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Main Findings

• The majority view was for authorisation forms to provide for separate and specific authorisation of the research use of blocks and slides.
• A frequently expressed view was that in the case of a child's death, if both parents/carers disagree on authorisation, then the post-mortem should not go ahead.
• The consensus view was in favour of introducing an authorisation form for use of tissue blocks and slides following Procurator Fiscal post-mortems.
• Issues surrounding communication with the bereaved family attracted the most comment out of all the topics raised in the consultation.
• No clear picture emerged on preferences for the most appropriate personnel to communicate with a bereaved family, although the notion of some form of dedicated Bereavement Officer attracted most support.
• Of those responses containing a clear recommendation, all supported the proposal that the list of deaths to be reported to the Fiscal should not be included in legislation.
• The main reason given for this recommendation was the need to retain flexibility to review and amend the list items as required.

Context

The disclosure that hospitals in Scotland had been retaining organs at post-mortem examination without the consent of the next of kin provided the impetus for the Ministerial establishment of an independent Review Group to examine post-mortem practice. The Group sought to take forward initiatives to ensure lessons were learned and new safeguards governing organ retention were put in place.

The Review Group undertook its work in phases. Its first phase covered a study of past practice. The second looked at changing the law and also drew up standard information leaflets and forms. Following consultation, the third phase has developed further the standard information leaflets and authorisation forms, addressed the issue of procurator fiscal post-mortem examinations, and drawn up criteria for local Research Ethics Committees to use when considering research involving human tissues retained at post-mortem.

The consultation on Retention of Organs at Post-Mortem focuses on the outcome of the Review Group's Phase 3 work.

The Consultation

The consultation on the Report of Phase 3 of the Review Group on Retention of Organs at Post-Mortem took place between 24 November 2003 and 27 February 2004. Over 100 copies of the consultation paper were distributed to a wide range of people and organisations in the public, private and voluntary sectors. The launch of the paper coincided with the publication of the Review Group's Phase 3 report and sought comments on a number of specific key recommendations on which the Review Group thought it vital to seek wider views. It also coincided with the launch of another related consultation on hospital post-mortem examinations which is the subject of a separate analysis report. A press release helped publicise the consultation paper which was made available on the respective websites of the Scottish Executive and the Review Group.

The consultation paper highlighted specific points on which views were invited. These were:

• Standard authorisation forms and information leaflets
• Procurator Fiscal post-mortem examinations: research on retained organs and tissues
• Cases to be reported to the Procurator Fiscal
• Nineteen responses were received from a range of professional organisations and individuals.

Aims and Objectives

The aim of the research was to analyse the comments contained in written responses to the consultation on the Report on Phase 3 of the Review Group on Retention of Organs at Post-Mortem, to present the findings of the analysis and to identify any gaps in respondent sector.

Methodology

Responses to the consultation were sent to the Scottish Executive consultation team either in hard copy or via e-mail. The consultation team sent copies of each response to The Research Shop for analysis. The consultation attracted a small volume of responses but represented a wide range of respondent categories.

An electronic Excel database was used to store and assist analysis of the responses. Most of the analysis was qualitative in nature although where scope for quantitative analysis existed, this was exploited.

A few gaps in respondent organisations emerged. Amongst these were the views of legal establishments and those of representative minority ethnic organisations.

Nature of Responses

The general mood of responses was one of concern over ensuring an appropriate and sensitive handling of the issues. Most of the responses contained relatively detailed points, with responses ranging from one page submissions to long arguments documented over several pages.

Standard authorisation forms and information leaflets

The majority of respondents considered that the forms should provide for separate and specific authorisation of the research use of blocks and slides.

In the case of a child's death, a recurring view was that if both parents/carers disagreed on authorisation, then the post-mortem should not go ahead. However, justification for proceeding with a post-mortem on the authorisation of only one parent was envisaged in certain specific circumstances.

There was unanimous agreement on the proposals regarding cases where a child had died whilst under the guardianship of a local authority. In these circumstances it was recommended that the local authority should not give authorisation without first consulting the parents and if one or both parents objected, then the post-mortem should not go ahead.

The balance of views was in favour of including a specific authorisation for genetic testing although respondents commented that the issues were not clear-cut.

There was agreement that on admission to hospital, the nomination of a preferred next of kin and/or other appropriate person to speak on behalf of the patient should be standard. The balance of views was in favour of adopting the next of kin hierarchy as suggested in the consultation.

There was general support for the plans for piloting of the forms.

Additional topics for discussion were raised by respondents and included support for a more flexible approach to telephone authorisation; consideration to be given to the most appropriate professional personnel to communicate with the bereaved family; support for proposals for appropriate training for hospital staff involved in the process of seeking authorisation; and specific points regarding the drafting of the proposed forms.

Procurator Fiscal Post-Mortem Examinations: Research on Retained Organs and Tissues

Most respondents were in favour of introducing an authorisation form for the use of tissue blocks and slides following Procurator Fiscal post-mortems. Many people commented on the issues surrounding communication with the bereaved family although no clear picture emerged on preferences for the most appropriate personnel to communicate with a bereaved family. The idea of some form of a dedicated Bereavement Officer attracted most support in this regard.

Few views were put forward on the best location for such communication with a recommendation for some flexibility to be maintained.

There were mixed views regarding the seeking of authorisation in cases of non-accidental injury where the authorisee may be implicated in the death. Some respondents urged that authorisation should always be required, whilst others suggested that in certain circumstances, such as unexplained deaths, any refusal to give authorisation could be overruled.

Cases to be Reported to the Procurator Fiscal

Where a clear recommendation could be identified from responses, all supported the proposal that the list of deaths to be reported to the Fiscal should not be included in legislation. The main rationale provided was the need to retain flexibility to review and amend the list items as required.

Suggestions were made for transmitting the information from the list more effectively: including it as part of doctors' training; publicising changes made to the list in the books of blank death certificates; promoting greater public awareness for example via newspapers, TV and the internet.

A concern was raised that there appeared to be inconsistency amongst hospital practitioners regarding the practice of referral of cases to the Fiscal.