By Nicola Williams, Laura O’Donovan and Stephen Wilkinson
England is about to follow Wales by moving to an ‘opt-out’ system for deceased organ donation. Under such policies individuals are presumed willing to become organ donors after their death unless they have explicitly refused. The new system, also known as ‘deemed’ or ‘presumed’ consent, is expected to be fully operational by Spring 2020.
As part of the process for finalising the details of the policy, the Department of Health and Social Care (DHSC) is currently consulting on its scope and more specifically on which organs and tissues (if any) should be excluded. The consultation document proposes a long list of ‘routine’ organs that will be within the scope of the policy (e.g. heart, lung, liver, kidney – plus many less common ones) and a longer list of organs and tissues described as ‘novel and/or rare’ which will lie outside the scope of the policy (e.g. brain, face, uterus, finger). For this latter list, consent will not be ‘deemed’ and must instead be explicitly provided by the donor prior to their death or, and more likely, their families post-mortem. The closing date for the consultation exercise is the 22nd of July 2019.
The government’s rationale for excluding ‘novel and rare’ transplants from deemed authorisation is explained in the consultation document by reference to concerns that it would be inappropriate to ‘presume’ consent to donate rare/novel organs and tissues for transplant as members of the public may not have considered donating when contemplating organ donation and/or may believe that such tissues should lie outside the scope of deemed authorisation. Two claims about public expectations, can therefore be seen to underpin this proposal. The first is that opt-out should not apply to organs/tissues that the public would not ‘expect’ (in a descriptive/predictive sense) to be used for transplantation. This regards the public’s empirical beliefs about the kinds of organs and tissues that will be used for transplant. The second is that the public may expect that “someone’s consent should not be deemed [presumed]” for novel/rare organs and tissues and thus that such organs and tissues should require express consent. This has more to do with the public’s normative beliefs about the kinds of organs and tissues which ought to be included in opt-out.
In what follows we raise some critical questions about both the consultation itself and the approach to organ and tissue exclusions it proposes, many of which are relevant to any country with an opt-out system (or considering introducing one).
First, as noted above, the two senses of ‘expectation’ employed in the document are distinct. People’s predictive expectations about what organs will be used for transplant are not the same as their normative beliefs about what organs/tissues ought to require explicit consent. In other words, what people expect in one sense of the word ‘expect’ needn’t be the same as what they expect in the other.
Second, if these really are the government’s sole criteria for exclusions then applying either or both would require a significant amount of robust social science evidence about social attitudes and beliefs regarding organ donation, transplantation and consent. This kind of evidence is not something that any consultation exercise alone is likely to deliver, especially one with as narrow questions as this one. It is also, unfortunately, not evidence readily available elsewhere. For while data regarding organ donation preferences in the UK can be found in NHSBT’s transplantation activity report, this only includes data on the more common organs and tissues included in organ donation registration forms.
Third, it is not clear that the contents of the actual lists in this case can be easily justified by reference to criteria provided. With regard to predictive expectations, one example of this is the proposal that tendons, nervous tissue, and the rectus fascia all be included within opt out. Yet, we suggest that these are not particularly well-known. Consequently, many people may not have heard of them nor expect them to be included. Indeed, given recent publicity, people may well be more familiar with face, hand, and uterus transplants and yet these are proposed to lie outside the scope of the opt-out policy. In terms of normative views we wonder whether many people would really suggest that certain things on the excluded list, such as feet, legs, spinal cord, toes, or trachea ought to require explicit consent. What reasons would people have for setting a higher consent standard in these cases than for kidneys, livers, and hearts? Can the descriptors focussed on in the consultation – ‘novelty’ and ‘rarity’ – adequately capture these reasons or are there other (and similarly/more important) factors which influence organ donation preferences at play? Conversely, given the sensitivity many people might have about eyes and possibly skin (presently included within the scope of opt-out) is it safe to assume that people would be happy for consent to be ‘deemed’ for these? NHSBT data, for example, show that almost 11% of all registrants to the organ donor register in the UK opt out of donating their corneas, and a recent survey of the donation attitudes of 755 students at a German university showed that more than 67% of respondents were unwilling to donate ‘a large area of skin.’
On a more general level, is it wise to draft a list of exclusions based in part on public beliefs and attitudes regarding transplantable organs and tissues when these are often misinformed and/or under-informed? And, where this is the case, surely public education is a better way to go than altering policy to reflect a defective belief system. Few signees to the current organ donor register in the UK are likely to be able list all of the organs and tissues they have ‘agreed’ to donate post-mortem, but this is not generally seen to be a problem or a reason to amend the existing list, provided the information regarding included organs and tissues organs was accessible to them when they signed the register.
Given these concerns, a better approach to determining which organs and tissues to exclude from the remit of opt-out would take account of a broader range of considerations. These might include –
- How willing would people be to donate if the donation-type in question was explained properly and presented to them (even if they haven’t presently heard of it)? We might ascertain this through a more sophisticated approach to public engagement (e.g. citizens’ juries) rather than using a snapshot of public attitudes as they are now (potentially in a misinformed state).
- Is the organ/tissue emotionally/psychologically significant due to its ‘visibility’, or beliefs regarding its importance for identity? We might consider faces, eyes and brains to be different from toes and kidneys in this respect.
- Is the transplant for which the organ/tissue is to be used life-saving or quality-of-life enhancing? Here we might think that while the imperative to save lives gives us at least some defeasible reason to presume consent, quality of life transplants require a higher standard of consent due to the lower stakes involved.
- Will the organ/tissue be used for human reproduction (e.g. ovary, uterus, penis, testicle)? Should higher consent standards apply if there is the potential for a donor to provide genetic material or play a causal role (albeit indirectly) in reproduction?
- Might presumed consent be appropriate for a particular organ/tissue in one context, but not another? This may prove relevant for tissues such as skin, which are generally used as dressings for wound healing and can therefore be used in multiple contexts including that of elective plastic surgery. A list of exclusions might therefore not always be best captured by listing particular organs/tissues/transplants as opposed to, for example, a list of acceptable goals or purposes.
Finally, we wish to draw attention to another aspect of the DHSC consultation document: the criteria proposed for removing novel and rare transplants from the excluded list. The consultation states that ‘if a novel transplant became standard practice and there was high demand for transplants of that organ or tissue, the Government would consider removing it from the list of organs and tissues excluded from opt-out.’ There are good practical reasons to reconsider an exclusion once it is the case that demand for a previously novel and/or rare transplant can no longer be met through express consent. However, while demand may motivate reconsideration of an exclusion it should not affect the decision to include or exclude an organ, tissue or transplant. Such a decision should, as at the time of an original decision to exclude an organ, tissue or transplant, be based on empirical data and (where such data is not available) reasoned assumptions regarding the donation preferences of potential donors.
Authors: Nicola Williams, Laura O’Donovan and Stephen Wilkinson
Affiliation: Department of Politics, Philosophy and Religion, Lancaster University
Competing interests: No competing interests to declare