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Legislative framework

In the context of consent and authorisation

The legislative framework for donation in England, Scotland and Northern Ireland is that of a hard 'opt-in' system of consent. The Human Tissue Act 2004, which governs practice in England , specifically uses the term 'consent', whilst The Human Tissue (Scotland) Act 2006 uses the term 'authorisation'. Practice in Northern Ireland is governed principally by common law, although broadly it follows the legal principles that are applied elsewhere in the United Kingdom.

Since the 1st December 2015, Wales have been operating under the Human Transplantation (Wales) Act 2013 which changes the legislative framework to a soft opt-out system. This means that unless an individual makes a clear decision that they either wanted to or did not want to be an organ donor, they are treated as though they have no objection to donation after their death and their consent is deemed. To support this change, the NHS Organ Donor Register (ODR) has now been modified to allow anyone in the UK to register a decision to donate, to register a decision not to donate or to nominate others to make a decision for them after their death. (Although the soft opt-out system of consent only applies in Wales, anyone in the UK can now register a decision not to donate)

Patient autonomy

All three legislative frameworks for donation in the UK describe how consent/authorisation for organ retrieval after death may be given.

Both the Human Tissue Act 2004 and the Human Transplantation (Wales) Act 2013 use the term 'consent'. In contrast the Human Tissue (Scotland) Act 2006 uses the different term 'authorisation'. Practice in Northern Ireland is governed principally by common law, although broadly it follows the legal principles that are applied elsewhere in the United Kingdom.

The Human Tissue Act 2004, the Human Tissue (Scotland) Act 2006 and the Human Transplatation (Wales) Act 2013 give primacy to the decision of the individual however they have been stated and recorded. This can be done in various ways – verbally, by having a Donor Card, in writing, via the various means of accessing the ODR or in Wales by not opting-out of donation. All are regarded as equally valid forms of consent/authorisation for organ retrieval after death. If it is known that an individual has given their prior consent, this should be reflected in how the possibility of donation is introduced to a family.

It is vital that the ODR is checked before raising the possibility of organ donation with a family. If the individual has recorded a 'no' to donation on the ODR the family must be informed. An example of how this might be done is given below:

"Your relative recorded a decision on the Organ Donor Register to say they did not want to be a donor. This will be the decision we will be relying upon unless you have any other information you’d like to bring to our attention."

The role of the family

There is no provision in any of the Acts for family members to be able to overturn an individual’s intentions, be this to be a donor or not. Scottish legislation requires families to complete a written waiver should they seek to obstruct a loved one's decision to be a donor.

However, if the wishes of the individual are not known or cannot be determined then authority for decision making passes to a nominated/appointed representative (England and N. Ireland), and then to a person in a qualifying relationship to the individual. (England, Scotland and N. Ireland). In Wales, deemed consent would normally be applicable; only if it does not (for instance, in the case of a child) would those in a qualifying relationship be approached for consent. For a list of the qualifying relationships as described in the three Acts, see below:

Ranking order of family for consent and authorisation

The list of the qualifying relationships for the Human Transplantation (Wales) Act 2013 is the same as the Human Tissue Act 2004

Common reasons for family refusal 2016/17

Common reasons for family refusal
Common reasons for family refusal
% of refusals
% of refusals
Patient previously expressed a wish not to donate
% of refusals
21
Family were not sure whether the patient would have agreed to donation
% of refusals
15
Family felt the length of time for donation process was too long
% of refusals
12
Family did not want surgery to the body
% of refusals
10
Other
% of refusals
9
Family felt the patient had suffered enough
% of refusals
7
Strong refusal - probing not appropriate
% of refusals
6
Family felt it was against their religious / cultural beliefs
% of refusals
6
Family were divided over the decision
% of refusals
5
Family felt the body needs to be buried whole (unrelated to religious or cultural)
% of refusals
4
Family did not believe in donation
% of refusals
4
Family concerned that organs may not be transplanted
% of refusals
1
Family wanted to stay with the patient after death
% of refusals
1
Family had difficulty understanding / accepting neurological testing
% of refusals
<1
Family concerned that other people may disapprove / be offended
% of refusals
<1
Families concerned about organ allocation
% of refusals
<1

It is important to understand that although the Acts give precedence to the decision of the patient, when those decisions cannot be established, and in Wales when decisions cannot be deemed, authority for decision making passes to the individual in the qualify relationship / nearest relative to the patient.

Careful thought should be given to how donation is raised and which legislative framework applies, taking into account the specific circumstances of the patient and family. Approaches that place exclusive emphasis upon honouring the decision of an individual may lead families to erroneously conclude that donation should not happen when such decisions cannot be established, even though they then have the legal authority to consent to /authorise it.

Deemed Consent in Wales

The legislative framework of deemed consent came into force on December 1st 2015. Within this framework, consent in Wales is deemed if all the below apply:

  • Aged 18 and over (from 00.00 on their 18th birthday)
  • Adults who have lived in Wales for 12 calendar months or more and are ordinarily resident in Wales in a voluntary capacity
  • Adults who have had the capacity to understand the notion of deemed consent for a significant period before their death (12 months)
  • Adults who die in Wales

For individuals who meet these conditions and where there is no record of a person's decision on organ donation, their consent will be deemed to have been given unless a person with a close relationship can provide evidence that the person did not want to be an organ donor. This changes the default position to one where adults are viewed as having no objection to organ donation unless the evidence is to the contrary.

More information on deemed consent in Wales can be found here.

Donation from children

All three Acts recognise the validity of the wishes of competent minors. Where the wishes of the individual are not known or the minor was not competent to deal with the issue, consent/authorisation passes to those with parental rights and responsibilities, or in their absence to an individual in a qualifying/nearest relationship.

There is no age restriction for self-registration or self-withdrawal from the register. A parent can register their child, or a child for whom they have parental rights and responsibility, providing the child is under the age of 16 years. Alternatively, a child can register themselves. Children under the age of 12 years at the time of registration are assumed to have been registered by their parents, whilst those 12 years and over are assumed to have self registered. As a consequence, whilst the parents of a child under the age of 12 years at the time of registration can withdraw this consent/authorisation, if the child was 12 years or over at the time of registration then parents must provide evidence that they (rather than the child) were responsible for the registration should they seek to reverse it.