Publication - Impact assessment

Human Tissue (Authorisation) (Scotland) Bill: EIA

Published: 11 Jun 2018
Directorate:
Population Health Directorate
Part of:
Health and social care
ISBN:
9781788519427

The Equality Impact Assessment (EIA) outlines how the Human Tissue (Authorisation) (Scotland) Bill impacts on the different equalities groups.

Human Tissue (Authorisation) (Scotland) Bill: EIA
Key Findings

Key Findings

The EQIA process identified that there would be impacts for the following protected characteristics:

  • Age
  • Race/Ethnicity
  • Religion/Belief
  • Disability

Some responses to the consultation queried whether there would be implications for LGBT people, however this was discounted at the screening stage as no impacts were identified for this group as a result of the change to an opt out system.

Age

This assessment considers different age groups across the age range, in particular children and young people and older people. There is no direct evidence of the impact of opt out systems on different age groups or children.

Children/Young People

The provisions in the Bill provide a balance between safeguarding and enabling children's rights, in line with the principles of the United National Convention on the Rights of the Child. The opt out system includes a safeguard whereby children (under 16) will not be subject to deemed authorisation and instead authorisation will need to be explicit, in recognition that they may not understand the need to opt out if they do not wish to become a donor. Those aged 12 and over will continue to be able to authorise donation as they can now, and new provisions will enable them to make an opt out declaration.

A new provision will recognise the views of children aged under 12. The changes would have a positive impact on children under 12 in recognising that a child, whilst unable to legally authorise donation or make an opt out declaration, may have views on organ and tissue donation. The change would introduce a new requirement, in line with that for children aged over 12 and adults, for those authorising donation to take account of the potential donor's views. This is in the form of a barrier to donation where the authoriser is aware that the child would have been unwilling to donate.

Young people aged 16 and over are classified as 'adults' in the legislation and will therefore be subject to deemed authorisation. The legislation contains safeguards to prevent those people who do not wish to, from becoming a donor, even if they haven't recorded an opt out decision. Family members will be able to advise of any objection to donation the potential donor held, meaning donation wouldn't proceed. Importantly the aim of the legislation is to give effect to the wishes of the potential donor in all circumstances, which means the young person's views would take precedence over the views of family members.

A change is also being made to the current legislation to optimise the potential for the donor's views to be known and adhered to. When authorisation is being given by, in the case of a child, a person with parental rights and responsibilities, they will be required not only to take into account their own knowledge of the child's unwillingness to become a donor but any relevant information from other people e.g. family members or friends.

It will be important that the awareness raising campaign takes account of the needs of children and young people. It will be important that young people are notified as they approach age 16 that they will potentially be subject to deemed authorisation if they haven't recorded a donation decision. The focus groups with young people have helped to identify which methods of communication are preferred and will feed into the overall awareness raising strategy.

Additionally, the Scottish Government has developed an internationally recognised schools educational resource pack to increase awareness of organ and tissue donation amongst school pupils from age 12 and above. The pack will be updated to take account of the changes and will be a useful resource to continue to raise awareness under the opt out system and educate young people about how deemed authorisation would apply to those aged 16 and over.

The Bill includes provision to enable a Local Authority, in the absence of a donation decision made by the child, to make a donation decision on behalf a child for whom it holds parental rights and responsibilities. A focus group and small survey with care-experienced young people were carried out to hear their views on the proposal. Those in the focus group had mixed views on who was most appropriate to make a decision on donation and the discussion reflected the differing individual circumstances and need for flexibility in any approach. Those responding to the survey were supportive of allowing a local authority to authorise donation and had mixed views on whether views should be sought from others to inform the donation decision.

In order to take account of the varying individual circumstances as identified in the focus group, the Bill will require that, in deciding whether to authorise, the Local Authority would be required to take into account the views of other people. This will firstly include the child's views, and also those of other relevant parties, including the child's parents. The changes would have a positive impact for children, particularly those under 12, as they are unable to authorise their own donation so currently, where the Local Authority holds parental rights and responsibilities, donation could not proceed even if it was the child's stated wish.

Older People

Some consultation responses identified that older people may be part of a hard to reach group and might be less likely to know about or understand an opt out system. It will be important that the awareness raising campaign takes account of the communication needs of this group, by for example utilising print media. There is flexibilty about how donation decisions may be recorded and additionally an Organ Donor Register telephone helpline may be helpful for this group to enable them to register donation choices over the phone if they wish to, rather than doing so online.

Race/Ethnicity

There are impacts for two different groups of people – people from ethnic minority communities and people newly resident in Scotland.

No direct evidence of the impact of moving to an opt out system on ethnic minority groups was identified. More broadly, evidence shows that some ethnic minority communities generally have a higher need for transplantation (primarily of kidneys) than the population as a whole. This is significant, as the best match for a kidney is from someone within the same ethnic group, consequently ethnic minority patients on average face longer waiting times for transplants. People from ethnic minority communities are also much less likely to be registered donors and upon death their loved ones are less likely to authorise donation.

Moving to an opt out system has the potential to positively impact ethnic minority groups as it aims to encourage a culture change to encourage people to support donation and assumes that people are willing to donate unless they have opted out – this may help to increase the number of authorisations from ethnic minority communities. However there are a range of specific factors that relate to ethnic minority groups having lower levels of authorisation, including poorer knowledge about donation, less positive attitudes, and greater concerns around organ and tissue donation in general, which could affect the extent to which a move to a soft opt out system will affect change within these communities. Therefore it is important that current work continues to promote awareness and support for donation within ethnic minority communities, takes account of the change to an opt out system and seeks to allay concerns that communities may have.

The Scottish Government has been working with Kidney Research UK which trains volunteers from ethnic minority communities to become peer educators to increase awareness of kidney disease and organ donation. This work, along with that of those within the donation workforce with specific responsibility with regards to ethnic minority communities, will continue and will be important in promoting understanding and awareness of the change to an opt out system among ethnic minority communities.

The system provides a protection for adults who are newly resident in Scotland, to reflect the fact that a person who has only relatively recently moved to Scotland cannot reasonably be expected to have a sufficient awareness and knowledge about the operation of the opt out system to understand the implications of not opting out. Those who have been resident less than 12 months will not be subject to deemed authorisation and will instead require explicit authorisation, either from themselves or from a nearest relative. Additionally, information can be provided by others, for example friends, about the potential donor's views on donation which will also help to determine whether donation can ultimately be authorised.

It will be important that the awareness raising campaign takes account of the needs of people who don't speak English, or speak little English, by providing information in different languages.

Religion/Belief

Although there is some research exploring the role of religion in organ donation in general, there is less evidence about the impact of religion on views relating to opt in versus opt out systems of donation. One study of note explores the views of UK faith leaders, highlighting clear support for an opt in system because they perceive that it respects individual choice. A survey study of Western Muslims also explored this issue and found that 26% of respondents agreed with the concept of presumed consent, compared with 55% who did not .

More broadly, evidence shows that religion is likely to be a key influence on decisions about organ donation, although the impact is likely to vary within and between religious or faith groups. In addition to differences between religious or faith groups, there is often a lack of consensus within these groups on the issue of donation. Although the official positions stated by each of the key religious groups in the UK are broadly supportive, and none formally oppose donation, religion is still often viewed as a barrier by some as individuals are often uncertain about whether donation is supported by their faith.

There is some evidence to suggest that barriers relate more to knowledge and understanding of the processes involved, than to religious or cultural factors per se and that the importance of a specific barrier is likely to vary by religious and ethnic group. A lack of knowledge about the point at which organs are taken for example, can lead to cautious attitudes towards donation, particularly in light of the role of burial traditions and practices relating to honouring the dead and experiences of bereavement.

NHS Blood and Transplant ( NHSBT) produces leaflets for all the major religions to explain the views of that religion on donation. As well as this, the work carried out amongst ethnic minority communities is done primarily through faith networks. We will continue to use our links with these networks to raise awareness about donation more broadly and the opt out system. Additionally, in our engagement with faith groups we have made contacts to help disseminate factual information about the move to an opt out system. Information being provided in this way via a trusted source within the faith is helpful in demonstrating credibility.

Through the consultation process and our further engagement with faith groups it has been clear that there is a need for donation to continue to be seen as a gift and for people to choose to donate. One of the principles of the proposed soft opt out system is that people will still be able to opt in if they wish and awareness raising campaigns will still encourage them to do so. Additionally, in the context of high profile awareness raising campaigns about the need to opt out if a person does not wish to become a donor, it will be possible to view the absence of such an opt out decision as a wish to become a donor. These aspects, as well as the ability for family members to advise of any objections the potential donor held will mean that donation won't proceed where a person would have been unwilling to donate, which will maintain the concept of donation as a gift.

As the evidence suggests, the point at which death occurs is an important factor in decision making about donation for some people of particular faiths. An individual's religion is currently taken into account in the palliative care pathway, of which donation is a part, and this will continue under the soft opt out system. However, moving to an opt out system may prompt some people to opt out of donation for fear that donation might not be permitted depending on the type of death (circulatory death or diagnosis of death following neurological criteria). The Bill includes specific provision about the particular circumstances of death which will mean that in all cases – whether a person has opted in, opted out, or is deemed to have authorised donation, it may only proceed where it is consistent with that person's views.

Disability

No evidence was identified with regards to organ and tissue donation and disability.

There are impacts on some people with disabilities with regard to two issues: how the system operates in relation to people without capacity to understand the opt out system, and how the awareness raising campaign takes account of the needs of people with disabilities.

The soft opt out system includes a safeguard to ensure those people without capacity to understand the system are not subject to deemed authorisation. Instead explicit authorisation will be required from this group of people either from themselves in their lifetime or from family upon their death. In the case of the family being asked to make a donation decision at the point of death, there is an extra protection for this group, in line with the principles of the United Nations Convention on the Rights of People with Disabilities, which requires that any known wish of the individual is taken into account when making that decision on their behalf. Additionally, information can be provided by others, for example friends, about the potential donor's views on donation, which will also help to determine whether donation can ultimately be authorised.

Some consultation responses queried whether moving to an opt out system may lead to a culture in which the retrieval of organs is prioritised over treatment which could impact negatively upon people with disabilities, long term or life-limiting conditions. Under an opt out system the care and treatment given to patients will remain the priority of clinical staff. Donation is only raised by clinical staff when it is clear that nothing more can be done for a patient and the family has come to terms with that; this approach will continue under the opt out system. Under the current system, different clinical teams deal with treatment to those which deal with donation and transplantation to ensure there is a separation and no perceived conflict of interest; this will continue under the opt out system.

The focus groups held with people with learning difficulties demonstrated a view that where possible people should be supported to make an informed decision about donation rather than it being assumed they can't make a decision due to a learning difficulty or other form of incapacity. The focus groups identified which ways are most effective to communicate with people with learning difficulties and other forms of incapacity. It will be important that the awareness raising campaign takes into account the needs of this group, by for example using easy read formats to help support those with learning difficulties to make informed decisions. It will also be important that the awareness raising campaign materials are accessible and take account of the needs of people with disabilities, such as those with visual impairments or those who are hard of hearing.


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