Transplantation Reviews 35 (2021) 100589

Contents lists available at ScienceDirect

Transplantation Reviews

journal homepage: www.elsevier.com/locate/trre

Review article

Opt-out policy and the organ shortage problem: Critical insights and
practical considerations
Sara Bea ⁎
Department of Global Health & Social Medicine, School of Global Affairs, Faculty of Social Science & Public Policy, King's College London, UK

a r t i c l e i n f o a b s t r a c t

Available online xxxx The legal shift to an opt-out system of consent for deceased organ donation is now official in England, Wales and
Scotland. While it is commendable that national governments across the United Kingdom have publicly signalled
their serious engagement with organ donation, it remains questionable that opt-out policy can in and of itself
Keywords: solve the public health issue of organ shortage. Opt-out policy risks becoming a futile solution if it fails to attend
Deceased organ donation to key factors in clinical practice. Thus, this article provides critical insights and practical considerations in order
Opt-out system of consent to work towards increasing the availability of organs for transplantation: 1) organ donation specialists on their
Organ shortage own are not enough, a collaborative hospital culture of donation is also needed; 2) investment in innovative per-
Health Policy fusion technologies is fundamental to increase both the quantity and quality of organs utilised for transplants;
Healthcare organization. and 3) opt-out does not solve the enduring problem of consent or authorization for donation, rather than hoping
that opt-out will shift the societal culture of donation and make donation the default choice, it is necessary to ac-
knowledge that families' authorization remains essential and their emotional experience can neither be mini-
mized nor excluded altogether. Importantly, consent rates are not the only factor to account for overall
deceased donation rates. The organ shortage cannot be solely attributed to a matter of negative public attitudes
reversible by law. Doing that does a disservice to the public and diverts strategic attention and resources from
fostering the organizational and technological enablers of organ donation in clinical practice.
© 2020 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license
(http://creativecommons.org/licenses/by/4.0/).

Contents

1. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2. Organ donation specialists on their own are not enough . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
3. Promoting a collaborative hospital culture of donation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
4. Increasing the quality and quantity of donated organs with perfusion technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
5. Addressing the enduring problem of consent in clinical practice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
6. Reframing organ donation as an end-of-life choice and the role of families. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Funding information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

1. Introduction
The legal shift to an opt-out system of consent for deceased organ
donation is now official in England, Wales and Scotland. The new legis-
lation introduces presumed or deemed consent for organ donation, it
reverses the former opt-in system of consent and stipulates that all
⁎ Corresponding author at: Room 3.13, Bush House North East Wing, King's College
London, 30 Aldwych, London WC2B 4BG, UK.
E-mail address: sara.bea@kcl.ac.uk.
adults are considered organ donors when they die, unless they opted
out in life or are in one of the excluded groups. Families preserve the
right to invalidate the deemed consent if they can provide information
to show that the deceased would not have consented to donation [1].
The British Medical Association has long endorsed a move to opt-out
to increase national rates of organ donation and decrease mortality
rates in the transplant waiting lists. Opt-out policy is said to normalize
donation as the default choice [2] and lift the burden of the decision
on the bereaved families [3]. In the political arena, since it was first pro-
posed [4], opt-out has also been hailed as the best solution to the

https://doi.org/10.1016/j.trre.2020.100589
0955-470X/© 2020 The Author(s). Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
S. Bea
persistent problem of organ shortage. It has been claimed that it will
shift the balance of presumption in favour of organ donation [5] and
promises to save hundreds of lives every year by boosting organ dona-
tion rates [6]. While it is commendable that national governments
across the United Kingdom have publicly signalled their serious engage-
ment with organ donation, it remains questionable that opt-out policy
can in and of itself solve the public health issue of organ shortage. For
here is the predicament: despite the political claims, in practice, we
are not all donors by default. The opt-out resolution culminates some-
what paradoxically a protracted period of heated debates that have
put into question both the efficacy of an opt-out system and its ethical
integrity [7–11]. Central to these disputes is the contention that the ev-
idence for an opt-out system leading to increased donation rates remain
inconclusive, other non-legislative factors, namely national organiza-
tion and infrastructure are said to contribute to higher donation rates
[10–17]. In what follows, it is argued that within the current opt-out
scenario such concerns are by no means left behind or silenced but
rather stand as pressing matters to be considered in practice. Opt-out
policy risks becoming a futile solution to the organ shortage if it fails
to attend to and foster key factors in clinical practice. This article focuses
on the UK setting and advances a critical analysis of opt-out policy
through an interdisciplinary approach – organ donation is indeed a
complex and multifaceted topic that calls for a capacious variety of
knowledges and forms of expertise. In particular, it is addressed to the
national and international community of legislators and policymakers
whose remit is to address the public health problem of organ shortage.
To wit, this discussion piece provides critical insights and practical con-
siderations by outlining the direction and scope of necessary measures
in order to work towards increasing the availability of organs for trans-
plantation. Firstly, the appointment of specialized donation profes-
sionals at hospital level is crucial, although, their work needs to be
supported by a collaborative hospital culture of donation. Secondly, in-
vestment in innovative organ perfusion technologies is also fundamen-
tal to increase both the quality and quantity of organs utilised for
transplants. And thirdly, regardless of deemed consent the conversation
about donation with bereaved families remains necessary and inevita-
bly difficult. The point at issue is to acknowledge that opt-out legislation
does not solve the enduring problem of consent, instead the situation
calls for a reframing of donation as an end-of-life choice and acknowl-
edging the legitimate role of families. In all this, it remains important
to stress that consent rates are not the only factor to account for overall
organ donation rates. Ultimately, the organ shortage cannot be solely at-
tributed to a matter of negative public attitudes reversible by law. Doing
that does a disservice to the public and diverts attention and resources
from fostering the organizational and technological enablers of organ
donation in clinical practice.
2. Organ donation specialists on their own are not enough
Across the United Kingdom, deceased organ donation rates have sig-
nificantly increased since in 2008 the Organ Donation Taskforce advised
against opt-out and instead recommended the integration of organ do-
nation as a usual procedure in end-of-life care [9]. The Taskforce re-
ported that the evidence of the policy's efficiency to increase donation
rates remained insufficient, and that the legislative change could create
an anti-donation backlash that would undermine the legitimacy of the
system. Thus, the report advised continuing to promote organ donation
within the opt-in model of informed consent and indicated that the key
aspects to improve on were at the level of organization and infrastruc-
ture so that donation became a usual rather than an unusual event in
end-of-life care. The NHS Blood and Transplant donation strategy in-
cluded the appointment of specialized professionals in organ donation,
an effective measure as demonstrated by the internationally recognized
“Spanish model” [18]. Spain holds the world's highest rates of deceased
organ donation and their experience shows that legislation alone is not
enough. Despite presumed consent law being in place since 1979,
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Transplantation Reviews 35 (2021) 100589
donation rates only started to increase following the creation of a na-
tional transplant coordination network and the appointment of trans-
plant coordinators, who are mainly professionals from critical care
units specialized in donor identification, management and approaching
bereaved families to consider donation at the hospital [13]. The
European Union approved a directive to boost rates of organ availability
by adapting the Spanish model and developing a coordination system at
national level and with the designation of donation specialists at hospi-
tal level [19]. The World Health Organization also urged countries to do
so in order to work towards achieving national self-sufficiency, reduce
mortality rates and combat organ trafficking [20]. Nevertheless, it is im-
portant to acknowledge that donation professionals do not work alone.
A case study of a transplant coordination team in Barcelona shows that
their work is enabled by the hospital-wide donation programme and
protocols that distribute donation-oriented tasks between key practi-
tioners in end-of-life care [21]. Transplant coordinators thus draw on
hospital resources and professional collaborations to focus on two key
moments of the donation process: firstly, maximizing the activation of
all possible donation cases, and secondly, if authorized by families,
then optimizing the utilisation of donated organs. Notably, these deci-
sive moments take place before and after the consent request stage,
and hinge upon hospital protocols that facilitate the necessary collabo-
rative arrangements with intensive care units and emergency depart-
ments, which in turn require appropriate technology infrastructure for
donor identification, management and organ procurement. Despite
opt-out policy framings that restrict organ donation to a matter of con-
sent or lack thereof, in practice, the authorization request with families
is neither the start of a donation process, nor the only condition that
must be met for the procurement of organs; it is an intermediate stage
in the complex and multi-factorial progression of any deceased dona-
tion process [22].
3. Promoting a collaborative hospital culture of donation
In order to effectively increase donation rates regardless of opt-out
legislation, it is important to continue to foster a collaborative hospital
culture of donation and to further integrate organ donation as a regular
process in end-of-life care in hospitals. The gist is to activate all potential
opportunities for deceased donation, both after brain-death and
circulatory-death diagnosis when possible [23]. After all, as repeatedly
stated, potential donor identification is the cornerstone measure to in-
crease donation rates [10–13,18,24]. The appointment and expertise of
specialist nurses and clinical leads in organ donation remains of para-
mount importance, but it needs to be coupled with the collaboration
of other healthcare practitioners in intensive care units and emergency
departments. Expanding the potential donor pool is possible, as recent
initiatives in Spain [25,26] and the UK [27,28] demonstrate, when the
intensive care and emergency communities are enlisted in the shared
goal of enabling the option of organ donation as part of the end-of-life
care pathway. In particular, this refers to the possibility of admitting
critical patients with a devastating brain injury to intensive care and
avoiding early withdrawal of life support treatment. The practice of
elective ventilation beyond futility is said to facilitate organ donation
without putting a strain on ICU resources, and, importantly, it is also
to the benefit of the patients and their families [28–30]. Thus, a key
area to continue to work on at hospital level is to provide up-to-date
training about eligibility criteria for donation to ensure early identifica-
tion and referral of potential donors. Donation specialists largely
depend on other practitioners' notification, thus enlisting their collabo-
ration and providing adequate training is an integral part of current
strategies of best practice in the UK [31]. Promoting the hospital culture
of donation, encouraging and informing all relevant practitioners about
their cooperation, is an ongoing and manifold task. Notably, it requires
dedicated organizational and financial investment to develop and
implement a hospital-wide donation programme; instrumental in
working towards streamlining and embedding organ donation. The
S. Bea
message to spread is that in light of the current situation of a markedly
decreased donor pool, a collective endeavour is required to make it pos-
sible, to enable the few cases of eligible donors to progress to the stage
of consent or authorization request. And, if families authorize the dona-
tion, then it is vital to make the most of the donated organs and ensuring
maximum utilisation for transplants.
4. Increasing the quality and quantity of donated organs with perfu-
sion technologies
Many identified and authorized donation cases might fall through
before transplantation if the necessary organizational and technological
infrastructure are not in place [32]. Besides specialized staff, technolog-
ical equipment is also essential to support donation processes and en-
sure the procurement of viable organs for transplants. For example,
effective donor management requires the use of in situ regional perfu-
sion technology to ensure optimal organ functionality and minimize
organ damage [33]. Furthermore, as recent studies indicate, the use of
ex situ perfusion machines that keep retrieved organs functional allows
enhanced preservation, longer timeframes before transplant, and a
more exhaustive assessment of each organ [34]. And in some cases,
the possibility to repair organs that would have otherwise been
discarded [35]. These technological innovations are of great value to in-
crease the availability of organs for transplants; especially with donors
after circulatory death and expanded criteria donors. Perfusion technol-
ogies enable the procurement of organs from older donors which are as-
sociated with a higher discard rate and inferior post-transplant
outcomes compared to those from younger donors. Nevertheless, the
inclusion of older age donors is to be considered as it responds to the
current old for old allocation strategy; patients on the transplant
waiting list are also older and their survival rate can be improved with
a transplant from an aged donor [36]. This means that perfusion tech-
nologies are fundamental in increasing the quantity and also the quality
of donated organs for transplants, especially in the settings with a dona-
tion after circulatory death programme. Therefore, if opt-out policy is to
deliver its promise of increased availability of organs for transplants in
the UK, special attention is to be given to the existing organ utilisation
strategy [37] and investing further in perfusion technologies.
5. Addressing the enduring problem of consent in clinical practice
An opt-out policy for deceased donation intends to raise organ dona-
tions by changing the consent system and making donation the default
choice [2]. This assumption has raised ethical concerns that identify pre-
sumed consent registration as a form of nudge [38], in itself a type of
‘manipulative’ influence in public health contexts [39]. Additionally,
the libertarian principle that every citizen is given the option to opt
out of donation, and thus autonomy of choice is respected, has been
put into question arguing that in most opt-out countries significant pro-
portions of the population are unaware of the policy [40,41] . Despite
opt-out being hailed as the solution to the enduring problem of consent
[3,42], the fact is that in practice the donor's consent cannot be
presumed or deemed without the authorization of donor families. A
prominent shortcoming of the policy, amply discussed in the protracted
‘opt-in or opt-out debate’ [15] is the fallacious rationale that if consent
or authorization is problematic then the solution is to remove the
need for it [12]. An opt-out legal framework sanctions donation against
family wishes, however, in practice proceeding to organ retrieval with-
out families' intervention would raise profound ethical concerns. Addi-
tionally, families also inform about the donors' medical and social
history which is included in the evaluation of organs' safety. In short,
families' role in the decision-making process is essential as authorizers
and informers and their emotional experience can neither be minimized
nor excluded altogether [43,44]. In an early evaluation of opt-out intro-
duction in Wales, it was noted that the number of NHS staff who be-
lieved that under deemed consent families no longer had any role had
3
Transplantation Reviews 35 (2021) 100589
increased [45]. Such misunderstanding might not be common, however,
even in small numbers it raises a matter of some concern [46]. There-
fore, the task at hand now is to acknowledge that regardless of whether
opt-out is in place or not the problem of consent or authorization en-
dures, and it requires to be addressed responsibly with families in the
hospital. This means that approaching bereaved families to discuss
organ donation is to be done in a respectful and caring way. The conver-
sation remains necessary and inevitably difficult, the point at issue is to
discuss donation in clinical practice with families in a way that encom-
passes both the need to increase organ availability for transplants and
the sensitive situation of bereaved families. In all this, it is important
to stress that consent rates are not the only factor to account for overall
deceased donation rates [11,12,15,47–49]. The organ shortage cannot
be solely attributed to a matter of negative public attitudes reversible
by law. A move from an opt-in to an opt-out system of consent, pro-
posed as the best solution to increase organ donation rates, is based
on the assumption that low donation rates are due to low levels of reg-
istrations and high levels of family refusals. Thus, it defines donation
rates exclusively as a consent-based issue and identifies negative indi-
vidual behaviours as the main barrier to increased organ availability.
Doing that does a disservice to the public and diverts strategic attention
and resources from facilitating the integration of organ donation as an
end-of-life choice embedded in clinical practice. The impact of an opt-
out policy is severely limited if it only focuses on one stage of the dona-
tion process; if only consent is being considered then the large numbers
of professionals and organizational arrangements in clinical practice are
left out of the question [50]. The ongoing and collaborative process of
embedding donation as a usual path in clinical practice is about making
donation possible by activating all opportunities [9]. Opt-out does not
entail that families of eligible donors, when approached at the hospital,
should be expected to authorize the donation as the default position. It
remains problematic that opt-out rationale presumes rather than fos-
ters a change in cultural values around organ donation. Instead of hop-
ing that the legislation will shift the societal culture and make donation
the norm [2,51], it is crucial to acknowledge that citizens might oppose
the opt-out system and object to donation if the policy is perceived as
authoritarian and shifting control from the individuals to the state
[52]. Communications with the public need to address these issues
fully to continue to promote a favourable public attitude towards dona-
tion with informative campaigns.
6. Reframing organ donation as an end-of-life choice and the role of
families
An opt-out system of consent, just like an opt-in system, reinforces a
definition of organ donation as an individual choice to be taken in life.
Citizens are nudged to record their wish or their objection to donate.
Families' right to object to donation might be preserved but their role
in the decision-making process is minimized, to invalidate the deemed
consent they must provide evidence that the deceased would not
have consented to donation [1]. In theory, opt-out lifts the burden of
the decision for bereaved families [3]. Yet, in practice, the use of default
nudges and rhetorical twists does not make the donation decision eas-
ier. In fact, discussing donation with an opt-out logic could lead to ten-
sions and compromise the specialist nurses' supportive relationship
with potential donor families. There is ample and conclusive evidence
to attest that the adequate training and skilled support of donation pro-
fessionals improve rates of family authorization for organ donation
[53–56]. A fact that stands in stark contrast with the insufficient evi-
dence on the impact of opt-out on donation rates; even in the Depart-
ment of Health's own impact assessment the existing evidence is
described as ‘ambiguous’ [57]. The new legal framework should not di-
vert resources from the ongoing best-practice training of donation pro-
fessionals, and others involved in the organ donation process, about
communication with and care for bereaved families [58,59]. Ultimately,
there is no magic bullet to convince people to accept donation as the
S. Bea
norm. It is a surgical intervention on a newly deceased patient who re-
ceives no direct therapeutic benefit. It is a thorny decision. Donation can
be glorified morally, appealing to the heroics of the gift-of-life meta-
phor, or nudged as the current legal imperative, but donation cannot
be expected to become normalized as the default choice. Instead of
insisting on donation as an individual choice to be taken in life, public
campaigns would be better served by reframing it as end-of-life choice
and acknowledging the legitimate role of families as part of the
decision-making process. Becoming an organ donor is extremely rare,
only twenty-four per million became deceased donors last year in the
United Kingdom [60] and given that by the time donation becomes an
actual possibility one is dead, then the final decision inevitably befalls
on the family. Yet, families often hesitate to authorize the organ pro-
curement because they do not feel entitled to interfere with such an in-
dividual decision, especially when the deceased's wish is unknown [61].
However, by reframing donation as a rare end-of-life choice and encour-
aging individuals and families to discuss donation in life, families could
be given the opportunity to take the decision on their loved one's behalf,
not instead of, or against. Some families would still refuse to authorize
the donation, a valid decision that should be respected even when the
deceased wish was to donate. Such situation is by no means frequent
as most families tend to authorize organ procurement when intention
to donate had been registered in life [62]. Nonetheless, in the event of
family refusal, it remains important to preserve the override and to at-
tend to the bereaved families' expressed needs in regard to their de-
ceased relative's body [7]. This is common practice by donation
professionals – their supportive role towards families is enshrined in
current donation policies in the UK clinical setting [58,59]. A caring
ethos towards families, regardless of their decision about donation, is
also a matter of great consequence to safeguarding the public trust in
the organ donation system in particular, and the medical institution at
large [9]. Therefore, regardless of opt-out legislation, preserving fami-
lies' right to object is essential and it should not be considered the
next barrier to remove in order to increase organ donation rates [63].
Fundamentally, the problem of organ shortage cannot be restricted
solely to a matter of consent or lack thereof. Instead of removing con-
sent barriers to donation, responsible organ donation policies need to
foster the organizational and technological enablers in clinical practice.
And that can only be done with adequate funding and by working col-
laboratively in hospitals. By jointly ensuring all opportunities for dona-
tion are activated, and if authorized, then honouring and making the
most of an act of such generosity that significantly helps those in need
of an organ transplant.
Funding information
The writing of this article was based on a research project funded by
the Economic and Social Research Council UK (ESRC grant number
1012649, Organ Donation and Transplantation).
Declaration of Competing Interest
The author has no conflicts of interest.
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