COMMENTS FROM CONSULTATION
50 The consultation exercise on the Review Group's 'Final Report' showed general support for the concept of standard information leaflets and authorisation forms, and for separate forms for adult and paediatric post-mortem examinations. The BMA and the Royal College of Pathologists approved in particular of the fact that the adult form had tackled a deficiency in current models in seeking to make sure that any wishes expressed by the deceased should be given proper weight. The Scottish consultant neuropathologists suggested that there should be a completely separate form for those who do not wish any information about the post-mortem process.
51 Overall, however, the general opinion was that the previous version of the information leaflet was too long and detailed, and was intelligible only to those of fairly high academic attainment. A number of respondents suggested that there should be two leaflets, the first in question and answer format, with a second leaflet giving a more detailed description of the post-mortem process for those who wished that further information.
52 The authorisation forms were also criticised by everyone who responded on this issue as being too detailed and cumbersome and likely to be seen as intimidating by recently-bereaved relatives. These views were echoed by the NHS QIS Project Group on Hospital Post-Mortem Standards, and were also made at the two open meetings at which the draft standards were discussed.
53 Arrangements were made for the paediatric authorisation form to be piloted by Lothian University Hospitals NHS Trust. However, initial discussions amongst the clinicians led them to pilot the forms in 'mock' interviews with midwives and previously-bereaved parents who were willing to take part in the study. The clear view was that the form was too long and complex to be acceptable or useful in the acute stress of bereavement, and the Trust therefore felt unable to move to the next stage of using the forms with newly-bereaved parents. There was no piloting of the adult version of the form.
54 Against that background, a sub-group was set up with the following remit:
55 In taking this work forward, the sub-group would be expected to consider the examples of more recent forms developed by the BMA and Lothian University Hospitals NHS Trust and any others which might be drawn to its attention. It should also take account of the work of the Department of Health in London (DH) on consent forms.
AUTHORISATION FORMS
56 The sub-group took as its starting point the Review Group's requirement that there had to be absolute clarity about what was being authorised, and that the forms should be capable of being produced in triplicate, with one copy given to the family, one retained in the medical records and the third copy given to the pathologist. At the same time, the forms needed to be user-friendly. There also needed to be separate forms for children and adults. The sub-group did not underestimate the difficulty of producing forms which would be intelligible to the public but which would also provide the health professionals with the clear mandate they need.
57 In order to draw on best practice, the sub-group asked each Trust to provide a copy of its current post-mortem examination consent form, along with a note on whether these had been piloted with focus groups, and information about Trusts' experience of using the forms. The Department of Health also provided a copy of the draft consent forms it was then in the process of devising. A copy of the consent form in use at the Boston Children's Hospital, USA, was also obtained for purposes of comparison. Further consideration of the experience of other countries was considered impractical, although the sub-group was shown a presentation prepared by Dr Irene Scheimberg, Senior Lecturer in Paediatric and Prenatal Pathology, University of London, which indicated that in most other countries consent forms were generally one or two pages at most. The consultations undertaken by the Department of Health also emphasised the importance of clarity and brevity.
58 After making comparisons of all the available models, the sub-group selected the DH forms as its starting point. It felt that this would also help to promote consistency of approach across the UK. In the event, the layout of the forms changed considerably during the course of work on them. This was in part to take account of the differences in approach, for example in relation to the concept of 'authorisation'.
59 The sub-group has produced the following documents:
60 The Review Group also worked on standard forms for the authorisation of use of material retained at a Fiscal post-mortem examination for purposes of research, medical education or audit, once the Fiscal has indicated that the material is no longer needed for his/her purposes. These forms are considered in the next chapter of this report.
61 The text of all of these forms and leaflets can be found in Appendix 3 to this report.
62 The child form is intended to fulfil the Review Group's overarching aim of placing control with the parents. Section 1 establishes that they are the ones with the power to give authorisation. The first option offered is to authorise a full post-mortem examination, in the knowledge that this will involve keeping small tissue samples which will form part of the medical record and which may be used for purposes of medical education, training, research and audit. This is intended to shorten the form and reduce the burden on parents by making it unnecessary to include a section for each of these specific purposes, while at the same time making clear what can be done with these tissue samples.
63 There was considerable discussion within the sub-group and the Review Group itself on whether the forms should provide for separate and specific authorisation of the research use of the blocks and slides kept as part of the medical record. In the event, the Review Group has taken the view that it set out the position sufficiently clearly in paragraph 74 of its 'final report':
We further recommend, in common with the Alder Hey report, that once a properly informed decision has been made to authorise a post-mortem examination, interests in the prepared blocks and slides should pass to the hospital authority, who may retain and use them for proper study and research purposes. This recommendation is also in line with those of the Nuffield Council on Bioethics.
As far as we are aware, no-one took issue with this statement during the consultation on our previous report. It is also consistent with NHS QIS Standard 3 (Storage, Handling and Disposal), the rationale for which says 'Glass slides and tissue blocks should also be retained for the following valuable purposes: . . . for research purposes.'
64 If this report is published on a consultative basis, we recommend that this point (whether there should be an authorisation for research separate from that for medical education, training and audit) should be clearly identified in the consultation letter, since it is essential that the forms command the support of both relatives and health professionals.
65 The hospital must use the medical record within the general constraints of the Data Protection Act 1998, the Human Rights Act 1998 legislation and subject to the general common law principles governing confidentiality, and any research involving the medical record must be subject to approval from a Research Ethics Committee.
66 The second option is for parents to authorise a limited post-mortem examination, with clear instructions as to the way(s) in which the examination is to be limited.
67 The third choice is for parents of babies or very young children
to authorise an external post-mortem examination. By this is meant an
investigation which does not require an internal examination, but is something
more than simply observing the body in order to write a death certificate (the
process known as 'view and grant' in forensic cases). There is value in a paediatric
pathologist examining a baby externally, particularly a stillborn fetus which
may not have been seen by an obstetrician. The parents can authorise an
X-ray or ultrasound examination or even a skin biopsy, which might give a chromosome
result. These, together with the external examination and assessment of the
placenta, can potentially yield a lot of useful information about the death,
as well as possibly providing guidance for advising in future pregnancies. The
form itself does not explain that this is likely to yield less information,
though the information leaflet does. The sub-group felt that inclusion of this
information on the face of the form could be seen as an attempt to influence
parents' decisions. The process is more impartial if this is explained in the
leaflet or by the person completing the form.
68 Section 2 allows the parents to authorise the retention of whole organs for further examination, as well as for purposes of medical education, training, audit and research. The sub-group understood that it was only in a small number of cases that whole organs need to be retained. However, it felt that, because of the emotional significance of whole organs to many families, this.htmect of the post-mortem examination needed to be the subject of separate authorisation.
69 Section 2 also sets out the options open to the parents once the whole organs have been subject to detailed examination. These are:
70 Section 3 of the form allows the parents to mention any requests or impose any conditions on the retention or future use of the organs, tissue blocks and slides. These will be recorded on the form.
71 The form then provides for the signature of the member of hospital staff witnessing the authorisation. This will in most cases be the member of staff who has taken the parents through the form. Parents should be offered information as a matter of course. Where they choose to receive it, the details of what has been provided should be recorded, so that there will be no doubt in future about the nature of the information given. The parents would then sign the form.
72 It will be noted that there is a box in the 'witness' section to cover the situation where only one parent or guardian is present. The sub-group took the view that it would be appropriate to proceed on the basis of the authorisation of one parent where only one parent was normally in contact with the child, or where there were compelling reasons for the post-mortem examination which outweighed the objection of only one of the parents. The sub-group, however, accepted that there could be difficulties if a parent who was present authorised the post-mortem examination and subsequently the other parent, who had not been present, objected. The sub-group felt it was reasonable that, where only one parent was present to give authorisation, that would normally be sufficient to proceed, and a pathologist performing a post-mortem examination on that basis should be protected in law. When authorisation is being sought, enquiries should be made as to whether the absent parent would be likely to object. If it appeared likely that there would be disagreement, ordinarily the post-mortem examination would not take place until further enquiries were made of the absent parent or legal advice taken. Where both parents were present but could not agree on whether to authorise the post-mortem examination, the examination should not go ahead.
73 This is highly sensitive territory, and the Review Group would wish to see wider views canvassed on the approach outlined in the previous paragraph.
74 The sub-group noted that there might be some limited circumstances in which the pathologist may wish to remove tissue additional to that required for the post-mortem examination, for example as part of an approved research project. Specific authorisation for this would be needed, and this must be recorded on the form.
75 The adult authorisation form follows the same pattern as the form for a post-mortem examination on a child, except that it draws attention to the need for the person giving authorisation to alert the hospital staff to any instructions which the deceased might have left in respect of post-mortem examination. In this context, it would be good practice to make sure that any wishes expressed by the deceased were clearly recorded in the medical notes and placed prominently in those notes. A system, for example, of labelling a folder which includes notes containing this type of advance directive should be devised to make such cases easier to identify. The right of the individual to make provision in advance for the use to which his/her body may lawfully be put is in part reflected in the Anatomy Act 1984, which allows an individual to donate his/her body after death for dissection. Our approach proceeds from the assumption either that this authority is wide enough to cover decisions about post-mortem examinations also, or - failing which - that the decision to pre-authorise post-mortem examination or removal and retention of organs or tissue takes the form of an advance directive, which, if applicable in the circumstances, is generally agreed to have lawful force. It should be noted that advance directives need not be in written form to be lawful. Indeed, in our 'Final Report' we made the point in paragraph 29 that we could see no justification for requiring written evidence of the wishes of the deceased. This recommendation is in line with our earlier comments.
76 A further difference in the adult authorisation form is that the notes for hospital staff discuss the possibility of the deceased's nominated representative or nearest relative granting permission over the telephone for another person to give authorisation. The sub-group noted that this was a possibility in forms used in the USA. The reason for this is that the nominated representative or nearest relative may be unable or unwilling to attend the hospital. As the form recognises, this would only be done in exceptional circumstances. Any such discussion would also have to be witnessed by another member of staff. By and large, the Review Group does not believe that over-the-phone authorisation should be acceptable, but recommends that this approach should be the subject of wider consultation.
77 The sub-group felt strongly that the presentation of the forms and leaflets required careful consideration, in particular to avoid giving people more information than in fact they wish to receive. It therefore decided that there should be an Information Pack consisting of an A4 folder with a pocket on the right inside cover which would contain the authorisation form and the level one information leaflet. The front of the pocket on the inside of the folder would be left blank so that each hospital had a space in which to insert local contact details. On the inside left of the folder there would be a list of the key points for parents or relatives, including key points about the post-mortem examination. In particular, the summary would explain that:
78 The sub-group believed that it was appropriate to devise two information leaflets containing different levels of information. The first, level 1, information leaflet, which would be offered as a matter of course, is intended to provide answers to the kind of practical questions families are most likely to ask. The second, level 2, information leaflet gives more detailed information (for those who wish to know more) about the post-mortem examination itself, and the reasons for wishing to undertake it. It also contains information about the retention of organs, since the relatively small number of cases in which this is considered necessary would not justify including this information in the level 1 leaflet. The sub-group recognised that not every family would wish to read through even the level 1 information leaflet, and there is no requirement that they should do so. The forms allow the post-mortem examination to be authorised once the person feels he or she has received enough information to do so. While there are certain questions on the form that must be answered, making inevitable the receiving and considering of a certain amount of information, the overall intention is that information should be offered and received to the extent that the family wishes to have it.
79 Although every effort has been made to keep the forms as simple as possible, it is not easy to reconcile that aim with the need to be sure that families have been made aware of all of the options. This underlines the importance of an informed member of the hospital staff being on hand to take the family through the form. While the Review Group has indicated in previous reports that - under the current regime - this should, where possible, be someone already known to the family, the need to have a member of staff available also reinforces the importance of creating, as a priority, a cadre of Bereavement Officers across NHSScotland. In addition, however, all hospital staff who are likely to be involved in seeking authorisation must be properly trained, and the authorisation forms should act as a focal point for that training. Such training might include a video prepared for staff, as well as the guidance for professionals which we have already developed. The video might be based on a simulation of the process of taking parents through the form, which would give an opportunity for the parents' support groups to participate in the training programme. The Review Group recommends that the Chief Medical Officer should explore this with the Deans of Medical Schools, Medical Directors, the Royal Colleges and NHS Education for Scotland. Such training programmes should also take account of others being developed elsewhere in the UK, although allowance would have to be made for the differences of approach reflected in the forms being used.
80 The Review Group accepts that, as well as training of hospital staff, there needs to be greater public awareness of the hospital post-mortem examination process. It recommends to the Executive that it should explore the possibility of developing an equivalent of the Teaching Resource Pack which has been produced for organ donation and transplantation. A further possibility might be the establishment of an education programme with the participation of the Royal College of Pathologists. No matter the form(s) adopted, the Review Group wishes to reinforce the need for adequate education and training in this area to be made widely available.
81 One issue which the sub-group discussed in detail was whether there was a need to include in the forms a section allowing specific authorisation of genetic testing, because of the implications that would have for the present or future health of other members of the family. This reflects concerns about the possibility of genetic information becoming available when either it is not wanted or it might be regarded as confidential. However, such a section has not been included, on the grounds that any post-mortem examination has the potential to reveal diseases or conditions with implications for the family, and this would be masked if genetic testing were to be singled out. Nonetheless, the Review Group recognises that genetic information can be different, and would welcome wider discussion of this point. Where a genetic condition is revealed, the family should of course be offered specialist counselling.
82 In this phase of the Review Group's work, we reinforced our view that - where possible - the wishes of the deceased person should be those which are determinative of what happens after death. Although we have used the term 'relative' throughout this report, we repeat our initial attitude that this is only a shorthand for the person most likely to know what the deceased would have wished (in the absence of clear instructions from the deceased). Although this person may well be the closest relative(s), the reality of modern life may mean that this is not so. In order to ensure that the deceased's wishes are prioritised, it is obviously necessary to know what they were. Thus, we believe that it would be appropriate when a person is admitted to hospital, for them not only to be asked for the name of their next of kin, but also (or instead) that they are invited to nominate a person whom they feel would most accurately be able to speak on their behalf. General Practitioners could also record such information in the patient's records.
83 The Review Group accepts that there is a limit in practice to the extent to which hospitals can be expected to inquire into the intimate details of patients' relationships. For this reason, the adult form allows the person with whom the hospital is dealing to confirm that he or she is not aware of anyone with a nearer relationship to the deceased who ought to be asked to make decisions about a post-mortem examination. Where a patient has not nominated someone as their nearest relative, the Review Group recommends that the default position should be the hierarchy set out in the Adults with Incapacity (Scotland) Act 2000 and the Mental Health (Care & Treatment) (Scotland) Act 2003. Any consultation on the report should ask specifically for comments on this point.
84 The sub-group had concerns about cases where
a local authority had guardianship of a child and might, therefore, under the
arrangements proposed, be able to authorise a hospital post-mortem examination
on the child.
The Review Group takes the view that local authorities should not give such
authorisation without having consulted the parents, and if one or both parents
objected, as a general rule the post-mortem examination should not go ahead.
85 It is essential that there should be a single authorisation form in use across Scotland for post-mortem examinations on a child, and a single form for adults. The format proposed by the Review Group allows for the inclusion of local contact details, but otherwise there should be no local variations. Even treating the form as a minimum requirement to which other local provisions could be added is unsatisfactory, since that approach would cast doubt on the validity of a standardised form and there would be no way to assess whether the addition of local information detracted from the basic form, even if inadvertently.
86 The Review Group realises, however, that there needs to be local acceptance of the new forms. It therefore recommends that fully designed versions of both the child and the adult form should be piloted in the first place through focus groups consisting of parent or family support groups, pathologists and all levels of staff from Intensive Care Units. Those who saw and commented on the forms and leaflets included in the 'Final Report' should also be consulted, and the material should also be open to public scrutiny on the Review Group's website. The Executive should make sure that there is a widespread opportunity for the public to comment on the forms. This will mean advertising their availability and, if requested, supplying copies by post, as well as placing them on the Review Group's website.
87 Consideration also needs to be given, in conjunction with the National Resource Centre for Ethnic Minority Health, to the most effective way of conveying the existence of, and information in, the Information Packs to members of ethnic minority groups. The forms and information leaflets will also be sent to the Campaign for Plain English.
INFORMATION LEAFLETS
88 Research has shown that 23% of the population is illiterate and a further 20% have the reading skills of a 5 year old. These statistics had to be borne in mind when drawing up the information leaflets, and adds weight to the value of developing a video for families, as has been done in England. This re-emphasises the need for appropriately trained members of staff to be available at all stages to provide any information and assistance which may be needed.
89 In devising the forms and the information leaflets, the sub-group was aware of NHS QIS standards, and the need for its material to be consistent with the detail of the standards.