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.

Annex A – Interpretation

220. Express authorisation for donation – refers to a decision by the potential donor to authorise donation, made during life. If this is not recorded on the ODR, then it must have been given in writing, for example in a will or other written declaration.

221. Opt-out declaration – refers to a decision by the potential donor not to authorise donation, made during life. If this is not recorded on the ODR, then it must have been made in writing, for example in a will or other written declaration.

222. Deemed authorisation – the HTS Act enables authorisation to be deemed for most adults where there is no express authorisation (opt-in) or opt out declaration (opt-out) recorded and no evidence of unwillingness to donate. Deemed authorisation applies only to transplantation and doesn't apply to excepted body parts or excepted adults.

223. Nearest relative – the HTS Act recognises the position of the 'nearest relative' and enables them to give authorisation on behalf of an adult potential donor in certain circumstances. It also requires that inquiries about the potential donor's views are made of the nearest relative, amongst others. The nearest relative hierarchy is listed in paragraph 145.

224. Family – in practice, there will often be a broad group of people involved in the end of life care of a potential donor - for example family, friends or others. This guidance often uses the term 'family', which could encompass any individuals. The guidance also makes clear that in addition to requiring that inquiries about the potential donor's views must be made of the nearest relative, the HTS Act requires such inquiries to be made of any person who wishes to provide evidence of views and any other person the SNOD/SR/TDC considers appropriate. In many cases, these will be people who are involved in the end of life care.

225. Evidence – the HTS Act enables evidence of the potential donor's latest views to establish whether or not donation is authorised. The Act does not require the evidence to be in any particular form – it may be written information (for example, the potential donor's views as expressed on social media) or oral information (for example, a recollection of a prior conversation held with the potential donor). Evidence from which the potential donor's views can be inferred, rather than being known absolutely should not be excluded if it is produced, for example if the potential donor expressed views that they didn't like the idea of donation. The HTS Act isn't prescriptive about who can provide such evidence, meaning that it can come from anyone.

226. Evidence threshold – the HTS Act requires evidence of a potential donor's views to be capable of leading a reasonable person to conclude either that the potential donor was unwilling to donate (where they have opted in or are potentially deemed to have authorised donation) or that they were willing to donate (where they have made an opt-out declaration).

227. Not unwilling – the HTS Act requires that, if donation is to proceed, the potential donor must not be unwilling to donate. This means that they must not have expressed an objection to donating.

228. Excepted adult – an adult to whom deemed authorisation does not apply (either an adult who lacks capacity or non-resident adult).

229. Adult who lacks capacity– an adult who, over a significant period ending immediately before the relevant time, lacked the capacity to understand the nature and consequences of deemed authorisation. This means that the adult must have been incapable of understanding that they may be deemed to have authorised removal and use of part of their body for transplantation and that if authorisation were so deemed, part of their body could be used for transplantation purposes after death.

230. Significant period - the HTS Act is not prescriptive as to what constitutes a "significant period", as it is likely to vary from case to case, but it should be long enough so as to mean that the potential donor cannot have been reasonably considered to have had an understanding of the opt-out system.

231. Non-resident adult - an adult who has not been ordinarily resident in Scotland for at least 12 calendar months ending immediately before the relevant time.

232. Ordinarily resident – refers to people living in Scotland on a lawful, voluntary and settled basis. Ordinary residence can be of long or short duration but deemed authorisation will not apply unless the potential donor has been ordinarily resident for at least 12 months before the relevant time.

233. Pre-death procedures – These are medical procedures which are carried out on a potential donor for the purpose of increasing the likelihood of successful transplantation, rather than as part of their ongoing care to promote their physical or mental health. The HTS Act includes a framework for the authorisation and carrying out of these procedures. (See chapter 8).

234. Health worker – for the purposes of the HTS Act, a health worker is a registered medical practitioner, a registered nurse or a person authorised to carry out health worker functions (see paragraphs 21-25 for more detail).

235. Registered Medical Practitioner – this term refers to a fully registered person within the meaning of the Medical Act 1983 who holds a licence to practise under that Act.

236. Relevant time – this term replaces the language regarding steps being taken 'immediately before death' used in the 2006 Act, to reflect the growth in DCD donation. In practice the relevant time will be when end of life care discussions are taking place (see paragraphs 38-42 for more detail).

237. Duty to inquire - the requirement in the HTS Act that inquiries are made about whether a donation decision is in force, whether a potential donor is in an excepted category and about the potential donor's views about donation and pre-death procedures (see paragraphs 29-37 for more detail).



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