Submission by L. O’Donovan, N. J. Williams and S. Wilkinson
Q1 Would you be willing to donate your organs and / or tissue after your death [under the current legal system of consent in Northern Ireland]?
Yes – all organs and tissue
Q2 Have you already recorded your donation decision, e.g. by joining the NHS Organ Donor Register or otherwise?
Yes
Q3 If you answered ‘yes’ to the above, have you shared your decision with your loved ones? Please tick all that apply
Face to face conversation, In written form (text, email, as part of a Will)
Other- :
4 Would a move to a statutory opt-out system change your decision regarding organ donation?
No – It would make no difference
Exemptions to Opt-out legislation
Q5 To what extent do you agree that opt-out legislation should NOT apply to children (those under 18 years) and that the donation decision should be made by those with parental responsibility? Rate your agreement with this statement.
Agree
Q6 Do you think that any of the following people should be exempt from deemed consent for organ donation and the family should provide that consent? (please tick all those that apply)
Adults who lack capacity, Visitors, including cross-border workers from ROI & tourists to Northern Ireland, People who are temporarily resident in Northern Ireland (e.g. students from overseas or RoI, overseas Armed Forces personnel), people on work placements from overseas or RoI, Prisoners, People whose identity is unknown
Other-:
The Role of the Family and Loved Ones
Q7 To what extent do you agree that, in situations where there is a known decision to donate recorded on the NHS Organ Donor Register, the family should always be asked about the last known organ donation decision of their loved one, to ensure it’s still accurate?
Agree
Q8 To what extent do you agree that, in situations where there is no known organ donation decision, the family should always be asked about whether their loved one would have objected to organ donation?
Agree
Q9 Which of the following statements best summarises how the introduction of opt-out legislation would influence your support for donation of a loved one’s organs and/ or tissues?
I currently support organ donation and would continue to do so.
Novel and Rare Transplants
Q10 To what extent do you agree that organs and tissues that could be used for rare or novel types of transplantation (e.g. limb or face) should be excluded from opt-out legislation?
Strongly Agree
Research
Q11 To what extent do you agree that the donation of organs and tissues for research purposes should be excluded from statutory opt-out and the family approached for express consent?
Strongly Agree
Faith and Beliefs
Q12 To what extent do you agree that people’s faith or beliefs should continue to be taken into consideration as part of the donation discussion after any move to an opt-out system?
Strongly Agree
Raising Awareness of the Change in Legislation
Q13 What do you think is the most important and effective activity for raising awareness of the law change? (please select no more than 3)
TV, radio, Social media adverts, Mail drop to all houses in N. Ireland
Other-:
Q14 If you have any other comments or views you would like to express in relation to the proposed opt-out legislation, please comment below.
Please comment below :
1. Organ and tissue exclusions
In the operational opt-out donation systems in England and Wales and in the proposed Scottish system, exhaustive lists of organs and tissues excluded from opt-out legislation are central features of regulation. If Northern Ireland pursues the proposed move to opt-out outlined in this consultation and similarly seeks to formulate an exhaustive list of excluded organs and tissues, it is important that policymakers ensure that membership of this list is based on consistently applied and clearly articulated principles – a shortcoming of the current Welsh and English systems.
For example, the Welsh Government recently consulted the public on proposals to include additional female and male sexual and reproductive tissues in the list of exclusions specified in the Human Transplantation (Excluded Relevant Material) (Wales) Regulations 2015 (the 2015 Wales Regulations). This follows the approach also recently adopted by the Department of Health and Social Care (DHSC) in England following public consultation, formalised in the Human Tissue (Permitted Material: Exceptions) (England) Regulations 2020 (the 2020 England Regulations). See fig 1 for a full list of all draft and enacted organ and tissue exclusions for England, Scotland and Wales.
According to DHSC’s consultation response, the stated rationale for the inclusion of female and male sexual reproductive tissues additional to those proposed in draft regulations, arguably tissues of a more sensitive nature, is to ‘make the list commensurate with the list of parts of the male reproductive system’, and to ‘give assurance and put beyond doubt that no part of reproductive organs and tissues will be covered by deemed consent’ (the same rationale upon which the proposed Welsh amendments are based).
We suggest that if this rationale is accepted, then further tissues such as the anus, rectum, breasts (including skin from the breasts) and nipples should arguably also be excluded from opt-out legislation. This is because they may be viewed as dual- or multi-purpose in that they both serve other biological functions and may
be seen as sexual and reproductive tissues in much the same way as the perineum and prostate are (excluded relevant material at Regulation 2(2)(y) and (aa) of the 2020 England Regulations and proposed for addition to the 2015 Wales Regulations). These tissues may similarly be viewed as sensitive in nature, and given that ‘many [respondents] expressed concern about the transplantation of reproductive organs and tissues’ in the English consultation, including some but not all sexual and reproductive tissues is inconsistent and unjustified.
In response to this same suggestion put forward in our submission to the recent Welsh consultation, the Welsh government accepted that ‘there could always be arguments for adding more materials to the list [of exclusions]’, but felt that ‘overall it strikes the right balance in favour of those sexual and reproductive organs that were discussed both during the scrutiny of the 2013 Act and as part of the consultation on the England Regulations, without breaking down all the anatomical structures in detail’. It is understandable that governments may not wish to overcomplicate legislation in this way and indeed, many of these transplants are not yet surgically feasible. However, we suggest that the ad hoc approach to deciding which organs and tissues to exclude from new opt-out laws adopted by the other UK nations, is unsatisfactory. Making the list of transplant exclusions as comprehensive and as consistent as possible is desirable, as is ‘future proofing’ it to cover all reasonably foreseeable transplants. As such, we would urge the Northern Irish government to take a more transparent and principled stance regarding how organ and tissue exclusions are identified, categorised and adopted.
We further suggest that if Northern Ireland’s Department of Health takes forward its proposed legislative plans for opt-out organ donation, organ and tissue exclusions from this new system should not be based on novelty, rarity or ‘contentiousness’ alone. A broader range of considerations should be taken into account, such as –
- How willing people would be to donate if the donation-type in question was explained properly to them (even if it is not one that they have presently heard of)?
This could be ascertained through a more sophisticated approach to public engagement (e.g. citizens’ juries or focus groups) rather than using a snapshot of public attitudes as they are now (potentially in a misinformed state). For example, accompanying the previous consultation by England’s Department of Health and Social Care on the introduction of opt-out consent for organ and tissue donation, NHSBT commissioned Ipsos MORI to undertake a series of focus groups with the general public and groups who may be less likely to engage in the formal written consultation process.
- Is the transplant for which the organ/tissue will be used life-saving or quality-of-life enhancing?
Here we might think that while the imperative to save lives gives us at least some defeasible reason to presume consent, quality-of-life transplants require a higher standard of consent due to the lower level of benefit involved.
- The purpose for which organs and tissues may be used.
Rather than merely listing types of organ or tissue, it may be more appropriate (instead or as well) to incorporate a list of purposes for which transplanted materials may be used without explicit consent. This is because, for certain tissue types, potential donors may have very different views of donation depending on the use to which the tissue is put. For example, skin could be used as a dressing to facilitate wound healing but also for elective cosmetic surgery, and it is reasonable to suppose that some potential donors would be uncomfortable with the latter while maintaining a positive attitude to the former.
2. Recording donation preferences in the Organ Donor Register
We suggest that the Organ Donor Register website should be updated to allow members of the public to record their donation preferences regarding excluded organs and tissues as well as routine transplants. The maintenance of public trust in the transplant system is a key factor underpinning blanket exclusions of novel and rare transplants from deemed consent laws. However, we suggest that the maintenance of public trust engenders also a second element – allowing individuals to exercise their autonomy to give or refuse consent while alive in respect of any and all non-routine transplants, ensuring preferences in respect of all organs and tissues are officially recognised.
Relying solely on information from families, and failure even to attempt to record preferences regarding excluded organs and tissues, is problematic. It is well known, for example, that many prospective organ donors will not have discussed their organ donation preferences with family members prior to death. And, given that the proposed lists of exclusions may contain more than thirty specified transplants (depending on how organs, tissues and cells are defined and categorised), it is reasonable to assume that only a small percentage of those who have discussed their organ donation preferences with family members will have comprehensively discussed the complex issues raised by these specific organs and tissues and, more generally, by novel, rare, or experimental forms of transplantation. Furthermore, family members are imperfect proxies and may find it difficult to both ‘don the mental mantle’ of their relatives and separate their own views and preferences regarding organ donation from those of the family member they represent.
Given these shortcomings, allowing donor preferences to be recorded on the organ donor register prior to death would provide a more accurate account of those preferences. This would also be a better way to obtain consent for novel or rare transplants, ensuring respect for individual autonomy.
3. Public information campaigns
While this consultation represents a first step in moving towards an opt-out system, from the outset careful attention must be given to how the Northern Irish government can make more people aware of this potential rule change.
Depending on the outcome of this consultation, should plans to move to an opt-out system proceed in Northern Ireland then initially ‘new rules’ regarding organ donation should be publicised both via online and more traditional media campaigns which cast a wide net over media sources used by various different demographics: i.e. via social media, television advertisements, newspapers and circular advertisements. Particular effort should be made to ensure that ‘harder to reach’ groups who may not frequently access or may have trouble accessing more common media sources are, indeed, reached. This may be done in a number of ways such as through disseminating materials (including materials in other languages and in large print and braille format) regarding these changes to individuals and to faith and community groups.
Lessons may also be learnt from the experience of other UK nations where public information campaigns were undertaken in England and Wales to publicise the move from opt-in to opt-out both in the lead up to ‘deemed consent’ legislation passing through Parliament, and around the time new laws came into effect. However, while these media and print campaigns highlighted the fact that individuals will be considered to have agreed to be an organ donor when they die without needing to opt-in to the organ donor register as was previously the case, they failed to make clear that the new law applies only in respect of routine transplants. See for example the following two videos produced by the NHS (https://www.youtube.com/watch?v=3_Ulk-Zc4vE and https://www.youtube.com/watch?v=22JdKKPB3P4) where no mention is made of the fact that this new rule does not apply to all organs and tissues. This is particularly concerning given the strength of feeling some people have in relation to a number of the organs and tissues excluded from opt-out. Anecdotally we are aware of discussions on social media platforms where users have expressed outrage that certain organs like uteri may be taken and transplanted under new deemed consent legislation (which is incorrect as the uterus is listed as an excluded relevant material). This outrage has led some to claim that they will register a decision not to donate on the Organ Donor Register, and attempt to convince others to do the same. In order to ensure that similar confusion and incorrect interpretation of new laws does not arise in Northern Ireland, carefully constructed campaigns should be created and disseminated making clear that new opt-out legislation would only apply in respect of routine transplants such as hearts, livers, lungs and kidneys.
Further, in order to maintain awareness once initial interest in the changes wanes sustained efforts should be made to make new UK residents aware of the policy and to ensure that children are aware of their options regarding donation once they reach majority such as by incorporating organ donation and transplantation into the national curriculum, perhaps through school ‘Learning for Life and Work’ provision.
END
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