Organ and tissue donation - authorisation requirements: guidance

Chapter 7: Authorisation by a person other than the potential donor

This chapter sets out the circumstances in which authorisation for donation may be given by a person other than the potential donor. The person giving authorisation should take into account any evidence of the potential donor's views before doing so. Although evidence about a potential donor's views can come from any person, the HTS Act is prescriptive about who may give authorisation, as reflected below.

142. Deemed authorisation does not apply to:

• excepted adults
• children (under 16 years of age)
• excepted body parts
• purposes other than transplantation.^[3]

143. In relation to these categories, authorisation for donation may be given by a person permitted by the HTS Act to do so, in certain circumstances (see paragraphs 167-168 for more information).

Authorisation on behalf of an adult

144. In certain circumstances, authorisation for donation may be given in respect of:

• Excepted adults: Authorisation may be given on behalf of an excepted adult for donation of any organ/tissue for any purpose^[3] set out in the HTS Act.
• Excepted body parts: Authorisation for donation of excepted body parts for transplantation may be given on behalf of an adult who is deemed to have authorised donation. The "excepted body parts" have been specified by the Scottish Ministers in regulations.
• Purposes other than transplantation: Authorisation may be given on behalf of an adult who has authorised donation for transplantation (either expressly or through deemed authorisation) for donation of any organ/tissue for purposes^[3] other than transplantation.

145. Authorisation for donation on an adult's behalf may be given only by the potential donor's 'nearest relative'. For the purposes of the HTS Act, that person is the person who, at the relevant time, is highest in the following list (taking into account the factors set out at paragraph 146):

• the adult's spouse or civil partner (except in the case of permanent separation or continuing desertion);
• a person living with the adult as husband or wife or in a relationship which had the characteristics of the relationship between civil partners, if they had been so living for a period of not less than 6 months (or if the adult is in hospital at the relevant time, if they had been so living for such period when the adult was admitted to hospital);
• the adult's child (including step-child, ranked equally with child);^[21]
• the adult's parent;
• the adult's brother or sister (including half siblings, ranked below full siblings);^[22]
• the adult's grandparent;
• the adult's grandchild;
• the adult's uncle or aunt;
• the adult's cousin;
• the adult's niece or nephew;
• a friend of longstanding of the adult.^[23]

146. The SNOD/SR/TDC should establish who the nearest relative of the potential donor is and who is therefore permitted to provide authorisation. The SNOD/SR/TDC should leave a person's relationship with the potential donor out of account where:

• they are under 16 years of age;
• they do not wish or are unable to make a decision about authorisation; or
• it is not reasonably practicable to communicate with the person in the hierarchy in the time available.

147. Where any relationship requires to be taken out of account, the SNOD/SR/TDC should move down the list in order and identify who is the 'nearest relative' for the purposes of the HTS Act.

148. When there is a disagreement between people in different positions on the ranked list, it is recommended that the SNOD/SR/TDC seeks to provide those people with the time and information they need to come to an agreement.

149. If it is not possible to reach an agreement, the hierarchy of authorisation applies and a decision on authorisation should be obtained from the person whose relationship to the potential donor is listed highest. The SNOD/SR/TDC may wish to refer to senior managers.

150. Where there is more than one person in the highest ranking category, authorisation may be given by any person in that category. This does not mean that the authorisation of one person must be acted on, and if agreement cannot be reached between people of the same rank, the SNOD/SR/TDC will need to carefully consider the emotional impact of any decision on family and friends.

Authorisation on behalf of a child

151. If a child aged 12 or over did not make a valid decision about donation, or was not competent to make the decision they have recorded, in this instance authorisation may be provided by a person with parental rights and responsibilities^[24] in relation to the child at the relevant time, including a local authority (see paragraphs 155-158 for more information). Authorisation may be given for donation of any organ/tissue for any purpose^[3] set out in the HTS Act.

152. The framework of the HTS Act does not permit a child aged under 12 to make an express authorisation or opt-out declaration in respect of donation (see paragraph 76). In the case of a child aged under 12, authorisation for donation may be provided by a person with parental rights and responsibilities in relation to the child at the relevant time, including a local authority (see paragraphs 155-159 for more information).

153. The authorisation of only one person with parental rights and responsibilities is required. This does not mean that the authorisation of one person must be acted on, and if agreement cannot be reached between parents, the SNOD/SR/TDC will need to carefully consider the emotional impact of any decision on them and others.

154. When there is a disagreement between parents, it is recommended that the SNOD/SR/TDC seeks to provide them with the time and information they need to come to an agreement. If it is not possible to reach an agreement, the SNOD/SR/TDC may wish to refer to senior managers.

Where a Local Authority holds parental rights and responsibilities in relation to the child

155. The HTS Act enables a local authority to authorise donation where it holds parental rights and responsibilities in relation to the child.

156. There may be occasions where parental rights and responsibilities are shared between the local authority and others. If there is another person who holds parental rights and responsibilities, it may be more appropriate for them to consider authorisation. The SNOD/SR/TDC will need to carefully consider who in such circumstances would be most appropriate to consider authorisation and encourage parties to reach a consensus. If it is not possible to reach an agreement about who should consider authorisation, the SNOD/SR/TDC may wish to refer to senior managers.

157. Authorisation from only one person with parental rights and responsibilities is required. This does not mean that the authorisation must be acted on, and if agreement cannot be reached between different parties, the SNOD/SR/TDC will need to carefully consider the emotional impact of any decision on the different parties.

158. Where a local authority is considering providing authorisation, the SNOD/SR/TDC should advise and guide the local authority through the requirements of the HTS Act. The local authority must, as far as is reasonably practicable, ascertain and have regard to the views of:

• the child,
• the child's parents, and
• any other person whose views the local authority considers to be relevant.

159. In practice, the relevant people are likely to be at the bedside and the local authority should discuss with them, supported by the SNOD/SR/TDC.

Where no person holds parental rights and responsibilities in relation to the child, or such a person is incapacitated

160. In very exceptional circumstances, there may be no person with parental rights and responsibilities in relation to the child or it may be impossible for them to give authorisation as they have become incapacitated. Those with parental rights and responsibilities would be considered to be so incapacitated if they are also critically ill and are expected to die, as a result of a common calamity, for example a road traffic accident involving parents and children. In these extremely limited circumstances, authorisation may be given by another adult with a close relationship with the child. Authorisation may be given by a person who, at the relevant time, ranks highest on the following hierarchy, (taking into account the factors set out at paragraph 161):

• a person who has (or has recently had) a significant involvement in the upbringing of the child;
• the child's brother or sister (including half siblings, ranked equally to full siblings);^[25]
• the child's grandparent;
• the child's uncle or aunt;
• the child's cousin;
• the child's niece or nephew;
• a friend of longstanding of the child.^[23]

161. The SNOD/SR/TDC should establish who is the highest ranking person and therefore permitted to provide authorisation. The SNOD/SR/TDC should leave a person's relationship with the potential donor out of account where:

• the person is under 16 years of age;
• the person does not wish or is unable to make a decision about authorisation; or
• it is not reasonably practicable to communicate with the person in the time available.

162. When there is a disagreement between people in different positions on the ranked list, it is recommended that the SNOD/SR/TDC seeks to provide those people with the time and information they need to come to an agreement.

163. If it is not possible to reach an agreement, the hierarchy of authorisation applies and a decision on authorisation should be obtained from the person whose relationship to the potential donor is accorded the highest ranking on the list. The SNOD/SR/TDC may wish to refer to senior managers.

164. Where there is more than one person in the highest ranking category, authorisation may be given by any person in that category. This does not mean that the authorisation of one person must be acted on, and if agreement cannot be reached between people of the same rank, the SNOD/SR/TDC will need to carefully consider the emotional impact of any decision on family and friends.

Authorisation of transplantation of excepted body parts

165. The Human Tissue (Excepted Body Parts) (Scotland) Regulations 2020^[26] specify the parts of the body that deemed authorisation for transplantation does not apply to. Where the potential donor's authorisation for commonly transplanted organs/tissue is deemed, parts of the body listed in columns 1 or 2 of the table in figure 2 may only be removed and used for transplantation if authorisation is given by the nearest relative. Tissue or material listed in column 3 may be removed from a body part in column 2 with deemed authorisation. The regulations don't affect which organs/tissue may be donated under express authorisation.

166. This means that deemed authorisation for transplantation will apply to the following commonly transplanted organs and tissue: kidneys, liver (including for hepatocyte cell transplantation), pancreas (including for islet transplantation), heart, heart tissue (including valves, conduits and patches), lungs, intestinal organs and corneas. It will also apply to blood vessels, bone, muscle, nervous tissue, skin, and tendons unless they are part of a body part listed in column 1.

Figure 2: Parts of the body which are excluded from deemed authorisation.

Column 1 - The whole or any part of the following is excluded from deemed authorisation

• brain
• cervix
• clitoris
• face^[27]
• fallopian tube
• labia (labia minora)
• ovary
• penis
• perineum
• placenta
• prostate
• spinal cord
• testicle
• trachea^[28]
• umbilical cord
• uterus
• vagina
• vulva (labia majora)

Column 2 - The whole of the listed body part is excluded from deemed authorisation

• finger
• foot
• forearm
• hand
• lower leg
• thigh
• toe
• upper arm

Column 3 - Tissue that can be removed from a part listed in column 2 with deemed authorisation

• blood vessel^[29]
• bone
• muscle
• nervous tissue
• skin
• tendon

Circumstances in which authorisation may be given

167. Authorisation for donation may only be given on a potential donor's behalf where they have not made a valid, express authorisation or opt-out declaration (on the ODR or in writing). Additionally, it is not permitted for authorisation to be given for purposes other than transplantation where the potential donor has made an opt-out declaration for transplantation.

168. Authorisation may only be given where the person permitted to give it has no knowledge that the potential donor would have been unwilling to donate, either in general or in the specific circumstances (see paragraph 60). The person who is considering whether to give authorisation should have regard to any evidence of the potential donor's views brought forward under the duty to inquire and if donation is to proceed, they must be satisfied that the potential donor would not have been unwilling to donate.

169. In a case where a nearest relative is considering whether to authorise donation on behalf of an adult who lacks capacity, they should have regard to the adult's past wishes and feelings as far as these are reasonably ascertainable.

170. The HTS Act makes clear that the mere absence of an explicit authorisation by the potential donor should not be considered as unwillingness to donate.

How authorisation can be given and withdrawn

171. Authorisation for donation by a person other than the potential donor must be either in writing and signed, or, if it is given orally, it must be given to a health worker, who will, in this case, normally be the SNOD/SR/TDC. If the authorisation is in relation to donation for a purpose^[3] other than transplantation, it may be withdrawn by the person who provided it, by the methods given above. If it is in relation to transplantation, it may not be withdrawn.