The ethics of transplantation

and legal issues

Ben M Stutcheld
Stephen J Wigmore
Abstract
Organ donation and transplantation present many challenges to the
medical community and society as a whole that require legal and ethical
frameworks. This article sets out the key principles of modern bioethics
and shows how these can be used to understand a number of areas of
controversy in organ donation and transplantation practice. In many
cases there is no single answer to a problem and the concept is intro-
duced that ethics and implementation of ethical principles to policy is
often governed by societal values or represents a best compromise.
Organ donation and transplantation will continue to throw up challenging
questions for law and medical ethics and it is key that doctors understand
the language and principles involved so that they can contribute to the
debate.
Keywords Conditional donation; consent; directed donation; equity of
access; justice; medical ethics
Introduction
Advances in organ transplantation have continued at pace since
the rst successful kidney transplant over 50 years ago. In
addition to greatly improved long-term outcomes for transplant
recipients, donated livers can be divided to serve two recipients
and living donation is common practice. Many surgical, medical,
immunological, pharmacological and logistical barriers have
been overcome. Despite these advances fundamental ethical and
moral dilemmas continue to pervade the practice of organ
transplantation. This is brought into particular focus by the ever-
increasing gulf between organ supply and demand. While the
study of medical ethics has developed over many centuries, the
practice of organ transplantation is a relatively new phenomenon
bringing with it a range of ethical dilemmas which societies have
struggled to deal with over the years.
Dealing with issues such as who should donate organs, how
organs should be allocated and who should receive organs
requires careful and rational evaluation of the moral and ethical
concerns, long before the practical aspects can be considered.
Questions of how this mismatch could be addressed, including
nancial reward for donation, presumed consent, restricted
transplant criteria, and even xenotransplantation, have been
much debated in recent years. While the correct path may vary
based on the moral code and ideals of the society as well as
technological advance, understanding the key ethical principles
can assist in formulating a rational approach to these complex
issues.
Benecence, Non-Malecence, Respect for autonomy and
Justice are four trans-cultural principles that are widely accepted
as forming the basis of medical ethics (Figure 1). These prima
facie ideals serve as a basis on which to consider and rene
ethical dilemmas. Understanding these principles in the context
of human disease is fundamental to the practice of medicine.
Principles of medical ethics
Benecence is the obligation to strive at all times to do good for
the patient. Benecence demands competence and encompasses
all of the quality assurance processes we have come to expect as
a medical profession, including accreditation, continuing medical
education, research and audit. Non-malecence, or avoiding
harm, has been a cornerstone of medical practice since the days
of Hippocrates (Primum non nocere e First do no harm).
Respect for autonomy, where individuals should be treated as
ends not means, considers the importance of dignity, integrity
and authenticity. It encompasses the process of consent and
condentiality. Justice addresses the importance of fairness in the
delivery of medical practice. In the context of transplantation this
necessitates a transparent system of organ donation and alloca-
tion based on a philosophically justied prioritization system.
While each of the four principles in itself can be applied to
a given situation, conict can arise. The principles of benecence
and non-malecence may appear to coexist, but an intervention
to improve a condition may risk or lead to harm. Finding the
correct balance between benet and harm is an important clinical
judgement which must take into account the patients own
perspectives. In the past the mainly paternalistic views of the
medical profession may have paid little attention to patient
autonomy, with the predominant weight applied to the clinicians
own judgement. With changing times, the importance of
combined professional judgement and informed patient choice is
clear. At the other end of the scale affording overwhelming
emphasis on patient autonomy, with little professional direction
risks creating a culture of medical consumerism. Respecting
autonomy may be challenging where a competent patient makes
a seemingly irrational decision, or where the age of the patient
demands that a parent or guardian makes the decision on behalf
of the patient. Justice in delivering medical treatments risks
prejudice based on the medical practitioners own beliefs.
Discrimination based on age, race, gender, or social value
clearly violates this principle.
These four key principles do not provide ordered rules in
which to follow, but rather aim to aid decision-making. The
context and culture in which they are considered can vary
greatly. Traditions or codes of practice have developed reecting
approaches to these principles.
Approaches to ethical principles
Two prominent systems have emerged, reecting traditions, or
codes that have developed within society. These include the
Ben M Stutcheld MSc MRCS is an ST3 general surgical trainee at the
Royal Inrmary Edinburgh, UK. Conicts of interest: none declared.
Stephen J Wigmore MD FRCSEd is Clinical Lead for Transplantation and
Consultant Hepatobiliary and Transplant Surgeon at the Royal inrmary
of Edinburgh, UK. Conicts of interest: none declared.
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deontological, or duty-based approach and the utilitarian or
consequence-based approach.
The deontological approach focuses on the duties of medical
practitioners and the rights of patients. Examples include the
Hippocratic Oath and General Medical Council statements on
Duties and Responsibilities of Doctors. Deontological thinking
stresses the importance of patient autonomy and the primacy of the
doctorepatient relationship. Everyact is capable of being expressed
as universal law. However its basis in law may appear excessively
rigid with practitioners instructed to act in particular ways because
it is right, apparently irrespective of the consequences.
The utilitarian approachaspires to act insucha way that always
leads to the right outcome. In essence, Seek the greatest good of
the greatest number. The need to ration healthcare makes this
approach particularly prominent within the NHS. Within the
utilitarian approach two strands can be identied- act and rule
utilitarianism. Act utilitarianism considers the consequences of
a particular act, suchas not proceeding withtransplantation where
there is a high risk of primary disease recurrence. Rule utilitari-
anism contemplates the consequences of acting according to
a general moral rule, such as patients over a certain age should not
undergo transplantation.
The deontological and utilitarian approaches do not provide
opposing views on ethical dilemmas, but rather offer different
perspectives on solving a particular problem. There is clearly
a spectrum of real-life dilemmas requiring careful analysis of the
context and situation, rather than blind application of principle.
The four ethical principles should be considered with concern for
the scope of their application, providing a common framework
and moral language to assist decision making.
1
Importantly, the
choice of action does not always lie with the individual practi-
tioner. At the root of society, moral code and ethical principles
lead to rules, regulation and law, reecting what society deems
right and wrong.
Rules, regulation and law
In England, Wales and Northern Ireland the Human Tissue Act
2004 regulates the removal, storage and use of human tissue.
2
In
Scotland the Human Tissue (Scotland) Act 2006 applies, which is
founded on similar principles.
3
Offences under the acts are
comparable. These include the removal, storage or use of human
tissue without appropriate consent; storing or using human
tissue for another purpose; and trafcking in human tissue for
the purpose of transplantation. Consent is the fundamental
principle governing this, with different requirements applying
when dealing with tissue from the dead and living.
In the case of deceased donors the UK has adopted an opt-in
system, where individuals register their willingness to donate
organs in the event of their death. The electronic record of this is
the organ donor register. The traditional denition of death as
cardiopulmonary demise has been adapted to include death
diagnosed by examination of the nervous system. This concept of
brainstem death has provided a pool of potential heart beating
donors in countries with intensive care units. While brainstem
death did not evolve specically to benet organ transplantation it
is inextricably linked to the successful development of trans-
plantation as a specialty.
4
The concept of whole brain death is
accepted by most countries, where testing may occur via electro-
encephalography and/or cerebral blood ow measurement.
5
The
UK has adopted clinical criteria to determine brainstem death
based on guidance from the Academy of Medical Royal Colleges.
The whole system of organ donation in the UK is based on the
principle of a living will. We ask people to state in life whether if
they were to die in appropriate circumstances they would like
their organs to be used for transplantation. This process is based
on affording autonomy to the persons wishes in life which are
then carried over into death. Interestingly, under UK law a dead
person is considered to have no autonomy and while a deceased
individuals money and property are protected in law, their body
is not. If a representative had been nominated by the deceased
while they were competent then that person can consent to organ
donation. In the absence of this a qualifying relative can be used
such as a spouse or partner. By their very nature deceased donors
meet the requirements of non-malecence.
In recent years optimizing the condition of brainstemdonors to
improve organ quality via anaesthetic or preconditioning tech-
niques have been considered. There is already a precedent, in that
the use of desmopressin (DDAVP), thyroxine and inotropic
support to optimize the organ donation process is well established.
Inthe case of non-heart beating donors the Department of Health is
clear intheir guidance that registrationfor organdonation does not
provide consent to premorteminterventions to procure organs and
such interventions are only lawful if they are in the best interests of
the patient.
6
In particular systemic heparinization or continuing
external cardiac massage would be deemed unlawful.
According to World Health Organization data the majority of
organs donated across the world come from living donors,
although in the UK the annual numbers are similar. With regards
to living donors the Human Tissue Act (2004) states that no
reward can be given or will be given to the donor, lawful consent
to donation must be obtained and an independent assessor must
interview both the recipient and donor separately. A report must
then be submitted to the Human Tissue Authority. It is an offence
to remove any organ or part of an organ from a live donor unless
all the requirements of the Act and Regulations are met. The
living donor may direct an organ to a known recipient or can
donate a non-directed organ. Non-directed, or altruistic organ
donors cannot specify who can and cannot receive their organ.
The Human Fertilization and Embryology Act 2008 conrmed
that it is lawful to select human embryos which are suitable for
Beneficence
Non-maleficence
Ethics Justice Autonomy
The four key principles of medical ethics
Figure 1
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organ or tissue donation to a sibling or family member. This
notably prompted stories in the press of potential Saviour chil-
dren [BBC news story].
Views of society change over time. Activities which are deemed
legal today may be challenged in the future and practices which are
currently deemed illegal may be legalized. Single events,
campaigns, or technological advances may raise concern, highlight
discrimination or demonstrate potential benets. This can prompt
debate andlead tochanges inthe process andpracticalities of organ
donation and transplantation. For example the Human Tissue Acts
came about in part as a response to public outrage about pathology
practices of tissue retention, with relatives successfully suing for
legal damages. Changes to the Human Fertilization and Embry-
ology Act came about due to a combination of technical advance
and public pressure. Living donation is only possible through
advances in surgical and anaesthetic techniques which have
reducedrisks tothe donor. It is therefore important toconsider both
favoured and unfavoured practices in organ transplantation to
understand the main issues surrounding the organ procurement
andallocationprocess inthe context of the growing organshortage.
Issues in organ procurement: consent
Prior to the 2006 Human Tissue Act the situation in the UK was
that the family of an individual had to give lack of objection to
organ donation proceeding. With only 28% of the population
listed on the organ donor register this can be a tricky process and
when placed in the situation, up to 40% of families refuse
transplantation.
7
If prior discussion of the potential donors
wishes about organ donation had not been undertaken then
frequently families would decline to agree to organ donation
proceeding. With the Human Tissue Act came a change of
emphasis in the law with a greater priority given to the wishes of
the donor made in life and the family now not legally required to
give assent to organ donation but rather being informed of the
donors wishes. Even despite clear evidence of the patients
wishes, if the family were to vehemently oppose organ donation
the process is unlikely to go ahead. Here it could be argued that
the principle of non-malecence extends beyond the deceased
patient to the psychological well being of the family. How does
this t in with deontological thinking and the patient autonomy?
The conict between benecence and non-malecence in this
context may be difcult to negotiate. In practice, transplant co-
ordinators deal with living people and it is with concern for
non-malecence that the families wishes are respected.
The system of presumed consent has been suggested as
a method of increasing the donor pool, whereby patients must
opt out if they are not in agreement. In this situation family
agreement would not be legally necessary in the absence of prior
consent. While no causal relationship has been established, data
from other countries where presumed consent has been intro-
duced suggest that the change from an opt in to an opt out
system could increase organ donation rates.
7
Critics of this
system have claimed that patients may be unaware of the opt
out clause, risking removal of the patients autonomy. Respect
for donor autonomy in the face of family disagreement to
donation could risk considerable negative publicity to the prac-
tice of organ donation. In a markedly ckle society, this could be
counterproductive to organ donation as a whole. The balance
here between rule and act utilitarianism can be challenging. Rule
utilitarianism would suggest that following the patients express
wishes to transplantation would lead to the best outcome in
terms of organ availability; however in considering act utilitari-
anism potential negative public opinion could jeopardize the
entire transplantation programme. In the UK a task force was
established in 2008 to research the potential effect of presumed
consent on organ donation rates. Concerns about the application
of the system, as well as its implementation lead the committee
to recommend that the current opt-in system should remain.
The committee suggested a range of measures aiming to increase
deceased organ availability by 50% over 5 years, suggesting
further review of consent process at this time.
8
In some societies a mandated choice policy has been trialled.
Here individuals are presented the opportunity to agree or
disagree to potential organ donation at the same time as
completing other documentation, such as application for driving
license or passport. This places individual patient autonomy at
the centre of the process. Following deontological principles the
clinician must then comply with the patient wishes, regardless of
the inuence of family or other outside factors. Respecting the
autonomy of the patient is a major strength of this system, but it
may not have the desired effect. The state of Texas passed a law
enacting mandated choice in the 1990s. Rather than increasing
the potential donor pool, almost 80% of people chose not to
donate organs, later leading to the repeal of the law.
9
Issues in organ procurement: living donation
The rst successful kidney transplants were all living donor
transplants usually between siblings. Living donation became
less common in the UK with recognition of the state of brain stem
death and the ability to undertake kidney transplants from brain
stem dead heart beating donors. Recognition of the superior
outcomes from living donor kidney transplantation has lead to
a resurgence of interest over the past 20 years and some centres
now undertake more living donor than cadaveric kidney trans-
plants. Living donation has always presented an ethical chal-
lenge because of the principle of primum non nocere or rst do
not harm, a pillar of the Hippocratic Oath. Exposing an other-
wise healthy patient to considerable risk concerns many.
While living donation of a kidney is considered relatively safe
in the healthy individual (0.03% mortality), signicant comor-
bidity may sway the benecence : non-malecence balance. The
counter argument states that a donor may derive great psycho-
logical benet from donation and that this justies the risks
incurred. What should be the dominant force in this situation -
the professional judgement of the clinician or the autonomy of
the hopeful donor? The guidance of the transplant team in such
situations is crucial. Involving independent advocates can assist
in understanding an individuals motives and intent. A number
of living donor studies have shown that there are higher rates of
psychological and physical complaints from living kidney donors
when the transplant outcome for the patient is poor, for example
early graft failure. Similarly if we increase the level of risk to the
donor such as the situation in living donor liver or lung trans-
plantation then we could ask is the psychological benet of
donation still justiable? These questions are ones that the donor
must make for themselves with appropriate medical advice.
Family members may feel pressured to donate, potentially
fostering guilt or resentment within the family. Informed support
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from the transplant team in this setting may include the opportu-
nity to offer a way out for the potential donor not willing to
donate, ensuring that consent is not given by coercion. Is it ethical
for the clinicianto create a reasonfor anindividual not todonate? It
could be argued that from a non-malecence perspective it would
be important that the unwilling donor is not coerced into trans-
plantation and family difculties could be avoided. However, is
this lie justied from a deontological view point?
The issue of balance of risk to living donors has been one of
the drivers for proposing paid organ donation. Proponents argue
that we should be able to buy organs. They argue that a market
exists for almost everything else, an organ is a commodity and if
a patient gives full consent to donate an organ why deny them
this opportunity? Furthermore it has been argued that payment
would take away some of the uncertainty about what benet the
donor would derive from the procedure. In addition the wealthy
are at an advantage, with potentially unfair access to organs. A
review of the economic and health consequences of selling
a kidney in India revealed that 96% of people sold a kidney to
pay off debt, 74% of these people still had debt 6 years later and
86% of those selling a kidney reported a deterioration of their
health status.
10
Organs for sale is clearly at odds with the
principles of justice and non-malecence. However, does this
mean we place less value on the autonomy of the disadvantaged?
A truly equal society does not exist, why should this apply to
organ transplantation? In the UK living donation can be altruistic
or directed to a known recipient. No nancial or other incentive
can be offered or given for transplantation of any organ. While
patients cannot be paid for organ donation in the UK, the Human
Tissue Act does not prohibit the payment of reasonable costs.
No specic limit is placed on this and a reimbursement thought
unreasonably large could risk prosecution. There is potential for
real problems requiring careful thought on a case-by-case basis.
Issues in organ procurement: optimizing organ condition
In the context of patients diagnosed with brainstem death is it
appropriate to take all necessary steps to optimize organ quality?
Benecence in this context would suggest that the maximum
benet should be obtained from the transplanted organs. The
Human Tissue Act states that for the purpose of preserving the
organ to be transplanted authorization only for the minimumsteps
necessary and the least invasive procedure is given. Howdoes this
t inwithorganpreconditioning? Organpreconditioning strategies
aim to improve outcome by utilizing physical or pharmacological
methods to induce intrinsic protective mechanisms within organ
tissues. Techniques that may be benecial include elevation of
body temperature, ischemic preconditioning and medications that
induce cellular protective mechanisms (e.g. heat shock protein
inhibitors). These techniques may go beyond the minimum steps
necessary to obtain the organ for transplantation. If it is agreed
that a brainstem dead or non-heart-beating donor should proceed
to transplantation is it reasonable that all steps to optimize the
organs to be donated should be taken?
A process of elective ventilation was developed in Exeter,
whereby articial ventilation is applied to a comatose patient who
is close to death for the purpose of protecting the organs prior to
donation. Ventilation in this context is not performed for the
benet of the patient and these patients had not been diagnosed
brainstem dead. Elective ventilation increased the number of
kidney donors for the 19 months following the implementation of
elective ventilation by 80%.
11
However the practice was aban-
doned on legal grounds soon after its introduction. In common law
medical treatment should be in the patients best interest, this is
not the intention with elective ventilation. Admission criteria to
intensive care unit (ICU) beds vary considerably around the world.
In countries where there is a higher ICU bed provision per capita
patients may be admitted for ventilation who might have been
considered too poor a prognosis in the UK. Some of these coun-
tries, such as Spain, are known to have higher donation rates.
Could this constitute elective ventilation?
Issues in organ allocation
There is general presumption in the UK that the state has
a responsibility for the distribution of organs, although currently
there is nospecic legal standpoint. Organdonationinthe altruistic
sense must be unconditional. To specify recipient characteristics in
terms of ethnic background, religion or political beliefs amounts to
discrimination. However should a valuable organ be wasted if
a donor only wishes to donate to a patient of the same religious or
ethnic persuasion? From a utilitarian standpoint the greater good
maybe accepting the organ, but this clearlydoes not t witha sense
of justice under deontological analysis. In the UK the principle of
distributive justice applies, underpinning the system of organ
allocation. In this setting deontological ideals hold precedence over
utilitarian concerns. In acknowledging this, the solution to other
situations may be more easily considered. For example, the ques-
tion should then not be who is the more worthy recipient, rather
how can we prioritize patients on the basis of equality and justice?
There is a general societal consensus that a transparent system
balancing welfare maximization with equity is acceptable.
In the UK we allow individuals to stipulate which organ they
would like to donate and which not, but this is the extent of their
permitted involvement about the donationprocess. Instances have
occurred in the past where the family of a potential donor have
requested that donation go ahead subject to certain conditions. For
example a man becomes a potential donor and his family state that
they will only permit organ donation to go ahead if a kidney is
donated to the deceased mans nephew. This situation is termed
conditional donation, that is the organ donation can only proceed
if the condition is met. As a general principle requests for condi-
tional donation have been declined in the UK even at the cost of
losing the donor and other organs. The reason for this is concern
that allowing conditional donation might incur racial or religious
consequences which would conict with the principles of equity
and justice. Suppose the family had stated that they would agree to
organ donation, but would like if possible that a kidney should be
donated to the deceased mans nephew. This is termed directed
donation because the donation can go ahead irrespective of
whether the familys request is met. Ethically this is a difcult
situation because in the case of a living donor the donation is
always directed so why should this not be the case in a deceased
donor? Finally imagine if the deceasedmanhadbeenbeing worked
up as a potential living donor for his nephew at the time of death.
The familys desire to have a kidney donated to the nephewwould
seem to be entirely justied in this context.
What should the recipient be told about the donor? Recent
high-prole cases associated with poor outcomes from trans-
planting marginal organs has raised the issue about what rights
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the donor should have to know and consider whether to accept
an organ for transplant. In this situation the urgency of the
process of transplantation can come into conict with the right of
choice of the recipient. Consider the patient who is on a waiting
list for a liver transplant. The various different types of donor, for
example donation after cardiac death (DCD), donation after brain
death (DBD), split liver, can be discussed with the patient and
their attendant risk and broad agreement reached over what
categories of donor liver could be used for that recipient. But
what about at the time of transplant? Should the recipient have
full information on the circumstances and attendant risks asso-
ciated with the donor, their lifestyle and the potential impact on
the quality of the liver? Alternatively should they accept the view
of the transplant team over the suitability of the organ for them?
Giving the recipient choice runs the risk of them declining
transplant and potentially compromising the use of the organ for
another individual because of prolonging cold ischaemic time.
Making the transplant entirely reliant on the medical team runs
the risk that if the procedure is unsuccessful that the recipient
might have redress to the transplant team over the choice of
organ. Transparency is key in patient management, particularly
where the consequences may be grave, but achieving a balance
between this and the need for expediency is difcult.
The practice of organ transplantation presents many chal-
lenges. None less than the ethical dilemmas experienced both as
a society and on an individual level. By rational application of the
key ethical principles of moral responsibility a path can be
navigated through these complex issues. A
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