Organ and tissue donation - authorisation requirements: guidance

Guidance on authorisation requirements for deceased organ and tissue donation and pre-death procedures, as introduced by the Human Tissue (Authorisation) (Scotland) Act 2019 from 26 March 2021. First edition published March 2021.

Chapter 5: Express authorisations and opt-out declarations for donation

This chapter explains how express authorisation for donation and opt-out declarations can be given and that if they are not recorded on the ODR, then they must be made in writing.

75. The HTS Act permits adults and children aged 12 years and over in Scotland to give an express authorisation or an opt-out declaration in respect of donation. A decision may be recorded in relation to any specific organ or tissue and in relation to any permitted purpose.[3] An authorisation applies to only those organs and/or tissue and only the purpose(s) that the potential donor has indicated.

76. The HTS Act does not permit children aged under 12 to make an express authorisation or opt-out declaration. In the case of a child aged under 12, authorisation may only be provided on behalf of the child. An "express authorisation" by a child under the age of 12, for example on the ODR, would not permit donation to proceed and authorisation should be sought on behalf of the child. The fact that the child has attempted to register on the ODR would though be evidence of the child's views which may be taken into account when a person is deciding whether to authorise on behalf of the child.

Recording a decision about donation

77. The most common way of recording a decision will be via the ODR, but the HTS Act does not limit decisions to being recorded there. The HTS Act requires that, if a decision about donation is recorded outwith the ODR, then it must be recorded in writing. This applies to express authorisations and opt-out declarations. Expressions of views about donation expressed orally would, however, be evidence about the potential donor's views about donation.

78. The HTS Act does not require written express authorisations or opt-out decisions to be witnessed. The HTS Act only requires a witness to be present where an express authorisation or opt-out decision is withdrawn in writing by a person who is blind or unable to write.[16]

79. As long as the potential donor registered their decision voluntarily, had the information they needed to make the decision and had mental capacity or competence when they did so, then the decision recorded (on the ODR or elsewhere) constitutes a valid decision at the time of recording. Unless there is a suggestion that this is not the case, for example from the potential donor's family, then the assumption would be that the decision is valid. Any such suggestion should prompt further discussion and investigation.

The NHS Organ Donor Register

80. The ODR operates throughout the UK to allow individuals to record their decision about organ and tissue donation. The HTS Act provides a statutory basis for the ODR in Scotland and makes clear that decisions recorded on the ODR are in relation to transplantation only. The ODR allows the following decisions to be recorded:

  • I authorise the donation of all my organs/tissue after death;
  • I authorise the donation of some (specified) organs/tissue after death;
  • I do not authorise donation of my organs/tissue after death (an opt-out declaration).



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