Organ and tissue donation and transplantation: analysis of consultation responses

6.The operation of a soft opt out system (Q4 and Q5)

6.1 This chapter discusses respondents' views on the proposed operation of a soft opt out system, and covers the responses to consultation questions 4 and 5.

6.2 The consultation paper explained that a workable soft opt out system would involve: (i) high profile awareness-raising campaigns for at least 12 months before the introduction of the new system, and on a regular basis after implementation; and (ii) upon the death of an individual in hospital, a process of undertaking a range of checks to decide whether a donation from that individual could proceed.

6.3 The consultation paper explained that five checks would be undertaken as follows:

• If the person had registered as opting out, the donation would not proceed (unless the family provided evidence that the person had confirmed in writing that they had changed their mind)
• If the person had registered as opting in, the family would be informed and the process to examine the feasibility of a donation would begin (unless the family provided evidence that the person had confirmed verbally or in writing that they had changed their mind)
• If the person was not on the ODR, the family would be approached to discuss this. In the absence of any other information, the person would be deemed to have authorised donation. The person's family / friends would be asked if the person had expressed any objections to organ donation. If the person was not known to have expressed any objections, then the assumption would be that the donation could proceed - this is known as 'deemed authorisation'.
• However, potentially, there is still scope for a donation not to proceed if it was clear that going ahead with a donation would cause distress to the family and result in their refusal to provide important background information.
• In the relatively rare cases where a person did not have any family or close friends (or none that could be contacted within the necessary timeframe) - and if the person was not in a category where explicit authorisation was required (i.e. one of the 'excepted categories') - then donation could be considered to be authorised unless the person had opted out. However, in such cases, NHS staff would need to consider whether they had sufficient information about the medical history of the patient to ensure that the patient's organs / tissues would be safe to transplant.

6.4 The consultation asked the following questions in relation to these checks.

Question 4: If there was a soft opt out system, what do you think of the proposed checks above? [These are sufficient to decide if a donation can be deemed to be authorised / These are not sufficient to decide if a donation can be deemed to be authorised / Don't know]

Question 4a: If you think these are not sufficient, what other checks would be needed (apart from those covered in Questions 6 to 8 below)?

Question 5: In any opt out system, what do you think should happen if a deemed authorisation donation was likely to distress the potential donor's family? [The donation should still proceed / The donation should not proceed / Don't know]

Views on the proposed checks (Q4 and Q4a)

6.5 Respondents were asked what they thought of the proposed checks set out in the consultation paper. (See paragraph 6.3 above.)

6.6 Altogether, 798 respondents replied to this question - 33 organisations and 765 individuals. Two-thirds (67%) of organisational respondents and 86% of individual respondents agreed that, in a soft opt out system, the proposed checks set out in the consultation paper were sufficient to decide whether the donation should proceed. However, 4 out of 6 faith groups thought that the checks outlined were not sufficient ( Table 6.1).

Table 6.1: Q4 - If there was a soft opt out system, what do you think of the proposed checks set out in step 2?

Respondent types	These are sufficient to decide if a donation can be deemed to be authorised	These are not sufficient to decide if a donation can be deemed to be authorised	Don't know	Total
NHS and / or local authority	9	1	1	11
Charity, voluntary sector or patients' rights groups	8	-	1	9
Professional groups and regulatory bodies	4	3	-	7
Faith groups	1	4	1	6
Organisation total	22	8	3	33
Organisation percentage	67%	24%	9%	100%
Individual respondents	657	68	40	765
Individual percentage	86%	9%	5%	100%
Total (orgs and individuals)	679	76	43	798
Total percentage	85%	10%	5%	100%

6.7 Respondents who indicated that the checks were not sufficient, or who said they did not know whether the checks were sufficient were then asked what other checks they thought would be needed (Question 4a). Ninety-eight (98) respondents commented in response to this question - 18 organisations and 80 individuals.

6.8 Of those who commented, 67 considered that the proposed checks were insufficient, and seven said they didn't know if the checks were sufficient. In addition, four organisations provided comments, but did not tick any of the boxes at Question 4.

6.9 The remaining 20 respondents who commented had indicated that they were satisfied with the checks proposed. The comments of this latter group generally described the proposed checks as 'adequate' (or 'more than adequate'), 'sensible', 'reasonable', 'comprehensive', and 'robust'. In exceptional cases, the checks were described as 'excessive' by respondents who called for all organs to be available for transplant unless there was clear evidence that an individual had opted out. Where further comments were made by these 20 respondents, they focused on the following issues:

• Family authorisation: Some respondents argued that family members should not be able to overrule a choice by an individual to opt in, and it was noted that the Human Transplantation (Wales) Act 2013 does not give family members the power to override the deemed authorisation of an adult with capacity. However, there was also the contrasting view that, for ethical reasons, family authorisation would remain essential. Some respondents also expressed concern about the potential impact on families in a deemed authorisation situation (i.e. where an individual had not opted in to the ODR) if a donation proceeded without family authorisation.
• Exceptions to deemed authorisation: Some respondents expressed satisfaction with the proposed checks, but suggested that exceptions should be made in certain cases, for example, in relation to children, or where a potential donor lacked the capacity to decide about organ donation. (These issues were addressed as part of the consultation - see Chapter 7.)
• Type of donation: Some respondents suggested that these checks were sufficient for most types of donations, but not for less common donations or donations which could result in the disfigurement of the donor (the examples given were facial donation, and tissue such as skin and bone). (This issue was addressed as part of the consultation - see Chapter 8.)
• Improving IT access to a donor's medical history: Some respondents suggested that efforts could be made to improve access to a potential donor's medical history, thus helping to reduce the burden on family members to provide this when they are grieving.
• Development of a Code of Practice: In relation to the Welsh context, it was noted that a Code of Practice had been drafted by the Human Tissue Authority and approved by the Welsh Government. This provides practical advice and guidance as to the role of family and friends and what should be done when the family are unhappy about donation. It was suggested that a similar Code of Practice should be developed in Scotland.

Views of those who indicated that the checks were NOT sufficient

6.10 Respondents who thought the proposed checks set out in the consultation document were not sufficient largely expressed opposition in principle to the introduction of a soft opt out system. The main arguments from this group were that:

• It should never be assumed that an individual had authorised organ donation unless that individual had done so explicitly.
• It would be a violation of human rights for the state to assume 'ownership' of an individual's body when they are dying.
• The views of the person's family (or nearest relative) must always be respected and the family must agree with the process in order for a donation to proceed.
• It is not realistic to assume that a person's family would know what their wishes are in relation to organ donation.
• There is a significant potential for IT failure or human error, where opt out instructions had been lost or mistakenly overlooked.

6.11 Less often, this group made suggestions about additional checks that could be included in a soft opt out system. Many of these focused on the situation in which an individual's family / friends were unable to be contacted or identified. There were three different perspectives on what should happen in such a situation:

• Inability to contact family or close friends within the required timeframe should result in the donation not proceeding.
• A third party (suggestions included a sheriff, advocate, or Procurator Fiscal) should be asked for a 'rapid review' of the case to ensure that it was appropriate to proceed, that all reasonable attempts to identify family had been exhausted, and that all procedures had been complied with.
• A solicitor should be appointed to act in the best interests of the deceased.

6.12 Some in this group also echoed the point made in the consultation paper that if a person had no family / friends who could be contacted, there may be insufficient background information about the patient to allow the donation to proceed in any case.

6.13 This group also made the following suggestions: (i) training GPs to have discussions with their patients about organ donation and how to incorporate decisions about this into a 'living will' (either to opt out or opt in); and (ii) introducing a mechanism for those who had explicitly opted out or opted in to check and update their registration on an annual basis.

6.14 Within this group of respondents, there were also a few individuals who held an opposing view. That is, in relation to the suggestion that a donation may not proceed if it might cause distress to the family, these respondents argued that the family should not have the right to refuse.

6.15 A small number of other specific issues were raised by those who thought the proposed checks were not sufficient. These focused on: (i) the proposed awareness raising campaigns and (ii) the requirement for written versus verbal evidence of a potential donor's change of mind. Both of these are discussed briefly here.

The proposed awareness raising campaigns

6.16 A range of respondents highlighted the importance of ongoing awareness raising if a soft opt out system is introduced. It was noted that the campaign to raise awareness of the Human Transplantation (Wales) Act 2013 had a lead in time of two years. Such a campaign would require considerable resources. It was also noted that, even after the Welsh campaign, surveys showed that over one-third of people in Wales were still unaware of the need to opt out of donation if they do not want their organs to be donated. Respondents made the following additional points:

• Any communications campaign conducted prior to the implementation of the system would have to be repeated on a regular basis in the future. Some respondents queried whether it would be possible for such a campaign to be sustained long-term.
• Communication would also need to be targeted appropriately to specific sub-groups of the general population, including children, ethnic minorities (people whose first language is not English), those lacking capacity, hard-to-reach groups (such as homeless people), and visitors to Scotland.
• It is important for any awareness campaign to include clear information about how to opt out. A lack of information could disadvantage people who might have wished to opt out, but did not know how to do so. It was thought this could potentially result in legal challenges.
• The effectiveness of any communications campaign should be evaluated regularly.

The requirement for evidence of a potential donor's change of mind

6.17 There were several points made in relation to this requirement. Organisational respondents from the NHS commented that providing evidence of a change of mind 'in writing' would be impractical in most cases, onerous and uncompassionate. One respondent discussed the Human Tissue Authority guidelines for Wales on verbal and written authorisation in the context of a deemed authorisation system, stating that there was no requirement for 'written evidence' in the Welsh system.

6.18 Some individual respondents (all of whom were opposed to the principle of an opt out system) echoed the first point, stating that where a person is gravely ill, it would not be reasonable or appropriate to ask their relatives to leave their bedside to search for their written instructions.

6.19 Other respondents queried why written confirmation was required as evidence of a person's change of mind where they had registered as opting out, but verbal confirmation was sufficient as evidence of a person's change of mind where they had registered as opting in. It was argued that, if written evidence is required at all in an opt out system, then it should be required to overrule a donor's expressed decision to opt in. This is because if a person had registered their wishes to be a donor, then that person would have taken active steps (beyond that which is required) to make their wishes known.

6.20 Finally, there was also a group of respondents who expressed concern about whether 'verbal evidence' of a change of mind given by families could be relied upon. This group argued that such verbal evidence should not play a factor in decisions taken by medical staff. This latter view was expressed by respondents who were supportive of the principle of an opt out system.

Decision-making where a donation may distress the donor's family (Q5)

6.21 Consultation Question 5 was a closed question asking respondents for their views about what should happen if a deemed authorisation donation was likely to distress the potential donor's family. The consultation paper suggested that, in such cases, a decision could be taken for the donation not to proceed.

6.22 Altogether, 805 respondents replied to this question - 32 organisations and 773 individuals. Most organisational respondents (23 out of 32, 72%) believed that if deemed authorisation donation was likely to distress the potential donor's family, then the donation should not proceed - although, there were divided views on this question among charities and voluntary sector groups. A small majority of individual respondents (57%) were in favour of the donation proceeding in this situation ( Table 6.2).

Table 6.2: Q5 - In any opt out system, what do you think should happen if a deemed authorisation donation was likely to distress the potential donor's family?

Respondent type	The donation should still proceed	The donation should not proceed	Don't know	Total
NHS and / or local authority	1	10	1	12
Charity, voluntary sector or patients' rights groups	4	4	1	9
Professional groups and regulatory bodies	-	3	1	4
Faith groups	1	6	-	7
Organisation total	6	23	3	32
Organisation percentage	19%	72%	9%	100%
Individual respondents	439	242	92	773
Individual percentage	57%	31%	12%	100%
Total (organisations and individuals)	445	265	95	805
Total percentage	55%	33%	12%	100%

6.23 Chapter 5 discussed respondents' views about what should happen in a situation where a person had opted in to the ODR or otherwise explicitly authorised organ donation, but the family opposed the donation. If the findings shown in Table 6.2 above are compared with those set out in Chapter 5 ( Table 5.1), it can be seen that a smaller proportion of individuals were in favour of a donation proceeding in a deemed authorisation situation as compared to a situation where the donor had explicitly stated their wishes (57% in a deemed authorisation situation vs 85% in an explicit authorisation situation). Similarly, a larger proportion of the organisational respondents were also of the view that a donation should not proceed in a deemed authorisation situation if the donation is likely to distress the potential donor's family.

6.24 Although Question 5 did not include space for comments, some respondents - most often organisations - did explain their views, either along with their tick-box response for those responding offline, or at Question 15 for those completing the online questionnaire. While some respondents were strongly against families being able to overrule decisions (deemed or otherwise), others prioritised the wishes of the family, and cited the risk of causing distress and increasing pressure on relatives as key reasons for not supporting an opt out system (see Chapter 3).

6.25 However, amongst those respondents who commented specifically on the situation described at Question 5, most of which were organisations, the most common view was that it would be appropriate for specialist staff to discuss the issue with the family to try to alleviate their concerns, and encourage them to support the decision of the potential donor (who chose not to opt out). Respondents stressed that this should be done sensitively, but agreed that the donation should not proceed if it was going to cause significant distress. Some respondents highlighted the importance of professional judgement based on the circumstances of any individual case. It was also noted that professional guidance was available to healthcare staff in dealing with situations such as this, and it was further suggested that if an opt out system were introduced, that this scenario should be addressed in a Code of Practice.

6.26 Some respondents did, however, suggest that establishing the cause of any distress was crucial to the ultimate decision on proceeding as families should only be able to intervene if they believed the individual would not have wished the donation to proceed, not just because they, themselves, did not wish it to proceed.

6.27 A few respondents also raised ethical considerations, querying: (i) the right of families to make decisions in the absence of any indication of the individual's own views, and (ii) the extent to which families may feel pressurised to agree to the donation if this was perceived as the 'default' position.

6.28 A small number of additional points were made as follows:

• That over time, as people became accustomed to the opt out system and organ donation became the norm, the likelihood of family distress and objections would reduce
• That the likelihood of families agreeing to donation was greater if the individual's views were known and that further work to encourage conversations within families about organ donation wold help avoid this situation
• That the continued involvement of families in the authorisation process was an important positive feature of the sort of soft opt out system proposed in the consultation paper
• That further research into understanding family distress in such situations and the long term impact of overriding family objections would be useful.