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Interim Report: Removal and retention of human material
Part IV: Recommendations
Introduction
Introduction
General principles
- As was made clear at the outset, this report has two purposes. It is an interim report of the Inquiry on one of many important issues investigated. It also serves as advice to the CMO. It falls, therefore, into two parts. The first is our account of the events at Bristol, set in the context of time and the national scene. The second is a set of recommendations which arise from what we have learned. It is these latter which constitute our advice to the CMO. It will be for him and others in government to determine the action to be taken in the light of this and other advice.
- We emphasise that our focus is on parents, [78] following the death of a child. There may well be certain recommendations, however, which go beyond this focus. We concentrate on deaths in hospital. Where it is appropriate to do so, however, our recommendations should be applied generally. This applies to both options set out below. Our recommendations constitute what we consider to be the minimum requirements for the future. They are informed by two overarching principles: respect for the families of the child and the benefit to medical knowledge and treatment to be derived from the use of human material. [79] We wish to make it clear again that, although these recommendations have been framed with reference to the conduct of Coroners' post-mortems which follow a death of a child in hospital, the underlying principles hold good for all Coroners' post-mortems. Those responsible for managing the Coroner's post-mortem process, and for liaising with families in the case of non-hospital deaths, should ensure that these recommendations, where applicable, are followed.
- We have approached our task from two different, but overlapping perspectives. Initially, we have made recommendations in the form of a code of practice, working within the fabric of the present law. When we refer to a code of practice, we do not mean something drawn up by, and regarded as belonging to, any professional body or organisation. Rather, we have in mind a code which is produced through the collaboration of all those interested and endorsed by government.
- We recognise the drawbacks of this approach, not least the uncertainty and inadequacy of the current law. We also recognise its benefits, provided always that it is properly observed. Principal among these is the ability to amend the code quickly to take account of developments, for example in our case the science of pathology. Moreover, we would point out that while passing a law may represent a symbolic statement of the importance a subject has in the scheme of things, there is no necessary guarantee that it will be more likely to be followed than a code of practice. Indeed, there is much in public life which is regulated by the latter rather than the former. Finally, to add force to any code, we identify two alternatives. The matters considered in this report may be consolidated with the wider concerns of the CMO, for example, tissue banks and their regulation. If this course were adopted, we recommend that the supervision of the proposed code of practice falls within any more broadly based public body or agency charged with overseeing the whole question of collection, preservation and disposal of human material. (We continue to use the term human material, see para 11). Alternatively, we recommend that government appoint some person or institution to act as a regulator for a fixed period of time to monitor compliance with the code. If after, for example, two years, compliance is unsatisfactory, the legislative option remains open.
- We also point to the practical politics of seeking to change the law. First, while the conduct of Coroners' post-mortems falls to be regulated by the Home Office, hospital post-mortems fall within the broad jurisdiction of the Department of Health (DoH). Co-ordination between these departments would be needed. Second, as regards Coroners' post-mortems, the status of the Coroner as an independent judicial officer means that piecemeal legal restraints on the conduct of Coroners' post-mortems may be seen as unravelling the whole system of coronial jurisdiction. While this may have its merits, it should not be as a side wind from changing certain detailed practices. Third, legal changes affecting the conduct of hospital post-mortems will involve a re-examination of the 1961 Act and this may, in turn, require the consideration of a variety of other legal arrangements, touching on such diverse issues as the definition of death and the development of DNA banks. Again, this is not to say that it should not be done. It is merely to remark that once the legislative option is raised, it will be difficult to confine the legal changes to issues surrounding post-mortems.
- We set out now our recommendations. We then consider the option of
implementing them by changing the law through legislation.
General principles
- The ruling principle in the removal, retention, use and disposal of human material must be respect for the dead child and for the concerns and, to the extent allowed by law, the wishes of parents. (Recommendation 1)
- There is benefit to be gained, in terms of developing the understanding and treatment of disease, from the use of human material. Such benefit must only be obtained, however, with the informed co-operation of parents. (Recommendation 2)
- Hospital Trusts must have in place appropriate management systems to allow them to comply with the code of practice or changes in the law. Responsibility for compliance should rest with the chief executive of each Trust. (Recommendation 3)
- In the case of the code of practice, Coroners should bring their practice into line and the 1984 Rules should be amended to the extent necessary to give effect to the code. [80] (Recommendation 4)
- Wider questions having to do with, for example, the establishment and maintenance of tissue banks (including whether the meaning of tissue extends to include DNA sequences), the commercialisation of tissue, intellectual property rights, genetic testing, confidentiality and privacy, which fall outside the immediate remit of this report should receive urgent consideration, with a view to establishing an appropriate regulatory system. (Recommendation 5)
- While we acknowledge the possible benefits which can flow from the use of human material, we also recognise the emotional concerns which attend such use. Wherever possible, increasing use should, therefore, be made of alternative means of education and research, for example three-dimensional modelling and other technology, rather than of human material. (Recommendation 6)
Introduction
Footnotes
78 We repeat here that this is a term which is not free of difficulties. We do not resolve them here, but, instead, refer to the general law on the matter [Return to text]
79 We should say that, in formulating our views, we were much impressed and assisted by The Fetal and Infant Post-Mortem: Brief Notes for the Professional, issued in April 1999 by the Confidential Enquiry into Stillbirths and Deaths in Infancy. We commend it as a source of guidance [Return to text]
80 The 1984 Rules are Statutory Instruments and can be changed by laying the proposed change before Parliament, after which it becomes the new Rule after 30 days unless objected to [Return to text]