objections
or reservations on religious grounds.
Nuffield Council on Bioethics
- It is to be noted that, in 1995, the authors of the Nuffield Council's report highlighted the lack of clarity in the law in this area, and particularly in relation to any property rights in tissue.
- They recommended that, as an aid to ensuring that consent to treatment was properly informed, bodies such as NHS Trusts and independent hospitals responsible for consent procedures 'should consider whether any addition to their explanations or forms are needed to make it clear that consent covers acceptable further uses of human tissue removed during treatment'. [144]
- They also recommended that these bodies review their practices on
all handling and disposal of human tissue to ensure that they met 'the
requirements both of law and of professional standards and also to ensure
that major body parts (for example, limbs and hands), and tissue subject
to special public concern or scrutiny (for example, foetal tissue) are
handled and disposed of in ways which show respect.'
[145]
Consensus statement of recommended policies for uses of human tissue in research education and quality control [146]
- In the notes reflecting UK law and practice, the working party note that, by 1999, the recommendations of the Nuffield Council's report had not yet been translated into legislation. [147]
- In relation to 'ownership' of tissue, they adopt the term 'custodian' for the pathologist who holds pathological records and archives. In their view it is for the pathologist to exercise discretion over requests for research access to them. [148]
- They note the recommendation of the authors of the Nuffield Council's report that general consent forms for the removal of tissue might refer to the possibility that removed tissue may be used for research, teaching or study. They also note the apparently contradictory advice of the Royal College of Physicians that the use of left-over tissue for research is a traditional and ethically acceptable practice that does not need consent from patients or relatives. [149]
- The working party conclude that 'the prevailing legal opinion is that tissue obtained with consent or under [the 1961 or 1984 or 1989 Acts] is obtained free of all claims and the user obtains at least a right to possess and probably a right of ownership'. [150]
- This conclusion may suggest a degree of confidence bordering on the
rash.
Retention and storage of pathological records and archives [151]
- The Working Party of the Royal College of Pathologists and the Institute of Bio-Medical Science made recommendations in relation to minimum retention times for pathology records, including retained tissue.
- In relation to retained tissue generally (the paper does not at this stage distinguish between a Coroner's post-mortem and a hospital post-mortem), they note that the mere possibility of tissue constituting material evidence in future litigation is not sufficient ground for the imposition of a duty to store indefinitely (following the decision in Dobson). [152]
- They recommend that 'wet tissue' (whether a representative aliquot or whole tissue or organ) be retained for a minimum of four weeks after the final post-mortem report.
- In relation to tissue retained under Rule 9, 1984 Rules, they note that this is to be retained until the completion of the inquest and, in deaths subject to criminal inquiry, until both the Coroner's interest has expired and other interests such as those of the Crown Prosecution Service have been fulfilled.
- The working party notes that the retention of tissue beyond 30 years, 'other than in the case of recognised historical or teaching or research archives already kept in approved places of deposit...requires application to the Lord Chancellor...if there is a need for them to be retained by the Health Authority'. They therefore recommend that pathologists should be prepared to destroy tissue after 30 years. [153] However they do not, in terms, recommend the destruction of tissue on the expiry of minimum retention periods.
- In relation to the 'ownership' of retained tissue the working party
advises that 'Property in pathological materials and records, as in
other Health Service (NHS) records and items, vests ultimately with
the Secretary of State for Health or in NHS Trusts (Scotland). In private
practice it vests in the maker of the records...Property in records,
reports and materials relating to procedures within the jurisdiction
of [the Coroner] does not vest in the same way.'
Human tissue and biological samples for use in research [154]
- The interim guidelines published by the Medical Research Council (MRC) deal principally with tissue taken from living donors, and defer, in para 1.4 to the then forthcoming guidelines from the Royal College of Pathologists in relation to tissue taken from the deceased. Their recommendations about the ownership of tissue and consent are considered here by way of analogy.
- In relation to the ownership of tissue they note [155] present uncertainties in the law as to whether tissue may be considered 'property' and suggest that it is 'more practical and more attractive from a moral and ethical standpoint to adopt the position that, if a tissue sample could be property [on the basis of Kelly], the original owner was the individual from whom it was taken.'
- They recommend, in paras 2.1 and 2.2, that tissue samples taken with consent from the living be treated as having been donated (rather than abandoned as recommended by the authors of the Nuffield Council's report), and that the hospital or other institution where the researcher is based should have formal responsibility for the custody of new collections, whilst the researcher has responsibility for the day to day management.
- They use the term 'custodianship' in preference to 'ownership' and define 'custodianship' as the responsibility for safe keeping of samples and the control of their use in accordance with the terms of consent given by the donor. They state, in para 3.1, that 'Custodianship implies some property rights over the samples, but also some responsibility for safeguarding the interests of the donor' [156] and 'We understand that custodianship brings with it the right to determine what happens to a collection' once the research is concluded.
- We suggest that this approach would result in the 'custodianship' of the tissue passing on removal rather than on the exercise of whatever skill or work might bring it within the exception to the 'no property' rule.
- In relation to consent, as samples may be stored for long periods and may be of value for future research which could not have been foreseen at the time the tissue was obtained, they recommend that unless the sample is to be used for a single project, consent must be obtained for storage and for future use for other research. A two-part consent process is recommended where the donor is first asked to consent to the research which has been planned, and is then asked to give a broader consent to the storage and future use of the tissue for a specified type of future research. They recommend, in para 2.6, that when seeking consent, the information should be presented in a form easily understood and, where necessary, by way of audio-taped information.
- However, in relation to collections of tissue already in existence
they advise, in para 4.2, that, generally, these can be used for further
research, for which consent has not been obtained, provided the tissue
has been coded or anonymised and there is no potential harm to the donors.
The European Convention on Human Rights and Biomedicine
Introduction
- 'The European Convention for the protection of Human Rights and dignity of the human being with regard to the application of biology and medicine: Convention on Human Rights and Biomedicine' ('the Convention'), was opened for signature in Oviedo, on 4 April 1997. Since it was opened for signature it has been signed by 24 member states of the Council of Europe. [157]
- The Convention is designed to protect the dignity and integrity of
human beings, and to guarantee respect for their rights and freedoms,
with regard to developments in science and medicine. It stipulates that
the interests of human beings must prevail over those of science or
society. The Convention is the first internationally-binding legal text
designed to protect people against the misuse of biological and medical
advances. The Convention does not, of course, prevent a State from giving
greater protection than that set out in the Convention.
The general philosophy of the Convention
- The Explanatory Report to the Convention [158] provides that, 'The whole Convention, the aim of which is to protect human rights and dignity, is inspired by the principle of the primacy of the human being, and all its articles must be interpreted in this light'.
- Article 2 of the Convention provides:
'The interests and welfare of the human being shall prevail over the sole interest of society or science.'
- This general philosophy is reflected by Article 5, which provides:
'An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.
This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time.'
- Article 5 is obviously concerned with consent given by living persons.
However, many of the principles elaborated in the Convention and the
Explanatory Report are relevant also to the issues considered by the
Inquiry in this Interim Report. The Explanatory Report states that Article
5:
'...makes clear patients' autonomy in their relationship with health care professionals and serves to restrain the paternalist approaches which might ignore the wish of the patient...
The patient's consent is considered to be free and informed if it is given on the basis of objective information from the responsible health care professional as to the nature and the potential consequences of the planned intervention or of its alternatives, in the absence of any pressure from anyone...In order for their consent to be valid the persons in question must have been informed about the relevant facts regarding the intervention being contemplated. This information must include the purpose, nature and consequences of the intervention and the risks involved... Requests for additional information made by patients must be adequately answered.
Moreover, this information must be sufficiently clear and suitably worded for the person who is to undergo the intervention. The patient must be put in a position, through the use of terms he or she can understand, to weigh up the necessity or usefulness of the aim and methods of the intervention against its risks and the discomfort or pain it will cause...'
Removal of human material
- Chapter VI of the Convention is concerned with the removal of organs and tissue from living donors for transplantation purposes. One of the conditions for a living donor transplant is that there is no suitable human material available from a deceased person. [159]
- Article 22 of the Convention, [160]
goes on to provide that:
'When in the course of an intervention any part of a human body is removed, it may be stored and used for a purpose other than that for which it was removed, only if this is done in conformity with appropriate information and consent procedures.'
- Legal oversight and the promotion of consistency in approach throughout
States which are parties to the Convention is provided by the provision
for the Steering Committee on Bioethics, or any other committee designated
by the Committee of Ministers or the parties to the Convention, to request
the European Court of Human Rights in Strasbourg to give advisory opinions
on legal questions concerning the interpretation of the Convention.
[161]
The draft Protocol to the Convention
- The Council of Europe draft Protocol to the Convention ('the draft Protocol') was published in February 1999.
- The draft Protocol amplifies the principles embodied in the Convention, with a view to ensuring protection of people in the specific field of transplantation of organs and tissues of human origin. [162] It contains general principles and specific provisions. The draft Protocol was accompanied by an Explanatory Report. For the most part, the draft Protocol addresses issues beyond the particular concerns of this Report. One provision, however, is worthy of note.
- Pursuant to Chapter V of the draft Protocol, concerned with the disposal
of human material which has been removed, when, in the course of an
intervention, an organ or tissue is removed for a purpose other than
'donation for implantation', it may be transplanted only if this is
done in conformity with appropriate information and consent procedures.
[163] This
principle of Chapter V could, perhaps, be given wider application, such
that no human material could be used for a purpose other than that for
which it was initially removed from the body, without the appropriate
express consents first being obtained.
'Organ' and 'tissue'
- Finally, we note that the Explanatory Report to the draft Protocol
contains an interesting passage on the definitional difficulties of
the words 'organ' and 'tissue'. The Report describes how medical advances
can give rise to difficulties of definition. The Report says:
'There is...difficulty in agreeing on a scientifically precise definition of "organ" and "tissue". Traditionally an "organ" has been described as part of a human body consisting of a structured arrangement of tissues which, if wholly removed, cannot be replicated by the body. In 1994 the Committee of Ministers adopted a definition of tissues as being "All constituent parts of the human body, including surgical residues, but excluding organs, blood, blood products as well as reproductive tissue such as sperm, eggs and embryos. Hair, nails, placentas and body waste products also excluded". These were useful definitions in the early days of transplantation when only a few solid organs were transplanted, for example kidney, heart and liver. However, developments in transplantation have given rise to difficulties of definition. For example, only a part of an adult liver may be removed and transplanted into a child and the residual liver will regrow and the transplant will grow to adult size. This is a liver transplant but is clearly not an "organ" transplant according to the traditional definitions. Conversely, if a whole bone is removed and transplanted, the body cannot replicate the bone, but bone is normally considered to be a tissue not an organ...
For the purposes of this Protocol, the term "organ" is accordingly applied to vital organs or parts of vital organs which require a major surgical procedure for removal and which need to be transplanted rapidly. The term "tissues" covers all other those parts of the body, including cells, not specifically excluded.'
- We have already drawn attention elsewhere in this Interim Report,
to the fact that the terminology of 'organ' and 'tissue' is apt to confuse.
It is vital that the terminology employed on consent forms and the like
is kept under regular review to ensure that it continues to be appropriate
as science develops and medical advances permit new techniques to be
performed.
Royal College of Pathologists Guidelines for the retention of tissues and organs
- The Guidelines published by the Royal College of Pathologists in March 2000 constitute advice to doctors (particularly pathologists) and Coroners. They are not primarily addressed to the public. They consist of the Guidelines themselves and three Annexes, comprising a model information leaflet, a model form for agreement to a post-mortem examination and a model form for a post-mortem required by law.
- Some overarching points are apparent:
(a) there is no sanction for any breach of the Guidelines;
(b) the legal status is that of advice, and nothing more;
(c) they apply only to the 'retention' of 'tissues and organs' [164] from post mortem examinations, and do not cover the retention of material from biopsies or surgical resections;
(d) although Coroner's post mortems [165] are distinguished from hospital post-mortems [166] in the Introduction [167] to the Guidelines, both are treated indistinguishably. In the Introduction there is said to be a need in some cases to retain one or more whole organs for further examination not only to verify the cause of death but also to study the effect of treatment. Establishing the cause of death is the principal focus of a Coroner's post-mortem: any study of the effects of treatment as a separate exercise is not in fact permitted within the scope of a Coroner's post-mortem.
- There is no separate definition of many of the terms used in the Guidelines. The use of the words 'tissue', 'tissue samples', 'fluids', 'tissues and organs' and 'tissues or organs' is considered in the report to which this is an Annex. Equally, there is no definition of 'post-mortem examination' in the Guidelines although the Glossary which forms part of the Information Leaflet does describe a post-mortem in some detail. The scope of a post-mortem appears to be wider than an examination by dissection of the corpse on one occasion: it is said [168] that the post-mortem examination is not just the external and internal examination of the body, but includes histological or other laboratory examination of retained tissues.
- The Guidelines take the view that the law requires 'proper authorisation' for the retention [169] of even the smallest amount of tissue. Since a Coroner, pursuant to Rule 9 of the Coroner's Rules 1984, may require the retention and preservation of material which in the opinion of the pathologist bears upon the cause of death, and since the Coroner's powers are otherwise limited to enquiring into the cause of death, the identity of the deceased, and how and when he met his death, it would appear to follow that a Coroner has no power to authorise the retention of tissue for any other purpose. At Paragraph 3.6, however, it is suggested that a pathologist should retain appropriate samples when, during the course of the post-mortem, he discovers a condition 'which has no bearing on the cause of death', [170] but may have implications for other family members. Even though the Guidelines go on to say that the agreement of relatives should be sought and, if refused, the tissue samples should be reunited with the body, this advice on its face would appear to exceed the Coroner's authority.
- The distinction between that which is recommendation or guideline, and that which is intended as an exposition of the existing law is not stated as such. [171] Ordinarily, if the Guidelines and recommendations are followed it is likely that the practitioner will be within any permissible interpretation of the present law, save where the Guidelines appear to go beyond what the law provides. [172]
- Of particular relevance to the terms of reference of this Inquiry,
the Guidelines suggest:
a) pathologists should routinely, in the case of a Coroner's post-mortem, preserve samples from major organs for histopathological examination, unless it is known there are objections to that course or that retention has been disallowed by the Coroner, [173] and protocols providing for this should be drawn up between pathologists and Coroners;
b) that where a hospital post-mortem is intended, it must be made clear that the retention of 'tissue samples' is an integral part of the conduct of a post-mortem itself, and that 'the retention of whole organs for verification of the cause of death and investigation of the effects of treatment must also be explicit', and, thus, subject to potential objection; [174]
c) that, in the case of children, 'asking parents to agree to the post-mortem examination of a young child is a difficult and challenging task' which 'must be the responsibility of a senior member of the clinical team'. [175] The Guidelines refer to and adopt the well-regarded advice produced by the Confidential Enquiry into Stillbirths and Deaths in Infancy (CESDI, 1998);
d) that where the primary purpose of retention is to conduct research on retained material, the research protocol must be approved by a Research Ethics Committee. [176] It will be noted that this leaves somewhat unclear the propriety of research on other retained material, an uncertainty not dispelled by para 5.9, which merely provides that 'research on residual tissue may not require individual agreement' [177] provided that not too much was initially taken and the identity of the person from whom it was taken is not disclosed. Neither of these conditions is entirely clear;
e) that written agreement must be obtained for the retention of 'whole organs' in all cases; [178]
f) that where it appears unexpectedly to the pathologist that there is either 'necessity for or desirability of' the retention of a whole organ, it should be retained pending immediate steps to obtain written agreement. [179] This appears to contradict the previous guideline which calls for agreement in advance 'in all cases'. The two guidelines cannot readily be reconciled, and the appearance of this latter guideline may be said to undermine the trust essential for the guidelines to succeed, that, in an important development of practice, the pathologist be available directly to the family. Para 5.4 provides that: 'Relatives should be informed that a pathologist can be available to answer any specific questions or concerns'. The Para concludes: 'Pathologists must be willing also to speak to relatives, on request, after the autopsy and this is best done in liaison with the patient's clinician.'
- There are detailed provisions in respect of the disposal of tissues retained at any post-mortem examination. [180]
- The Guidelines conclude with 10 recommendations,
[181] urging
(a) training for medical and other appropriate personnel in the requesting and obtaining of agreement for post-mortem examinations and in dealing with relatives' concerns about tissue and organ retention;
(b) the need for liaison of such a person with the pathologist to determine the necessity of and grounds for retaining tissue;
(c) the advisability of an information leaflet for relatives;
(d) the need for relatives to be given and to keep a copy of the signed form authorising (a) the post-mortem and (b) the retention of tissue;
(e) that post-mortem examination forms should offer a range of options for which agreement may separately be granted or withheld;
(f) that Coroners should provide an information leaflet explaining the legal necessity in certain circumstances to retain tissues or organs, and explaining the relatives' right to material when examination has been completed;
(g) that reports of post-mortem examinations should state what, if any, tissues or organs have been retained;
(h) that there should be standard procedures for the archiving and disposal of tissues retained from post-mortems, with safe and secure storage of any retained material, and a respectful safe and lawful method of disposal;
(i) that where the body has been buried or cremated, any remaining tissue which has been retained should be released for disposal only with authoritative confirmation of the identity of the organs or tissue and of the deceased to funeral directors chosen by and acting on behalf of those who have 'legitimate responsibility' for the disposal of the body; and finally,
(j) a recommendation that such Guidelines be periodically reviewed.
- The Guidelines are accompanied by three Annexes; Annex A is an Information leaflet, and Annexes B and C are model forms.
- Annex A is a leaflet providing information about post-mortems for relatives. The leaflet explains what is involved in a post-mortem, and makes quite clear that internal organs are removed from the body in the course of the examination. The leaflet sets out the principles of a 'full post-mortem' and a 'limited post-mortem'. The latter might, for example, only involve examination of those organs directly involved in the deceased's illness, such as the heart for cardiac deaths. Reference is also made to the fact that laboratory examinations carried out after the post-mortem may take several weeks. It is made clear that there may be a delay to a funeral if all organs removed are to be returned to the body before the funeral takes place.
- The leaflet touches on the vexed question of what happens when one
relative has no objection to a hospital or 'consented' post-mortem or,
to go further, consents to it, but knows that another relative does
object, or would object if asked. The leaflet says:
'You should not give your agreement if you know that another close relative would object, or has already objected to the post-mortem examination'.
The model form at Annex B does not appear to take account of this part of the leaflet at all. Furthermore, the leaflet's use of the qualification 'close' is a gloss on the statutory provisions which does not appear to be justified by it. The 1961 Act refers only to 'any surviving relative' [182] without offering a definition of relative.
- Annex B of the Guidelines is a model form for consenting to a hospital post-mortem. It does not make any express provision for identifying whether any other relative or spouse has an objection although there is a question about the deceased's attitude and a tick box for the answer. Consistently with the leaflet the form ought to say something such as, 'do not sign this form if you know that any living relative of the deceased objects to the deceased's body being dealt with in the way proposed' or words to such effect.
- The form does not highlight at the outset that whole organs may be removed, although express provision for this is made later in the form.
- Any tissue removed at a hospital post-mortem if, pursuant to the
1961 Act it is truly a post-mortem under Section 2, as well as a section
1 removal, can only be removed:
a) to establish cause of death (s2);
b) for therapeutic purposes (s1);
c) for medical education purposes (s1); or
d) for research purposes (s1).
In the section of the form headed 'Organs being taken and held', however, the form departs from the purposes of removal designated under section 1 of the 1961 Act, namely 'therapeutic, medical education or research' and uses the terminology of 'any further examination which could provide a more detailed understanding of the illness'.
- It may be that this part of the form is intended to be concerned with establishing the cause of death of the deceased, and therefore is referring to the true post-mortem part of the examination (under section 2 of the 1961 Act) and not with removal for medical education or research at all. But there is an argument that the words used in the form, which refer to the 'illness' generally, are apt to cover medical research or even education. If the 'organs' section is about cause of death then the form should say so explicitly. At present 'cause of death' appears only in the first of the three options but not the other two. The terminology of 'any further investigation which could provide a more detailed understanding of the illness' is, therefore, a recipe for confusion.
- Annex C provides a model form for a Coroner's post-mortem. The form asks for a lack of objection to be expressed to the 'taking' of tissues, fluid or organs. That would certainly cover non-Rule 9 material. The form still does not grapple, however, with the main area of contention highlighted in the report, namely the eventual disposal of material 'taken' pursuant to Rule 9 at a Coroner's post-mortem. Arguably, the form should include some reference to objection or lack of objection to subsequent use for medical education or research purposes of material that the pathologist is obliged to remove at post-mortem in order to discharge his duties to the Coroner.
The Human Rights Act 1998
Footnotes
133 Section 3 [Return to text]
134 Section 4(2) [Return to text]
135 Section 2 [Return to text]
136 Section 6(1) and 6(3)(b) [Return to text]
137 Section 7 [Return to text]
138 INQ 23/86-89 [Return to text]
139 Article 8 - The right to
respect for private and family life:
'1- Everyone has the right to respect for his private and family life,
his home and his correspondence.
2- There shall be no interference by a public authority of the exercise
of this right except such as is in accordance with the law and is necessary
in a democratic society in the interests of national security, public
safety or the economic well-being of the country, for the prevention of
disorder or crime, for the protection of health or morals, or for the
protection of the rights and freedoms of others'. [Return
to text]
140 Article 13 - The right to
an effective remedy:
'Everyone whose rights and freedoms as set forth in this Convention are
violated shall have an effective remedy before a national authority notwithstanding
that the violation has been committed by persons acting in an official
capacity.' [Return to text]
141 Belgian Linguistics (Merits) Series A No 6, 23 July 1968 [Return to text]
142 Department of Health, HMSO, London, 1991, HOME 0001 0001-0013 [Return to text]
143 HA(A) 0163 0043-0078 [Return to text]
144 Nuffield Council report para 13.13 [Return to text]
145 Nuffield Council report para 13.15 [Return to text]
146 'Consensus Statement of Recommended Policies for Uses of Human Tissue in Research, Education and Quality Control - with notes reflecting UK law and practices', Working Party of the Royal College of Pathologists and the Institute of Biomedical Science, Royal College of Pathologists, 1999, RCPath 1/88-110 [Return to text]
147 'Consensus statement' Note A [Return to text]
148 'Consensus statement' Note C [Return to text]
149 'Consensus statement' Note H [Return to text]
150 'Consensus statement' Note I [Return to text]
151 Report of the Working Party of the Royal College of Pathologists and the Institute of Bio-Medical Science, 2nd Edition, 1999, RCPath 1/20-47 [Return to text]
152 RCPath 1/31 [Return to text]
153 RCPath 1/42-43 [Return to text]
154 'Human Tissue and Biological Samples for Use in Research' Interim Operational and Ethical Guidelines, published for consultation by the Medical Research Council (November 1999) [Return to text]
155 Interim Guidelines, MRC para 2.2 [Return to text]
156 Interim Guidelines, MRC Appendix 1 [Return to text]
157 Not, so far, by the United Kingdom [Return to text]
158 Authorised for publication by the Committee of Ministers on 17 December 1996. See http://www.coe.fr/oviedo/rapporte.htm [Return to text]
159 Article 19 [Return to text]
160 Part of Chapter VII, headed 'Prohibition of financial gain and disposal of a part of the human body' [Return to text]
161 Article 29 [Return to text]
162 The draft Protocol is not, therefore, concerned with xenotransplantation [Return to text]
163 Article 18. This article is intended to deal with so-called 'domino transplants', for example where the valves of an explanted heart are suitable for transplantation into another recipient, whereby the first recipient (of a heart) becomes a live donor (of valves) for a second recipient. [Return to text]
164 Neither is comprehensively defined [Return to text]
165 Called 'post-mortem examinations required by law', no doubt because the guidelines apply to Scotland as well as to England and Wales, and in Scotland there is no coroner as such [Return to text]
166 Called 'post-mortem examinations performed with relatives' agreement' [Return to text]
167 Para 1.4 of the Guidelines [Return to text]
168 Para 1.5. [Return to text]
169 This word itself is not defined, but presumably, in the light of the scope of 'post-mortem', means the keeping of tissue beyond the time needed to perform not just the original dissection of the corpse but also any histological or other laboratory examination of tissues removed from the corpse at post-mortem [Return to text]
170 Para 3.6 (emphasis added) [Return to text]
171 Thus at Para 5.14 'written agreement must be obtained for the retention of whole organs in all cases' is almost certainly a guideline rather than a statement of law: but the world 'must' suggests the latter [Return to text]
172 Para 3.6 and see also Para 6.3 [Return to text]
173 Para 3.5 [Return to text]
174 Para 5.3 [Return to text]
175 Para 5.6. Agreement is the word used to describe the absence of objection by a relative after such reasonable enquiries as are practicable have been made pursuant to the 1961 Act [Return to text]
176 Para 5.7-5.10 [Return to text]
177 Emphasis added [Return to text]
178 Para 5.14. This statement is followed by the sentence 'Organs must not be retained without relatives' agreement', which appears merely to be an echo of the statement quoted, though the adjective 'whole' is missing. It is difficult to see whether this repetition serves any, and if so what, purpose [Return to text]
179 Para 5.15 [Return to text]
180 Para 6.1-6.6. [Return to text]
181 Para 8.1-8.10 [Return to text]
182 Section 1(2) [Return to text]