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“A Gift for Life. Considerations on
Organ Donation”
Alessandro Nanni Costa
INTRODUCTION
he Pontifical Academy for Life, the Italian National
Transplant Centre and the World Federation of Catholic
Medical Associations organized an international Congress on
organ donation entitled: “A Gift for life. Considerations on
organ donation”, in Rome, November 6 to 8 2008, at the
Auditorium della Conciliazione, near the Vatican City.
The event had two purposes; on one side, it aimed at
deepening the most crucial aspects of organ donation all
around the world; on the other side, it was a unique, unprecedented occurrence to present the official position of the
Church on this delicate topic. The Congress focused on the
issue of organ donation presented by scientists, researchers
and ethicists as well as Catholic Associations from all over the
world. During the Congress, scientific, legal, ethical and organizational aspects of transplants and donation activity
around the world was widely discussed.
The first day of the Congress introduced the current
transplant system on an international basis focusing specially
on the historical evolution of both transplant sciences and
organ donation. The crucial and alarming aspect of organ
shortage, traffic and organ tourism was also deeply debated.
The second day of the Congress was dedicated to ethical and
anthropological aspects of organ donation and to all the
issues related to the organ-donation-living will, organ allocation criteria and ethics of the transplant organization.
Of particular interest were the training paths and pastoral
initiatives promoting organ donation culture.
During the second day of the event, Congress participants were received by the Holy Father Benedict XVI who
presented the Church’s position in favor of organ donation
and transplants, defining donation as an admirable act, not
just morally licit, because it expresses a genuine testimony
of charity. The Holy Father, moreover, underlined the
need to respect all conditions that make organ donation
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The author declares no conflict of interest.
Transplantation • Volume 88, Number 7S, October 15, 2009
and transplantation legal and to fight any kind of coercion
or organ commercialization. Lastly, the Holy Father urged
researchers and scientists to increase research to dispel
people’s “prejudices and misunderstanding” and disperse
their “mistrust and fear”, replacing them with certainty
and guarantee.
The final session of the Congress, dedicated to the role
of mass media in promoting organ donation culture and in
influencing people’s perception of it, outlined the need to
build an alliance between the world of transplants and media
to promote an ethical communication oriented to increasing
the actual knowledge of this field among people through correct information and keeping them at a safe distance from a
superficial and sensationalistic use of news.
More than 500 people registered at the Congress were
health and pastoral professionals, donors’ and patients’ associations, Directors of national transplant systems, journalists
and patients. All Italian and various international media attended the meeting with the Holy Father Benedict XVI and
published news from the Congress as well as the reflections
the Holy Father expressed on the subject.
Eight years after the international Congress on transplants
in 2000, the Congress “A Gift for Life. Considerations on Organ
Donation” represented an important occasion to build up a
global awareness on organ donation and transplant. The success
of the Congress in terms of people registered and media coverage
was mainly due to the precious words of the Holy Father and the
organizing contribution of the Pontifical Academy for Life and
the World Federation of Catholic Medical Associations in generating ethical and cultural considerations on organ donation.
The Congress was sponsored by the National Transplant Centre, FITOT, the Non Profit Foundation for the Advancement of Organ and Tissue Transplantation, created by
the Veneto Regional Government, and Novartis Pharmaceutics. Transplants have been an integral part of the history of
Novartis for 25 years and the group has made a major contribution towards progress in this area, to which it continues to
dedicate its commitment to innovation.
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A Message from the Holy Father Pope Benedict XVI
ear Brothers in the Episcopate, distinguished Ladies and
Gentlemen.
Organ donation is a peculiar form of witness to charity.
In a period like ours, often marked by various forms of selfishness, it is ever more urgent to understand how the logic of
free giving is vital to a correct conception of life.
Indeed, a responsibility of love and charity exists that
commits one to make of their own life a gift to others, if one
truly wishes to fulfil oneself. As the Lord Jesus has taught us,
only whoever gives his own life can save it (cf. Lk 9:24).
In greeting all those present, with particular thought for
Senator Maurizio Sacconi, Minister of Labour, Health and
Social Policies, I thank Archbishop Rino Fisichella, President
of the Pontifical Academy for Life, for the words he has
addressed to me illustrating the profound meaning of this
meeting and presenting the synthesis of the Congress’ works.
Together with him I also thank the President of the
International Federation of Catholic Medical Associations
and the Director of the Centro Nazionale Trapianti, underlining my appreciation of the value of the collaboration of these
Organizations in an area like that of organ transplants which,
distinguished Ladies and Gentlemen, has been the object of
your days of study and debate.
Medical history clearly shows the great progress that it
has been possible to accomplish to ensure to each person who
suffers an ever more worthy life.
Tissue and organ transplants represent a great victory
for medical science and are certainly a sign of hope for many
patients who are experiencing grace and sometimes extreme
clinical situations.
If we broaden our gaze to the entire world it is easy to
identify the many and complex cases in which, thanks to the
technique of the transplantation of organs, many people have
survived very critical phases and have been restored to the joy
of life.
This could never have happened if the committed
doctors and qualified researchers had not been able to
count on the generosity and altruism of those who have
donated their organs. The problem of the availability of
vital organs to transplant, unfortunately, is not theoretic,
but dramatically practical; it is shown by the long waiting
lists of many sick people whose sole possibility for survival
is linked to the meagre offers that do not correspond to the
objective need.
It is helpful, above all in today’s context, to return to
reflect on this scientific breakthrough, to prevent the multiple
requests for transplants from subverting the ethical principles
that are at its base. As I said in my first Encyclical, the body can
never be considered a mere object (cf. Deus Caritas Est, n. 5);
otherwise the logic of the market would gain the upper hand.
The body of each person, together with the spirit that
has been given to each one singly constitutes an inseparable
unity in which the image of God himself is imprinted. Prescinding from this dimension leads to a perspective incapable
of grasping the totality of the mystery present in each one.
Therefore, it is necessary to put respect for the dignity
of the person and the protection of his/her personal identity
in the first place.
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With regards to the practice of organ transplants, it
means that someone can give only if he/she is not placing
his/her own health and identity in serious danger, and only
for a morally valid and proportional reason.
The possibility of organ sales, as well as the adoption of
discriminatory and utilitarian criteria, would greatly clash
with the underlying meaning of the gift that would place it out
of consideration, qualifying it as a morally illicit act.
Transplant abuse and their trafficking, which often involves innocent people, like babies, must find the scientific
and medical community ready to unite in rejecting such unacceptable practices.
Therefore they are to be decisively condemned as
abominable. The same ethical principle is to be repeated
when one wishes to touch upon creation and destroy the human embryo destined for a therapeutic purpose. The simple
idea of considering the embryo as “therapeutic material” contradicts the cultural, civil and ethical foundations upon which
the dignity of the person rests.
It often happens that organ transplantation techniques
take place with a totally free act on the part of the parents of
patients in which death has been certified. In these cases,
informed consent is the condition, the subject to freedom, for
the transplant to have the characteristic of a gift and is not to
be interpreted as an act of coersion or exploitation.
It is helpful to remember, however, that the individual
vital organs cannot be extracted except ex cadavere, which,
moreover, possesses its own dignity that must be respected.
In these years science has accomplished further
progress in certifying the death of the patient. It is good,
therefore, that the results attained receive the consent of the
entire scientific community in order to further research solutions that give certainty to all.
In an area such as this, in fact, there cannot be the
slightest suspicion of arbitration, and where certainty has not
been attained the principle of precaution must prevail. This is
why it is useful to promote research and interdisciplinary reflection to place public opinion before the most transparent
truth on the anthropological, social, ethical and juridical implications of the practice of transplantation.
However, in these cases the principal criteria of respect
for the life of the donor must always prevail so that the extraction of organs be performed only in the case of his/her true
death (cf. Compendium of the Catechism of the Catholic
Church, n. 476).
The act of love which is expressed with the gift of one’s
vital organs remains a genuine testimony of charity that is able to
look beyond death so that life always wins. The recipient of this
gesture must be well aware of its value. He/she is the receiver of a
gift that goes far beyond the therapeutic benefit.
In fact, what he/she received, before being an organ, is a
witness of love that must raise an equally generous response,
so as to increase the culture of gift and gratuity.
The right road to follow, until science is able to discover
other new forms and more advanced therapies, must be the
formation and the spreading of a culture of solidarity that is
open to all and does not exclude anyone.
A medical transplantation corresponds to an ethic of
donation that demands on the part of the commitment to
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invest every possible effort in formation and information and
to make the conscience ever more sensitive to a issue that
directly touches the lives of many people.
Therefore, it will be necessary to reject prejudices and
misunderstandings, widespread indifference and fear, and to
substitute them with certainty and guarantees in order to per-
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mit an ever more heightened and diffused awareness of the
great gift of life in everyone.
With these sentiments, while I wish each one to continue in his/her own commitment with the due competence
and professionality, I invoke the help of God on the Congress’
works and impart to all my warm Blessing.
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Congress Photographs
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A Colloquium on the Congress “A Gift for Life.
Considerations on Organ Donation”
Alessandro Nanni Costa, J. M. Simón i Castellvì, Antonio G. Spagnolo, Nunziata Comoretto, Jean Laffitte,
Håkan Gäbel, Francis L. Delmonico, Ferdinand Muehlbacher, Walter Schaupp, Alexandra K. Glazier,
Valter D. Garcia, Mario Abbud-Filho, Jose O. Medina-Pestana, Mariangela Gritta Grainer,
Pier Paolo Donadio, Anna Guermani, Riccardo Bosco, Francesco Giordano,
Blanca Martinez Lopez de Arroyabe, Marco Brunetti, Martí Manyalich, Gloria Páez, Ricardo Valero,
Rafael Matesanz, Elisabeth Coll, Beatriz Dominguez-Gil, Beatriz Mahillo, Eduardo Martin Escobar,
Gregorio Garrido, and Felix Cantarovich
Ethical Principles of Organ Donation
MAIMONIDES
BIOETHICAL CONSIDERATIONS
J. M. Simón i Castellvì
Antonio G. Spagnolo and Nunziata Comoretto
nce upon a time, a man insulted a physician called Maimonides, and his Jewish religion, within the hearing of
the king. The king ordered him to take out the heart of that
bad man, but the doctor looked after that poor bad man, gave
him food, cured him and even paid for his medicines. His
heart though changed.
O
After some time, once again the king and the doctor met
that man.
Isn’t this he who insulted you and your religion?
Yes, My Lord.
Why didn’t you obey my order?
I did obey you, My Lord! I have changed his wooden heart
and I have given a human and peaceful heart!
So, it is possible to operate without a knife, the king said!
Rabbi Moshe Ben Maimon, also known as the RAMBAM,
was born in the Spanish city of Córdoba in 1135. He was a rabbi,
a physician and a philosopher.
The medieval Arabic poet Al Said Ibu Sural al Mulk
wrote about him: “Galen’s art healed only the body, but Abu
Imram’s (Maimonides) the body and the soul”.
Maimonides said that it is impossible for the truths arrived at by human intellect to contradict those revealed by
God. Saint Thomas Aquinas held him in high esteem. A beautiful daily prayer of a physician is attributed to him.
. . . Thou hast created the human body with infinite wisdom. Ten
thousand times ten thousand organs hast Thou combined in it
that act unceasingly and harmoniously to preserve in the envelope of the immortal soul. They are ever acting in perfect order,
agreement and accord. Yet, when the frailty of matter of the unbridling of passions deranges this order or interrupts this accord,
then forces clash and the body crumbles into the primal dust from
which it came.
. . . Almighty God! Thou hast chosen me in Thy mercy to watch
over the life and death of Thy creatures. I now apply myself to my
profession. Support me in this great task, so that it may benefit
mankind!
. . . Today, we can discover our errors of yesterday and tomorrow we
can obtain a new light on what we think ourselves sure of today.
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n the past half-century, solid organ transplantation has become standard treatment for a variety of diseases, potentially
restoring patients with terminal illness to normal life (1).
The technique of successful transplant operations has
given rise, for both individual and society, to several ethical
questions. Some of them are common to those arising from
the ethical implications of all developing techniques, such as
the weighing of risks involved in early experimentation, the
likelihood and degree of success in particular cases, the need
for informed and free consent on the part of those involved
and the justification of investment in terms of resources and
personnel. However, there are some ethical questions peculiar to the concept of transplantation, that is, those related to
the transference of organs from an individual to another (2).
One of the first moral quandaries in transplantation, in fact,
concerns whether it is right to remove a healthy organ from a
healthy person (in violation of the Hippocratic aphorism “do
not harm”), even if the aim is to save the life of another person. Another is whether or not individuals have the moral
authority to mutilate their bodies (3).
Currently, the major ethical problems in organ transplantation come out of the shortage of organs, as presently thousands
of people are on waiting lists for transplants and their lives are
dependent on the recruitment of organs (4). Moreover, the
number of people needing transplants is expected to grow in the
next decades, especially due to the aging of the baby boomer
population and the increase of kidney disease due to hypertension and diabetes (5).
The organ shortage has motivated a host of efforts to increase organ supply, some of which are controversial, such as the
acceptance of expanded criteria for increasing cadaveric donors
pool (for instance, older and sicker donors), donation after cardiac death (so-called nonheart-beating donation) and the increasing number of living organ donors (outside of the living
related donation) (6).
The purpose of this essay was to explore some of the
ethical issues involved in transplantation and particularly
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The authors declare no conflict of interest.
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those connected to recent proposals, which seek to address
the scarcity of organs, but at the same time might threaten the
applicability of the notion of donation in the context of organ
transplantation (2).
Bioethics and Self-Giving in Organ Donation
The situation of organ donation, both by living and
dead donors, is an expression of self-giving to another person,
the recipient, characterizing every voluntary transplantation
primarily as an interpersonal action (2). To be more precise,
the present voluntary procedure of organ donation is based
on a call to altruism. The act of organ donation could be seen
as giving a gift; the reason is that the giver wants to benefit the
recipient, acting freely and nothing being expected in return
for the donation (7). The practice of organ donation shares
also many elements with the ordinary understanding of charity (that is helping or giving to those in need of something);
organ donation indeed has been described as a gift for life.
According to the Charter for Health Care Workers
(point 85), transplants “are legitimized by the principle of
solidarity, which joins human beings, and by charity, which
prompts one to give to suffering brothers and sisters. We are
challenged to love our neighbor in new ways; in evangelical
terms, to love event unto the end (Jn 13:1)” (8).
In the perspective of self-giving, the donation of an organ (an inessential organ for the living donor) to someone
who is needy is widely recognized as legitimate and laudable
(2), a “service to life”, a “particularly praiseworthy example”
of gesture of human sharing, “which build up an authentic
culture of life” (9).
Moreover, in this perspective, the donation after death
cannot also be regarded as a moral duty, but exclusively depending on the generosity of donors who are undertaken with
the reason of a genuine willingness to help someone who has
a particular need and might not be known by the person
performing the charitable act. This situation does not exclude
that some people perceive organ donation as a moral “duty”,
in the same meaning that many people perceive that they have
a moral duty to perform acts of charity (7).
On the contrary, stressing the current “shortage” of organs for transplantation could give rise to the impression that
individuals who are unwilling to make organs available in
some vague way are morally responsible for what is perceived
as a “social problem”.
The central question in transplantation, indeed, is
whether or not a human being can be helpful to another one.
Therefore, it would be regrettable if society, to solve distressing
statistics, would decide to destroy the interpersonal character of
transplantation and the aspect of human and voluntary service
of another, which is intrinsic to it (2).
On this ground, the refusal of organ donation should be
necessarily respected. In the same way, it is believed that the
family’s wishes about organ removal from the dead relative
should be respected—without overriding the wishes of the
dead person—as the relatives generally may be the best interpreters of the deceased’s wishes.
Based on the concept of self-giving, all organ donations
may be permitted only when they represent an altruistic act,
meaning that nonfinancial incentives are associated to living
or after death organ donation (10).
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Bioethical Principles in Organ Transplantation
The ethics of transplantation are based on the tension
between bodily integrity and human solidarity. On one side,
bodily integrity should be protected because of its uniqueness, a means by which we live. On the other side, we are also
social beings, interdependent for life in human society (10).
Several widely accepted bioethical principles are relevant to practices in transplantation. They include nonmaleficence (avoiding harm), beneficence (producing benefit),
autonomy (respecting personal choices) and justice (distributing benefits and burdens equitably) (11). These principles
require the satisfactions of basic conditions for an organ donation to be ethical.
The Beneficence/Nonmaleficence Principle
This principle of medical ethics requires a benefit/burden
ratio in the perspective of both the donor and the recipient.
Serving as an organ donor is not in the donor’s best
medical interest as there is not a therapeutic benefit for him.
On the contrary, there are some significant medical risks for
the living donor, such as the risks of surgery and anesthesia,
postoperative bleeding and infections, and pain. Sometimes
an additional risk is the temporary, or even permanent, restrictions in social activities because of the donation (5).
However, it is well accepted that there are psychologic
and emotional benefits (an increased self-esteem) that donors may experience both as living donors and in donation
that will be effective after death. Potential psychologic and
emotional benefit cannot be extended to those persons with
cognitive disabilities: usually this is prohibited by the law and
regarded as unethical, because the individual does not understand implications of the operation.
Another given reason of benefits to the donor in the
case of relative living donor is the fact that the donor will
receive more intrafamilial companionship after transplantation has been executed (5).
However, there are also data on psychologic risks of
serving as a living donor, such as lower self-esteem, a sense of
neglect and a lack of expected appreciation after the donation
as the attention refocuses on the recipient. Although the vast
majority of donors do not regret their decision, cases of donor
suicides have been reported.
The real direct benefit to the donor is the “moral” benefit; psychologic and emotional benefits may be indirect, as a
further positive consequence of a primarily moral benefit.
The moral benefit of donation consists of the awareness of a
moral good action, regardless of the transplant results or gratitude manifested by the recipient or by the relatives. In the
case of a dead donor, such kind of moral benefit of a good
action is the only benefit the potential dead donor may experience with regard to donation.
The major factor to be considered in nonmaleficence of
organ transplantation after death regards the criteria to pronounce the donor death. A debated ethical dilemma is
whether it is justifiable to incur the risk of shortening the life
of a person in the attempt to improve the life of another one.
According to the “dead donor rule”, the subject must be recognized dead before removal of organs (2). The Charter for
Health Care Workers states (point 74): “There must be certainty, however, that it is a corpse, to ensure that the removal
of organs does not cause or even hasten death” (8). This
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means that “the removal of organs requires that steps to ensure
that the subject is actually dead must be duly verified” (9).
Until comparatively recent times, it was generally
accepted that the cessation of spontaneous breathing and
spontaneous heart beat, during a well-defined period of
time, indicated the end of an individual. Progress in medicine has made it possible to reverse this cessation and also
determine the cessation of all cerebral functions as a significant factor in identifying the onset of death. According
to the concept of brain death, a person is dead when it has
been established that he or she has suffered an irreversible
cessation of all brain functions and is incapable of spontaneous respiration (11). At the point when the whole brain
death occurs the individual ceases to live, as since that
moment there is no integrated functioning of the body as a
whole (13).
Initially, intensive care units faced the necessity to diagnose brain death to determine when to stop mechanical
ventilation, as ventilation of a corpse has no real reason (14).
The newly accepted criteria of brain death also consents to the
timely removal of transplant organs. As we know, the transplanting time is a crucial factor. Damage from ischemia can
irreversibly decrease the quality of organs and it would be
unethical to transplant such organs.
Living organ donation is most distinguishable from cadaveric donation in that it involves a healthy living person
who consents to have a kidney, liver lobe or lung lobe removal. Notwithstanding his or her consent, the removal of an
organ from an otherwise healthy patient, for no therapeutic
benefit to the patient, constitutes a prima facie harm. It is still
unclear whether removal of organs from living donors results
in a decrease in life expectancy and in the increase of required
medical care. However, it is certain that procurement of organs from living donors results in unneeded surgery, debility
and risk of death.
Indeed, after the success of cadavers as organ donors,
the concern that using the living as donors is unethical has
risen. Therefore, living-related donation is the only type of
living donation that has traditionally been accepted by the
transplant community and society. This is because the familial relationship allows us to make sense of what is otherwise
an unusual choice; having a healthy organ removed. Livingrelated donation is allowed on the grounds that it can also be
beneficial for the donor because of an existing, close relationship with the recipient. Over time, the paradigm of related
donation has been extended, on the same grounds, to living
unrelated donation within a relational context, such as close
friendship (6).
The main benefit to the recipient is a healthy living
graft. Risks to the recipient include medical risks of the
transplantation procedure and adverse effects of immunosuppression, which include increased risk of infection and
malignancies. The requirement for chronic antirejection
therapy, the presence of chronic or relapsing viral infections and environmental exposures to many opportunistic
pathogens have created a state of increased vulnerability in
transplanted patients (15).
In the case of living donation, the recipient could experience psychologic and emotional feeling of being indebted;
in addition, there is the potential risk of guilt if the donor
experiences a significant morbidity or dies (5).
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With regards to the safety of transplantation for the
recipient, we are challenged today with the problem of socalled marginal donors. Elderly donors, pediatric donors,
diabetic donors, donors with hepatitis B or hepatitis C virus,
hypertension and elevated creatinine, donors with long cold
ischemia time and nonheart-beating donors are usually considered as marginal donors, that is, their organs are not considered
optimal due to age or concomitant diseases (16). However, the
chronic shortage of donors has resulted in attempts to use these
donors, particularly for critically ill organ recipients, who would
not survive without an immediate transplant. At present, there is
a lack of uniform criteria concerning which organs ought to be
discarded. The results of several studies (17, 18) demonstrate a
survival disadvantage among transplant recipients who received
a marginal organ, providing support for the position that transplanting organs from marginal donors should be avoided.
The Autonomy Principle
According to the ethical principle of autonomy, living
donors have the right to get all the relevant information concerning the outcome, for both the recipient and himself. In
the same way, all citizens should receive all the information
about procedures involved in transplantation to give an informed and free consent “to offer during life a part of their
body, an offer which will become effective only after death”
(19). Before they are allowed to give the consent to organ
donation and transplantation, both donors and recipients
should be educated about these procedures and counseled at
various steps, as well as being informed that it is permissible
to withdraw consent at any time before the procedure (5).
The Charter for Health Care Workers states (point 90):
“In life or in death the persons from whom the removal is
made should be aware that they are donors—that is, those
who freely consent to the removal”. In this way, organ donation after death offers to the donors the possibility of “projecting beyond death their vocation to love [. . .] a great act of
love, that love which gives life to others” (8).
Organ donation by a living donor is regarded as a human and generous, even supererogatory, act to save a human
being whose life is threatened by disease or whose quality of
life is severely impaired. The consent to a potentially hazardous course of action, however, requires to take in account
how donation will influence his own future and that of others,
such as relatives, who may depend on him. Considering the
moral obligation for a living donor to weigh and the foreseeable results of his action for all concerned, it might be argued
that consent to such donation should be a shared decision of
the donor and those closely related to him (2).
One of the major objections to living organ donation is
that there is the potential for the prospective donor to be
induced or coerced in some way. In such cases, the donation
would not be sufficiently voluntary to be called a gift. Conversely, the prospective donor could demand something from
the recipient before donating the organ to him or her (7).
As the efforts to use altruism for organ donation have
met limited success, several recent approaches have been
adopted to prompt self-interest in organ donation by financial incentives. Financial incentives are payments, and the
living donors (or the family of a deceased donor) become vendors of parts of the human body. Buying and selling human
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organs would lead to an increasing objectification of the human
body, compromising the respect for the human dignity (20 –22).
Therefore, allowing forms of financial incentives to organ
sources should not be considered an ethical attitude.
In the same way, in the case of deceased organ donors,
extensive adoption of presumed consent procedures or legislations to provide a solution to the problem of supply and
demand are irrespective of the real willing of the person in life
and, therefore, they are ethically inadequate solutions to help
some unfortunate members of society (2).
Perhaps, altruism alone will not be enough to satisfy the
needs of the thousands of patients who are on organ transplant waiting lists, but not all means (i.e., marketing of bodily
parts) are ethically acceptable to a certain end (i.e., supply of
organs) (10).
Especially in living donation, great attention towards
psychologic and emotional pressure must be paid. For example, the decision to donate prompted by the emotional wellbeing that the donor may experience from receiving many
warm appreciations by relatives could be regretted after the
donation if the attention refocuses on the recipient. Organ
donation must primarily be based on a moral decision rather
than on a psychologic enthusiasm.
The Justice Principle
The justice principle requires that equity and fairness in
the organ allocation system must be guaranteed. The growth in
living organ donation, welcomed by many as an answer to the
shortage of cadaveric organs donated for transplantation, gives
rise to a number of serious ethical challenges regarding just and
fair allocation of organs. In the United States, for instance, the
current growth has been driven by several factors, including direct appeal by waiting list patients through media or pay-commercial websites that allow patients to advertise their need in the
hope that a sympathetic person will make a directed donation of
the required organ. This kind of non-related directed donation,
also called “altruistic living donation”, opens doors to the market of organs. In fact, in the case of living directed acquaintance
donation, there is the realistic fear of financial compensation.
Especially, commercial efforts fostered by websites enable the
recipient to find his or her own donor through high financial
incentive, effectively buying an organ. Moreover, this type of
donation also gives rise to the social justice concern of recipients
unfairly jumping the waiting list through direct solicitation. Furthermore, advertising through news or media outlets or through
commercial websites, even if there is no clandestine financial
incentive, enables donors to select recipients in a biased fashion,
based on race, ethnicity or social status (6).
However, we should remember that the present expanding gap between the numbers of patients needing organs
for transplantation and the number of organs available is not
due to a shortage of potential donors. By far, the most common reason for non-donation is denial of consent by the donor’s family, which may be due to stresses surrounding death,
misperceptions about the results of transplantation, mistrust
of the medical community in general, doubts that the allocation system is equitable and the lack of understanding of
brain death, leading to suspicion that the brain dead patient is
not really dead (13). As death is still a taboo in western societies, people usually do not stop and consider the issue of
organ donation, unless they lose a close relative and in a short
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time and stressful context they are asked to make a choice
about organ removal from the deceased’s body, to which they
have often come to totally unprepared, as they have not
thought through the issue sufficiently. People may refuse to
donate their organs or their relatives’ organs because of incorrect belief about brain death (for example, that the person
is not “wholly” dead) or transplantation procedures (e. g.,
fairness of organs allocation); they do not know enough to
feel to consent to it.
Educational campaigns to increase organ donation and
transplantation should consider correction of people’s false
belief and promotion of public information and clear discussion about what is involved in organ donation and transplantation. Moreover, educational programs should include
education for social solidarity and education on the more
troublesome-specific aspects of organ donation and transplantation. Gift-giving concept, that is giving organs as a gift,
implies voluntarism and altruism in organ donation. This
feature of organ donation should always be present in current
organ donation awareness campaigns and during counseling
sessions with relatives of potential organ donors.
Educational efforts also primarily include schools and
universities as the best target to form a renewed personal and
social conscience on the importance of organ donation for
transplantation and to state the background for a clear and
responsible personal choice.
Education on organ donation should focus on the high
moral value of helping another human being through donation, and not merely on the emotional participation to the
suffering of an individual. As we know, moral ideals and convictions are more steady and durable than the emotional or
psychologic feelings, which could easily change to their opposite, simply due to the changing of emotional circumstances in the situation.
In our opinion, education is the only ethically feasible
way to guarantee the respect for responsible choices of each
person in the society and, at the same time, to effectively
promote the recruitment of organs. The law is a means
(although not the only one) to increase the supply of organs;
it sets the context, not only legally but also socially and ethically in which transplantation is performed and regarded.
The law works well only when doctors incorporate, through
education, the ethical and social view expressed by the law
into their consciousness and practice. As the attitude of the
medical profession towards organ transplantation could be a
factor in inhibiting the supply of organs, this would not be
significantly increased by simply changing the law to an opting out principle (4).
Conclusions
Organ donation is a noble act of human solidarity,
therefore, the medical community and society should support this highly valued gift. However, donation remains a
personal decision made by the donor being well informed and
after expressing the consent. In the respect of the human dignity of the donor, this act should preserve the life of the donor
or integrity of the organ system. Although this donation
should be encouraged, the sale of organs should be regarded
as a reductive, materialist and instrumental use of the person
and, therefore, always forbidden.
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In our opinion, voluntary gift-giving organ donation is
the only morally permissible procurement procedure, as it is
the only procedure preserving the respect of the donor. Organ
donation should be accepted only when performed voluntarily (i.e., organ procurement procedures do not assume that
someone should feel obliged to donate his or her organs) and
when motivated by altruism. An analogy between organ donation and acts of charity may be a better way of promoting
organ donation.
The society should maximize the availability of organs
for transplantation, eliciting informed and free choice on organ donation. Financial incentives are a form of coercive organ acquisition because they attempt to encourage or force
people to do something that they would not otherwise be
inclined to do.
In the past, some authors (1) identified apathy of the
medical profession as the main cause of the lack of organ
donors. As organ donation and transplantation usually
struggles to cope with difficult ethical questions, we suggest a role for bioethicists on organ transplantation services. Bioethicists can educate staff on the application of
ethics to clinical practice of organ donation and transplantation, thus increasing ethical awareness among the medical
profession (23). Donation as a responsible choice should be
based on information, education and accurate consideration
of the reasons for making a personal decision.
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SELF-GIVING AND ORGAN DONATION: AN
ANTHROPOLOGICAL PERSPECTIVE
Jean Laffitte
he University of Osaka in Japan recently unveiled a robot
with human features that are incredible. This robot,
which is female in appearance, carries out elementary movements, such as moving its lips, its eyelids, its arms and its
torso. It has a silicon skin, which conceals a series of sensors
that ensure the movement of the various parts of its body.
With its promising prospects, robotics is attracting increasing
interest on the part of writers and directors who often offer
visions of worlds populated by these beings, which are similar
to humans and are only distinguished, with difficulty, from
men in flesh and blood. The famous film by Ridley Scott,
Blade Runner, comes to mind. In the final part of this film, it
appears that the protagonist, a replicant, is capable of feelings
and sensations that are typically human (regret, sadness, pity,
etc.). One could at this point easily imagine, to come to the
subject of this article, a replicant who, needing a spare part to
replace a part of his own damaged body, receives one from
another replicant, thereby creating a kind of organ donation
between machines. But even if this were possible, this approach would anyway be completely different from what
takes place between humans through the experience of organ
donation. I am referring above all to the symbolic and anthropological value that this kind of experience, which brings into
play solidarity, altruism, suffering, a sense of one’s own death
and that of other people, has for man.
Although it takes place in practical terms within the
sphere of medicine, the donation and acquisition of an organ
is not only a medical act. It constitutes an experience that goes
beyond the mere clinical and technical fact and incorporates
symbols and values of an anthropological, ethical, social and
also theological order.
To be understood in its complexity, organ donation,
which is present in nearly all contemporary cultures, therefore requires, greater examination at the level of the anthropological structure of what a gift is.
Naturally, the anthropological approach determines
the conception that one has of a gift, as a result of which
different anthropological approaches determine different
conceptions of the idea of a gift. Some anthropological visions
are not compatible with each other because they lead to contrasting practical conclusions.
In the first part of my article, I will try to illustrate
briefly certain specific anthropological models to see what
meaning they attribute to a gift. Then, after expounding and
T
The author declares no conflict of interest.
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clarifying the perspective of this article, I will explore the
meaning that a gift acquires according to this point of view.
This will lead us to examine a particular form of a gift, namely
“self-giving”. I will then go on to examine the modality and
the conditions that are required, so that one can see the donation of an organ as a true and authentic “gift”. At this point,
it will be necessary to distinguish, at an anthropological level,
between the donation of an organ from a living person and
the donation of an organ from a cadaver.
At the level of donation from a living person, many anthropological meanings are involved: the perception of one’s
own body, physical deformation, the wish to be truly useful and
so forth. But when one is dealing with donations ex cadavere,
other high symbolic meanings can come into play: the idea of
one’s own death, the mourning of family relatives and the expression of a last will, to give only a few examples.
At these fundamental levels, one immediately realizes that
the categories of analysis are not first of all those of science, technology, or, in part, of the art of medicine. From a scientific point
of view, indeed, the removal of an organ always has the same
value. It is for this reason that it was believed useful, during the
planning stage of this congress, to propose an anthropological
approach to the subject of organ donation as well.
Materials and Methods
Self-Giving and Its Anthropological
Characteristics
The Anthropological Models of Reference
In the vast contemporary cultural scene, it is possible to
identify some of the major currents of thought that offer different solutions to bioethical problems in general and, on the
basis of which, different interpretations are given of organ
transplants. Based on the classification drawn up by Anthony
Fisher1 of the great dominant moral systems of contemporary culture, we may distinguish four principal anthropologies. Each one generates different positions with regards
to organ donations: individualism (which is linked to various
forms of ethical subjectivism and relativism), utilitarianismconsequentialism, communitarianism and deontologism of a
Kantian imprint.
Individualism
In an individualistic vision of the world, the characteristic element is the free choice of the individual, as long as the
rights and freedoms of other people are respected. This means
that everything that is freely chosen by an individual and
which does not injure the autonomy and the life of other
individuals should be seen as right. Thus in the legislative and
political field, the state should guarantee the highest freedom
of action for its citizens in matters that concern personal existence. One understands that in the field of organ donation,
this is translated into the need for every person to be able to
choose whether to donate his organs, to sell them or to completely reject their donation. The body is thus seen as private
property, an object that can be disposed of according to one’s
own free will. Questions that are ethically difficult are often
ignored. In the absence of anthropologically founded criteria,
in the individualistic approach, the explicit consent of the
1
Fisher A. Contrasting ethical approaches to organ transplantation and xenotransplantation. Text presented to the Post-graduate Course in Bioethics at the St. Thomas University of Manila on 4 February 1999.
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donor is fundamental—a consent that eliminates all doubts
about the real wish of the subject to donate his organs. The
tendency is for presumed consent or the consent of third
parties not to be allowed. For this reason, the system of opting-in
is privileged.
Utilitarianism-Consequentialism
According to this approach the legitimacy of an action
is ascertained by a precise assessment of consequences or by
the greatest utility, by which between two possibilities the one
which has the greatest number of positive consequences and
which reduces to the minimum the negative consequences is
chosen. Therefore, the fundamental criterion of choice, independently of the intentions of the agent subject, is a result of
the means used and the purpose of the action. This model sees
efficiency and efficacy as the criteria of the practical action.
The donation of organs thus seems a positive act in that its
consequence is a high probability of saving human lives. Opting-out is the most effective system for this purpose given that
it is what assures the greatest number of transplants. This
approach, although it involves various risks and is subject to
various criticisms, is today widespread because of the mentality that underlies it. It is widely accepted in various sectors of
learning (science, economics, etc.) and inherent in the logic of
feasibility and results.
Communitarianism
Contrary to the individualistic interpretative model,
communitarianism privileges relations between people and
identities in the community and it needs the fundamental
element for the legitimacy of choices. The common good has
precedence over private interests; the ethos of public service is
exalted. In the field of the donation of organs, although this
vision does not theorise an explicit duty on the part of the
citizen to engage in the donation of organs, it evokes a sort of
social responsibility, which has the individual participating in
the common good through the donation of organs, if this
does not involve, for the person concerned, an excessive damage. For this reason, the system of opting-in is privileged.
The Deontologism of a Kantian Imprint
Of a clear Kantian imprint, deontologism places emphasis
on the importance of moral rules and on responsibility that is
morally ascertained and of universal range. This system stresses a
sense of duty being understood as the need to adapt to objective
moral rules, which are independent of circumstances and other
elements external to the action that is performed. The objectivity
of the rule given by the Kantian maxim, “treat your neighbor
always as an end and never as a means” is formalized, by what is
known as positive law. In this approach, the system of opting-in,
in the policies for the removal of organs, respects the principle of
the nonexploitation of the donor. One can, thus, dispose of one’s
own body but with the limit imposed by the need to not cause
damage to the living donor.
An Alternative Vision
Faced with the four models which have just been listed,
a conception based on a Christian vision of the world and of
the person seeks to organize medical ethics that come from a
long Hippocratic tradition of ethics of virtue. This conception is accompanied by a rediscovery of natural law in the
classic sense of the word (and not the physicistic caricature
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that is often made of it). This is a system of thought that places
at the center of the analysis the authentic good of the person
and his full realization. The approach is not only located in
being a good person but in becoming one; in becoming a
person of virtue. Within the context of organ donation, the
question that is raised is whether this constitutes a true good
for the person? The good end of donation, without a doubt,
encounters the need to do good, but it also implies the need to
avoid evil, which presupposes, for example, a prohibition on
suppressing one life to help another or carrying out a removal
of organs or parts of the bodies of people who are not consentient. The needs of other people, in this approach, are
not dealt with through the violation of the true moral good
of the donor. The end does not justify the means. The
donation of organs, therefore, is also seen in the perspective of the full realization of the donor who, through the
decision to donate an organ, achieves a good that helps to
make him better (compassion for the infirmity of the recipient, the engagement of proportionate and ethically legitimate means).
Results
From Altruism to Giving
In the broadest and most common meaning of the
word, altruism (from alter, other) designates a form of moral
quality characterized by the interest that a person expresses
for the good of another. It seems that the term was used for
the first time in 1854 in the Positivist Catechism of the French
philosopher, Auguste Comte.
This approach marks out the human species. Over recent decades, some scientists have studied various animal
species and have been able to observe forms of social relationships that are believed to include behavior analogous to altruistic behavior. The development of such behavior, according
to the kin selection theory, is said to be an important element
in the evolution of species. However, in none of these animal
species can one observe cooperation between individuals who
are not genetically correlated (1) in the form that one can
observe in humans. Altruism can take the form of a certain
reciprocity, which has positive or negative characteristics.
The positive characteristics concern the predisposition to reward the other for cooperative behavior, whereas the negative
characteristics concern the propensity to impose sanctions
for the violation of the rules of cooperation.
However, the form of altruism that is of interest to us in
this article is that which acquires its highest moral value when
the interest in, and action for, the other are disinterested; not
conditioned by the logic of a return, in other words when they
are completely freely given. Affirmation of the possibility of
free giving is not a philosophical or religious prejudice, even
though various sociologists call into question the possibility
of a completely disinterested form of altruism. In the view of
these scholars, what is at play are different forms of gratification, such as, self-fulfilment and self-esteem, the satisfaction
of a sense of justice and social reputation.
The human altruistic approach in a positive sense takes
the name of giving and was already present in Greek philosophy with the concept of kharis. As the verb khairein (to rejoice), from which it comes, indicates, the term kharis refers
to a reason for joy and by extension a favor; a gift. Giving is the
action that benefits a recipient of a kharis produced by a sub-
Transplantation • Volume 88, Number 7S, October 15, 2009
ject and expressed by an object. Because everything that exists
comes from a supreme source, which for the Greeks was the
gods, then everything that makes the heart of men rejoice was
a divine gift. In the poet Homer, in the playwrights (Sophocles in particular) and in Socrates, we have this idea of a
supreme and original gift, a divine favor made over to humans and an expression of divine filia. The gift, in as much as
it characterizes the lives of all the members of the polis, establishes the constitutive ties of the koinonia; it is to do with the
common good and in this sense it is not extraneous to the
moral sphere. It does not bring with it the need for a
“counter-gift” (we would then be in another logic, that of
dosis-antidosis), but makes the donor appreciated; it generates gratitude. In the Nicomachean Ethics of Aristotle, we already have an entire philosophy of the gift, which is totally
extraneous to the logic of an exchange of interests.
The gift would never cease to be at the heart of philosophical thought. The kharis becomes gratia, a term that has
different meanings in profane and sacred contexts. In the Latins, and above all in Seneca, we find a theorisation of the gift
in its most oblative meaning, of the gift that each person can
make to his neighbor as he can to a stranger. Seneca (2) in De
Beneficiis comes to say that the practice of gifts (beneficia)
constitutes the most powerful tie of human society. Not only
does he say that a gift has a beauty in itself but also adds that to
give without hoping for something in return is the very essence of a gift. To give, for Seneca, defines the essential of our
relations and constitutes the heart of a moral relationship. To
the extent of which his vision sees in giving a unilateral act, in
which the stoic sees the highest moral expression, we have the
first break with the traditional conception of the ceremonial
or ritual gift. For this reason, some people have seen in Seneca, the father of modern individualism (3).
Within the context of the sacred, gratia expresses the
gift that God makes to his creature. It designates not only the
spiritual capacity that is conferred on the human soul (spiritual grace), which is made capable of wanting and doing what
pleases God, but also the Gift that God makes of Himself, the
Holy Spirit. In the Christian tradition, a distinction is thus
made between Created Grace and Increated Grace. In the first
meaning, we find the idea of what the tradition of the Old
Testament designated with the term “hén”, a generous gift of
God to his people. In this article, it is not appropriate to analyze the three forms that this act of divine benevolence can
take (election, covenant and law). However, it is significant
that the conception of a radical, transcendent, unconditional
and merciful gift by the God of Israel seems an exceptional
case in the eyes of the historians of religions. What interests us
is that in revelation was unveiled the beauty of the free giving
of a generous gift that knows that it cannot be repaid. Until
modern times, nobody would contest the coherence of a divine justice that cannot be measured with the criteria of simple human justice: proportion, measure and ratio.
The Calling Into Question of the Gift
Today, reflection on gifts is characterized by two antagonistic currents— one which affirms the possibility of a disinterested gift and another which denies this. The first is
represented above all by Christian tradition. It has shown how
freely given gifts consolidated human societies. In the Catholic family, a gift enters in the constitution of communion
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and can generate the development of an ethos of giving. Man,
created in the image and likeness of God, is linked to other
men because of a common origin; from this shared dignity
derives the fact that biological and family relationships are
expanded to a form of transfigured and spiritual kinship, that
makes the whole of the human species a family, in which the
need for altruism is born. The so-termed communion of
saints refers to a society in which love is offered and received
as a gift; in the Protestant family the concept of religious ethics of brotherhood, to take up the famous phrase of Max
Weber (4), makes every relationship with the other a personal
relationship. The communitarian experience of brotherhood
marks a necessary step toward the constitution of a society in
which in the future a universal goodness is established, where
every man can be seen as the recipient of an oblative love.
The second modern current tends toward a negation of
the possibility of a gift as it is understood in Christian tradition. A gift is certainly recognized as a relationship of solidarity
between he who gives and he who receives and also a relationship of the superiority of the giver over the receiver. In the
famous study by Mauss (5), we encounter the most elaborate
sociological and anthropological reflection of what a gift is. In
the view of Mauss, many societies are structured around an
economics and a morality of the gift due to the fact that personal relationships in these societies are predominant. Individuals and groups have an interest in showing that they are
disinterested. Men are led to make gifts because the act of
giving imposes an obligation on the recipient. Why, then, is
he who receives led to reciprocate? In the view of the author,
because beliefs exist according to which the things that are
offered have a soul that leads them to return to the person
who has given them. In this way, Mauss thinks that he has
solved the enigma of what a gift is (6). I will not explore here
the legacy of a vision, which in the end denies the true ability
of man to be generous through a truly freely given gift. However, the fact remains interesting, that despite the suspicion
cast on one of the most essential elements of every human
society, the author recognizes the existence of a form of symbolism in a gift that has been made. This will allow us to
examine how the gift of a human organ is the bearer of symbolic values even though it has the capacity to be the fruit of a
totally disinterested act.
The study of the structure of what a gift is did not
end with the work of Mauss or other authors who denied
the possibility of free giving (the sociological school of
Durkheim, for example). Some currents of modern philosophy have retrieved the gift (moral phenomenology, Jewish or
Christian personalism). The dialogic structure of man has
been explored and the terms solidarity and responsibility
have become philosophical concepts (Ebner, Buber, Jonas
and Levinas). Some have seen in the gift an original datum of
the nature of man (Claude Bruaire). However, in this article,
I cannot explore the specific contribution of these representatives of personalism.
Discussion
Organ Transplant as an Expression of a Gift
It is now appropriate to examine the two forms of organ
transplantation on the basis of the source of the organ—
cadavers or living people.
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Ex Cadavere Organs
In the case of the removal of organs ex cadavere, we
have two very different modalities for the expression of consent. Indeed, consent can be given either by the person himself before his death or by a family relative when a person dies,
without having expressed beforehand any indication on the
question.
From the point of view of the anthropological value of
the gift, it is important to identify the subject who gives the
gift. In the case of the direct consent of the individual, this
consent can be expressed in different ways: through a classic
will and testament, through so-called prior treatment directives (on which the Italian National Bioethics Committee
has expressed its view) (7), through the compilation of
specific forms that are then kept in data banks created for
this purpose, or orally, but in a repeated, and somehow
verifiable, way.
The direct expression of consent to the donation of
organs is what most expresses the meaning of the gift in its
most authentic form as an intimately matured and freely chosen choice. In this, there comes into play the view that the
person has of his body and his death, and thus implies a previous acceptance and a full awareness of the limits of his own
existence.
In the case of consent expressed by a family relative
after the death of another family relative, the view of the body
of the dead person and above all of a person to whom another
was especially close, a body which, in the imagination, still
represents a link with the deceased person, acquires importance. In the case of consent expressed by a family relative, the
value of “giving oneself”, of donating oneself, remains intact
because to consent to the removal of organs, an act of profound acceptance of the death of one’s relative, is necessary.
One consents to the “physical deformation” of the cadaver of
the loved person, which is still perceived as the presence of his
being, a center of meanings, of experiences and of affective
and existential ties. Dominion over this feeling toward the
lifeless body of a loved person is made possible by awareness
of the need of another person, by a perception of a greater
good, perceived as such.
However, this process is very arduous and often generates reticence on the part of the family to consenting to a
donation. The idea that one can manipulate the body of the
deceased person is, at times, felt as a lack of respect during
the crucial moment of the first working out of mourning.
The cadaver after a certain fashion, is perceived as still
“belonging” to the family.
This idea, paradoxically, is less strong when one proceeds, for example, to the cremation of a cadaver. This is seen
as a ritual act which attests definitively to the death of the
person and does not obstruct the working out of mourning by
the family relatives.
On May 15, 1956, Pius XII, when addressing the Association of the Donors of Corneas and the Italian Union of the
Blind, laid stress on a suitable sensitization of family relatives:
“it is necessary to educate the public and to explain with intelligence and respect that to consent expressly or tacitly to
interventions that violate the integrity of a cadaver in the
interest of those who suffer does not offend the piety because
of the deceased if the reasons are particularly important.
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Despite this, this consent can constitute a suffering and a
sacrifice for the near relatives, but this sacrifice brings the
aurora of merciful charity toward brethren who suffer” (8).
At times, doubts are raised about the validity of consent
to donation granted by a family relative given the fact that the
deceased did not express this readiness when he was still alive.
This demonstrates the importance of sensitizing people to
expressing their own wishes on the matter in an explicit way
and preferably in written form. Tacit consent to donation is
applied in some legislation. This article does not include in its
aims an examination of the questions and issues connected
with presumed consent, which will be analyzed elsewhere
during this congress.
At an anthropological level, as was illustrated at the
beginning of this article, some models come to see the cadaver
in juridical terms as res communitatis, justifying its use for
social purposes independently of the direct consent of the
person involved or his family relatives. For example, in the
view of Childress, there are four ways of acquiring human
organs: donation, abandonment and sale are the first three;
and he invites a development of the fourth, which he calls
“societal appropriation” (9).
In this article, I cannot dwell on the special difficulties
that a family could encounter in consenting to the donation
of certain specific organs, for example, the heart or a part of
the encephalon, even though this last possibility is still purely
theoretical. It is sufficient to say that the anthropological
meaning linked to the donation of these organs is made up of
the fact that symbolically the brain refers to the spiritual and
intellective personality of the subject, whereas the heart refers
to the person in his totality.
In definitive terms, the problem concerns the question of
the symbolic location of the existence of the person. The metaphysical nature of the question deserves a specific analysis.
Organs From Living People
In medical practice, certain forms of donation by the
living, which involve a rather reduced risk for the donor and
the recipient, are by now widespread. Such is the case with
blood and bone marrow. The donation of blood, in particular, is by now seen as a routine medical action and today
involves a large number of people.
With regards to the donation of bone marrow, conversely, the procedure is much more complex and the number of donations is notably lower, above all because of the
difficulties that are encountered in finding a donor who is
compatible with the patient at the immunological level. In the
removal procedures, as well, there is a substantial difference
compared with blood donation. To donate the bone marrow
involves hospitalization and total or local anesthesia, otherwise, the action would be rather painful.
In these forms of donations and in others, such as kidney donation, the donation of a part of the liver or lung, the
value of self-giving; of giving a part of one’s body for the good
of other people and without any condition or personal benefit, emerges with especial force. In addition, donations of this
kind are, in some cases, carried out without there being any
personal link between the donor and the recipient, as a result
of which the person who decides to donate does so simply
because of the value present in the act in itself, independently
of the actual person who is the recipient of this gift.
Transplantation • Volume 88, Number 7S, October 15, 2009
The donation of an organ seeks to eliminate a deficiency in another person. Obviously, this is a good for the
recipient, a good for his health, but it is also a deeper good.
Indeed, the recipient becomes the recipient of an altruistic
and generous act in which he discovers and sees confirmed
the fact that his recovery and his health, is an authentic good
for society.
With regards to the donor, he too discovers a good: he
finds in the physical good of the other his moral good, and for
this reason, he wants to achieve it. We are beyond simple
justice. There is a beauty in the gift that cannot be reduced to
the beauty of justice. The gift is doing good (a beneficium,
Seneca would say). Indeed, in the concept of justice is implicit
the meaning of exchange, of proportion between two greatnesses that must be commensurable (indeed to explain this
logic Aristotle (10) has recourse to a clearly mathematical
argument).2 Justice consists in giving to someone what is due
to him. Referring to distributive justice, that is to say to
justice in the public sphere, Aristotle (11) asserts that what
is just is proportional . . . whereas the unjust is what violates proportion.3
In the gift, instead, this logic disappears in that the principle of asymmetry between the donor and the recipient, and
apparently therefore, the principle of disproportion between
the gift made and what is gained from it belongs to the very
nature of the gift.
The gift comes first. It cannot be derived. Man finds in
self-giving a good. This good belongs to the category of fundamental goods (to use a phrase of John Finnis [12]), that is to
say goods that cannot be explained. They are “first principles
that cannot be demonstrated because they are evident”.4 It is
interesting to note than among the seven fundamental goods,
Finnis also perceives that of sociability or friendship, which
we may consider to be at the basis of the concept of a gift:
there is the value of that sociability, which in its weakest form
is achieved by a minimum of peace and harmony among
men, and which runs through the forms of human commu2
“For proportion is equality of ratios, and involves four terms at least . . . e.g.
‘as the line A is to the line B, so is the line B to the line C’; the line B, then,
has been mentioned twice, so that if the line B be assumed twice, the
proportional terms will be four); and the just, too, involves at least four
terms, and the ratio between one pair is the same as that between the
other pair; for there is a similar distinction between the persons and
between the things. As the term A, then, is to B, so will C be to D, and
therefore, alternando, as A is to C, B will be to D. Therefore also the whole
is in the same ratio to the whole; and this coupling the distribution effects,
and, if the terms are so combined, effects justly. The conjunction, then, of
the term A with C and of B with D is what is just in distribution, and this
species of the just is intermediate, and the unjust is what violates the
proportion”.
3
“For the justice which distributes common possessions is always in accordance with the kind of proportion mentioned above (for in the case also
in which the distribution is made from the common funds of a partnership it will be according to the same ratio which the funds put into the
business by the partners bear to one another); and the injustice opposed
to this kind of justice is that which violates the proportion”.
4
Finnis, following St. Thomas Aquinas, places the self-evident fundamental
goods in a close relationship with the nature of man: “The fundamental
forms of good, understood by the practical intellect, are what is good for
human beings with the nature that they have. The Aquinate observes that
practical reasoning does not begin knowing this nature from the outside,
as those he proceeded defining it with observations and judgements of a
psychological, anthropological or metaphysical character, but experiencing his own nature, so to speak, from inside, in the forms of his own
inclinations’ (p. 37).
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nity until it reaches its strongest form in the flourishing of full
friendship. Some forms of cooperation between one person
and another are only instrumental to the achievement by each
of them of their own individual goals. Friendship, however,
implies that one acts out of love for one’s friends’ well-being.
We may observe that, for this author, the fundamental forms
of good grasped by the practical intellect are what is good for
human beings given their nature.
In the human heart, there is a natural inclination to do
good, which is realized in the gift of oneself, without expecting a return.
The gift of organs belongs to the structure of a gift: at
the outset, we have a life that we experience spontaneously as
a gift. We observe first of all that the phrase “self-giving” is not
a phrase with a literal meaning but an analogical one.
Self-giving has two meanings. The first is, for example,
the one that we find in the Constitution Gaudium et Spes of
the Second Vatican Council: “man . . . cannot fully find himself
except through a sincere gift of himself” (13). In this context,
the phrase designates the offering of one’s own life in imitation of the gift of his own life that Christ made to men; in the
second meaning, self-giving refers to the object of the gift.
The object of the gift can take many different forms, for example, one can give one’s own time, offer one’s readiness to
help, give one’s most fundamental personal goods, make
available to the other one’s own freedom or take on risks for
another person. In the case of transplants, the object of the
gift refers to a part of the body (14).5 This part, after a certain
fashion, can be assimilated to an exterior good, given that the
donor does not cease to be himself after donating his kidney
or a lobe of his liver. The phrase is ambiguous, because here
we find a medical perspective that specifies first of all the
position of the recipient. I cannot analyze here what ultimately founds the medical act, but I will observe that a medical doctor, when he exercises his art, does so in respect of the
unity of the organism and of the patient.
So, how can we define the act of giving an organ? One
chooses to forgo one’s own physical integrity to the extent
that this act can save the life of another person. Thus, we have
a proportionate good; proportionate because we have in the
donor and the recipient the same nature.
The measure of the legitimacy of self-giving is the
health of the other. Thus, it is not an irrational and romantic
act, but it is a concrete and realistic act. It is to be inscribed
within a strictly medical finality.
How can a transplant be the expression of a gift in the
sense that I have given to this word?
This is not a religious or philosophical stance, a priori. It
is in this way that men naturally perceive their lives: the life
that we have precedes all consciousness of self and thus every
personal stance towards this original fact. This life can be
expressed in various ways in self-giving, the gift of organs is
one of the possible concrete expressions of this self-giving.
For John Paul II, the decision to offer, without recompense, a
part of one’s body possesses the characteristics of love: “Here
precisely lies the nobility of the gesture, a gesture which is a
genuine act of love. It is not just a matter of giving away
5
“every organ transplant has its source in a decision of great ethical value:
«the decision to offer without reward a part of one’s own body for the
health and well-being of another person»”.
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something that belongs to us but of giving something of ourselves, for “by virtue of its substantial union with a spiritual
soul, the human body cannot be considered as a mere complex of tissues, organs and functions. Rather, it is a constitutive part of the person who manifests and expresses himself
through it”” (14).
In this approach, what is an organ? It is the instrument
of the gift, not in itself but in service to the whole of an organism. In the biological life of a man, the whole is not the mere
addition of the organs: we have a psychosomatic unity; it is
the body of the recipient, in its own unity, that is ultimately in
the transplant that has been carried out; the cause of the practical outcome (success) of the gift.
An adequate counterparty does not exist. In the world
of interpersonal relations, which Levians loved to characterize with the phrase “asymmetrical reciprocity”, the gift of an
organ can only be corresponded by the gift of gratitude; it is
the free giving of the gift that generates gratitude.
I will not here take into consideration the donations
connected with human sexuality and procreation, such as
that of ovocytes or sperm, which can be made for research
purposes or within the field of heterologous artificial fertilisation. The fact that this kind of donation raises specific ethical
problems requires a more detailed analysis, but this would
place my article outside its purpose.
In the case of the donation of organs by a living person,
the approach of the recipient is also important. He adopts a
sense of responsibility toward the organ that has been received, being aware that the donor has had to accept a decrease in his own state of health. This sense of responsibility
can have a particular relevance in social behavior at risk. A
subject who is addicted to alcohol and is suffering from hepatic cirrhosis and receives the transplant of a lobe of the liver
from a living donor, for example, could adopt a prudent and
responsible lifestyle that does not damage the organ that has
been received.
We have been able to see that the gift corresponds to a
profound and fundamental tendency in the heart of man.
Like every value, it may be not understood, and certainly, it is
not compatible with a certain utilitarian vision that considers
man a fundamentally selfish being.
I believe that the true gift exists and that it naturally
corresponds to an aspiration that is very deep in the human
being. The gift of an organ is ethically justified when the subject has expressed his own consent to the donation. But in the
process that leads to the decision to donate an organ, another
level of reflection emerges, which is that of its anthropological
meanings. In this article, an attempt has been made to emphasize this. If one wants to encourage this kind of gift, efforts
must be directed toward informing and educating people.
The body of a man cannot be seen as an object or as a
good to be exchanged. It conserves its dignity even after the
death of the person. Only the form of donation allows the
body to be used without denying the meanings of which it is
the bearer.
I would add, to end this article, that the act of donating
an organ is always a strong and natural symbolic expression of
a love. I would like to evoke, even though with a certain
straining to which I willingly confess, the way in which the
Apostle St. Paul rendered homage to the love that the Galatians demonstrated towards him: “For I bear you witness that,
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if possible, you would plucked out your eyes and given them
to me”.
References
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AQ: 12
2.
3.
4.
5.
6.
7.
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9.
AQ:13 10.
AQ:14 12.
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AQ: 15
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AQ: 16
Fehr E, Fischbacher E. The nature of human altruism. Nature 2003;
425: 785.
Seneca LA. De Beneficiis, I, IV, 2.
Henaff M. Le prix de la vérité. Le don, l’argent, la philosophie. Paris,
Seuil 2002, pp 337.
Weber M. L’Ethique protestante et l’Esprit du capitalisme. Paris, Flammarion 2000.
Mauss M. Essai sur le don. Paris, Quadrige 2007.
Godelier M. L’énigme du don. Paris, Flammarion 2008, pp 19.
Comitato Nazionale per la Bioetica. Dichiarazioni anticipate di trattamento. Presidenza del Consiglio dei Ministri, Dipartimento per
l’informazione e l’editoria, 2003.
Pope Pius XII. Allocution to the donors of corneas and to the Italian
Union of the blind (14 May 1956). Acta Apostolicae Sedis 1956; 48: 464.
Kreis H. The question of organ procurement: Beyond charity. Nephrol
Dial Transplant 2005; 20: 1303.
Aristotle. Nicomachean Ethics, Book V.
Finnis J. Legge naturale e diritti naturali. Torino, Giappichelli Editore
1996, pp 93.
Second Vatican Council. Pastoral Constitution Gaudium et Spes. Acta
Apostolicae Sedis 1966; 58: 1025.
Pope John Paul II. Address to the 18th International Congress of the
Transplantation Society (29 August 2000). Acta Apostolicae Sedis 2000;
92: 826.
THEORETICAL ASPECTS OF INFORMED
CONSENT IN ORGAN DONATION AND
TRANSPLANTATION
Håkan Gäbel
heoretical aspects cannot be entirely separated from legal
and ethical aspects, but the title relieves me of the task to
discuss in detail all legal and ethical issues. To my mind, ethical and theoretical deliberations lead to legislation, which
may be implemented in different ways and which may or may
not be followed.
In national transplant acts, the autonomy of the individual and the possibility to decide for himself on matters
regarding organ or tissue donation and transplantation
ranges on a scale with many steps, from total autonomy to no
autonomy. There are differences between donation and
transplantation and there are good summaries of transplant
legislation in Europe (1, 2).
T
Some Definitions: Informed and Presumed
Consent and the Need for Surrogate Decision
Makers
Informed Consent
Informed consent is a process where you are told (or get
the information in some other way) about the possible risks and
benefits of the treatment. You are informed of the risks and benefits of other options, including not getting treatment; you have
the chance to ask questions and get them answered to your satisfaction; you have had the time (if needed) to discuss the plan with
family or advisors; you are able to use the information to help make
a decision that you think in the best interest and finally you communicate that decision to your doctor or treatment team.
There are several distinct and separate elements of informed consent as outlined in “How informed is informed
The author declares no conflict of interest.
Transplantation • Volume 88, Number 7S, October 15, 2009
consent?” (3): competence, voluntariness, disclosure, recommendation, understanding, decision and authorisation.
The elements disclosure and recommendation are in the
realm of the medical profession. One wonders how detailed the
information should be? Can it always be factual and neutral or is
it biased? Is the information always understandable?
The information and the recommendations given by
the medical professionals to the patient (the “decision
maker”) and his or her proxy form the basis for their deliberations. Some of the elements such as competence, voluntariness, understanding, decision making and authorisation are
in their realm.
When it comes to decision making, we are all more or
less competent. We may have a clouded consciousness because of a medical condition or advanced age, we may be
sedated or even unconscious when our opinion on treatment
is asked for. We might not have been informed enough and
prompted to give consent to treatment when we were not
fully competent and our proxies are now asked to be our
deputies.
Presumed Consent
“Presumed consent is a fiction. Without the actual consent of the individual there is no consent: Many see presumed
consent as synonymous with contracting out . . ..” The underpinning message of the system to which conflation of these
terms refer is something like this: “unless you make it clear
during your lifetime that you would refuse to donate organs
on death, we will presume that you consent to organ removal,
even though you do not actually consent” (4).
Informed consent and presumed consent can be expressed in many ways. The Swedish Transplant Act that does
not regulate transplantation but only donation is stated as
follows:
Material intended for transplantation can be procured
from a deceased person having consented to the procedure
(informed consent).
Or else material for . . . can be procured unless the deceased had objected in any way (presumed consent).
And moreover, relatives have to be informed about the intended procedure and about the option to veto the procedure.
Thus, the transplant act has also introduced the family
or significant others as surrogate decision makers.
Proxies or Surrogate Decision Makers
Because very few have either given a valid informed
consent or paid attention to the option to object to donation,
there is obviously a need for proxies or surrogate decision
makers.
Legislation on proxies varies from state to state, and, in
some states, there are no rules at all. The proxies, substitutes
or deputies may be of several kinds.
For minors, the parents are most often the legal
guardians, according to the Convention on the Rights of
the Child (5). Most often spouses, other relatives or significant others can act as proxies. Temporarily medical professionals can act as proxies in the best interest of their
patients especially in life threatening situations—most patients want to survive. Most often there can be many deputies and sometimes they do not agree as to what is in the
best interest of the person in question.
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I doubt very much that the proxies are fully aware of
how they are supposed to act: “Certainly one would like to
know more about how surrogates are chosen, on what
grounds they make their decisions; how they feel about this
responsibility, how well they succeed in following the guidelines currently in place” (6).
Do they act in the best interest of their principal—
the best interest standard? What is actually in the best interest of a critically ill, dying patient or of an already dead
person? Is there a living will or registered will to be a donor
as on a donor card or a registration on a donor register? Do
the deputies always follow the will—the precedent autonomy standard or advance directive principle? Another alternative for the deputies would be to try to imagine what
the principal would have decided taking all the current
circumstances into account—substituted judgment standard (6). Most often the standards for decision making are
intermingled and also influenced by what a reasonable or
virtuous person would do.
Consent for Live Organ Donation and for
Transplantation
Despite the shortcomings of informed consent, (7) it
can be argued that informed consent is the sine qua non for
human subjects’ research and live organ donation. In these
circumstances, the subject or patient is healthy and volunteers to carry the risks of the procedure in the interest of
science, as in human subjects’ research or in the interest of the
recipient as in live organ donation.
But how much and how detailed is the information
given to the potential living donor. There seems to be room
for improvement. “More prospective studies are needed to
improve the process of informed consent in this population
(live organ donors)” (8) and “As dependence on living
organ donation increases best practices for informed consent, donor evaluation and uniform risk conveyance need
to be established” (9).
According to the Vancouver forum (10, 11), which addressed the care of the live lung, liver, pancreas and intestine
organ donation, the potential donor must have a cognitive
capacity sufficient to make the decision to donate, the decision must be voluntary and the donor must receive and
understand relevant and sufficient information about the
procedure.
A similar forum on the care of the live kidney donors
had previously arrived at a similar consensus (12). Considering the information given by other speakers (K. Laouzbdia-Sellami, F. Delmonico, V.D. Garcia and L. Noel) at this
International Congress, in the session on Organ Donation,
the need for organs and the question of trafficking organs
can be questioned as well as whether most living donors
meet the prerequisites for giving an informed consent.
There are regrettably many exploited living donors in
some parts of the world.
Before we subject live donors to risks and use their organs, we need to increase the availability of organs and tissues
from deceased donors at no risk to them. It is a deplorable fact
that deceased organ donation is not a realistic option in many
parts of the world. “It is now evident that live donors are the
sole source of organs for transplantation in many societies”
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(10, 11). It is a major task for the transplant community to
make deceased organ donation a possibility everywhere. Informed consent also seems to be the best consent option for
the transplantation of organs.
The questions once again arise: How much information? How detailed should the information to the recipient
be? How competent is he or she when the information is
given? Should information also be given on the donor and the
quality of the graft? There are regulations in place, as in European Union (EU)-directives, intended to prevent the transmission of infectious or malignant diseases, but there are also
suboptimal or extended criteria donors, donors of advanced
age having died from cerebrovascular disease where the function of the graft may not be ideal. How to inform the recipients about the quality of the graft? (13) “As our list for
extended donor pool kidneys grows, we must devise a standard means of true informed consent” (14).
Can we accept that the patient, who is offered a kidney
transplant from a marginal donor, turns down that offer? In
fact, does the patient give the opinion that “this kidney is not
good enough for me”— but maybe for someone else? Or is it
a medical obligation to decide what is good enough to be
transplanted and what is not?
Consent for Deceased Organ Donation
In an ideal world, mostly everyone would take a stand
on postmortem donation, after adequate information, and
communicate his or her stand. There would be good systems
for recording the wishes or preferences of individuals (donor
cards or registries)— be they in favor of or opposed to—
informed or presumed consent. There would be a good
system of proxies in the event there was no information
and proxies would always honor the wishes of the deceased
if known. But we do not live in an ideal world.
What constitutes adequate information on deceased
organ donation? Of course it has to be factual and neutral, but
how detailed? Should it include the care of the critically ill and
the possibility that the treatment is futile, but given to make
organ donation a possibility of nontherapeutic ventilation, or
the Exeter protocol (15, 16). It should of course cover brain
related, as well as circulatory criteria, of death because many
countries now and again procure organs from donors after
cardiac death.
No doubt the information has to be similar regardless
of the pattern of consent— be it informed or presumed consent. Is it appropriate to convey the message of the great need
of organs for transplantation?
How should the information be given and how do we
make sure it reaches everyone? We live in an information
society with an abundance of information. In giving information on deceased organ donation we would compete with
other interested parties at a great expense.
It can be questioned if it is reasonable to inform the
entire population in detail about deceased organ donation,
with special problems regarding minors and those with restricted autonomy or who are less competent, on issues that
will affect, at most, 60 per million population (PMP)? It can
be argued that it would be better to give general information on
donation and transplantation to create a society where donation is considered the norm, vide infra, and to concentrate on
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informing and caring for the family of the dying or deceased
potential donor.
Most pay lip service to deceased organ donation, but
few take action and make their wishes known to their relatives, with donor cards or on donor registers. In Sweden, for
example, 66% of the population has discussed organ donation with their relatives (EU average 41%), 81% would be
willing to donate their own organs and 74% would donate the
organs of a deceased relative (EU averages 56% and 54%,
respectively). Ninety-five percent support the use of donor
cards in Sweden (EU average 81%); however, only some 30%
carry donor cards (17). Interestingly enough, there is an inverse relationship between the percentage of donor card
holders and the number of deceased organ donation PMP. In
the Netherlands, Sweden and Spain, more than 40%, some
30% and some 5% of the population, respectively, carry donor cards. The number of donors PMP are as follows: 12 PMP
in the Netherlands, 15 PMP in Sweden and 35 donors PMP in
Spain.
In many states national organ donor registers have been
introduced to allow citizens to register their attitudes to deceased organ and tissue donation (18). The registers are all
different and dependent on the transplant act in the country.
In some countries with informed consent legislation there are
donor registers where you can only register as a donor. In
countries with presumed consent legislation there can be
non-donor registers accepting only objections to donation.
There are also combined registers where you can register either an acceptance or a refusal to donate.
Despite costly efforts to increase enrolment on national
donor registers, too few have registered to make them really
useful. To be sure, many registrations would be desirable in
donor registers, whereas few would be desirable in nondonor registers. In some of the combined registers as in the
Netherlands and Sweden, where you can either register as a
donor or object to donation, some 20% to 40% of the population has registered, and in non-donor registers, as in France,
only some per thousand have registered. Moreover, the
legal status of a registration as an informed consent can be
questioned.
“The websites and consent forms for public enrolment
in organ donation do not fulfil the necessary requirements for
informed consent. The websites predominantly provide positive reinforcement and promotional information rather than
the transparent disclosure of organ donation process” (19).
Donor registers have not lived up to the expectation
that they would, by themselves, increase the number of deceased donors (18).
Presumed Consent Versus Informed Consent for
Deceased Organ Donation
There is an ever ongoing discussion on the merits of
presumed consent versus informed consent for deceased organ donation. Most recently the issue was brought up in the
United Kingdom.
It can be argued what is preferable—informed consent
or presumed consent (20). “Presumed consent for organ
donation—Is an ethical and effective way of dealing with organ donation shortages”. The organ donation taskforce is
currently conducting an inquiry into the practical, ethical,
legal and societal implications of presumed consent.
Transplantation • Volume 88, Number 7S, October 15, 2009
Is presumed consent the answer to organ shortages?
Yes
It would be good for those who support donation, because they have to make no effort to ensure their wishes are
followed; good for those who oppose donation, because
their wishes will be formally recorded and must be
followed; and good for the families, because they are relieved of the burden of decision making . . . Good for those
who need a transplant . . . (21).
No
Systems of opting out do not ensure higher rates of donation than opting in systems. Strategies to encourage people
to donate and public education seem to help and are independent of whether people have to opt in or out (22).
The Lords committee comes down against presumed
consent for organ donation. “The system of presumed consent would be ineffective without the numbers of skilled staff
and a coordinated system needed to deal with the greater
volume of donor organs that this might generate”.
Baroness Howard, House of Lords, declares: “All parts
of the National Health Service (NHS) must accept organ donation as a usual—not an unusual— event and (must accept)
that many more, and better trained, medical staff should have
the role of providing organ donation services” (23).
The House of Lords and Baroness Howard touch on the
importance of skilled staff and a coordinated system needed
to deal with the greater volume of donor organs that presumed consent might generate. The necessity of skilled staff
was brought up by other invited speakers at the congress (R.
Matesanz and M. Manyalich). Why not provide the additional staff and the coordinated system needed?
All arguments considered I think there may be a case for
presumed consent, but it must be properly implemented as
suggested by the House of Lords and Baroness Howard.
As mentioned earlier, most individuals support donation, but few have made their support known, and if they have
done so, surrogate decision makers do not always follow the
wishes of the deceased.
Religions Support Transplantation
In Transplants—Ethical Eye (24), there is information
on the views of the major religions (Catholicism, Protestantism, The Orthodox church, Judaism, Islam, Buddhism and
Agnostic ethics on transplantation).
Suffice to give here the views of the Catholic Church
and Judaism.
John Paul II has appeared at meetings with transplant
professionals on (at least) two occasions.
To the participants of the Society for Organ Sharing,
June 20, 1991, he said: “Above all, this form of treatment is
inseparable from a human act of donation. In effect, transplantation presupposes a prior, explicit, free and conscious
decision on the part of the donor or of someone who legitimately represents the donor . . .”. And: “It is obvious that
vital organs can only be donated after death, but to offer in life
a part of one’s body, an offering which will be effective only
after death, is already in many cases an act of great love, the
love which gives life to others”.
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On the visit of His Holiness, John Paul II at the XVIII
International Congress of the Transplantation Society, Rome,
August 29, 2000, he said: “Here it can be said that the criterion
(of death) adopted in more recent times for ascertaining the fact
of death, namely the complete and irreversible cessation of all
brain activity, if rigorously applied, does not seem to conflict
with the essential elements of sound anthropology”.
Judaism is especially interesting because it acknowledges that donation is permitted despite the fact that: “Under
Judaic law removing organs from a human body after death
conflicts with three rules: No benefit must be derived from a
dead body; A dead body must not be mutilated; The body
must be buried”. The reason for this being that “Saving lives is
regarded as a Mitzvah (a religions commandment)”.
The statement of the Holy Father Benedict XVI is published elsewhere in this supplement. All things considered,
presumed consent seems better suited for deceased organ donation than informed consent. It offers a good way to initiate
the discussion with the relatives of the deceased who are to
honor the wishes of deceased. The question in the title of an
article, “How presumed is presumed consent?” was answered;
not very or not at all. “It is evident that, regardless of the law,
be it opting in or opting out, presumed consent or presumed
non consent, the family is almost always consulted. The family has the preferential right of interpretation. Their interpretation of the attitude towards organ donation by the deceased
is usually not contested” (25).
There May Be Alternatives to Informed and
Presumed Consent for Deceased Organ and
Tissue Donation
Who should actually give the informed consent to, or
use the option to veto, as in presumed consent, deceased organ donation. Who owns the dead body? Whose organs are
they anyway? (26).
Is it immoral to require consent for cadaver organ donation? Emson (27) believes so; “In my opinion any concept
of property of the human body either during life or after
death is biologically inaccurate and morally wrong” and “I
believe that the right of control over the cadaver should be
vested in the state as representative of those who may benefit
from organ donation”.
“In fact, the human being has only the usufruct of his
body. The usufruct being the right to enjoy the use and the
advantages of another’s property short of the destruction or
waste of its substances” (26). After death, the substances making up our bodies will be given back to nature and recirculated
in the eternal cycle after decomposition, cremation or donation of some organs and or tissues. As Mårten Werner (1918 –
1992), former chaplain to the King of Sweden, said: “To give
a gift for life—through donation after my death—It would be
a blessing”.
Custodianship and Conditional Societal
Appropriation
Moore, the Chairman of the Department of Surgery at
the Peter Bent Brigham hospital in Boston, where transplantation originated in the 1950s, saw already in the 1980s the
end of voluntarism when it comes to deceased organ donation and asked “would our society accept some sort of statutory or mandated transfer of ownership of those organs from
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the family to some social agency, such as the city, town, country or state?” (28).
He suggested that the concept of ownership be replaced
with the concept of custody and “once in the custody of that
organ bank, the organ bank must discuss with the family (the
recent custodians) what disposal they would like to make and, if
possible, gain their voluntary assent (not consent) to donate”.
Moore was far sighted in anticipating that it might be
difficult to implement a system where the custodianship of
the organs is taken over by an organ bank.
Troug (29) suggests rightly, that in consent to organ
donation, there is a need to balance conflicting ethical obligations. According to the amended Uniform Anatomical Gift
Act (2006), physicians must continue the use of life-sustaining
treatments for dying patients until the organ procurement
organization (OPO) can determine whether the patient’s organs are suitable for transplants, even if the patient has an
advance directive in place stating that such treatment is not
wanted. Critical care physicians voiced their ethical concerns,
and the Uniform Anatomical Gift Act was again amended in
2007 stating that the attending physician should consult with
the patient or surrogate as early as possible to determine and
follow the patients’ wishes, even if doing so resulted in the loss
of transplantable organs.
Of course, the informed consent process should, as
Troug suggests, consist of a balanced discussion of the available options and counseling to help patients or their relatives
to reach the choice that is best for them.
According to Troug, further tensions remain because
the OPO representative, the designated requestor and the clinicians face conflicting obligations. “The growing transplant
waiting lists oblige us to strive to increase the supply of transplantable organs, but our commitments to respecting the
rights of our patients and their families require the consent
obtained by people who are, in turn committed to being fully
transparent, fair and even-handed”.
According to the comments in the same issue of The
New England Journal of Medicine by Luskin and Delmonico,
there is a confluence between the ethical commitments that
Troug outlines: “that the desires of people who want to donate organs are respected and that the consent process is informed and voluntary” (30). The New England organ bank
and other OPOs apply a consent process of dual advocacy.
“By supporting the family’s right to make a choice that is
based on complete information, including the positive impact that the gift will have on others and the solace derived
from organ donation, dual advocacy recognizes that those
requesting donation must also consider the needs of the donor family”.
It is of the utmost importance who discusses organ
donation with the relatives. In an interesting study where
physicians of 25 deceased patients and 20 relatives were
interviewed (31), half the physicians experienced conflicts
regarding prerequisites of procuring organs and dealing
with relatives. The physicians were characterized as being
pro-donation, neutral or ambivalent based on their handling of the discussion on organ donation. The relatives
felt that the neutrals were opposed to donation. Only physicians with a pro-donation approach received acceptance
for donation.
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Transplantation • Volume 88, Number 7S, October 15, 2009
Routine Recovery
“Routine Recovery of Cadaveric Organs for Transplantation: Consistant, Fair, and Lifesaving” (32) is only the most
recent of Aaron Spitals suggestions to improve deceased organ donation (33, 34).
In 1996, he suggested that we give mandated choice for
organ donation a try. “The plan would require all adults to
record their wishes about posthumous organ donation and
would consider those wishes binding” (33).
He now suggests that “since many families deny organ
recovery from recently deceased relatives”, another approach
would be superior and “this is rarely discussed: routine recovery
of all transplantable organs without consent”.
But the families have to be involved and consulted
because they will always have to be informed about the
imminent or actual death of a close relative. They will have
to be well cared for and they are the interpreters of the
wishes of the deceased—the last will— but not themselves decision makers. Moreover, they are the only ones who can give the
information necessary to evaluate the suitability of the potential
donor.
As a comment to the families not being themselves decision makers, reference is to Kreiss (35) and his suggestion
for conditional societal appropriation. “Based on this concept, society may declare that after a person’s death, internal
vital organs— but not the entire body— can be procured . . ..
Conditional societal appropriation does not require anyone’s
permission . . .. However in order to acknowledge the concept of autonomy . . . society . . . should accept individual,
and not family refusal to donate”.
Reciprocity is of course similar to the golden rule— one
should do to others as he would have others do to him (Mt
7:12 and Lk 6:31). On a wider scale, society expects citizens to
reciprocate and citizens expect society to handle matters respectfully and fairly.
A Communitarian Approach
Another approach to facilitate deceased organ donation is suggested by Amital Etzoni of the Kennedy institute of
Ethics (36). It would be the communitarian approach: “. . . it
seeks to make organ donation an act people engage in because
they consider it their social responsibility, something a good
person does, akin to volunteering”. Amital Etzoni takes exception to altruism as did Moore (vide ante). “It cannot be
stressed enough that the reference here is not to altruism,
which critics correctly point out often is an insufficient motive for action . . .. Rather reference is to making organ donation a part of one’s sense of moral obligation, something one
cannot look in the mirror or face friends without having lived
up to”.
References
Reciprocity
Nadel and Nadel (37) contend “that a reciprocity policy
could dramatically increase donations and thereby decrease
associated deaths”. Under the policy, those who committed
to donate organs would be granted preference in the event
that they later required a transplant.
The authors suggest that the individuals would continue to record their commitments in a manner they currently do or in registries and would receive preferential
treatment should they need a transplant. The authors see
some problems: most people are not sufficiently motivated to
commit to donate, some are apathetic or reluctant to contemplate their own mortality and still others prefer to be buried
intact for personal or religious reasons (although all major
religions permit, if not encourage, life-enhancing donations).
Final Remarks
With due respect for the transplant acts, be it informed
or presumed consent or any combination of these principles,
would any or all of those other alternatives for deceased organ
donation discussed earlier create a society where donation is
the norm?
No doubt some conditions have to be met for everyone
to unconditionally accept to be a donor after death: medical
professionals must proceed in a manner compatible with respect for the dead person’s dignity, allocation of organs and
tissues must be fair and ethical. Moreover, commercialism is
not acceptable.
The ethics of organ allocation were discussed in a
session of this meeting. Unfortunately, transplantation is
not yet free from trafficking and commercialism. It is a
challenge for the transplantation community to live upto
the legitimate claims we can insist on to accept donation
on the day we die.
It can be argued that at the present time, the emphasis is
on the autonomy and the interests of the individual to decide
for himself on deceased organ donation at the expense of the
common good. Organ and tissue donation is in the best interests of the donors, of those who are left behind and of those
who need a transplant.
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health/Source/organshortage_en.doc. Accessed November 2008.
Merion RM. How informed is informed consent? Transplant Proc 1996;
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Valapour M. The live organ donor’s consent: Is it informed and voluntary? Transplant Rev (Orlando) 2008; 22: 196.
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Woien S, Rady MY, Verheide JL, et al. Organ procurement organizations internet enrollment for organ donation: Abandoning informed
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Nadel MS, Nadel CA.Using reciprocity to motivate organ donations.
Yale J Health Policy Law Ethics 2005; 5: 293.
THE CONCEPT OF DEATH AND ORGAN
DONATION
Francis L. Delmonico
definition of death was established in the United States
in 1980 by the National Conference of Commissioners
on Uniform State Laws that formulated the Uniform Determination of Death Act (UDDA) (1). The UDDA states that
“An individual who has sustained either irreversible cessation of
circulatory and respiratory functions, or irreversible cessation of
all functions of the entire brain, including the brain stem is
dead”. This definition was approved by the American Medical
Association in 1980 and by the American Bar Association in
1981 (2). Today, all 50 states and the District of Columbia follow
the UDDA as a legal and medical standard of death.
The UDDA criteria for brain death assesses the function of the entire brain; both the cerebral and brainstem. The
conceptual significance of assessing the brainstem function is
A
The author declares no conflict of interest.
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to assure that an individual breathing spontaneously is not
declared dead. In the definition of irreversible coma by the Ad
Hoc Harvard Committee in 1968, the concept included an
absence of spontaneous respiration (3).
My personal interest in this topic dates to a period of
my medical school education that culminated in a project
analyzing the opinion of physicians regarding the concept of
death (4). At the time, the concept of death was in transition
and controversial, but there was a clear leadership from individuals, such as pioneering transplant surgeon, Dr. David
Hume. Dr. Hume wrote: “there is only one definition of
death; irreversible brain damage. Cessation of heart beat
does not constitute death unless it has caused irreversible
brain damage; (and) to diagnose irreversible brain damage
there must be no spontaneous respirations” (personal
communication).
These observations were later corroborated by Dr. William Sweet in the New England Journal of Medicine when he
wrote: “it is clear that a person is not dead unless his brain is
dead. The time-honored criteria of stoppage of the heartbeat
in circulation are indicative of death only when they persist
long enough for the brain to die” (5).
More recently, Shemie (6) has clarified the paradigm
for donation and death by emphasizing a required absence of
circulation (as stipulated by the UDDA; and thus, not just
heartbeat) by underscoring the vital function of the brain as a
criterion of life. “Where extracorporeal machines or transplantation can support or replace the function of organs such
as the heart, lung, liver or kidney, the brain is the only organ that
cannot be supported or replaced by medical technology” (6).
Challenging the Concept of Death as Determined
by Evaluating Neurologic Function
Byrne et al (7) have rejected brain death as constituting
death contending that “cessation of the entire brain function,
whether irreversible or not, is not necessarily linked to total
destruction of the brain or the death of the person”. Byrne
evidently thinks of death in terms of a disintegration and
“destruction of the unity of a single organism”; and philosophically constituting a separation of the soul from the body.
Philosophical contentions, however, do not address legal,
medical, ethical and practical necessities. No one knows when
the soul separates from the body, but a precise time of death
must be specified for obvious legal, medical and social reasons, for example, so that proper disposition of the body with
burial and estate and property transfer, etc, can be exercised (6).
In an intensive care unit setting, it becomes unethical to
impose futile clinical treatments to a comatose individual, if
the function of the entire brain is irreversibly lost. Treatment
can be concluded, because there is no obligation or responsibility to provide useless resuscitative or supportive technology. What is the practical alternative?
For many years, Truog (8) has also objected to the determination of death by neurologic evaluation (and by circulatory function). He has recently written in the New England
Journal of Medicine that “arguments about why these patients
should be considered dead have never been fully convincing.
The definition of brain death requires a complete absence of
all functions of the entire brain yet many of these patients
retaining essential neurologic function, such as regulated secretion of hypothalamic hormones” (9). The rebuttal to this
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assertion has been given by Shemie (personal communication):
“the release of antidiuretic hormone from the hypothalamus is
not considered to be essential neurologic function; rather, neurologic function is determined by an absence of consciousness,
receptivity and responsiveness, spontaneous movement, spontaneous breathing and an absence of brainstem reflexes”.
Brain death does not require every brain cell to be nonviable. The Ad Hoc Harvard committee convened by Dr.
Beecher was confronted by patients with a clinical condition
that fulfilled the criteria of an irreversible loss of neurologic
function but could be interminably supported by a mechanical respirator. For Truog (and Shewmon [10]), however,
these patients are not considered dead, because they can be
supported indefinitely beyond the acute phase of their illness.
It is well known, however, that despite the irreversible loss of
brain function, the remainder of the body can be maintained
by mechanical support; for example, even by patients who
become brain-dead during pregnancy yet successfully have
their fetuses brought to term. The clinical condition still constitutes the death of the mother and a viable fetus by continued mechanical support until birth (6).
Challenging the Concept of Death as Determined
by an Absence of Circulation
Again in the New England Journal of Medicine, Truog
and Miller (9) and Veatch (11) assert that donation after cardiac death (DCD) is not acceptable; that is, the recovery of
organs after the determination of death by circulatory and
respiratory criteria. Troug suggests that the recovery of the
heart after DCD is “paradoxical”, because “the heart of patients who have been declared dead on the basis of the irreversible loss of cardiac function have in fact been transplanted
and successfully functioned in the chest of another”. Veatch is
similarly not convinced that the donor is dead: “if someone is
pronounced dead on the basis of irreversible loss of heart
function, after all, it would not be possible for heart function
to be restored in another body” (11).
Both Veatch and Troug misinterpret the UDDA,
which, precisely stated, applies to an individual who has sustained irreversible cessation of circulatory and respiratory
functions. It is not a matter of the cessation of heartbeat or
heart function but an irreversible cessation of circulation in
the donor. The consequence of the absence of circulation is
based on the function of the brain. An irreversible loss of
blood flow (circulation) to the brain results in an irreversible
loss of neurologic function; the UDDA definition of death.
Bernat (12) has written, in the same New England
Journal group of articles, that circulation, not heartbeat, is
the critical function that must be lost using circulatory-respiratory tests to determine death. Patients are not declared
dead when on heart-lung machines during cardiac surgery,
on extracorporeal machine oxygenation (ECMO) awaiting
heart transplantation (even if they never receive a heart),
or carrying artificial hearts because, despite an absence of
heartbeat, circulation is continuously maintained. Regarding donation after cardiac death or nonheart-beating donation,
“whether the asystolic heart is subsequently left alone, removed
and not restarted, or removed and restarted in another patient is
irrelevant to the circulatory status of the just-declared dead patient” (12).
Transplantation • Volume 88, Number 7S, October 15, 2009
Defining Cessation and Irreversibility
For the determination of death by the irreversible cessation of circulatory and respiratory functions in a controlled
setting of organ donation (that is after the withdrawal of futile
treatment-controlled DCD in the hospital setting), cessation
and irreversibility should be defined. Cessation is recognized
by clinical examination that detects the absence of responsiveness, heart sounds, pulse and respiratory effort (13). The
medical circumstances of DCD may require the use of confirmatory object of tests, such as electronic monitoring or an absence
of pulse pressure as determined from an arterial catheter.
Bernat et al. (13) has introduced the concept of permanency to confirm irreversibility with the following formulation: an “irreversible” loss of function means that the
function cannot be restored by any known technology.
“Irreversible is an absolute condition that implies impossibility (with currently available technology) and does not rely on
intent or action. In contrast, a permanent loss of function
means that the function will not be restored, because it will
neither return spontaneously, nor will it return as a result of
medical intervention because physicians have decided not to
attempt resuscitation. “Permanent” is a contingent condition
that admits possibility and relies on intent and action. The
two conditions are causally related. All functions that are irreversibly lost are also permanently lost (but not vice versa)
and in DCD death determinations, functions that are lost permanently, quickly and inevitably become lost irreversibly” (13).
The National Conference on Donation after Cardiac
Death accepted this formulation that the irreversible loss of
circulation is confirmed by the observation that circulation
will not resume spontaneously and circulation will not be
restored on medically and ethically justifiable grounds. Irreversibility is recognized by persistent (permanent) cessation of
functions during an appropriate period of observation (13).
The Duration of an Absence of Circulation
The Institute of Medicine recommend a period of 5
min in witnessing the cessation of circulation by the patient
care team—independent of the organ recovery or transplant
team— before the patient is declared dead (14). The National
Conference on Donation after Cardiac Death subsequently
accepted a recommendation by the Society of Critical Care
Medicine to wait at least 2 min (and at most 5 min) after the
initial observation of asystole (13, 15). In an adult, there has
been no experience of the resumption of circulation in a DCD
circumstance after 2 min.
The reason to wait at least 2 to 5 min is to attest to the
irreversibility of the absence of circulation (and the consequences of that permanent absence of circulation on the
function of the brain). The reason not to wait longer is to
enable recovery of organs with an expectation that the organs
could function successfully after transplantation.
It should be noted, however, that with withdrawal of
futile treatment regularly being done in the intensive care
units preceding death, data could be prospectively collected
to determine the period in which the absence of spontaneous
resumption of circulation prevailed.
The Denver Protocol
Boucek et al. has presented four cases of the recovery
and transplantation of hearts from infants: “when cardiocir-
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culatory function ceased, the first patient was observed for 3
min before death was declared and the organ-donation process initiated. On the basis of recommendations of the ethics
committee, for the other two donors the observation period
was shortened to 1.25 min” (16).
Bernat (12) has criticized this approach: “What minimum duration of asystole ensures that autoresuscitation will
not occur is an empirical question that can be answered conclusively only after observing many hundreds of patients”.
The Use of Extracorporeal Machine Oxygenation
Protocols administering ECMO to the donor after the
determination of cardiac death have become controversial.
Bernat (12) has written in the companion article in the New
England Journal of Medicine specifically addressing the issue
of ECMO. He notes: “If ECMO adequately provided circulation and oxygenation to the donor’s entire body, it would
retroactively negate the death determination by preventing
the loss of circulation and respiration from becoming permanent or irreversible, potentially “reanimating” the heart and
preventing the progression to brain destruction on which the
circulatory criterion of death is predicated” (12).
These protocols attempt to circumvent heart reanimation or resumption of brain circulation by the placement of a
catheter in the diaphragmatic aorta. In those instances in
which heart recovery may be intended after DCD, ligation of
the carotid arteries has been considered.
Restoring circulation by ECMO after the declaration of
death by a reversible cessation of circulation is contradictory
to the death declaration. To accomplish a declaration of death
by an absence of neurologic function in this setting by either
the insertion of a balloon catheter in the thoracic aorta or the
ligation of the carotid artery is unacceptable, because it becomes the active causation of an absence of neurologic function. If that approach was to be ethically permissible, why not
ligate the carotid artery antecedent of the absence of
circulation?
The Use of Heparin in DCD Protocols
The administration of heparin at the time of the withdrawal of life sustaining treatment is the current standard of
care and a key component of DCD best practice. The longterm survival of the transplanted organ may be at risk if
thrombi impede circulation to the organ after reperfusion.
The omission of heparin could negatively impact organ recovery and hinder the acceptance of recovered organs for
transplantation.
The use of heparin has been considered controversial
on the basis of theoretical concerns that it may hasten the
death of the donor (17). There is no evidence that heparin
would cause sufficient bleeding after the withdrawal of treatment to be the cause of death. Although heparin may prevent
clotting in a patient who is actively bleeding, it is unlikely to
cause bleeding in a head-injured patient who is not actively
bleeding. It should not be overlooked that the event of demise
is the withdrawal of life support that affects the loss of circulation and respiration (and not the use of the heparin).
Finally, the principle of double effect asserts that an
action that produces a good effect and a bad effect might be
permissible if the good effect is intended and the bad effect is
merely foreseen but unintended.
The Dead Donor Rule and Organ Donation
Robertson (18) wrote more than a decade ago that the
retrieval of organs for transplantation should not cause the
death of a donor. This rule has since been the ethical axiom of
organ donation, thus, no organ recovery should precede the
declaration of death.
Despite the contentions of Truog and Miller (9), there
is no support within the organ donation community to rescind the dead donor rule. The public trust in organ donation
hinges on a trust that medical professionals will prioritize the
care of the dying patient over any other objective, however
noble or good. One could readily anticipate a societal skepticism if medical professionals present the following approach
to the family of a dying patient (as prescribed by Troug):
“your family member has a devastating neurologic injury but
is not dead. If you consent to the removal of organs now
before the determination of death, it will result in the death of
your family member and it would enhance the possibility of
successful transplantation of organs”. The rejection of that
scenario is evident in the recent trial of a transplant surgeon
that was accused of hastening the death of an individual in the
recovery of organs (19).
Church Position
In the address of John Paul II to the Transplantation
Congress in Rome, 2000, he noted: “. . . it is helpful to recall
that the death of the person is a single event, consisting in the
total disintegration of that unitary and integrated whole that
is the personal self. It is a well-known fact that for some time
certain scientific approaches to ascertaining death have
shifted the emphasis from the traditional cardiorespiratory
signs to the so-called neurological criterion. Specifically, this
consists in establishing, according to clearly determined parameters commonly held by the international scientific community, the complete and irreversible cessation of all brain
activity (in the cerebrum, cerebellum and brain stem). This is
then considered the sign that the individual organism has lost
its integrative capacity” (20).
For those who are involved in the transplantation of
organs from the deceased, this Papal testimony is reassuring
of a moral propriety that can be defended medically—the
valid concept of death by neurologic criteria (21).
References
1.
2.
3.
4.
5.
6.
7.
8.
Uniform Determination of Death Act. 12 Uniform Laws Annotated
320. 1990 Supp.
President’s Commission for the Study of Ethical Problems in Medicine
and Biomedical and Behavioral Research, Defining Death: A Report on
the Medical, Legal and Ethical Issues in the Determination of Death.
Washington: Government Printing Office 1981, pp 73.
Ad Hoc Committee. A definition of irreversible coma: Report of the Ad
Hoc Committee of the Harvard MedicalSchool to Examine the Definition of Brain Death. JAMA 1968; 205: 337.
Delmonico FL, Randolph JG. Death: A concept in transition. Pediatrics
1973; 51: 234.
Sweet W. Brain death. N Engl J Med 1978; 299: 410.
Shemie SD. Clarifying the paradigm for the ethics of donation and
transplantation: Was ‘dead’ really so clear before organ donation?
Philos Ethics Humanit Med 2007; 24: 18.
Byrne PA, O’Reilly S, Quay PM. Brain death–An opposing viewpoint.
JAMA 1979; 2242: 1985.
Truog RD. Is it time to abandon brain death? Hastings Cent Rep 1997;
27: 29.
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www.transplantjournal.com
Truog RD, Miller FG. The dead donor rule and organ transplantation.
N Engl J Med 2008; 359: 674.
Shewmon DA. Chronic “brain death”: Meta-analysis and conceptual
consequences. Neurology 1998; 51: 1538.
Veatch RM. Donating hearts after cardiac death—Reversing the irreversible. N Engl J Med 2008; 359: 672.
Bernat JL. The boundaries of organ donation after circulatory death.
N Engl J Med 2008; 359: 669.
Bernat JL, D’Alessandro AM, Port FK. Report of a national conference
on donation after cardiac death. Am J Transplant 2006; 6: 281.
Ethics Committee, American College of Critical Care Medicine; Society
of Critical Care Medicine. Recommendations for nonheartbeating organ donation. A position paper by the Ethics Committee, American
College of Critical Care Medicine, Society of Critical Care Medicine.
Crit Care Med 2001; 29: 1826.
Transplantation • Volume 88, Number 7S, October 15, 2009
15.
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17.
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21.
Institute of Medicine, National Academy of Sciences. Nonheart-beating
organ transplantation: Medical and ethical issues in procurement. Washington, DC, National Academy Press 1997.
Boucek MM, Mashburn C, Dunn SM, et al; Denver Children’s Pediatric Heart Transplant Team. Pediatric heart transplantation after declaration of cardiocirculatory death. N Engl J Med 2008; 359: 709.
DuBois JM, Delmonico FL, D’Alessandro AM. When organ donors are
still patients: Is premortem use of heparin ethically acceptable? Am J
Crit Care 2007; 4: 396.
Robertson J. The dead donor rule. Hastings Center Rep 1999; 29: 6.
Doctor Cleared of Harming Man to Obtain Organs Jesse McKinley.
New York Times, San Francisco, December 18, 2008.
http://www.cin.org/pope/organ-transplant-cloning.html.
Delmonico FL, Murray JE. A medical defense of brain death. Ethics
Medics 1999; 24: 1.
Current Considerations in Organ Transplantation and
Organ Donation
HISTORICAL DEVELOPMENT,
REGULATION, RESULTS, AVAILABILITY,
AND ACCESS
Ferdinand Muehlbacher
Regulation, Results, Availability, and Access
It all began with the dream of mankind to be able to
replace deceased organs to prolong life or quality of life.
According to a legend, the saints Cosmas and Damian
transplanted the leg of a black donor to a male recipient who
had lost his leg. Today, this would be a “Composite Tissue
Transplantation”.
In reality, however, the first successful kidney transplantation in an autologous setting was carried out by Ullmann (1) in 1902, when he took a kidney out of a dog and
transplanted it to the neck of the same animal. He was able to
demonstrate that a kidney that was removed, flushed and
transplanted to another site in the same animal was able to
produce urine. He did not observe any immunologic reactions because the system was autologous.
Carrel (2) developed vascular surgical techniques,
which were fundamental for both vascular and transplantation surgery. He was awarded the Nobel Prize in 1912 for his
pioneering work in vascular surgery. During the following
years, many attempts were made to transplant kidneys to uremic patients. The donors were in most cases animals and the
transplantation site was usually the cupidal area on the upper
arm. All these transplantations failed immediately and doctors had no explanation for these acute rejections.
In parallel, Landsteiner (3) described the agglutination
reaction in human blood, which led to the discovery of the
A-B-O blood system, which is still a basic principle in current
organ transplantation. Landsteiner was awarded the Nobel
Prize for his discovery of the A-B-O blood system in 1930.
The real explanation for the failure of all the early
kidney transplantations came from Gibson and Medawar
(4), who described the immunologic nature of skin rejection in 1943.
The same group published a landmark article in 1953
(5), a protocol which created specific tolerance by creating
The author declares no conflict of interest.
chimerism (6), a system which is still followed today to create
donor-specific tolerance (7, 8). Transplant surgeons who
were aware of the immunologic nature of rejection did not
have a strategy to prevent rejection, but they nevertheless
tried to develop a feasible transplantation site for kidney
transplantation. David Hume transplanted kidneys in the
subcutaneous region of the thigh, whereas René Küss, a urologist from Paris, designed the operation technique, which is
used in most kidney transplantations today: the iliac fossa of
the recipient. In addition, Küss tried to lessen rejection by
selecting a biologically related donor-recipient combination:
a mother donated one of her kidneys to her 17-year-old son.
Despite this close relationship (haploidentical), the transplant failed several weeks after transplantation and the patient died (9).
A total circumvention of the immunologic barrier was
achieved in a transplantation between identical twins on December 23, 1954, by John Merrill and Joseph E. Murray at the
Peter Bent Brigham Hospital in Boston.
Strategies to overcome the immunologic barrier are as
follows:
• Special donor-recipient constellations
• Identical twins
• Human leukocyte antigen (HLA) matching
• Immunosuppression
• Radiation
• Chemical
• Biologicals
• Tolerance induction
A further strategy to prevent immunologic rejection
became possible because of the discovery of the HLA system
by Dausset, Jon Van Rood and Bernard Amos, and in consequence the selection of the best possible donor-recipient
combination. This led to “HLA matching”, a concept which
has been confirmed by thousands of patients to date and is
still valid as an allocation principle (10).
Joseph Murray, the surgeon who performed the first
successful kidney transplantation in identical twins, investigated the feasibility of total body irradiation (TBI). His
colleague, John A. Mannick, was the first to demonstrate
long-term survival in renal transplantation in dogs after
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TBI and methotrexate, an agent used in the treatment of
cancer (11).
Küss and Jean Hamburger competed with Murray and
Merill in Boston, step-by-step, from identical twin transplantation to non-related transplantation with various body irradiation protocols (e.g. TBI). Calne (12) was the first to develop a drug called 6-mercaptopurine as a successor of
methotrexate. In parallel, Thomas Starzl and coworkers (13),
in Denver, applied steroids for rejection treatment and thus
had a protocol in hand, which enabled him to achieve longterm graft survival in a few cases.
With the same immunosuppressive method, liver
transplantation was developed by Starzl in Denver, Colorado in 1963 and by Sir Roy Calne in Cambridge, England
in 1968. Calne was one of the first to develop a derivative of
6-mercaptopurine, azathioprine, in the clinical setting, which
along with steroids became the standard immunosuppression in the 1970s. Henry Bismuth in Paris and Rudolph
Pichlmayr in Hannover were also pioneers in the development of liver transplantation on the European continent,
but they all suffered from a low-level immunosuppressive drug
regimen. The first long-term survivers of liver transplantation
were observed in Denver, Colorado, when Thomas Starzl turned
to pediatric liver transplantation, enabling several children who
had previously suffered from biliary atresia to survive for more
than a year.
Heart transplantation was pioneered by Norman
Schumway and Richard Lower in the 60s. The first clinical
heart transplantation was performed on December 3, 1967,
by Christian Barnard in Capetown, South Africa (14).
First Regulatory Attempts
As early as 1978, the European Council issued the
resolution (78/29), which was adopted by the Committee
of Ministers of the Council of Europe on May 11, 1978, as
well as an explanatory memorandum. In this resolution,
the European Council laid down basic rules of organ transplantation and organ donation and proposed to adopt a
presumed consent regulation, which was finally introduced to national legislation in 13 member states of the
European Council.
In 1978, Borel (15), from the research laboratories at
Sandoz in Basel, Switzerland, discovered the immunosuppressive properties of cyclosporine A, which was then developed for clinical use by Calne and coworkers and became
available in 1983 for clinical use for all organ transplantations.
The availability of this new drug led—along with several
other cofounding factors—to an explosive development of
liver transplantation. Many transplantation centers developed rapidly. In Europe, the number of transplantations
increased from a few hundred to 5000 per year within the
next 20 years. But it became clear that there was a limitation to this development because organ availability was
limited.
Living donation in liver transplantation was developed
first by Broelsch (16) in Chicago, but most of the experience
in living donor liver transplantation was made in Japan in the
following years, due to the lack of deceased donors for cultural reasons.
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Current Standard
With the available techniques for kidney, liver, heart,
lung and pancreas transplantation and with immunosuppressive agents of the calcineurin inhibitor type, such as
cyclosporine A and tacrolimus, solid organ transplantation
became a standard all over the world. In 2006, 96,828 solid
organ transplants were carried out in 93 countries of the
world; of which, 65,511 kidney transplantations, 20,366 liver
transplantations, 5313 heart transplantations, 3051 lung
transplantations and 2559 pancreas transplantations are recorded and published in the Transplant Newsletter (17).
Transplantation in Europe developed according to the
diverse health care systems of the countries involved. Ways of
gaining donor consent, procurement logistics, tasks and performance of transplant coordinators, financing system and,
of course, the legal framework in the various countries, differ
greatly. Despite all the diversity, a substantial amount of organs are procured in the European countries, however, with
greatly varying degrees of success. The top runner in the last
20 years is Spain with 34 donors per million inhabitants; the
lowest donor rate is found in Romania and Bulgaria at 1.7 and
1.3 donors per million, respectively. There is much work
ahead of us, if we are to improve organ donation in these new
member states of the European Union.
The Effect of Modern Transplantation Medicine
Survival
The top runners in patient survival are recipients of
live-donor kidneys, with 95% of the organs surviving for at
least 1 year and 90% for 5 years. Heart and liver recipients
have survival rates of 82% for 1 year and 70% for 5 years,
respectively. Lung recipients show similar results at 1 year,
but only 55% for 5 years. This number will improve in the
near future because lung transplantation is the “youngest
branch” of organ transplantation and there is still a learning curve to account for (18) (Fig. 1).
Comparing survival rates of patients on dialysis with
the normal population shows a 30% to 40% chance of survival, dependant on age. Kidney transplantation raises the
rate of patient survival immediately to 60%, in higher ages to
70%. It is important to note that not even successful renal
F1
C
O
L
O
R
FIGURE 1. Percentage of graft survival throughout the
years (1985–2006).
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transplantation can normalize survival chances in the population suffering from end-stage renal disease (19).
The transplant operation itself increases the risk of
death by a factor of 2.84. The risk breaking-even point is at
106 days, and in the long term the risk of death compared
with patients on dialysis is reduced to 32% (20).
Similar observations were made in a cohort of heart
transplant recipients who were compared with stable heart
failure patients, in which the operative risk reduces the survival rate within the first 3 years to 80%. But in the long term,
after 10 years, the survival rate of patients with successful
heart transplantations is in the order of 70% versus 47% in
stable heart failure patients.
Quality of Life
As for quality of life, patients on dialysis are kept alive,
but many of them suffer from dietary restrictions, fluid intake
restrictions, deterioration due to comorbidities, such as vascular diseases, and sometimes hemodynamic effects around
the dialysis procedure. Kidney transplantation returns them
to an almost normal life. A quality of life survey carried out in
heart transplant recipients shows that the physical complaints
encountered preoperatively almost disappear in the course
of the following 10 years. A similar observation can be
made with psychologic and emotional complaints, which
improve dramatically after heart transplantation (21). The
improvement in the quality of life is best seen in daily
clinical practice (22).
Is Transplantation Available to Everybody?
With regards to kidney transplantation, the top running countries show a kidney transplant frequency between
40 and 55 per million per year for both deceased donor organs
and live donor organs. In these countries, waiting time is in
the range of 1 to 2 years, whereas in countries with transplant
frequencies of only 35 per million per year, the average
waiting time increases up to 6 years. With transplant rates in the
order of 10 to 15 per million per year, waiting times become
unacceptable, with many patients never receiving a kidney.
In addition, renal transplantation is a highly efficient
way of treating patients suffering from end-stage renal disease. In Austria, for instance, the number of patients suffering
from kidney failure rose from 2500 in 1987 to 8000 in 2007.
This increase is explained by the extended life expectancy in
the general population, and, as a matter of fact, the higher
numbers are due to patients beyond the age of 65 years.
Almost 50% of this population have successfully undergone renal transplantation, whereas the number of patients on dialysis eligible and suitable for transplantation
has remained constant at approximately 800 during the
last 11 years. Patients on dialysis not suitable for transplantation have a very short life expectancy of only a few years.
Death on the waiting list is an additional concern at the
Vienna Transplantation Centre; 23% of patients awaiting
liver transplantation die on the waiting list because of a
lack of alternative treatment for chronic liver failure. Similarly, death on the waiting list in heart transplantation is
approximately 15%, whereas death on the kidney waiting
list is under 5%, because of the possibility of renal replacement therapy on dialysis.
Transplantation • Volume 88, Number 7S, October 15, 2009
Is There Equal Access to Transplantation
Treatment?
Seven countries in Europe (Germany, Belgium, the
Netherlands, Luxembourg, Austria, Slovenia and Croatia) are
intensively cooperating in organ allocation in a foundation
called Eurotransplant. These countries, with a combined
population of 120 million inhabitants, maintain common
waiting lists for organ allocation, with varying levels of organ
exchange. For kidneys, all organs are distributed through the
computer program in the Eurotransplant headquarters in
Leiden, the Netherlands, whereas nonrenal organs are allocated either through a national waiting list or through agreed
protocols within the center. However, the mandatory exchange of acutely needed organs all over the Eurotransplant
area is served first, if an appropriate organ is available. This
applies to combined transplantations, and in the case of kidney programs, also to highly immunized patients. There are,
however, certain prerequisites to maintain this system, one of
them being 100% of prospective donors reporting to the central office in Leiden. This office finally decides either on the
level of the center or on that of the individual patient, who is
to receive which available organ, according to agreed upon
algorithms.
Problems and Side Effects
Organ transplantation is a full success story and there is
a common saying that “organ transplantation is a victim of its
own success”. With a high success rate, the demand increases
and is only limited by organ availability.
In addition, for the time being, all organ transplant
patients need immunosuppressive medication in order to
achieve pharmacological tolerance to avoid acute or chronic
organ rejection. The available drugs effectively suppress rejection, however, they have severe side effects, which are in part
harmful to the newly transplanted organ, or may otherwise
affect other organ systems. Finally, they generally increase the
risk of developing new malignant diseases. Recipients of heart
or lung transplants have a 25% to 30% risk of developing a
malignant tumor within 10 years. In liver and kidney recipients, the risk is in the order of 15%, in live donor kidney
recipients 8%, probably reflecting the total amount of immunosuppressive agents consumed (18, 23).
A possible way to avoid these side effects can be the
development of true transplantation tolerance, a top priority
project at many transplantation centers all over the world
with— until now—mixed success, but with potential clinical
application in the next 10 to 20 years.
Summary
Organ transplantation has been established as the standard treatment for end-stage organ failure within the last 40
years and has reached a high level of performance to improve
life expectancy and quality of life. Current strategies yield
acceptable results, but organ shortage and the pharmacological immunosuppression currently applied are still the
major limitations of its success story, which started just
100 years ago.
References
1.
Ullmann E. Experimentelle Nierentransplantation. Wien Klin Wochenschr 1902; 15: 11.
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Carrel A. The transplantation of organs. N Y Med J 1914; 99: 839.
Landsteiner K. Über die Aggultinationserscheinungen normalen menschlichen Blutes. Wien Klin Wochenschr 1901; 14: 14.
Gibson T, Medawar PB. The fate of skin homografts in man. J Anat
1943; 77: 299.
Billingham RE, Brent L, Medawar PB. “actively acquired tolerance” of
foreign cells. Nature 1953; 172: 603.
Kingsley CI, Nadig SN, Wood KJ. Transplantation tolerance: Lessons
from experimental rodent animals. Transpl Int 2007; 20: 828.
Wekerle T, Kurtz J, Ito H, et al. Allogeneic bone marrow transplantation
with co-stimulatory blockade induces macrochimerism and tolerance
without cytoreductive host treatment. Nat Med 2000; 6: 464.
Fehr T, Sykes M. Clinical experience with mixed chimerism to induce
transplantation tolerance. Transpl Int 2008; 21: 1118.
Küss R, Teinturuier J, Milliez P. Quelques essais de greffe de rien chez
l’homme. Memoires de l’Academie Chirurgique 1951; 77: 755.
Dausset J. Iso-leuco-anticorps. Acta Haematol 1958; 20: 156.
Mannick JA, Lochte HL Jr, Ashley CA, et al. A functioning kidney
homotransplant in the dog. Surgery 1959; 46: 821.
Calne RY. The rejection of renal homografts. Inhibition in dogs by
6-mercaptopurine. Lancet 1960;1: 417.
Marchioro TL, Axtell HK, Lavia MF, et al. The role of adrenocortical steroids in reversing etablished homograft rejection. Surgery 1964; 55: 412.
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Barnard C, et al. Human heart transplantation. S Afr Med J 1967:
1257.
AQ: 26
Borel JF, Feurer C, Gubler HU, et al. Biological effects of cyclosporin a;
a new antilymphocytic agent. Agent Actions 1976; 6: 468.
Broelsch CE, Whittington PF, Emond JC, et al. Liver transplantation in
children from living related donors. Surgical techniques and results.
Annal Surg 1991; 214: 428.
Transplant Newsletter vol. 13, Nr. 1. November 19, 2008.
Collaborative Transplant Study. Available at: http://www.ctstransplant.
org/.
Kramar R, Oberbauer R. Österreichisches Dialyse und Transplantregister, ÖDTR, Jahresbericht 2007 der Österreichischen Gesellschaft für
Nephrologie.
Wolf RA, et al. N Engl J Med 1999: 1762.
AQ: 27
Bunzel B, Laederach-Hofmann K, Grimm M. Survival, clinical data
and quality of life 10 years after heart transplantation: A prospective
study. Z Kardiol 2002; 91: 319.
Kousoulas L, Neipp M, Berg-Hock H, et al. Health-related quality of
life in adult transplant recipients more than 15 years after orthotopic
liver transplantation. Transpl Int 2008; 21: 1052.
Gaumann A, Schlitt HJ, Geissler EK. Immunosuppression and tumour
development in organ transplant recipients: The emerging dualistic
role of rapamycin. Transpl Int 2007; 21: 207.
Legal Considerations of Organ Donation in Various
Countries
AUSTRIA
Walter Schaupp
A Presumed Consent Policy
Deceased organ donation and transplantation has been
regulated in Austria as part of the 1982 Federal Hospitals Act
(1). First of all, it is important to notice that the respective
sect. 62 refers to the “removal of organs and parts of organs”
of deceased persons with the intention of transplantation.
Questions of living donation, organ allocation or other possible use of cadaveric organs and tissues beyond transplantation are not covered by this law.
In sect. 62, Austrian law prescribes a clear cut opting-out
or presumed consent policy. The original German notion is “die
enge Widerspruchslösung”, which literally means “narrow objection-solution”: every deceased person is a potential organ donor as long as he or she, or his or her legal representative, has not
made a declaration at the time of living, explicitly refusing the
use of his or her organs for transplantation. Family members do
not have the right to object. (An “extended objection-solution”
[“erweiterte Widerspruchslösung”] would extend the right to
object to family members).
Compared with the original draft, the existing version
of sect. 62 represents a notable progress in strengthening the
right of individuals to dispose of their own deceased body.
The working group had proposed to allow organ removal
without any restriction whenever this could “save the life” or
“restore the health of another person”. Juridically, this would
have represented a kind of “emergency regulation” (“Notstandsmodell”). The proposed formulation: “It is allowed to
remove organs or parts of organs of deceased persons for transplantation, in order to save the life or to restore the health of
another person”, has been amended by adding the clause “the
The author declares no conflict of interest.
retrieval is not allowed if there is a declaration at hand to the
physicians by which the deceased person or, before his or her
death, the legal representative, has expressly refused organ donation” (3).
Other relevant topics of sect. 62 are as follows: determination of death by an independent physician, prohibition of
commercialization, anonymity of donors and recipients, reference and respect for the human body and obligation for
physicians and health institutions to consult the opting-out register before every planned explantation.
Objection to Postmortem Organ Removal
According to the Austrian law, a legally valid objection
can be made in three ways: (1) Oral, for instance to relatives
who later testify to the physician; (2) Written, for instance by
a short written declaration of will, carried with the identification papers or enclosed within the clinical records; (3) Registration in the central opting-out register at the Austrian
Federal Institute for Health Affairs (Österreichisches
Bundesinstitut für Gesundheitswesen [ÖBIG]).
Physicians are obliged by law to consult the central register before every planned explantation (sect. 62 e), but they
will also respect any written statement at hand and any testified will of a deceased person. However, they are not obliged
to search actively and extensively for a possible objection.
The Opting-Out Register
In 1995, a central nationwide opting-out register was
established, which is currently maintained by the aforementioned Austrian Institute for Health Affairs (ÖBIG). To be
recorded, one has to order a form, fill it in, sign and submit it
back. The objection can be revoked at any time. For the time
being, foreigners (non-residents) can also have their name
recorded in the register. Collective registrations, however, are
not accepted (4). Although the register had been imple-
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mented in 1995, an explicit legal obligation for physicians and
health institutions to consult the register had not been formulated before 2004 (4).
Within 2007, 2087 persons have had their names recorded in the register; at the end of December 2007, there had
been a total amount of 14,992 entries, 13,595 of them residents and 1397 non-residents. The residents registered
amounted to 0.18% of the Austrian population (ÖBIGTransplant 2008, 29). By November 2008, the number of registrations had risen to 18,180, which accounts for 0.22% of
the Austrian population.
Special Donor Groups
Minors
In principle, there is no limitation of age with respect to
organ removal. Newborns and minors (under the age of 16
years) are potential donors as long as their legal representative
has not objected to donation. To be valid, such objection has
to be made before the death of the child.
At a practical level, however, there are two important
age limits: for persons under the age of 14 years, legal representatives have full authority to object. Between the age of 14
and 16 years, a minor can recall the objection to donate made
by his legal representative if he is psychologically competent;
his personal objection would also be respected in the case of a
missing objection from his legal representative (3).
Non-residents
Austrian Transplantation Law is implemented according to the principle of territoriality. This means that nonresidents, such as tourists from other countries, are regarded
as potential organ donors. If they want to prevent the removal
of their organs, they have to carry a written statement with
them, which will be respected. As mentioned earlier, they also
have the possibility to have their name entered in the central
opting-out register.
Other Limits to Organ Removal
Respect for the Visible Integrity and Dignity of the
Deceased Body
If no objection has been made by the deceased donor,
the law allows for the removal of “individual organs or parts
of organs” only if the visible integrity and the dignity of the
deceased body is not violated: “the removal must not result in
a deformation of the body which violates the respect for the
dead body” (sect. 62 a-1). According to the current legal interpretation, this clause is consonant with the explantation of
individual organs, with multiorgan-donation and with the
removal of tissues for transplantation (skin, heart valves and
corneas). As the annotations to sect. 62 a-1 suggest, in cases of
doubt, considerations regarding the life and the health of the
potential recipients should prevail.
A point of discussion has considered whether the removal
of body parts such as hands are also covered by the presumed
consent policy. Some are of the opinion that if the visible integrity of the body is severely distorted, consent of the relatives (or
of the deceased person) should be guaranteed.
Other Purposes than Transplantation
The use of procured organs for other purposes than
transplantation such as research or pharmaceutical interests,
Transplantation • Volume 88, Number 7S, October 15, 2009
is not allowed under the presumed consent policy of sect. 62 a.
Organs that are removed but then discarded have to be buried.
Acting against this policy would constitute an infringement of
sect. 190 of the Austrian Criminal Law (“Disturbing the peace of
the dead”). There is a similar problem with respect to the usage
of organs retrieved in the course of a routine postmortem autopsy. In contrast to a more liberal attitude in the past, legal
consensus is growing that any usage of such organs beyond diagnostic purposes would require the explicit consent of the deceased person or, at least, of family members (3).
Living Donation
At the present time, there is no explicit legislation on
living donation. The legal assessment follows common principles of positive Civil and Criminal Law. First, the retrieval of
an organ from a living person, according to sect. 90, Crimincal Law (2), constitutes a severe act of bodily injury. Therefore, personal and informed consent is mandatory in each case
of living donation. Exceptions are tolerated only in the case of
minimal bodily interventions, such as the donation of bone marrow by a minor sibling. The intervention must not be “contra
bonos mores”, which in this context means that no vital organs
must be removed irrespective of a given consent. There is no
restriction of living donation to genetically or emotionally related persons as in German law. Non-related donation and exchanged donation are allowed and practiced (3).
Communication With Family Members in
Cadaveric Donation
As we have seen, Austrian Law does not oblige physicians to inform the family members of a deceased donor and
it would also allow organ removal if the family members object to the procedure. Acting according to these principles,
however, has shown to be counterproductive for transplantation medicine. In some cases, it has deeply offended the
feelings of family members and provoked reactions in the
public sphere.
As a consequence, ÖBIG-Transplant (Austrian Federal
Institute for Health Affairs, Department of Transplantation)
released internal guidelines, some years ago (5), which among
others, wanted to harmonize diverging policies and attitudes
within the transplantation community with respect to the
problem of how to deal with family members in the course of
deceased organ donation. The main concerns of these guidelines
are: (1) If family members are present, they should be informed
and should be brought to accept the donation procedure; (2) If
they are informed but continue to object, no explantation
should take place; (3) In the case of a child or a non-resident,
extreme caution is recommended and organs should only be
removed in accordance with family members (5).
This policy will probably result in a slight decrease in
the organ donation rate (about 10%) (Ferdinand Muehlbacher, Vienna, personal communication, November 2008).
On the other hand, it will surely strengthen and promote
public trust in transplantation medicine.
Discussion
One could doubt if the Austrian model takes the idea
of a basic societal consent to routine organ donation seriously enough. The right to presume such a basic consent requires certain standards of public awareness of the problem,
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discussions, deliberation processes and information about
the possibilities to object to donation. Many Austrian citizens
are neither aware of the possibility to object nor of the way of
how to object. The law does not require concrete efforts of
public information and education. The low percentage of registrations in the opting-out register certainly reflects this situation and cannot be interpreted exclusively as a result of a
high rate of reflected positive judgements on organ donation.
Conversely, this situation is outweighed, to a certain extent,
by high transplantation rates. Moreover, the experience of the
author as a university teacher shows that students, when informed about the legal and medical aspects of organ transplantation in Austria, would typically wonder about the fact
that they have not been confronted with the problem earlier,
but they would not oppose the Austrian solution in principle. Discussion of the concept of brain death for instance
is much more sensible and regularly provokes deeper controversy than debates on the moral adequacy of the current
opting-out system.
In summary, the Austrian opting-out system will only
be successful and ethically justifiable in the long run if three
vital conditions are guaranteed: (1) Ongoing sensibility in the
communication with relatives and respect of their feelings
and wishes. The cited ÖBIG-Transplant guidelines can be
seen as a move in the direction of an “extended opting out
policy” (“extended objection-solution”), which also gives a
right to object to family members; (2) Better public information and education to enable reflected attitudes and judgements on organ donation on a collective and on an individual
level; (3) No commercial or research use of removed organs
and tissues under the existing presumed consent policy. The
original justification for the existing presumed consent policy
has been the direct and immediate life (and health) saving
intention of transplantation medicine. In research and pharmaceutical contexts, health interests are present but not in
such an urgent and pressing way.
References
1.
2.
3.
4.
5.
Austrian Federal Hospitals Act (Österreichisches Krankenanstalten
und Kuranstaltengesetz; KAKuG).
Austrian Criminal Law (Österreichisches Strafgesetzbuch; StGB).
Kopetzki, Christian: Organgewinnung zu Zwecken der Transplantation. Eine systematische Analyse des geltenden Rechts, Vienna
1988.
“Koordinationsbüro für das Transplantationswesen. ÖBIG-Transplant:
Jahresbericht 2007, Wien Mai 2008.” (http://www.goeg.at/media/
download/berichte/TX-JB_2007.pdf).
ÖBIG-Transplant: Internal Guidelines 5 & 6 (Legal Principles; Communication with Family Members (Leitfaden 5 u. 6: Rechtliche Grundlagen; Kommunikation mit den Angehörigen), 2005.
UNITED STATES
Alexandra K. Glazier
xplicit consent is the fundamental legal principle underlying organ and tissue donation in the United States. Accordingly, the United States maintains a true “opt-in” system
for donation. There are, however, differences in the legal constructs supporting consent to deceased organ donation as
compared with living donation. Consent is achieved in the
deceased donation context under a legal framework of gift
E
The author declares no conflict of interest.
S131
law, whereas consent for living donation relies on the informed consent doctrine. The following is a summary overview of gift law principles with respect to consent for deceased
donation in the United States and an examination of the significant legal and practical differences that exist between gift
law (consent for deceased donation) and the framework of
informed consent (consent for living donation).
Deceased Donation: The Law of Anatomical Gifts
The donation of an organ from a decedent is considered an “anatomical gift” under US law (1). The legal origins
of this began in 1968 when the Uniform Anatomical Gift Act
(UAGA) first defined organ donation through a gift law construct. Today, the UAGA has been adopted as law—with some
variation—by all 50 states and the District of Columbia (2).
Under US law, gifts of any type must fulfill three basic
elements to be legally recognized: (a) There must be donative
intent; (b) The gift must be physically transferred or delivered; and (c) The gift must be accepted (3). Once all three
criteria are met, the gift is complete and enforceable under the
law. Although a gift is distinguishable from a contract in several important ways (including, most notably, the lack of payment), gift law is firmly rooted in legal principles of property.
To “give” is understood under US law to mean “the act by
which the owner of a thing voluntarily transfers the title and
possession of the same from himself to another person without consideration” (4).
The law of anatomical gifts follows the general law of gifts.
An anatomical gift under the UAGA requires: (1) Donative intent expressed by the donor or donor’s family; (2) Recovery
of the organ on the donor’s death; and (3) Acceptance of
the anatomical gift by a donee. An anatomical gift is the
voluntary and uncompensated transfer of an organ from the donor to the recipient.
The legal requirement of donative intent is met under
the UAGA through a “document of gift”, which is simply the
documentation of consent to the donation. By consenting to
donation, the donor expresses an intent to make an anatomical gift after death. A legally binding document of the gift can
be through a donor registry, donor card or other signed document (5). Alternatively, if a potential donor has not made his
own decision regarding donation, then the donor’s family, in
a specified order, may consent to anatomical gifts to be recovered after the donor’s death (6).
Under the UAGA, an anatomical gift is “conditional”
on the death of the donor. Accordingly, once consent exists
and after the donor has died, the gifted organs may be surgically
recovered, transferred and accepted by a qualified third-party for
the specified purpose (in most instances transplantation or research) (7). The recovery and subsequent transplantation of donated organs thereby fulfills the second and third criteria of the
donation as a legally valid gift.
Notably, the anatomical gift law construct for deceased
donation in the United States does not incorporate an informed consent standard, as that term is understood under
the law. Although surprising to some given that informed
consent is a pinnacle legal doctrine of health care, the law
clearly views deceased donation as anatomical gifting and not
as a healthcare decision for the donor. The informed consent
doctrine fundamentally requires the consenting party to
make a decision regarding a proposed healthcare treatment
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or procedure through a facilitated understanding of the attendant risks and benefits. There are, however, neither risks
nor benefits of donation to the deceased donor.
Furthermore, the legal duty to obtain informed consent
is borne out of the doctor-patient relationship. The decision
to donate organs, however, may (and often does) occur completely outside of such a fiduciary relationship. For example,
an individual may decide to consent to organ donation by
signing a donor card in the privacy of his home or by registering as a donor during the driver’s license renewal process.
This consent event could be months, years or even decades
before the donor’s death. Criticisms of the US donor registry
system often focus on the lack of informed consent. The process of registering as a donor is not, however, designed to
meet legal informed consent standards. Rather, the act of registering as a donor fulfills the legal requirement of documenting the donor’s intent to make an anatomical gift and to
voluntarily transfer organs to another.
Some have argued that the informed consent standard
for human subject research in the United States (which is
established by regulation and applies only to living individuals) should be used as a model for consent to deceased donation (8). Informed consent in the human subject context,
however, focuses on the subject’s understanding of the risks
and benefits of participation in the research. These considerations are not relevant in the deceased donation context, because organ donation occurs after the donor’s death, thereby
eliminating the experience of either risks or benefits.
Gift law accommodates these realities of deceased donation. As with other types of gifts, a person may choose to
inform themselves or remain uninformed but the legal ability
to make an anatomical gift remains. Outside of the gift law
context, other post-death decisions (such as burial or cremation) are similarly not required to meet an informed consent
standard. In fact, individuals may sign advanced health care
directives (including “do not resuscitate”) without any legal
requirement that these significant decisions meet an informed consent standard. Most agree that potential donors or
donor families should be directed to information that may
assist in the donation decision making. It is nonetheless important to understand donor registries and other donation
consent practices in the United States within the legal constructs of anatomical gift law.
It is worth noting that consent to organ donation after
cardiac death (DCD) is a unique circumstance that incorporates legal concepts from gift law as well as the informed consent
doctrine. The potential DCD donor may have already made an
anatomical gift conditional on death, but there must be a decision to withdraw support preceding the donation of organs after
the donor’s death. The withdrawal of support requires informed
consent from the patient’s legal surrogate even if the patient had
previously consented to organ donation. For this reason, DCD
necessitates attention to both legal principles (Fig. 1).
The result is an interesting combination along the continuum of legal principles of consent for deceased donation,
which is founded in anatomical gift law, and the informed
consent principles that govern consent to living donation, as
discussed further later. This is not surprising; DCD falls under the deceased donation category as the dead donor rule
remains paramount in the United States (even if clinical debate exists over appropriate time intervals before death dec-
Transplantation • Volume 88, Number 7S, October 15, 2009
FIGURE 1. Legal constructs of donation after cardiac
death in the United States.
laration). But, DCD also requires coordination with end of
life decisions to withdraw support separate and aside from the
donation itself. Although some have raised concerns that
DCD oversteps legal boundaries of organ donation, the reality is
that DCD cannot proceed without appropriate consensus from
the care providers and the donor’s family. The convergence of
these events (withdrawal of support and subsequent deceased
donation) draws on both legal constructs. As a practical matter,
this requires obtaining informed consent for the withdrawal of
care and any premortem interventions and consent for an anatomical gift.
Living Donation
Living organ donation fundamentally involves a healthcare decision (surgical explant) with risks and benefits to the
living donor. The law recognizes a fiduciary duty formed by the
special relationship between the transplant surgeon and the living donor. This fiduciary duty gives rise to the legal obligation on
the part of the surgeon to obtain informed consent before performing the surgical recovery of the donated organ. As a result,
the legal principles underlying consent for living donation are
firmly grounded in the informed consent doctrine, which establishes the patient’s right to provide or withhold consent for
health care options after understanding the risks and benefits.
This informed consent standard in living donation has been the
subject of recent regulation (9).
This reliance on the informed consent doctrine for consent to living donation should not, however, limit the legal
understanding of the donated organ as a gift. Although no
reported legal opinions yet exist in the United States, the legal
status of the donated organ is likely to be understood as an
anatomical gift regardless of the fact that the donor was living
at the time that the gift was made. In the context of donated
research tissue from living subjects, courts have held that even
though the excision of the tissue may require informed consent under the human subject regulations, once given, the
tissue may be properly understood as a donation subject to
gift law (10). Similarly, the donation of an organ from a living
donor requires informed consent but once removed, the organ may be properly categorized under the law as an inter
vivos gift. Such a gift should be legally enforceable after delivery to and acceptance by the transplant recipient. This analysis would preclude an assertion of rights by the donor over a
donated organ once the organ has been transplanted into the
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recipient. The gift status of a donated organ, regardless of
whether the donor was living or deceased, provides the transplant recipient with consistent legal authority to continued
possession of the transplanted organ.
References
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Uniform Anatomical Gift Act (“Anatomical Gift” includes deceased
donation of organs and tissues). 2006. Available at: http://www.
anatomicalgiftact.org.
Uniform Anatomical Gift Act (2006).
Rubenstein v. Rosenthal, 140 A.D. 2d 156, 158 (1988).
Black’s Law Dictionary 338 [ed 6]. 1991.
Uniform Anatomical Gift Act, Section 2 (6).
Uniform Anatomical Gift Act, Section 9.
Uniform Anatomical Gift Act, Sections 11.
45 C.F.R. §46.102(f) and §46.116.
45 C.F.R. §482.102.(b).
Washington University v. Catalona, 437 F. Supp. 2nd 985 (E.D. Mo. 2006);
see also Greenberg v. Miami Children’s 264 F. Supp. 2nd 1064 (2003);
Moore v. Regents of the University of California, 793 P2d 479. 1990.
ITALY
Alessandro Nanni Costa
F1
The Role of Society
The organ donation transplantation process implies a
massive effort and engagement both by health professionals
and by society itself. In fact, among the different medical
fields, transplantation may be the only one that depends on
peoples’ decision to give; to be solid for those who suffer.
Therefore, society is the major protagonist of this delicate
process, because without donation there can be no transplant.
Society is formed by individuals who might decide to be prodonation. Once this happens, society becomes a source, the
unique source, of donors, but the donor pool would not be
helpful at all to the suffering if there was not a well organized,
safe and highly skilled team of health professionals all over the
country. This team is our national transplant network, whose
management is assured by the National Transplant Centre
(CNT) coordination, with the necessary support of interregional and regional transplant organizations. Transplantation brings the patient back to normal life and into society,
thus the transplant system is a means to close the life cycle of
people who had to stop their usual activities because of an
organ severe insufficiency.
This cycle is graphically represented by the Italian CNT
logo (Fig. 1). People holding hands stands for a united society
where everyone has understood that giving means to receive.
Among us, there are transplanted people (the one with the red
spot) who are necessary rings of the whole human chain. The
red line symbolises the transplant network activity, which
binds people by closing the chain.
S133
value of the Italian network is the activity, follow-up and survival data publication per transplant center (Fig. 2).
Italy is, in fact, the only European country who publishes such a detailed activity. By doing so, transparency is
total and data are easily comparable by experts and by the
general public. Electronic data processing and analyses are
performed by the Transplant Information System (1) located
at the CNT, where electronic entries inserted by transplant
operators all over the country are collected and processed.
Final data include yearly figures on the number of transplants
performed (pediatrics and adults), percentage of follow-up
reported, and organ and patient survival after transplant (Fig.
3). Analysis of the data collected also makes it possible to
receive international, external evaluation about transplantation in italy, as shown by the excellent results published by the
collaborative Transplant Study (Fig. 3).
F3
Donation: A Topical Issue
The Italian transplant network is not only engaged in
improving transplant outcomes, but also strongly involved in
spreading donation culture among citizens at all social levels,
by promoting yearly donation campaigns along with the
Ministry of Health, organizing congresses on major topics
and by enriching the website (2) with activity data, news and
useful information for patients and their families. The Italian
transplant network would not reach citizens and patients
without the necessary collaboration provided by volunteers’
and patients’ national associations whose presence among
citizens is widespread and consolidated throughout the years.
The most powerful means of spreading donation culture
is to reach the youngest and make them discuss the topic at home
with their families. This is why the CNT and the Ministry of
Health entered universities, as well as primary and secondary
schools with dedicated tools and projects. The aim of CNT and
of the whole Italian transplant network was twofold: on one side
to promote and spread donation culture to raise the number of
donors, on the other side to take care of patients waiting
for a transplant, as well as of their families, and of their
post-transplant conditions through a periodic follow-up to
bring them back to normal life and reintegrate them into society.
Taking Care of Patients: A Priority
Every medical field requires an accurate care of the patient and his family, but maybe transplantation needs to go a
little further. There is in fact a double aspect; a donor giving
Gaining Trust: A Daily Challenge
Organs, cells and tissues are a public asset, therefore,
transparency is the primary goal of allocation procedures and
of the network’s activity in general. Transparency is the basic
parameter to obtain the trust of people and patients. The
Italian transplant network achieves this ambitious goal by
providing and publishing monthly up-to-date waiting lists
and donation transplantation activity data, but the added
The author declares no conflict of interest.
F2
C
O
L
O
R
FIGURE 1. The Italian National Transplant Centre logo.
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Transplantation • Volume 88, Number 7S, October 15, 2009
C
O
L
O
R
FIGURE 2. Quality data regarding patient and graft survival in Italian heart transplant centers. All quality data are
available on www.trapianti.ministerosalute.it.
FIGURE 3. Comparison between Italian and European
data on percentage of graft survival.
an organ and a recipient receiving it. Both patients and their
families must be taken care of with extreme attention on both
physical and psychologic aspects, directly in hospital. All patients
need adequate information (where to go, whom to talk with and
what to expect). The patient’s family religious belief must be
totally respected; there must be a comfortable reading room
and specific rooms for meetings between the family and
health professionals, especially when they have to discuss the
donating option. This means that in each hospital, specific reception structures and dedicated space should be created to receive patients and their families in the most proper way.
Particular attention must be paid to patients waiting for
a transplant. Information on enrollment onto waiting lists
must be provided in the clearest way and the physical and
psychological care of the patient must be a priority. Patients
have the right to information on the transplant type they are
undergoing, waiting list time expectation, outcomes and obviously, possible risks.
A National Prompt Network
Organizing the donation-retrieval-transplant process is a
crucial issue, because it requires specific management, a solid
health organization and strict operational protocols and procedures (4, 5). As far as the Italian Transplantation is concerned,
the management is lead by national, interregional and regional
institutions and each time a transplant is performed about 150
people, of at least 10 different medical équipes, are involved and
working together. The Italian transplant system is, for sure, a
quality model for all health sectors and organizations (6).
Moreover, it can avail itself of the expertise of “second
opinion” advice from a group of five health professionals,
who are available 24 hours a day, 365 days a year (one legal
physician, one histopathologist, one infectivologist and
two CNT physicians). These practitioners can be contacted
by transplant centers and regional transplant coordinators through
encoded procedures for particularly complex cases.
The toughest issue in this specific medical field is the allocation of a scarce good i.e. an organ. It is of absolute importance
for transparency and ethics to be the protagonists of this daily
challenge. Physicians and the system must respect ethical aspects, clinical and therapeutic needs, the rights of the donor and
recipient, as well as perform in total objectivity and equity. Categories such as emergency and pediatric patients are to be prioritised.
During the last few decades, transplantation underwent
major changes on both a technical and organizational level, especially after the approval of the Italian “Transplant Law” (7).
Innovation and development are, thus, two keywords of transplantation progress and research can be identified as one of the
most important driving forces for this fields’ activity.
Transplantation and Sport: New Approaches to an
Old Topic
Donor and volunteer associations have a long established and well-built experience in organizing sporting activities for transplant patients such as marathons, soccer
matches and ski competitions. The CNT recently decided to
start up a dedicated research and activity line with the vision
of sport as a propelling force for:
Physical rehabilitation
Self enhancement of the patient
Reintegration into society
Psycho-emotional rebirth
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Positive image communication
Strong impact on media
Healthy lifestyle: “more sport, less pills!”
Given these positive spin-offs for the patient and his or
her social environment, the CNT has so far organized two
yearly meetings where transplanted sportsmen, sports
physicians and transplant researchers met in an open scientific seminar followed by a world renowned international biking competition (Maratona dles Dolomites),
held in the Italian Dolomites each summer.
Self-Donating: A Christian Value
The congress “A gift for life. Considerations on organ
donation” was an unprecedented chance to explore the ethical and Christian value of self-giving, solidarity, physical and
emotional sharing of ourselves. There are many crucial hints
in the Holy Bible on the concept of renewing one part of our
mortal body to give others the chance of surviving.
The concept of distributing bread, which stands for life,
is the materialization of the giving of a gift to many people
allowing their rebirth. The analogy with organ donation, particularly with multiorgan donation is astonishing:
LUKE 22, 17–19
22:17 “And he took a cup and, having given praise, he said,
Make division of this among yourselves”.
22:19 “And he took bread and, having given praise, he gave
it to them when it had been broken, saying, This is my body,
which is given for you: do this in memory of me”.
EZEKIEL 36, 26
36:26 “I will give you a new heart and put a new spirit in
you; I will remove from you your heart of stone and give
you a heart of flesh”.
References
1.
2.
3.
4.
5.
6.
Italian National Transplant Centre website. Transplant Information
System (SIT). Available at: https://trapianti.sanita.it/statistiche/.
Italian National Transplant Centre website. Available at: www.trapianti.ministerosalute.it.
Italian National Transplant Centre. Normativa italiana su donazione,
prelievo, e trapianto di organi e tessuti. Raccolta delle principali normative nel settore della donazione e del trapianto, Vol I. Rome, Italian
National Transplant Centre 2005.
Italian National Transplant Centre. Linee guida e protocolli della
rete nazionale trapianti, Vol II. Rome, Italian National Transplant
Centre 2007.
Fishman J. World Health Organization. Report on the review process
of the national transplantation programme in Italy (Italian version).
Trapianti 2008; 12: 37.
Italian law reference, Legge 1° aprile 1999, n. 91. “Disposizioni in materia di
prelievi e di trapianti di organi e di tessuti.” Gazzetta Ufficiale 1999; 87.
LATIN AMERICA
Valter D. Garcia, Mario Abbud-Filho,
and Jose O. Medina-Pestana
atin America refers to the countries in the American continent and has a population of 550 million inhabitants.
The official languages derive from Latin, mainly Spanish,
Portuguese and French. Apart from Guyana and Suriname,
L
The authors declare no conflict of interest.
S135
all other countries in South and Central America, Cuba,
Haiti, Dominican Republic in the Caribbean and Mexico in
North America are Latin American countries. These countries have striking geographic, ethnic, cultural and socioeconomic disparities. The gross domestic product varies from
U.S. $2800 per capita in Nicaragua to U.S. $14,300 in Chile.
Guatemala has the lowest human development index (0.689)
and Argentina, the highest (0.869). The population ranges
from 3.2 million inhabitants in Panama to 190 million in
Brazil (Table 1) (1, 2).
These characteristics may account for the strong discrepancy in the number of solid organ transplantation and
organ donation, as well as in the access to the deceased donor
organ pool among the different Latin American countries. As
socioeconomic inequities and low human development index
have been associated with nonuniform access to solid organ
transplantation and ethically reproved practices of organ
commerce, organ trafficking and transplant tourism (3), we
examined the overall rates of living and deceased solid organ
donation and transplantation in Latin America and its regulations and legal aspects.
Organ Donation
The number of transplantations performed with deceased donors is relatively small in Latin America when compared with countries from different regions of the world (4).
Retrospective analysis of the epidemiology of brain death in
Brazil has shown that the number of potential donors that are
formally notified of the local organ procurement organization vary from 78 to 105 per million of population (pmp) (5).
However, the actual rate of donation in Brazil did not surpass
7 donors pmp. The rate of identification of potential donors is
high in Uruguay and Puerto Rico (50 pmp), intermediate in
Argentina, Brazil, Colombia and Cuba (20 – 40 pmp) and low
in Chile, Venezuela, Mexico and Peru (less then 20 pmp).
Even so, the number of transplantations performed with deceased donors in Latin America, during the year of 2007, was
low when compared with the number of potential donors
notified during the same period. Puerto Rico, Uruguay and
Cuba performed more than 18 transplantations pmp with
deceased donors, Argentina performed 12 pmp and the remaining countries less than 10 pmp (Table 2). A year by year
analysis showed that the transplantation activity with deceased donors increased only 0.75 pmp in the last 5 years,
indicating that urgent interventions are needed to increase
the actual rate of deceased donation (6 –12).
The reasons for such a low effective rate of donation might
be due to an inadequate number of organ procurement organizations. The lack of appropriate training by the health care professionals dealing with the family members of the potential
donors may also play a critical role (5, 13). The rate of familiar
refusal to donate ranges from 10% to 80% among Latin American countries. It has remained steady, around 33%, in
Brazil, decreased from 62% to 36% in Uruguay and increased
from 46% to 80% in Peru over the last 7 years. The 2007 overall
rate of familiar refusal was 35% in Latin America, 15% in Cuba
and 80% in Peru. However, other family related reasons can
explain the low rates of effective donations (13).
The system of donation can also contribute to increasing the donation rates, but the final result varies among dif-
T1
T2
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Transplantation • Volume 88, Number 7S, October 15, 2009
TABLE 1. Demographic data and 2007 cumulative activity of solid organ transplantation among Latin American
countries
Organ transplanted
Country
Inhabitants (thousands)
GDP per capita (US $)
HDI
Kidney
Liver
Heart
Argentinaa
Boliviab
Brazilb
Chileb
Colombiaa
Costa Ricaa
Cubab
Dominican Republica
Ecuadora
El Salvadorb
Guatemalab
Hondurasb
Mexicob
Nicaraguab
Panamaa
Paraguaya
Perua
Puerto Ricob
Uruguaya
Venezuelab
Total
40.3
9.1
190
16.2
44.3
4.1
11.4
9.4
13.7
6.9
12.7
7.5
108.7
5.6
3.2
6.7
28.6
3.9
3.4
26.9
552,6
13,100
4400
9500
14,300
7400
11,100
11,000
6600
7400
6000
5100
4300
12,400
2800
10,700
4000
7600
18,400
10,800
12,800
8630c
0.869
0.695
0.800
0.867
0.791
0.846
0.838
0.779
0.772
0.735
0.689
0.700
0.829
0.710
0.812
0.755
0.773
—
0.852
0.792
0.797d
11,322
712
50,281
5234
7236
1415
4167
543
916
459
815
—
24,680
11
325
202
2433
1342
1248
3710
117,329
2,600
6
7895
653
975
40
226
—
1
—
—
—
754
—
—
—
35
—
28
42
13,246
1201
1
2288
188
464
14
130
—
9
—
—
—
228
—
—
11
34
105
99
1
4773
a
Countries that adopt the presumed consent for living organ donation.
Countries that adopt the informed consent for living organ donation.
c
Latin America mean GDP per capita.
d
Latin America mean HDI.
GDP, gross domestic product; HDI, human development index.
b
ferent countries adopting a specific system. Spain, France,
Italy and Austria have passed the presumed consent for solid
organ donation and all theses countries have high (⬎20 pmp)
deceased donor rates. These numbers are contrasted by Britain where the rate of refusal to donate peaks 40%. Britons
must register as a donor. Although lawfully established in
many countries, the presumed consent does not always improve living donation yields. Greece has a presumed consent
system and low deceased donor rates; United States, conversely, ranks pretty high adopting an informed consent system. Social and cultural factors represent critical barriers to
deceased organ donation. Brazil formally moved from an informed to a presumed consent system of donation in 1998
as an effort to improve the deceased organ donor pool.
One year later, 48% and 59% of newly issued identification
cards and drivers licenses, respectively, had registered the
people refusing to donate (14). At present, the presumed
consent system of donation is lawfully established in
Argentina, Colombia, Costa Rica, Dominican Republic,
Ecuador, Panama, Paraguay, Peru and Uruguay. All other
Latin American countries only legitimise the informed
consent system (Table 1).
Solid Organ Transplantation
The 2007 cumulative activity of solid organ transplantation among Latin American Countries is shown in Table 1. The
total number of kidney transplantations was 117,329 (13,246
livers, 4773 hearts, 782 lungs and 1672 pancreas). In 2007, 8743
kidneys (48% from living donors), 1710 livers (11%), 363 hearts
(Table 2), 247 pancreas and 86 lungs were transplanted in Latin
America, which represent, respectively, 13.4%, 8.4%, 6.5%,
9.6% and 2.8% of the transplants performed worldwide. Kidney
transplantationactivityincreased177%from1991to2007representing a mean annual improvement of 7.5%. There is a broad
range of variation in kidney transplantation rates among Latin
American countries. The overall activity in 2007 was 16 (range
0 –31) kidney transplants per pmp representing only 26% of the
Latin American waiting list. Uruguay, Argentina and Puerto
Rico have the highest rates of kidney transplantation, overcoming 20 transplants pmp a year. Thus, although steadily increasing, the number of kidney transplants performed in Latin
America is far beyond the countries need. Liver transplantation
was performed in nine countries at a rate of 3.1 pmp a year. The
number of surgeries increased at a rate of 10% a year from 1992
to 2007, representing 157% improvement during this period.
Even so, only 12% of the waiting list has been supplied. Accordingly, heart transplantation increased at a rate of 6% in the same
period, with 1.5 transplants pmp in 2007, supplying 10% of the
waiting list. Pancreas and lung transplantations had a poor performance in 2007 rating 0.5 and 0.16 transplants pmp, respectively. Only 15% and 2.6% of patients waiting for these organs
successfully underwent transplantation (6 –12).
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TABLE 2. Number of solid organ transplants performed by Latin American countries in 2007 and type of donors
Kidney
Liver
Heart
Country
Total
pmp
LD (%)
Total
pmp
LD (%)
Total
pmp
Argentina
Bolivia
Brazil
Chile
Colombia
Costa Rica
Cuba
Dominican Republic
Ecuador
El Salvador
Guatemala
Honduras
Mexico
Nicaragua
Panama
Paraguay
Peru
Puerto Rico
Uruguay
Venezuela
Total (mean)
867
72
3456
283
758
38
16.6
59
51
38
138
4
2132
—
31
28
80
95
102
345
8753
22.0
7.3
18.2
17.9
16.1
8.4
14.8
6.5
3.9
5.5
10.4
0.5
20.1
—
9.9
3.8
2.8
24.4
30.9
12.6
15.8a
17.3
68.5
50.5
23.5
8.1
52.4
10.1
98.5
79.5
100
74.0
100
75.1
—
36.4
86.8
21.5
9.4
5.8
46.0
48.0
268
—
1,014
79
193
—
39
1
—
—
—
—
103
—
—
—
—
—
4
10
1,710
6.9
—
5.5
4.8
4.1
—
3.4
0.1
—
—
—
—
0.9
—
—
—
—
—
1.2
0.4
3.1b
7.8
—
14.7
—
—
—
—
—
—
—
—
—
11.8
—
—
—
—
—
25.0
60.0
11.1
83
—
158
16
60
1
7
—
—
—
—
—
15
—
—
2
4
13
4
—
363
2.1
—
0.9
1.0
1.3
0.2
0.6
—
—
—
—
—
0.2
—
—
0.3
0.1
3.3
1.2
—
0.7c
a
Latin America mean kidney transplantation pmp.
Latin America mean liver transplantation pmp.
c
Latin America mean kidney transplantation pmp.
pmp, per million of population; LD, living donors.
b
Solid Organ Demand and Supply
The waiting lists for solid organ transplantation grow
ever longer as ageing, high-risk cardiovascular disease and
chronic disease population increases. According to the World
Heath Organization, only 1 in 10 people in need of a new
kidney manages to get one. The problem has been made
worse by a fall in strokes and head traumas in recent years (the
main sources of organs for transplantation). Different strategies have been developed and applied in different countries to
increase the supply of solid organs for transplantation. Kidney waiting lists have been shortened by allowing paired
organ exchange donations (15), accepting older donors than
previously (16) and transplantation with living unrelated donors
(17). Although honorable, these practices raise profound ethical
debate and are not taking place in Latin American countries.
Living unrelated donation is unlawful in Argentina and
Uruguay. Brazilian law allows living unrelated donation from
spouses but since 1997 judicial authorization is required for
other unrelated donors (18). Thus, the number of transplants
with organs from living unrelated donors remains steadily
low (19). In 1998, a new law determined that living unrelated
donation must also have an approval from the hospital
ethics committee and state health secretary. All other
countries accept spouses with restrictions to other living
unrelated donors.
The issue of giving financial incentives to living, solid
organ donors has deserved publication in the nonmedical
media (20). The Iranian system of officially sanctioned compensated living organ donation has eliminated the country’s
kidney transplant waiting list. The government’s approach
turns the illegal commerce to a state of regulated kindness.
Apart from the ethical aspects, Iranians are not allowed to
donate solid organs to a non-resident alien and no longer go
abroad for kidney transplantation (21). The problem of underground organ harvesting and paid cross-countries transplantation with the strong negative impact in the living
donation programs were pointed out in a special article recently published in The Economist magazine (20). These
illegal practices do not only take place in undeveloped countries. In the United States, an investigation carried out by the
Los Angeles Times found that four Japanese criminals received solid organ transplants from deceased donors at a
Medical Center of University of California Los Angeles; in
New York, an ex-dental surgeon was jailed for stealing bones,
skin, arterial valves, ligaments and other tissues from corpses.
The trade in human organs is illegal in Latin America,
and every country has specific legislations to address this issue. In addition, many Latin American countries pose different restrictions to perform transplantations on non-resident
aliens. Argentina and Uruguay do not allow transplantations
in non-resident aliens. Chile only allows foreigners who have
been living in the country, for at least 5 years, to receive an
organ for transplantation. In Colombia, non-resident aliens
can receive an organ for transplantation if there is not a
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Colombian citizen in need. Other countries, including Brazil,
have no specific legislations and allow, at present, solid organ
transplantations in alien recipients accordingly to the policy
in operation for the Brazilian citizens.
Although Latin America is considered a potential target
for organ commerce, much of the mass media reports regarding illegal activities of transplant tourism and the recruitment
of donors to go abroad for living organ donation were never
officially supported. Most of the debate is based on misinterpretation of old Latin American social problems, such as the
significant rates of infant prostitution and illegal adoption, officially recognized by the World Health Organization. Awful malpractices such as murder or kidnapping of children for organ
removal and forced organ removal have never been confirmed.
Occasional and nonsystematic episodes of unlawful solid organ
commerce and transplantation have been identified. The World
Health Organization has indicated Colombia as a possible destination for transplant tourism in Latin America, but precise data
about this illegal activity are not currently available. From 2001
to 2003, 14 people living in the Brazilian northeastern state of
Pernambuco were recruited to travel to South Africa to sell their
kidneys (22). These episodes characterized people trafficking but
not organ trafficking. The public ministry identified and jailed
the criminals and the court of justice judged and condemned
them. So far, no other similar situations have been observed.
In summary, the great majority of the countries in Latin
America perform kidney transplantations, with a few
countries performing a small number of other transplantations. The potential donor rate is low (less than 40 pmp
in most of the countries) and the rate of refusal to donate is
high, resulting in low deceased donor transplantation activity. The great majority of the countries have specific
legislations on organ transplantation. Organ commerce is forbidden and occasional irregularities are promptly investigated
by the public ministry and testified by the society. Thus, the
perspective is that the programs of solid organ transplantation among Latin American countries stand on ethical principles established by international societies and the World
Health Organization (23).
References
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Transplantation • Volume 88, Number 7S, October 15, 2009
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Different Views of the Organ Donation Experience
THE RECIPIENT
Mariangela Gritta Grainer
My husband Aldo had a liver transplant over 7 months ago.
Our experience was a complex, hard and extraordinary one, which cannot be expressed in a few minutes. We
thought we would try to give you the answer to a question:
Why and what were the elements that decided the positive
outcome of the illness, which was already in a desperate
state?
The author declares no conflict of interest.
1. A fruitful balance was found between the ethical and the
technical scientific aspects. Our experience is proof that it
is not only possible, but also necessary, to combine ethics
and science, especially when questions such as life and
death, which are often confused, are being faced.
2. The ethic of giving (suggested in the title of this conference) showed its power here. We were able to develop it
further because of the extraordinary team we found at the
transplant clinic of Padova, lead by Dr. Umberto Cillo.
3. Talent, professional attitudes, the ability to listen and
manage relationships. A team, who knew how to take
responsibility for decisions at every moment, even when
it was decided that a transplant from a living donor, our
son Alessandro, should be postponed, due to the wors-
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ening of Aldo’s state of health and to summon the
ethical-scientific emergency committee. It was Good
Friday; we went home and spent Easter in the dark. But,
on the day after Easter Monday, there was light, and it
was announced that a donor had been found whose life
had ended only to give a new beginning to Aldo’s and
also to all of our lives.
4. Our experience, which started at a different transplant
clinic in 2005, is proof that not all clinics are the same
and that it is worth aiming for quality, rather than
quantity, to get centers of excellence with the best
human resources and the necessary structure and financial support.
5. Our experience shows that guidelines have to be in place
but they have to be flexible and continually updated in
order, not just to cure, but to take care of the patient
who is “unique”, who has the right to be looked after in
safety (free from worry and at the least risk) but also
with curiosity (by those who are constantly looking for
knowledge and experimenting new things). Care is at
the root of both safety and curiosity.
6. Aldo’s strength and perseverance along with the active
help of the extended family network was another deciding factor before and after the transplant. After the awful experience at the first clinic (we were told on the
November 29, 2007, “the transplant cannot be performed, there is nothing we can do”), we chose not to
give up and to fight on to the end if we had to. We
studied, we got informed, we got hold of expert friends
and acquaintances in the medical field, we got in touch
with the national body, which coordinates transplant
clinics and with the help of Dr. Alessandro Nanni Costa,
we got to Padova. Information and knowledge (which
are always important) have been essential factors in our
story, as well as the support and involvement of the
family network. This suggests that information and
knowledge should be more accessible and that people
who are going it alone and would otherwise not get
through, should be supported by social-medical structures and volunteers. It was, and continues to be, important for us to have a positive relationship with the
local medical services, the day hospital in Valdagno
which is in connection with the transplant center, and
Dr. Sergio Urbani who takes care of us almost daily.
This was also an extraordinary experience for us, because
it made us question more strongly why we are in the world and
how we live. It confirmed to us that ethics are visible in the way in
which every person (on the basis of what they are offered by
society, their resources and history) decides their answer to the
question of meaning which life puts to them, developing their
own religious and political ideals and, in this way, expressing the
goals which they hope to achieve.
We think about the meaning of life all too rarely, but
the goals which we hope to achieve are not hidden: they are
expressed in our daily actions and in how we live in our private and public spheres.
The waiting lists for transplants are long and there are
still only very few “donated” organs.
A strong message for all of humankind goes out from
this important and significant event regarding organ dona-
tion because “A Gift for Life” is much more than a gift to give
life: it is a sign of love toward others and toward ourselves.
THE COORDINATOR
Pier Paolo Donadio, Anna Guermani
and Riccardo Bosco
he Italian National Health Care Service is organized on a
regional basis. Each region has its own organ procurement organization, where the key role is that of the transplant
Coordinator, who is present at each hospital where there is an
intensive care unit (ICU). In most hospitals of the Piedmont
Region, the transplant Coordinator is an anesthesiologist
with ICU experience, who is involved not only in organ procurement but also in the usual daily ICU activity. He or she is
also involved in the treatment of patients with brain damage,
who are typically those that eventually suffer brain death and
become potential donors. As a result, he or she is the one who
suggests the possibility of organ donation to families. In this
article, therefore, by “Coordinator” we mean the person who
suggests the possibility of an organ donation. He belongs to
the team who has taken charge of the patient’s treatment.
The death of a person always constitutes a moment of
sorrow and bereavement for his or her relatives. However,
this is especially true when death is caused by acute brain
damage, because it occurs suddenly and unexpectedly, and as
such, it does not possess any of the soothing and alleviating
aspects of predictable and expected deaths. Moreover, the
death of a patient represents a defeat for the physician who
treated him or her. When brain death comes, the physician’s
position, both towards the patient and his or her relatives,
radically changes. The physician can no longer give hope to
the relatives, nor can he or she do one’s best to heal the patient. Nonetheless, he or she still has the chance and an obligation to do more.
Even though it is no longer possible to treat the patient,
the relationship with the family does not cease. On the contrary, under the special circumstances of an abrupt loss, not
only it is still possible to comfort, to listen and to bring relief
to the relatives but, if a positive relationship was established
with them during the patient’s hospitalization, the moment
of death constitutes a time when it is possible to create
moments of extraordinary empathy toward the relatives
themselves. Those who have experienced the loss of a relative,
remember precisely all that happened on the day when the
relative died. Simple words and gestures of those who were
around, as well as seemingly unimportant things, in those
moments penetrate deep in the minds and souls of deeply
saddened people, to remain there forever. The Coordinator
must be aware of how delicate these moments can be. He or
she must be capable of preserving and nurturing the relationship with the relatives by accepting their many diverse
reactions when facing the death of a beloved one. The Coordinator must accompany the relatives along this difficult
path whilst ensuring his or her continued assistance.
As the relationship with the family does not cease, the
therapeutic effort does not cease either. The physician who
loses a patient to brain death must be aware that, from that
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time on, other people become his or her patients: they are
those who are waiting for a transplant. This awareness is very
important, because it justifies and motivates the continuation
of the therapeutic effort. The physician who does not strive to
recognize a potential donor and then to take care of the donor
management shows that they are not capable of understanding that they now have new patients. The physician does not
know them, but they must learn to “feel” them, even though
they are not present, and to operate in their interest, because
they alone have the means to secure the needed therapy for
them. This is why the physician must always suggest organ
donation.
Some claim that suggesting donation is the most difficult proposition to advance to families, made at the worst
possible time. With this, they justify their weak propensity
towards procurement. The effective Coordinator must realize
it is not so. He or she must be convinced that donation is a
positive opportunity to offer to the relatives of the deceased, a
way to turn a great evil into a great good. Donating does not
remove the suffering, but it can somewhat ease it. Certainly, it does not worsen it. To be able to correctly propose
donation, it is necessary to be intimately convinced that
the proposal is an offer and not a request: the Coordinator
is not asking for organs, but is offering the relatives the
opportunity to do some good at a time of utmost suffering.
They know that donation, besides being indispensable to
the patients on the waiting list, is also good for the relatives
of the donor. It is essential for the Coordinator to think of
themself as one who offers rather than one who asks for
something.
By far, in the majority of cases, the doubts of the relatives, implicit or explicit, come down to three main questions:
“Is he/she really dead? Was everything possible done by the
physicians in order to save him/her? What will be done with
the organs?”. These questions must be answered by the Coordinator clearly. The cadaver of the brain dead person does not
look like a corpse: it is not pale and cold; the heart is beating,
the chest is heaving. It is hard to believe that that person is
dead. The Coordinator must be capable of explaining brain
death simply and clearly, in a direct and easily understandable
way. An image, such as that of a single photon emission computed tomography (SPECT) scan, can be helpful to explain
what has happened. Words must be simple. The term
“dead” must be openly used. It is also necessary to give the
relatives some time to comprehend and internalize death.
When the family members refuse the removal of the organs
claiming that, for instance, their relative “has already suffered too much”, this shows that they have not truly comprehended death; they still do not consider the body of
their beloved as that of a dead person.
Conviction is rational, but being persuaded is emotional. To consent to a donation, it is necessary that the relatives are not only convinced but also intimately persuaded to
be in front of a corpse: this often takes time. The Coordinator
must be capable of helping the relatives to start the difficult
process of bereavement acceptance and he must avoid the
risk, among other things, of inadvertently proposing donation as a way to make a part of the deceased live on within the
body of someone else. This is why such words as “dead”,
“corpse” and other similar words, should not be avoided. On
the contrary, it is necessary to say them clearly over and over
Transplantation • Volume 88, Number 7S, October 15, 2009
again. It is also necessary to accompany the family members
toward the realization that that body, which still looks like
their living relative, has truly become a corpse and that he or
she has irreversibly passed away.
The second question asked by families, implicitly or
explicitly, is about the quality of treatment: was everything
possible done by the physicians to save their relative? The best
circumstance is when this question is not raised, because the
family have already found an unspoken satisfactory answer
through the relationship they have developed with the physicians during the administration of therapy and is also thanks to a
positive impression that the relatives formed about the overall
health care system. Unfortunately, this is not always the case:
many of the refusals to donations are due to the relatives perceiving a generally poor quality of care and treatment. Trust in the
health care system typically impacts the perceived quality level,
and poor quality is the likely cause of most refusals, more often in
Southern Italy than in Northern Italy.
The perception of quality, as well as the credibility
and trustworthiness of the Coordinator, are both established before the death of the relative, i.e., during the therapeutic endeavor. If before the death, there was keen attention, empathy,
dedication and consideration, when death comes the Coordinator will be viewed and felt as a trustworthy person, caring
for both the patient and the relatives. On the contrary, if before there had been only cold technical jargon, it will be most
difficult for the Coordinator to build the trust needed for
them to be able to propose donation, especially as an act of
consolation for the relatives and a gift for the potential recipients. In the context of sheer technicality, donation remains
organ procurement and organ procurement is a request and
not an offer. On the contrary, within a previously established
empathic relationship, organ procurement becomes a donation, and donation turns into an offered opportunity of bereavement alleviation.
Of course, this kind of attitude should not only be
followed by Coordinators when a potential donor is involved. It should be the standard attitude of all the ICU
team physicians towards all patients, so that their relationship with families can be one of empathy, solidarity and
consideration. This way, not only will the number of donors increase but also the quality of the relationship with
the relatives will improve.
The third question concerns the allocation of the organs. “Who is going to get the organs of my relative? And you,
who are asking me to allow you to take them, what will you do
with them?”. The lay people do not know that organ allocation takes place according to strict pre-established rules and
the Coordinator has absolutely no role the process. The Coordinator must be capable of clearly explaining the rules governing organ allocation. He or she must also be capable of
vouching for the ethicality of such rules, thanks to the credibility he has earned from the relatives. To do so, besides being
trustworthy, he or she must know the system and its rules
perfectly and the system must not have shown any signs of
questionable behavior. When scandalous mismanagement of
allocation takes place, the number of refusals sharply increases. Therefore, the system must be trustworthy. When a
Coordinator finds himself in the context of a system that is
ethically weak, or worse, plagued by scandals, his action is
objectively quite impaired. Confidence in the ethical merits of
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the system enhances the motivation and credibility of the
Coordinator.
If the three prerequisites; certainty of death; perception of quality care, both relational and medical; and assurance of ethical allocation of organs, are all met with
satisfaction then the donation proposal will finally be accepted. In essence, it is necessary to create conditions in
which the Coordinator can address the relatives with
words similar to those which Jesus spoke when he sent the
Disciples to spread the Gospel: “Freely you have received, freely
give” (Matthew 10, 8).
THE ANESTHESIOLOGIST
Franceso Giordano and
Blanca Martinez Lopez de Arroyabe
T1
Definitions
The main role of the anesthesiologist-intensive care
physician is to treat all the organ failures, especially the lifethreatening ones, which compromise vital functions. The patients affected by alterations of vital functions because of
acute reversible pathologies or exacerbation of chronic diseases need intensive medical treatment, monitoring and
nursing. The admission in the intensive care unit is considered adequate when a reasonable probability of beneficial
outcomes from the intensive treatment exists.
Regarding neurological failure, the severity of the clinical picture can cause an absent or insufficient response to the
adequate therapy performed and a secondary evolution to mild
(Glasgow Coma State [GCS], 13–15), moderate (GCS 9 –12),
severe (GCS 6 – 8) or high severe (GCS 3–5) comatose state (1).
Coma is the condition in which both components of consciousness, wakefulness (sleep-wake cycles) and awareness, are lost.
Often the vegetative functions (including breathing and cardiovascular activity) are severely altered. Coma is a deep, sustained
pathologic unconsciousness that results from dysfunction of the
ascending reticular activating system in either the brain stem or
both cerebral hemispheres. The eyes remain closed and the patient cannot be aroused for at least 1 hr (2).
The causes of coma can be classified in two main categories: primary encephalic lesions and diseases (trauma, vascular lesions, infections, tumors, seizures and degenerative
diseases) or systemic and extracranial lesions (metabolic disturbances and hypoxic-ischemic due to cardiac arrest) (3).
The acute phase is followed by a postacute phase and
subsequently the final phase of the outcome, which includes a
gradation of probable conditions defined by the Glasgow
Outcome Score (GOS). The GOS varies from a state of good
recovery, mild or severe disability, persistent or permanent
vegetative state, leading up to brain death (Table 1).
The vegetative state is a clinical condition of complete
unawareness of the self and the environment, accompanied
by sleep-wake cycles with either complete or partial preservation of hypothalamic and brain-stem autonomic functions.
The vegetative condition may be transient, because it is
merely a stage in the recovery from severe or permanent brain
damage as a consequence of the failure to recover from such
injuries. The vegetative state can also occur as a result of the
relentless progression of degenerative or metabolic neuro-
TABLE 1. Glasgow Outcome Score (4, 21–23)
Glasgow Outcome Score
GOS 5: good recovery
Capacity to resume occupational and
social activities, although there may
be minor physical or mental deficits
or symptoms.
GOS 4: moderate disability Disabled but independent.
Independent and can resume
almost all activities of daily living.
Disabled to the extent that they
cannot participate in variety of
social and work activities.
GOS 3: severe disability
Conscious but disabled. No longer
capable of engaging in most
previous personal, social, or work
activities. Limited communication
skills and have abnormal behavioral
or emotional responses. Typically
are partially or totally dependent on
assistance from others in daily
living.
GOS 2: persistant vegetative Not aware of surroundings or
state
purposely responsive to stimuli.
Patient exhibits no obvious cortical
function.
GOS 1: brain death
—
GOS, Glasgow Outcome Score.
logic diseases or from developmental malformations of the
nervous system. The diagnostic criteria of vegetative state are
as follows: (a) No evidence of awareness of self or environment and an inability to interact with others; (b) No evidence
of sustained, reproducible, purposeful or voluntary behavioral responses to visual, auditory, tactile or noxious stimuli;
(c) No evidence of language comprehension or expression;
(d) Intermittent wakefulness manifested by the presence of
sleep-wake cycles; (e) Sufficiently preserved hypothalamic and
brain-stem autonomic functions to permit survival with medical
and nursing care; (f) Bowel and bladder incontinence; and (g)
Variably preserved cranial-nerve reflexes (pupillary, oculocephalic, corneal, vestibulo-ocular and gag) and spinal reflexes (2).
The vegetative state was originally defined by Jennett
and Plum in 1972. According to the authors, the term “persistent”, when applied to the vegetative state, meant sustained
over time; “permanent” meant irreversible (4). The adjective
persistent refers only to a condition of past and continuing
disability with an uncertain future, whereas permanent implies irreversibility. Persistent vegetative state is a diagnosis;
permanent vegetative state is a prognosis (5, 2). The term
vegetative state explains the important contrast existing between the severe mental compromise and the preservation of
autonomic functions (6).
Finally, brain death is defined as the permanent absence
of all brain functions, including those of the brain stem.
Brain-dead patients are irreversibly comatose and apneic and
have lost all brain-stem reflexes and cranial-nerve functions,
they have unresponsiveness and a lack of receptivity and the
cause has been identified (7). The brain death is characterized
by irreversibility. The patients affected by this clinical picture
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(GCS 3, bilateral midriasis and absence of brain-stem reflexes) present the legal conditions and requirements to
perform the declaration of brain death. These subjects are
considered to be potential organ and tissue donors. To these
patients, the intensive treatment is clinically and ethically justified, up to the moment of organ withdrawal, to perform
organ transplant on patients suffering from terminal organ
dysfunction. The main limitation of transplant activity is the
low availability of organs and the disparity between the number of potential organ donors and the number of used donors
(8). The strategy to increase the number of suitable organs
consists in the improvement of the clinical management of the
potential donor, with prevention and early treatment of complications from brain death which cause hypoxemic- ischemic phenomena of the organs (9, 10). Therefore, the anesthesiologist is
the specialist in the middle of the donation withdrawal transplant process. When, despite maximum therapeutic efforts brain
death occurs, the focus of the anesthesiologist is not on cerebral
protection, but is directed to adequate organ conservation. At
this point, the role of the intensive care physician includes clinical aspects (identification and support of potential organ donors
as well as organ suitability), organizational aspects, legal
(declaration of brain death process) and relationship aspects, such as communication with the donor’s family and
with the local, regional, interregional and national transplant coordinating centers (11).
F1
Clinical Aspects
Regarding clinical aspects, the aim of the treatment of
the potential organ donor is to guarantee a satisfactory level of
perfusion and oxygenation of the organs and tissues destined
to transplant. These organs are compromised by hemodynamic instability and the inefficacy of homeostasis mechanisms. These phenomena are the consequence of the final loss
of feed-back neurovegetative mechanisms, due to the complete
and irreversible cessation of the encephalic functions (10).
The state of brain death is unavoidably followed by somatic death due to cardiac arrest after several hours. During
this period, if an early and intensive treatment is not performed, the evolution from brain death to cardiac arrest can
cause a loss of 10 –20% of potential donors (12). The treatment of the donor must correct the functional disturbances
resulting from brain death and restore and preserve the quality of the organs. The main pathophysiologic alterations due
to irreversible cessation of encephalic functions are the following: hemodynamic disturbances, respiratory exchange alterations, electrolyte derangements, coagulation, metabolic and
hormonal disturbances and alteration of temperature regulation
mechanisms. The hemodynamic alterations are the ones that
most influence the organ quality (13). Several therapeutic
schemes have been proposed for adequate hemodynamic management of the potential organ donor (Fig. 1).
Moreover, another important clinical aspect regards
organ suitability evaluation. The final result of a transplant
depends on multiple factors associated with the receiver’s
clinical conditions (i.e., urgent transplant) and to the donor’s
characteristics. The insufficient donor availability, the transplant risks or benefits relationship and the restricted ischemia
time of the grafts are responsible for the method and timing of
the evaluation of an organs’ suitability. In transplant activity,
the zero risk for infections and tumor diseases transmission
Transplantation • Volume 88, Number 7S, October 15, 2009
does not exist despite correct application of international
guidelines. Despite these limits, all the organs targeted for
transplantation must be of acceptable quality and must not
expose the receivers to unacceptable risks (15).
The levels of risk are classified as unacceptable, increased
but acceptable, calculated, unevaluated and standard risk. For increased risk cases, the receiver’s, informed consent is necessary.
The process of organ suitability evaluation is multidisciplinary and involves the intensivist, the coordinating centers,
the National Transplant Center experts (second-opinion) and
the transplant surgical teams in the operating theater. The standard evaluation is based on medical history, clinical examination, instrumental and laboratory tests and eventual histological
or postmortem examinations (15).
Legal Aspects
The anesthesiologist takes part in the process of brain
death declaration. In Italy, the diagnosis of brain death is
governed by the laws dated December 29, 1993 and August
22, 1994 (16, 17). These laws were updated in April 2008.
Clinical and instrumental requirements are necessary for
brain death diagnosis. The clinical examination remains the
standard for the determination of brain death but Italian law
requires that a compulsory instrumental tool, which is the
electroencephalography (EEG) must be performed. The EEG
and clinical examination must be performed twice during the
period of brain death diagnosis by three physicians (a legal
medicine specialist, an anesthesiologist and a neurophysiologist,
neurologist or neurosurgeon with expertise in EEG) (18).
The clinical examination includes the assessment of
coma state, the absence of brain-stem reflexes and the absence
of respiratory drive at a PaCO2 that is 60 mm Hg. In addition,
some prerequisites must be established; the cause of coma,
the ascertainment of irreversibility and the absence of possible confounding factors, such as particularly severe electrolyte, acid-base, or endocrine disturbances; the absence of
severe hypothermia, hypotension or drug intoxication, poisoning or neuromuscular blocking agents (19).
Confirmatory tests of brain death may be necessary
in some special cases. These confirmatory tests are instrumental research of the lack of cerebral blood flow. Nowadays, the most accepted tests are cerebral angiography,
transcranial doppler ultrasonography and single photon
emission computed tomography. The lack of cerebral
blood flow must be performed if the patient is a child under the age of one or cofounding factors are present (see
above), the cause of coma is unknown or conditions that
prevent brain-stem reflexes exploration or EEG performance are present (19, 20).
Communication Aspects
The carefulness of communicative and relational aspects with the potential donor’s family must be similar to that
which is applied to the families of patients admitted to the
intensive care unit. This is a process that involves all the intensive care unit staff and it is based on a relationship of trust
dependent on the level of transparence, consistency and clarity of communication. The relationship between the anesthesiologist and the family begins at the moment of the patient’s
admission to the ICU and continues until the communication of the patient’s death to the family.
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FIGURE 1. Management of the
hemodynamic instability of potential organ donors. Modified from
several authors (10,12,14).
The proposal of donating must be put forward by the
local transplant coordinator at a different time to when the
patient’s death is communicated to the family. Sometime
later, the family is informed of the result of the organ transplantation by the local coordinator (21).
3.
4.
5.
6.
7.
Conclusion
Society is the protagonist in the donation and transplantation process and everyone must work together so that
nobody dies waiting for an organ. The anesthesiologist has a
fundamental role in the donation transplant process because
he works on the front line and is charged with clinical, organizational, legal and relational duties.
The anesthesiologist above all is an impartial figure
with respect to the transplant and the allocation of organs,
and for these reasons, he is indispensable for the transparency
of the entire process.
12.
References
13.
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2.
Teasdale G, Jennett B. Assesment of coma and impaired consciousness.
A practical scale. Lancet 1974; 2: 81.
The Multi-Society task force on Persistent Vegetative State. Medical
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Verlicchi A, Zanotti B. Il coma and co. New Magazine 1999, pp 18.
Jennett B, Bond M. Assesment of outcome after severe brain damage.
Lancet 1975; 1: 480.
Jennett B, Plum F. Persistent vegetative state after brain damage: A
syndrome in search of a name. Lancet 1972; 1: 734.
Verlicchi A, Zanotti B. Il coma and co. New Magazine 1999, pp 175.
A definition of irreversible coma. Report of the Ad Hoc Committee of
the Harvard medical School to examinate the definition of brain death.
JAMA 1968; 205: 337.
Sheehy E, Conrad SL, Brigham LE, et al. Estimating the number of
potential donors in United States. N Engl J Med 2003; 349: 667.
Giordano F, Margarit O, Di Silvestre A, et al. Gestione del donatore
d’organi. In:Atti del corso postuniversitario F.E.E.A. Linee guida in
medicina intensiva e dell’emergenza. Lignano 2000.
Martini C, Lusenti F, De Angelis C, Procaccio F, et al. Trattamento del
potenziale donatore. In: Procaccio F, Ghirardini A, Nanni Costa A, eds.
Manuale del corso nazionale per coordinatori alla donazione e prelievo
di organi e tessuti (4 Ed). Bologna, Editrice Compositori 2002, pp 95.
Tufano R, De Robertis E. Organ donor and health policy: The anaesthesia and reanimation. Minerva Anestesiol 2004; 70: 131.
Wood KE, Becker BN, McCartney JG, et al. Care of potential donor.
N Engl J Med 2004; 351: 2730.
Giordano F, Martinez B. “Standard of care” per la terapia di supporto
del donatore d’organo. Minerva Anestesiol 2005; 71(suppl 1): 323.
Zaroff JG, Rosengard BR, Armstrong WF, et al. Consensus conference
report. Maximizing use of organs recovered from the cadaver donor:
Cardiac recommendations, March 28 –29, 2001, Crystal City, Va. Circulation 2002; 106: 836.
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Bologna, Editrice Compositori 2004, pp 66.
Legge 29 Dicembre 1993 n. 578 “Norme sull’accertamento e certificazione della morte.”
Decreto 22 Agosto 1994 n. 582 1994 “Regolamento recante le modalità
per l’accertamento e la certificazione della morte.”
Gianelli Castiglione A. Accertamento di morte. In: Procaccio F, Manyalich M, Venettoni S, et al. Manuale del corso nazionale per coordinatori alla donazione e prelievo di organi e tessuti [ed 5]. Bologna,
Editrice Compositori 2004, pp 168.
Wijdicks EF. The diagnosis of brain death. N Engl J Med 2001; 334:
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cerebral blood instrumental diagnostic tools application in order to
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establish brain death in patients with encephalic lesions. 2003 (Gruppo
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all’applicazione delle indagini strumentali di flusso ematico cerebrale
in situazioni particolari, ai fini della diagnosi di morte in soggetti affetti
da lesioni encefaliche). www.trapianti.ministerosalute.it/imgs/C_17_
normativa_506_allegato.pdf.
Feltrin A, Sommacampagna M. La relazione d’aiuto alle famiglie dei
donator: una modalità operative. In: Procaccio F, Manyalich M, Venettoni S, Nanni Costa A. Manuale del corso nazionale per coordinatori
alla donazione e prelievo di organi e tessuti [ed 5]. Bologna, Editrice
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King JT Jr, Carlier PM, Marion DW. Early Glasgow Outcome scale
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J Head Trauma Rehabil 2008; 23: 294.
Promotion of the Organ Donation Culture
SPECIFIC PASTORAL INITIATIVES
sanitary projects”. These two objectives highlight the commitment to focus on life and human solidarity.
Marco Brunetti
The Role of the Church
Donating organs means giving a part of ourselves.
This gift can be traced in the bible where John, in his first
letter, states: “We know love by this, that He laid down His
life for us” 1John 3:16. These words summarize the love
movement that characterizes the relationship between
God and men. It is from this kind of donation, above all, of
the Son Jesus, that every Christian should look up to becoming a gift for his own brothers and sisters who are made
vulnerable by suffering.
One of the key expressions of solidarity is properly constituted in organ donation, which is a true, proper, authentic
and efficient gift of oneself for the service of life. It is about
instilling a mindset of self-donation, among other various
possible forms. Organ donation is an authentic, inclusive act
of solidarity: above all it is a civil act—and I believe in this we
could have a common agreement between believers and
nonbelievers— but also Christian, which gives an added
value to give to this self donation in the context of Christian faith.
Now, to facilitate the development of the theme, I
would like to introduce a pastoral project draft focusing on
some initiatives linked to the donation of organs.
Pastoral Goals on Various Initiatives
Such objectives can be extracted from the notes of the
Italian Episcopal Conference (CEI) Pastoral Report related to
Pastoral Health Care, entitled “La Pastorale della Salute nella
chiesa Italiana” (Health Pastoral Care in the Italian Church),
released in 1989, which—at number 20 —sets among its pastoral objectives those of “performing health and moral education with the prospect of inestimable value of life from birth
to death” and again, “creating awareness among institutions
and pastoral organisations present in the territory of the
health problem and providing assistance to the sick, indicating
operative guidelines toward a responsible involvement in socialThe author declares no conflict of interest.
Those Involved in Animating and Proposing
Pastoral Initiatives
Entities involved in this education commitment may be
identified in some ecclesiastical personalities or representatives such as:
The Bishop who, as the shepherd in his diocese, preeminently carries out the role of a teacher, hence educator,
of the community entrusted to him. A Bishop’s unequivocal statement regarding the subject of organ donation
could help many consciences to decide on this issue.
Offices set up for Pastoral Care of Health, which are a point
of reference—and to some extent the operative hand, promote and amplify all the pastoral initiatives of a diocese
aimed at promoting the culture of giving in favor of life.
Spiritual care assistants in hospitals have a more difficult
task with regards to other pastoral care personalities; the
difficult task of consoling people, mostly hard hit, whose
relatives often pass their time in an intensive care unit waiting room. At times, such spiritual assistants are called upon
to lend a shoulder to a distressed relative who has just learnt
of the death of their loved one, and it’s precisely at these
crisis times that one needs the capacity to exercise the ministry of consolation but also to be able to propose, with due
sensitivity, the possible removal of organs, thus transforming a moment of grief into a reason for life and hope for the
organ receiver, who will have the possibility to continue
living, thanks to such gift.
Parishes, Associations and Formation Schools are important pastoral vectors, as during catechesis and spiritual
preparation and formation, they can transmit fundamental
messages to reach the motivated in order to make a decision about donating.
These are doubtlessly the main pastoral entities
assigned to deliver pastoral initiatives aimed at spreading the
organ donation culture.
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Suitable Places for Spreading Specific Pastoral
Initiatives
The most suitable places for introducing and spreading
pastoral initiatives, regarding the mentality in favor of organdonation, are as follows:
The Parish, which through its numerous occasions, is definitely a privileged place; easily accessible to everyone with
simplicity but deeply rooted.
Health care institutions, especially hospitals, are authentic
“human meeting points” in which it is possible to elaborate
on, with diverse initiatives, even in strictly scientific issues,
the matters related to donating one’s organs.
Formation courses, of university value and nonuniversity
level, for example the masters degree in Bioethics, where
issues regarding donation of organs, both at scientific and
ethical levels, are deemed of vital importance aimed at
preparation of some actual formators about open conscience of self-giving, including one’s organs.
Identifying the Object of Such Awareness
It is also important to define a wide spectrum of possibilities susceptible to an awareness campaign, including all
possibilities—starting from blood donation, organ donation
and up to donating one’s body for scientific research purposes—as
hoped for by St. Francis de Sales.
Obviously, each of these donations requires different
musings and diverse in-depth analysis, but preparation provided for gradual awareness may help in making ethical and
responsible decisions for the good of the entire humanity.
The Experience of the Diocese of Turin and
Piedmont Region
I now prepare myself to describe some concrete initiatives already implemented in the Diocese of Turin, to which I
belong and work, by trying to show how the roadmap
described earlier was accomplished.
The initiatives that I am presenting to you vary in form
and intensity and were performed in conjunction with the
Pastoral Offices for health as well as civil and health authorities, thus creating the network required for implementing the
initiatives:
A. February 8, 2003, Diocesan Congress “Giving out
oneself. The donation of organs”.
The congress, promoted by the Archdiocese of Turin in
conjunction with “Piccola Casa della Divina Provvidenza”
(Little House of Divine Providence – Cottolengo) and
“S. Camillo” (Camillian) Formation Centre, was purposely
held in a public venue—“A. Dogliotti” Conference Centre at
the “Molinette” hospital in Turin, and was sponsored by the
Region of Piedmont, Turin City Municipality and “Azienda
Sanitaria Ospedaliera San Giovanni Battista” (St. John the
Baptist Hospital Enterprise) in Turin. The event was a great
success with approximately 500 guests, including health and
pastoral workers, of the Diocese.
Experts intervened on various aspects of the subject;
professionals expressed opinions as did scientists, doctors,
ethics and Christian moral experts, as well as volunteers representing associations of this field.
The Cardinal Archbishop closed the event.
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This initiative, meticulously prepared over a long period of time, had a positive impact on the territorial and pastoral setup of the diocese, highlighting the Church’s existing
attention on these issues.
B. Explanatory pamphlet.
This other initiative, repeated several times, was performed in a joint effort between the regional coordination of
organs and tissues removal of Piedmont Region and the
Regional Consult for pastoral care for health of Piedmont
Episcopal Conference, and consisted of sending an organ
donation explanatory pamphlet to all Piedmont and Valle
d’Aosta Parishes with the aim of enlightening and promoting a conscious choice. Together with the pamphlet—
mainly scientific—were some declarations of the Church’s
teachings regarding the matter accompanied by a request,
directed to the Parish Priests, to distribute it on a given
Sunday after having talked about it to the faithful present
at the Eucharistic celebrations. Parish Priests welcomed
the initiative and distributed thousands of pamphlets.
C. Masters degree in Bioethics.
A third pastoral initiative is centered within the masters
degree in Bioethics promoted in conjunction with the Archdiocese of Turin, Association of Catholic Doctors and with
the sponsorship of the Faculty of Medicine, Turin University,
Turin’s Faculty of Theology for Northern Italy and Turin
parallel section, which had its first edition in the 2006/2007
academic year and is currently in operation. During the first
year of the programmed biennium, an entire section is dedicated to the organ transplant, with analysis of the scientific
and ethical aspects entailed, regarding both removal and organ transplant.
Bearing in mind that the number of students enrolled
for each masters degree is about 200, it is possible to guess the
potential impact that such targeted information would carry.
D. The conference: “I trapianti fra scienza ed etica”
(Science and ethics with regard to transplants).
Another formational event entitled “I trapianti fra scienza ed etica” (Science and ethics with regard to transplants)
was promoted by the S. Giovanni Battista Hospital in Turin in
May 2007, with the sponsorship of various institutional,
scientific and ecclesiastic entities, whose event attained an
Educazione Continua in Medicina (continuous medical education) accreditation from all health professions, hence a
great success too for this event. The conference lasted 3 days,
and both scientific and ethical issues were analyzed in an exhaustive and unbiased manner, with an educational impact
on all the fields represented by the participants.
Conclusions
My aim was to outline a base project roadmap, in such
a manner, as to take into account all the main elements required to build pastoral initiatives concerning donation of
organs. The Turin experience shows that in a pastoral sphere,
and by other various ways and means, some action can be
promoted, proposed and set in motion.
I would like to conclude with the words expressed by
the Cardinal Archbishop of Turin at the end of the aforementioned 2003 conference; “We should consider organ donation
as one of the utmost expressions of love. You have referred to
it as solidarity, but we Christians know that Jesus Christ called
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upon us to consider that the entire Law and Prophets is summarized in God’s commandment of love for our brethren.
Thus, organ donation is therefore an act of love; a great act of
love” (Card. Severino Poletto).
TRAINING OF HEALTH CARE
PROFESSIONALS
Martí Manyalich, Gloria Páez, and Ricardo Valero
uring the past 20 years, health care policies and individual programs have tried to analyze the different possible
factors that could influence organ donation numbers positively. Besides comparing the different legislation systems, no
real evidence was identified, as such, for better outcomes in
the cases of presumed consent versus explicit informed consent. Other possible causes could be identified according to
center or country-based analysis: donor detection, professional training or absence of clear guidelines (1, 2).
Advanced education has been seen as a possible solution to tackle the unfavourable donation rates and as a possible factor that could influence donation rates at different
levels within the healthcare area (3–5). The organ donor process still needs a multidisciplinary, advanced approach to
maintain quality and safety. To explain and motivate the professionals involved in the organ and tissue donation process,
different training courses have been held (6, 7). Therefore,
most of the undertaken actions have often been isolated
within one system or country, which could lead to only local
or regional factors being identified and analyzed. Based on
the analysis of the donors per million population rates, a large
variability was seen between different countries. Even countries with similar types of healthcare systems showed dramatic differences. Over the last 10 years, Spain has showed
to be number one worldwide in generating organ donors
per million population, averaging around 35 donors pmp.
Despite different, often very expensive analysis and approaches, no other country has achieved these rates. This
has led to what people in the professional environment
would call the “Spanish Model”. Analyzing this model has
shown that, besides the strong motivation and publicity
for the need of organs for the society, education has always
been an essential element in the entire process (3, 4, 8, 9).
In 1991, a group of professionals founded the Transplant
Procurement Management (TPM) Project.
The TPM was a pioneering program, initially started in
Spain, in response to the need of well-trained transplant coordinators. Since 1991, the course contents have been constantly reevaluated and adapted to meet the educational
needs. The “Vital Circle” theory, initially introduced during
the development of the TPM projects, highlights the fact that
organ donation and transplantation is a part of society and
organs are societal goods.
D
Purpose
The TPM educational project provides the participants with the knowledge and skills required to understand the process and to guide all possible professionals
involved in the donation process. The final goal is to generate more organs and tissues, ensuring that they are
effectively obtained, preserved and distributed, as well as
Transplantation • Volume 88, Number 7S, October 15, 2009
guaranteeing quality and transparency throughout the entire process.
Following is a report on the evaluation of TPM courses,
with relevant information on the total number of courses,
educational methodology and participant’ profiles, according
to the objectives established for each of the theoretical or
practical sessions, teaching program assessment results, practical simulations and technical organization.
The purpose is not only to analyze what type of courses
have been held throughout the last 17 years, but also to evaluate at which levels these types of courses meet the needs for
formation and permanent awareness required to increase
organ donor rates.
Methods
A retrospective and descriptive analysis was carried out
to map and evaluate the educational programs implemented
by the TPM project. Since 1991, seven crucial points have
been identified which provide the best possible education and
training. Initially, based on the learning through experience
model, the courses were organized around the transplant coordination activity with a general program.
Today, a clearly defined program is carried out at
different levels within the organ donation process and
within communities significantly impacting potental donor rates. With the intention to increase donor rates, TPM
has designed different kinds of courses adapted to local,
national and international educational needs, medical
practices and current laws.
Course Methodology
Basic knowledge includes topics of donor detection,
identification and selection, brain death diagnosis, maintenance of brain death donors, family approach, organ retrieval
and sharing, recipient selection, tissue recovery, processing
and distribution, the quality control of the donation process,
the organization of a transplant coordination office and a
global view of the ethical and legal aspects of the process.
Advanced courses are organized with a broad subject base,
structured in different modules. Theoretical sessions are followed by practical sessions. TPM facilitates the development
of proactive experimentation with training provided by
means of the relevant simulations. Instruction and practice
are a further step to complementing the previous skills. The
results have been analyzed according to the type of course,
professional profiles and course assessment. The faculty is
formed by professionals with conceptual and practical knowhow in the field of donation and transplantation. In general,
the teacher or participant ratio is close to 1:1, which enables a
more personalized training and teaching.
Assessments of the educational program followed by
participants (advanced, intermediate and introductory
courses) have shown compliance with teaching objectives.
Theoretical contents are rated 4.1 as an average (rating 1–5)
with regards to content, presentation and ability to answer
questions during theoretical classes. The know-how acquired
by the participants was assessed by means of a self evaluation
test. The percentage of correct answers exceeded 75%. Practical skills assessed through direct observation showed an average of 8.1 (rating 1–10).
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Results
TPM National Training Courses
In 1991, a national face-to-face course was launched
under the name of TPM at the University of Barcelona.
Within the course, three different levels were identified to
meet the needs of different levels of professionalization in
the process of organ and tissue donation and transplantation: “Introductory Courses” were designed to empower
active detection of donors in the hospital setting; “New Life
Cycle Courses” were designed to promote a positive attitude
with regards to donation; “Advanced Courses” were designed
to train specialized professionals in the field.
TPM Fellowship Programs
In 1994, TPM, based on needs analysis and also on the
increased success of its program at a national level, started
training people worldwide. Every year since, professionals
from all around the world have been invited to an international advanced course, which is held in Barcelona, Spain.
Since 1994, TPM has coordinated numerous international
courses, providing truly international training. Moreover,
participants can apply for a prolonged 2-month training
stage in the frame of the Intercatt Project, involving several
transplant centers in Spain. This was already in place for
national purposes, but has been enlarged to an international level.
TPM Training Courses Within a Country
Since 1997, Italy and since 2006, France, have organized, under the management of TPM, their own national
training courses on transplant coordination adapted to their
systems. The methodology of the international training
course was projected inside a national system, but with the
same elements as the advanced international TPM course. In
addition, managers of the national courses within those
countries also joined the international advanced courses in
Barcelona, mainly to fine-tune and optimize the national
courses for their country, together with the educational staff
of TPM. A well-defined balance of national and international teaching staff was performed. Since 1997, 24 Italian
courses with 1032 participants, and since 2006, six French
courses with 267 participants, were developed. On top of
this, a few short introductory courses were designed and
implemented in different countries.
TPM e-Learning Programs
The e-learning program was launched in 2002, with the
intention of overcoming the time and geographical barriers
and of facing the technological developments in the educational area. The use of the internet as the basic transmission
channel of knowledge facilitates individualized and interactive contact between all members of the virtual community.
The learning method used in the TPM online courses is highly
interactive. Moreover, each course develops a core structure
with factual information based on written materials (structured in modules) and audiovisual support, which promotes
learning by emphasizing the key concepts. This also invites
both participants and teachers to actively contribute and discuss different aspects of the course contents through open
forum debates. The participants are supported throughout
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their learning process by a team of trained tutors. Eight different modules have been created so far, covering the whole
process of organ and tissue donation: (1) Donor detection
system; (2) Brain death diagnosis; (3) Donor management
and organ viability; (4) Family approach for organ
donation; (5) Organ retrieval organization; (6) Preservation and allocation criteria; (7) International online tissue
banking course; and (8) Training for trainers (the last one,
in the frame of the European Training Program on Organ
Donation Project), with a total number of 671 participants
trained from 59 countries.
PIERDUB Project
In 2006, a new project was created at the Medical
School of the University of Barcelona to educate and motivate medical, healthcare science and other university students in the field of donation and transplantation. From
the philosophy that the organ donation principle can only
be successful if a wide trust within the entire health care
related community is secured, three different training
phases, within organ donation and transplantation, were
designed: (1) Train the trainers by giving theoretical and
practical training to medical students; (2) Training of
health science related faculties and others within Spain;
and (3) Research projects to evaluate methodology and
impact of this training towards attitudes. Since 2006, 240
trainers and students were trained within five schools
across the country. At the end of 2008, 600 questionnaires
had been revised.
TPM International Masters on Transplantation of
Organs, Tissues and Cells
The international master program was designed in
2005 and is based on 15 years experience of training professionals, around the world, within the field of organ and tissue
donation and transplantation. It was created to provide specific education that benefits those professionals working as
transplant coordinators, by developing an updated educational program and issuing a masters university degree. Its
aim is to complete the health professionals’ training on transplant coordination, tissue banking and cell therapy research
by having them complete a 1-year training and education
program and writing an applicable research project. Moreover, participants attend clinical sessions and an online module to create a network to facilitate communication among
the participants from different countries.
To date, there has been one edition in English, with a total
of three participants, three editions in Spanish, with 37 participants and four editions in Italian, with 55 participants.
European Training Program on Organ Donation
Project
The project’s aims were to validate a professional training program on organ donation at different professional
levels, to contribute to increased organ donation knowledge, to maximize the growth of organ donation rates and
to disseminate reliable information to the community. The
execution of the project is being carried out through 17
countries and 20 partner organization representatives in
25 target areas.
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The methodology of the project responds to the cycle
of: Analysis of the country’s current situation; Designing a
training program adapted to the needs, validation and implementation of the program; Follow-up; Evaluation and finally; Analysis of its transferability, observing again the country’s
current situation.
Within this framework, the learning methodology to
implement the European Training Program on Organ Donation is based on two modalities: blended learning and faceto-face training. To date, 51 Senior Transplant Coordinators
have been trained through Training for Trainers; 45 essentials
in organ donation seminars have been carried out; 49 Junior
Transplant Coordinators have been trained in the Professional Training on Organ Donation Program; and 23 Transplant Area Managers have attended Organ Donation Quality
Managers Training.
Overall, results show that since 1991, 66 advanced
courses have been held, with 2915 participants. Fifty-six
introductory courses, with 2523 participants and 15 intermediate, with 501 attendees, were developed.
Participants of the advanced courses came from Europe
(2462; 660 from Spain), America (317, mostly from Latin
America), Asia, Africa and Australia (136).
In advanced courses, the professional profile of the majority of participants was medical doctor (from 49% to 90%
depending on the courses), followed by nursing (13% to
49%) and other professions, such as psychology and biology,
among others. More nursing professionals participated in
introductory courses.
In advanced courses, the most common medical speciality was anaesthesiology (from 4% to 54%, depending on the
course), followed by intensive care medicine (7% to 46%)
and transplant coordinator (8%–30%). The rest of the pupils
correspond to a great variety of medical specialities, such as
cardiology, general surgery, emergencies and neurology.
Forty-one percent of the participants in Spanish courses
and 17% in English courses had no previous experience in
transplant coordination.
The faculty was formed by professionals with conceptual and practical know-how in the field of transplants. In
general, the teacher/pupil ratio was close to 1:1, which enabled more personalised treatment in each course.
Assessment of the educational program followed by
participants (advanced and introductory courses) showed
compliance with teaching objectives. Theoretical contents
were valued more than 4.1 as an average (rating 1–5) with
regards to content, presentation and ability to answer questions made in theoretical classes.
The know-how acquired by the participants was assessed
by means of a self evaluation test. The percentage of correct answers exceeded 75%. Practical skills assessed through direct observation showed an average of 8.1 (rating 1–10).
Conclusions
The professionalization of transplant coordination can
be achieved with suitable training. The TPM educational program offers its participants a wide range of necessary knowhow and skills to build their competences in the donation of
organs and tissues for transplant. Health professionals and
international organisations concerned about the scarcity of
Transplantation • Volume 88, Number 7S, October 15, 2009
organs may find TPM a useful tool for their training and
consequent work as transplant coordinators. Based on this,
the two essential elements for healthcare-related professionals to understand and be motivated to perform them in their
jobs are highly developed within the different TPM training
modules. Organ donation and transplantation within society
needs a multilevelled approach to be able to tackle organ donation issues at different levels. Motivation and ability to perform well can only be reached if both professionals and the
general public understand the different elements of the
process (10). It has been shown that advanced education
positively contributes to the motivation and ability of professionals working in the field of organ donation and
transplantation (11). TPM educational project has also
highlighted, in all its trainings, the need for a multidisciplinary approach, in which different medical and nonmedical
professionals have been trained. Professionals ranging from
medical doctors and nurses to health care administrators
were trained over the past 17 years at regional, national and
international levels. This unique mixture of different disciplines, with different experience levels, provided teachers and
students with the skills to analyze elements related to organ
and tissue donation as well as transplantation. The teaching
methodology of close to 1:1 teacher-student ratio created a
unique way of problem-solving teaching, and the fact that
students had no threshold to pose questions and give remarks
on subjects related to the course.
From a unique experience built up over the last 17 years,
the TPM project has become the largest international education
program in organ and tissue donation and transplantation. TPM
has also opened doors to third world countries and countries
seeking help to get their systems optimized and developed, to be
able to perform well on a national basis. Within the TPM project,
the students are quoted to be of extreme value and are widely
invited to share their experiences, no matter if they have had an
extensive or a limited experience.
TPM educational projects are supported by a professional international staff of teachers and collaborative centers
who build the bridge between educational needs in the specialized field of organ and tissue donation with the need for
improving results. But still, the enormous gap between
different countries in donor numbers remains the main
drive behind these courses; to perform better from sharing
experiences at an international level. Furthermore, the
TPM project’s ambition for the future is to create a new masters
degree, so that scientific value can be given to all those professionals working in this field and doing research.
Acknowledgments
The authors would like to thank F. Van Gelder for the
scientific consultancy and Mediconed Consultancy, for advice
and support writing the article and analyzing the methodology.
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GLOBAL APPROACHES TO ORGAN
SHORTAGE
Rafael Matesanz, Elisabeth Coll,
Beatriz Dominguez-Gil, Beatriz Mahillo,
Eduardo Martin Escobar, and Gregorio Garrido
rgan transplantation has progressively become the best,
and sometimes the unique, therapeutic alternative for
patients with end-stage organ failure as well as many other
life-limiting conditions. Thanks to the continuous improvement of immunosuppressive therapies and surgical
techniques, transplantation today no longer represents an
experimental procedure, but a well-established clinical
therapy, which saves the lives or enhances the quality of life of
thousands of patients every year. According to estimations
from The Global Observatory of Donation and Transplantation (1), there are almost 100,000 solid organ transplants performed annually all around the world.
The impressive evolution of organ transplantation activity in a 50-year period is greatly related to the extraordinary
results obtained with this therapy, which have progressively
improved for the different types of solid organ transplants
(2– 4). These results are well represented by the longest survivals described by Cecka and Terasaki (5) for transplanted
patients: up to 45, 38 and 29 years for a kidney, a liver and a
heart transplant recipient, respectively. However, these excellent results have led to transplantation becoming a victim of
its own success. Organ shortage is a universal problem that
precludes transplantation from developing to its maximum
potential and is related to a wide set of individual and
global consequences.
O
The Figures of Organ Shortage
Difficulty in obtaining accurate and transparent figures
of transplantation activity is highly increased when we reach
the point of analyzing the needs. There is no accurate global
The authors declare no conflict of interest.
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estimate for the number of patients on the waiting list for a
transplant, but a simple calculation can be performed by extrapolating the number of patients on the list in Spain (6) to
the world population, assuming the same criteria applied.
The result would be no less than 1 million people potentially
benefiting from organ transplantation each year: 10-fold
the estimated number of transplanted patients (1).
However, it is clear that any approach to the number of
patients on the waiting list is always an underestimation of the
needs. Focusing on the kidney, end-stage renal disease
(ESRD) has become a universal health problem, with more
than one and a half million patients on dialysis therapy (Luc
Noel, personal communication) and 66,000 kidney transplants performed each year (1) (Fig. 1). However, there are
marked differences in the number of patients per million
population accepted for renal replacement therapy in the different parts of the world (7). These differences might be partially explained by epidemiological aspects (as is the case of
Japan) but mainly by economical reasons.
Hence, demand is well above the supply of organs for
transplantation, according to current figures that possibly
underestimate the real needs. Finally, demand is expected to
increase in the near future, particularly for kidney transplantation. It has been estimated that the number of patients with
diabetes mellitus will double from the year 2000 to 2030, especially in developing countries (8). This 21st century pandemic of diabetes, added to the ageing of the population,
arterial hypertension and obesity, is expected to significantly
impact the prevalence of ESRD across the world and hence
the need for kidneys for transplantation.
F1
Consequences of Organ Shortage
The most important and obvious consequence of organ
shortage is the fact that many patients will never be placed on
the waiting list, and many will die or deteriorate whilst waiting for an organ. No less than 1 million people die every year
in the context of ESRD without adequate therapy all over the
world (Luc Noel, personal communication).
Another important problem derived from the shortage
is the cost to the systems of alternative renal replacement
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FIGURE 1. Kidney transplants. Annual global estimates
(per million population [pmp]). Percentage living/total
kidney transplants.
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therapies, i.e., dialysis, to kidney transplantation. Lysaght (9)
predicted the total cost of dialysis in the world would be U.S.
$1200 billion for the decade 2000 to 2010, probably underestimated. In Spain, Italy and Western Europe in general, renal
replacement therapy represents 2% to 2.5% of all health expenses. The total therapy cost per patient in dialysis, per year,
in the European Union is approximately €50,000 (U.S.
$70,830).
Kidney transplantation has proven to have a more favorable cost effectiveness ratio than dialysis. It is related to
better results in terms of survival (10) and quality of life (11).
In addition, depending on the country, the cost of kidney
transplantation can be offset in 2 to 4 years when compared to
dialysis. This has been clearly proven in Europe, the United
States, and also in countries like Pakistan, where renal transplantation remains being the best and least expensive renal
replacement therapy (12, 13).
Organ Shortage and Transplant
Commercialization
Desperation of patients waiting to be transplanted, at a
time of organ shortage, derives in another dramatic consequence; the development of criminal practices, such as
organ trafficking and the progressively better known phenomenon of transplant tourism.
Transplant tourism is defined as the movement of organs, donors, recipients or transplant professionals across jurisdictional borders for transplantation purposes (involving
organ trafficking and transplant commercialism), if the resources devoted to providing transplants to patients from outside a country undermine the country’s ability to provide transplant services for its own population (14). This phenomenon has
emerged due to a lack of organs, as an immediate solution for
patients in need and in the extreme context of an extremely unequal distribution of wealth, with 20% of the world’s population
controlling 80% of global resources. Not by chance, the most
usual practice is represented by the movement of patients from
rich to poor countries, profiling a “North to South” flow in
which wealthy patients, in their desperation for finding an organ,
travel to developing countries where the donor, usually a vulnerable and poor person, agrees to sell a kidney to solve his, also
desperate, economical situation (15).
These practices also have one of their main roots in
results related to living kidney transplantation, in particular,
to better outcome results in terms of patient and graft survival
than deceased kidney transplantation. Today, these better results are regardless of an existing relationship between donor
and recipient (16). Hence, living unrelated kidney transplantation has become a reality with excellent results after advances
in immunosuppression have reduced the relative importance of
human leukocyte antigen matching for postransplant outcome.
Examples of these practices, that have arisen as a modern horror added to the endless series of tragic disasters that
affect the whole world, are unfortunately too abundant. Asia,
with 60% of the world population, provides no more than 2%
to 3% of all deceased organ donors, leading to the proliferation of living transplants performed under the umbrella of
different forms of commercialisation. India, Pakistan, Philippines, Egypt and several Latin American countries are recognized as involved in organ trafficking and transplant tourism
(15). In China, most of the transplanted organs were alleged
Transplantation • Volume 88, Number 7S, October 15, 2009
to have been procured from executed prisoners (17), a practice which has been criticized by the international community, with a quite recent and fortunate compromise of the
Chinese Government to stop this practice.
Another particular form of commercialization is the
Iranian model (18). In this country, nearly 2000 patients receive a kidney transplant from a living donor every year, most
of them unrelated. Donors receive some bonus, partially supported by the state and partly by the recipient, in a system
which is organized and controlled by nongovernmental
organizations and forbidden to foreign citizens. Although
criticized by the international community, this system has
allowed the country to do away with the kidney transplant
waiting list and avoid transplant tourism. Defendants claim
that the system cannot be judged from the opulence of Occidental countries.
Organ trafficking and transplant tourism violate the
most basic of human rights. These practices are also related to
safety problems, especially in the case of the living donors,
with no guarantee of application of the international safety
standards, but also in many recipients transplanted by these
means (15). These practices also cause a profound damage to
the universal image of donation and transplantation, which
generates a climate of distrust toward the system that might
contribute even more to the exacerbation of the underlying
problem of organ shortages for transplantation.
Global Approach to Organ Shortage: The Role of
Transplantation Society, WHO and ONT
Organ shortage and its consequences, including organ
trafficking and transplant tourism, has become a universal
problem. The World Health Organization (WHO) estimates
that at least 10% of all kidney transplants in the world are
performed under some kind of commercialism. Universal
problems need global solutions. Some years ago, the WHO,
together with The Transplantation Society, initiated a global
project to overcome organ shortage and efficiently combat
unethical practices. Actions such as the recent generation and
wide dissemination of the “The Declaration of Istanbul
against transplant tourism and commercialism” (14), are
good examples of this global approach. The Spanish Transplant Organization (ONT), an official Collaborating Centre
of the WHO, has been actively participating in this process
from the very beginning.
The mission of the WHO in the area of transplantation
is to meet the requirements of the 57th World Health Assembly Resolution (WHA 57.18), regarding Human Organ and
Tissue Transplantation (19). Since 2005, the WHO, with the
support of Transplantation Society and ONT, began a set of
consultations, two of a global scope and several regional consultations, with national health authorities in the different
regions of the WHO. These regional consultations have been
held in Manila with the countries of Western Pacific, in Karachi with Muslim countries and in Slovenia with the Republics
of the old Soviet Union, among others.
From the very beginning, the structure, background,
stability and experience of ONT was offered to the WHO to
support a partnership in developing an International Observatory of Transplantation, a need that was to be covered
through the Global Knowledge base on Transplantation
(GKT), with four components. GKT1 and GKT2 led to the
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TABLE 1. Recommendations and other relevant
documents generated by the Iberoamerican
network/council on donation and transplantation
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FIGURE 2. Deceased organ donors in Spain, evolution
1989 to 2007.
F2
Global Observatory on Donation and Transplantation
(http://www.transplant-observatory.org/default.aspx). This
observatory, developed by ONT in collaboration with the
WHO, has been available since 2007 and provides an interface
for health authorities and the general public to access data on
donation and transplantation practices and legal frameworks
all over the world.
The international role of Spain in this field is also the
consequence of the successful donation program within the
country. Spain has the highest deceased donation rates ever
described in the world; double the mean value for the whole
European Union. The success of the Spanish system is based
on the implementation of a set of measures, mainly of an
organizational nature, that is internationally known as the
Spanish Model of Donation and Transplantation (20).
These measures followed the creation of ONT in 1989 and
led Spain to triple the number of organ donors, from 500
to more than 1500 donors in 2007 and more than double
the deceased donation rates, from 14 to 34 to 35 donors
pmp (Fig. 2), resulting in significant reductions in the
number of patients on the waiting lists and their waiting
times.
The Iberoamerican Example
It is in Latin America where the Spanish cooperation
is clearly becoming important for obvious historical and
linguistic reasons. Spain, in close cooperation with the
Panamerican Health Organization, is in charge of the development of Resolution WHA 57.18 (19), through the
“Iberoamerican Network/Council of Donation and Transplantation” (Red/Consejo Iberoamericano De Donacion y Trasplantes, RCIDT).
The creation of the RCIDT was approved by the Heads of
States and Governments at a summit held in Salamanca, Spain in
2005. ONT is in charge of the permanent secretariat of this newly
created organization. The mission of the RCIDT, composed by
21 Spanish and Portuguese speaking countries, is the development of cooperation between its members, in terms
of organizational, legislative, professional training, ethical
and sociological aspects, related to donation and transplantation of organs, cells and tissues in Iberoamerican countries.
The RCIDT considers organizational aspects as especially rel-
Mar de Plata Declaration. RCIDT 2005
Recommendation Rec RCIDT 2005 (1) on autologous cord blood
banks
Recommendation Rec RCIDT 2005 (2) on the role and training
of professionals responsible for organ donation (transplant
donor coordinators)
Recommendation Rec RCIDT 2005 (3) on the functions and
responsibilities of a national transplant organization
Recommendation Rec RCIDT 2005 (4) on quality assurance
programmes in the donation process
Recommendation Rec RCIDT 2005 (5) on the training plan for
training professionals in donation and transplantation
Recommendation Rec RCIDT 2006 (6) on solutions to organ
shortage (phases of the deceased donation process-areas for
improvement)
Consensus Document: criteria to prevent the transmission of
neoplasic diseases through transplantation
Recommendation Rec RCIDT 2007 (7) on guides for the quality
and safety of cells and tissues of human origin for
transplantation
Recommendation Rec RCIDT 2008 (8) on bioethical
considerations on donation and transplantation of organs,
tissues, and cells
Recommendation Rec RCIDT 2008 (9) on harmonization of
criteria for the diagnosis of brain death in Iberoamerica
Declaration against transplant tourism
evant in tackling organ shortage and cooperation indispensable in achieving the maximum effectiveness of the systems.
Since its creation in October 2005, the RCIDT has held
seven meetings; Mar de Plata (Argentina); Madrid (Spain);
Montevideo (Uruguay); Punta Cana (Dominican Republic);
Santiago de Chile (Chile); Havana (Cuba); and Mexico DF
(Mexico). The group has generated 11 recommendations and
consensus documents (Table 1) on relevant aspects on donation and transplantation.
As training is considered essential, one specific action developed by the RCIDT has been the development of
a whole training program in donation and transplantation
activities. Through this ALIANZA Master, professionals appointed by the different health ministries of Iberoamerican
countries are trained as transplant coordinators, in Spain.
Training seeks to facilitate the translation of the Spanish
Model to the Latin American reality. With a 2-month duration of each aspect, these selected professionals each completed a term in the biggest Spanish hospitals, participated in
a general coordination training course as well as other specific
courses relevant for their training, which were held in Spain
during the time of the Master. They had to present a final
written project before reaching the final degree of the Master.
ALIANZA Master has been performed annually since 2005
and so far 182 professionals have been trained, all of them
already working in their countries and many occupying positions of responsibility at a national level (Fig. 3).
In parallel to the ALIANZA Master, training courses on
specific aspects of the process of deceased donation and transplantation have been held in several American countries. In
particular, a program on training of trainers on the commu-
T1
F3
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Transplantation • Volume 88, Number 7S, October 15, 2009
of aspects, such as diagnostic criteria for brain death or
clinical evaluation criteria of the possible donors.
• RCIDT is progressively becoming a technical, ethical,
training and cooperative reference for the development
of transplant activities in all the countries within the
region.
• In addition, deceased donation activities are progressively increasing in countries within the region. The
most notable change was detected from the year 2005 to
the year 2006. In just one single year, deceased donation
activities increased as much as 60% in Colombia, 30% in
Cuba, 27% in Venezuela, 22% in Chile, 20% in Uruguay
and 11% in Argentina. In 2006, Uruguay achieved deceased donation rates close to those described in the
United States (25.1 donors pmp).
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FIGURE 3. Number of participants in the ALIANZA Master
according to the country of origin.
nication of bad news was held in Argentina, Chile, Colombia,
Central America and the Caribbean. In the context of these
programs, teams of monitors are being trained who will be
able to develop courses in their own countries as well as in
others within the region. Finally, courses on quality and safety
in the management of tissue banks are also being developed,
with wide acceptance and increasing demand, mainly in those
countries of the Southern cone.
In addition, the running problems of organ trafficking
and transplant tourism, which affect some of the countries
within the region, were raised at the last meeting of the
RCIDT in Havana, May 2008. Since its creation, the RCIDT
has expressed its complete opposition to these practices,
which facilitate transplant commerce, and has considered
them as morally condemnable. In this context, the relevance
of the document on bioethical considerations produced by
the RCIDT must be highlighted. In countries with problems
of organ trafficking and transplant tourism, the RCIDT is
providing specific support to those organizations in charge of
oversight of donation and transplantation, in order for them
to overcome their problems. This support has been documented in the Declaration against Transplant Tourism.
As a result of all these processes and of all the activities
developed by the RCIDT:
• Donation and transplantation organizations have been
created, restructured, or revived in countries which were
lacking this type of system or where activity was minimal
or null. These organizations rely on or are supported
by the health authorities, following the Spanish
model, and are being organized as a coordination
network.
• Training activities for coordinators are being consolidated through the ALIANZA Master and courses performed in Iberoamerica, in cooperation with several
countries. Training is focused to the different areas
within the region and tailored to their specific needs.
• Initiatives to harmonize criteria, in agreement with scientific societies and in accordance to international standards, are being developed, focusing on a wide number
Conclusions
In conclusion, organ shortage is a problem of a universal scope. It has important individual and global consequences. As a universal problem, it must be approached
through global initiatives that provide the basic standards and
pillars over which locally tailored actions are to be designed
and implemented. Although changes in organ donation take
time, what the Latin American experience shows is if steps are
taken into the right direction everything is possible, even the
construction of a successful deceased donation program.
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files/WHA57/A57_R18-en.pdf. Accessed October 2008.
Matesanz R, Domínguez-Gil B. Strategies to optimize deceased organ
donation. Transplant Rev 2007; 21: 177.
EDUCATIONAL PROPOSALS FOR
PROMOTING A CULTURE OF
DONATING ORGANS
Felix Cantarovich
Defining the Problem: What Needs to be Solved?
During the previous decades, society’s behavior with regards to organ donation remains reluctant. A recent study
showed that only 42% of potential deceased donors are used in
the United States (1). This finding is in agreement with current data
showing that the rate of willingness to donate an organ is 38%
among young adults in the United States and 42% in Europe (2).
Organ shortage is the main reason for the significant
number of patients dying on the waiting lists (3, 4). It was
mentioned that less than 40% of suitable people offered their
organs after death (5).
A survey showed that although people plainly accept to
offer their organs for transplantation, (6) when a person dies,
his or her relatives often refuse donation. To be able to change
this ambivalence in the public it is fundamental to search for
the reasons of this behavior (7).
Review of the literature points towards two groups
where actions should be performed to modify barriers for
organ donation and transplantation: (a) The patient and the
general public and (b) Healthcare professionals (8, 9).
Barriers From the Patient and Public Perspective
Most of the adverse reactions towards organ donation
are due to a lack of information, mixed feelings and prejudice.
Doubts About Medical Diagnosis and Treatment
Understanding the concept of “brain death” remains a
barrier for the family to accept the “use of organs” after the
death. It is understandable that relatives without previous
reliable information would feel reluctant to believe that the
beloved patient is dead whilst seeing the patient breathing,
with the heart beating. As well as this, the media publish and
comment on “the case of a brain death patient going home”
(10 –12).
In addition, a very common doubt of the general public
is the rigorousness of the patient’s treatment, if he or she is
already known as a registered organ donor and the relatives
have agreed to organ donation (13).
Respect for the Body After Death
The ancestral belief that the integrity of the body is
necessary to reach eternity (Egyptian mummies) has been
The author declares no conflict of interest.
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transferred by ignorance to present-day faiths, and remains a
barrier to donation (14).
Lack of Awareness About the Need of Transplants for
Thousands of Patients
Transplantation is, for many people (including professionals), an uncommon medical practice.
It is remarkable that only 53% of individuals prepared to donate organs have informed their family of their
wish (15).
In addition, the dilemma of increasing waiting lists and
patients dying because of organ shortage is not well known by
society (16).
Healthcare Professionals’ Point of View
Intensive care unit doctors face several challenges when
confronted with a potential organ donor.
Management of Brain Death and Request for Organ
Donation
Although brain death diagnosis is currently widely accepted, there are still challenges among the medical team
(17, 18). In addition, several studies have shown that for
many doctors requesting organ donation from the patient’s
family is a difficult and, many times, resisted task (19 –21).
Increased Work Load Leading to Loss of Interest to
Participate in the Process of Organ Donation
Several trials focusing on the workload and psychologic
stress of intensive care unit doctors and nurses, when working
on brain death diagnosis, showed the difficulties experienced
by them. The medical team taking part in this task should also
be involved in informing the family as well as in the request
for organ donation (22–24). As the management of candidates for organ donation is complex, (critical care management, the declaration of brain death, the identification the
and request for organ donation from the next of kin), it has
been suggested that these patients are best managed in tertiary
centers. These centers have professional staff with the expertise and interest in performing these tasks (25).
Lack of Appropriate Training to Face the Different
Medical, Ethical and Social Issues Related to Organ
Donation and Transplantation
The aptitude of medical teams, concerning issues of
death and organ donation, can make the difference between a
family accepting or refusing consent. Families expressed dissatisfaction with inappropriate communication and support
when brain death was announced and thereafter when a request for donation was made (26, 27).
Polls performed about the decrease in the number of organ donor shows a lack of knowledge among medical teams.
Questions on brain death legislation and religious opinions to
organ donation were incorrectly answered. When asked, “are
brain death and cardiac death the same state (i.e., are both death
of the patient)?” 45% of respondents answered “no” (28).
The following factors were also reported as barriers for
professional participation in organ request: (1) The value and
contribution made by donotransplantation; (2) The unique
idea of having another’s tissue in one’s own body; (3) The
importance of organ donation; (4) The individual’s moral
and nurses’ professional rejection of the responsibility for or-
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gan or tissue donation; (5) The postmortem mutilation of the
body; and (6) The potential distress donation may cause a
bereaved family (29 –32).
It was suggested that more knowledge among professionals would implicate larger society’s cooperation in the
donation and procurement process (33).
A significant correlation was observed between the
awareness of transplantation, brain death and organ donation and the workplace (operating room and intensive care
unit vs. other areas) (34).
How Can Organ Donation and Procurement Be
Improved?
The persistent organ shortage, the constant increase of
patients on waiting lists and the unfair mortality of people
waiting for the “Gift of Life” have encouraged searching for
alternatives in order to increase the availability of potential
donors. The following are the main suggested options:
1.
2.
3.
4.
Legal alternatives for consent
Economic incentives
Expanding donor pool
Education
The first three proposals aim for a rapid solution. However, their feasibility, ethical and moral acceptance, as well as the
medical advantage of each of them, is a matter for discussion.
Conversely, education, which could be a potential
long-term solution, is largely accepted by society. Education
may increase awareness about organ donation sustaining ethical principles (altruism, equality and fairness).
How Should a Constructive Educational Project
Be Organized?
Several surveys investigating awareness of transplantation and organ donation showed a public lack of knowledge
and insufficient university training of the medical team (doctors and nurses).
This is a long-standing problem that needs to be solved.
A structured and intensive educational program might consider the following priorities:
a. An active state participation
b. A full participation of all the sectors of society
c. A change in the message should be considered
An Active State Participation
An intensive educational activity, structured between
the State and the different interested partners (Transplantation community, interested ONGs (Organization NonGovernmental), schools and the university responsible)
should be evaluated as a significant mission to be accomplished for the State’s authorities, who are responsible for
health and education.
The main actions to develop might be; (a) To settle the
deficiency concerning donation and transplantation in all educational levels; (b) To develop pilot projects on education
and information on organ sharing and donation; and (c) To
collaborate with the media to create awareness and enhance
public understanding and human solidarity.
Transplantation • Volume 88, Number 7S, October 15, 2009
A Full Participation of All Sectors of the Society
The public needs unambiguous and persistent information concerning organ donation and transplantation.
Also, healthcare professionals present serious deficiencies in
their training on transplantation issues. This situation needs
to be modified by the educational authority responsible for
teaching programs in medical schools.
One sector of society that has not been a particular target of education regarding transplantation issues is the youth.
The meaning of child education and the potential of teaching
the subject of transplantation is remarked by several brilliant
educationists, for example, “The purpose of education is to develop the knowledge, skill, or character of students”. “In ancient
Greece, Socrates argued that education was about drawing out
what was already within the student” (35). “The central task of
education is to implant a will and facility for learning; it should
produce not learned but learning people. The truly human society is a learning society, where grandparents, parents, and
children are students together” (36).
“No one has yet realized the wealth of sympathy, the
kindness and generosity hidden in the soul of a child. The
effort of every true education should be to unlock that treasure” (37). “The young rarely think about their own death or
about giving their organs upon death, then they should be
constrained and enabled to do so by the institutions, practices
and laws we enact” (38).
“Teaching young people about organ transplantation is
not notably difficult”. “The organ transplant community has
to offer strong inducements for teachers in various settings to
take up the task”. “Strong persistent education efforts focused
specifically on young people seem comparatively rare”.
“Helping young people understand the facts about transplants early in life increases the chance of them being sympathetic to the idea of organ donation”. “They are also likely to
respond to a teacher’s suggestion to find an occasion to discuss this topic with their families or with their peers, thus
multiplying the educational effect” (39).
“Education on organ donation is important to reduce organ shortage” (40). “Education and information
will enhance the value of altruism protecting people from
exploitation and emphasizing the meaning and worth of
organ donation” (41).
Some of the words of John Paul II in his address to the
18th International Congress of The Transplantation Society,
supported the idea of youth education on organ transplantation as a pathway to improve society’s feelings.
“There is a need to instill in people’s hearts, especially in
the hearts of the young, a genuine and deep appreciation of
the need for brotherly love; a love that can find expression
in the decision to become an organ donor”.
“I am confident that social, political and educational
leaders will renew their commitment to fostering a genuine
culture of generosity and solidarity” (42).
Challenging Educational Programs
Conversely, the usefulness of education to change peoples
feelings toward organ donation has been criticized by economists that supported economic incentives, for example, Tabarrok considered that, “the public has been barraged with billions
of dollars worth of educational campaigns and yet the organ
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3. During life, we have more chances of being an organ
recipient than a donor.
4. Organ donation should be a citizen responsibility.
5. The use of organs and tissues for transplantation should
be considered as part of a fair agreement between individuals and society.
donation rate has remained essentially unchanged for the past
decade” (43).
Unfortunately, this statement is not entirely accurate,
because there have always been reasons responsible for the
current failure of education, for example, the media.
Information from the media usually contains negative
news regarding transplantation. Regrettably, preference is
given to inform more anecdotal rather than real issues, for
example, recovery from brain death, transfer of personality
from donor to recipient, the organs’ black market and corruption in the medical community and the organ allocation
system. On the contrary, the media does not give enough
information on organ shortage consequences, for example,
the increasing waiting lists and the number of people dying
every day, or positive information as the attitude of monotheist religions toward deceased organ donation.
Last but not least, the media should also use “A Gift
of Life” as the message to encourage donation as a gift.
Decades of unmodified organ shortage suggests that it
should be evoked why, despite such message, many people
still reject the idea to make a gift of the organs of their
beloved one (44).
It is most likely that a well-programmed media campaign, persistently diffused, could have influence in improving society’s attitude toward organ donation and
transplantation.
Could Education Lead Society to Acknowledge a
Different Message?
To evaluate this, possibility surveys and practical experiences have been performed.
Surveys
a. Between the public (n⫽2321) (Fig. 1), from five countries: Argentina, Austria, Brazil, France and Italy.
b. Among 139 transplant specialists (abstracts reviewers
of the XIX Congress of The Transplantation Society
[45, 46]).
Both groups considered the suggestion that organ donation means to share a chance of life acceptable. (Fig. 2)
Concerning school education, the positive answer was highly
significant (Fig. 3).
Conversely, an unexpectedly public disinformation
was observed with regards to the position of monotheist religions concerning organ transplantation (Fig. 4).
A Change of the Message Should Be Considered
The practically unchanged behavior of people towards
organ donation suggests that the main goal of an educational
program should be to improve the message to Society.
It is my proposal to include the following ideas in a new
message to the public:
Practical Essay of Young People Education
Young people have not been sufficiently informed
about their potential role and their future needs of organ
transplantation. It should be critical to define the goals of
education of organ transplantation as part of schools’ curriculum; it will be essential to explain facts and updated information on the subject.
To assess the impact of education on organ transplantation in elementary and high schools, 45 min class presenta-
1. Organ donation means sharing a chance of life with
everybody, including our families.
2. Decease organs are a source of health.
n=2321
46%
50
40
30
18%
20
16%
12%
8%
10
0
Argentina
FIGURE 1. Survey by country.
100
80
Austria
Brazil
France
6% 9%
7% 7%
1% 2%
No
Do not know
Other opinion
Italy
82%
66%
60
40
2%
20
FIGURE 2. Do you believe that the initiative of
sharing organs as a source of life for others may
be assumed to be a fair agreement between individuals and society?
0
Yes
Public = 2296
Transplantologists = 139
0%
May be
F1
F2
F3
F4
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Transplantation • Volume 88, Number 7S, October 15, 2009
120
100
98%
85%
80
Public = 2287
60
Transplantologists=139
40
9%
20
FIGURE 3. Agreement with educational programs targeting children at school.
1%
5% 1%
1% 0%
Do not know
Other opinion
0
Yes
No
n=2321
50
40%
36%
40
30
FIGURE 4. Do you know what is the attitude
or belief of the Catholic and Protestant religions towards the use of organs or tissues for
transplantation?
17%
20
7%
10
0
Accept
Do not know
No answ er
45 45
50
38
40
30
20
Refuse
25 27
24
12
11 9
Preadolescents Argentina
(n=33)
4
10
Preadolescents Canada
(n=55)
0
Share
Waiting List
FIGURE 5. Topic of interest preadolescents.
60
50
40
30
20
10
0
Tx Help
No answ er
56
44
33
41
33
23
16
9
12
2
Share
FIGURE 6. Topic of interest adolescents.
F5– 6
Donation
after dead
tions about organ donation and transplantation were given to
362 school students in Argentina (Buenos Aires) and Canada
(Montreal).
The topics included the history of transplantation,
brain death, the donor, waiting lists and religious thoughts
on transplantation.
Students were divided into preadolescents (⬍12 years)
and adolescents (⬎13 years). The afforementioned new concepts were discussed. At the end of the presentation, the students completed a questionnaire.
Overall, the students were interested in scientific topics
and waiting lists. (Figs. 5 and 6) They remarked their intention to
discuss the learned topics with parents, friends or both.
This essay showed that young students are open to
learning about organ donation and transplantation, to accepting new notions and to discussing them. This pilot
study suggested that education on organ donation and transplantation, adapted to students’ age and regional socio-cultural
characteristics, might be of value to developing changes in attitudes
towards organ donation.
Waiting List
Donation
after dead
Tx Help
Adolescents Canada
(n=45)
Adolescents Argentina
(n=204)
No answ er
Education will help students to work through the fear
and discomfort that might previously exist towards organ donation. Knowledgeable students could share information
with friends and families.
Parent Involvement in These Programs
In early childhood programs, there should be a frequent
exchange of information between parents and schools concerning the child, parenting, education and community services.
Parental involvement is important during the early
years of school life and it might be of extreme importance on
issues related with transplantation.
Participation of the Community
Public and private schools need to be open about
education on organ donation and transplantation programs. In collaboration with other organizations, they will
provide the community with the best programs for children and their families. As it was mentioned “A communitarian approach to the problem of organ shortage entails
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3. An integrated and enthusiastic protagonist team.
4. The support of Transplantation Community.
5. An active participation and sustain of the States and
Churches.
changing the moral culture so that members of society will
recognize that donating one’s organs, once they are no
longer of use to the donor, is the moral (right) thing
to do” (47).
New Promising Experiences Developing in
Argentina for Promoting a Culture of Donating
Organs
Argentina started experiences in school children education in 1979 (48). Looking forward to improve general
knowledge and behavior about organ transplantation, an educational programs at different society levels have started in
the last few years.
References
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2.
3.
4.
At National Level
INCUCAI (National OPO) will develop a new school
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5.
At Medical Team Level
A 2-year postgraduate course on “Transplantology”
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7.
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At Public Level
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Final Remarks
Education could be the pathway for promoting a culture to improve “organ shortage”.
Current people barriers and disinformation should
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society.
The message should be addressed to all society levels,
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information.
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Author Information
Mario Abbud-Filho
Faculdade de Medicina e Instituto de Urologia de São José do
Rio Preto. Rua voluntários de São Paulo 3826, São José do Rio
Preto, SP, Brazil. CEP: 15015-200.
Jean Laffitte
Via della Conciliazione, 1
00193 Roma, Italy
E-mail: jlaffitte@acdlife.va
Riccardo Bosco
Piemonte Regional Organ Procurement Organization
E-mail: rbosco@molinette.piemonte.it
Martı́ Manyalich
Transplant Procurement Management. IL3 – Institute for
LifeLong Learning – Universitat de Barcelona, Ciutat de
Granada, 131, 08018 Barcelona, Spain
E-mail: tpmproject@il3.ub.edu
Marco Brunetti
Director, Office of Pastoral Care for Health,
Archdiocese of Turin
Italy
E-mail: salute@diocesi.torino.it
Félix Cantarovich
14, Fantin Latour
75.016 Paris France
E-mail: felix.cantarovich@orange.fr
Nunziata Comoretto
Center for Bioethics, Catholic University of Sacred Heart,
1, Largo F. Vito, I-00168, Rome, Italy
E-mail: nunziata.comoretto@rm.unicatt.it
Alessandro Nanni Costa
Director of the Italian National Transplant Centre
viale Regina Elena 299
00161 Rome, Italy
E-mail: cnt@iss.it
Francis L. Delmonico
Professor of Surgery
Harvard Medical School
Massachusetts General Hospital
Transplant Center
Boston, MA 02114-2696
E-mail: francis_delmonico@neob.org
Håkan Gäbel
Olof Wijksgatan 4
412 55 Göteborg
Sweden
E-mail: hakan@Gäbel.se
Valter D. Garcia
Santa Casa de Porto Alegre. Rua Correa Lima 1493, Porto
Alegre, RS, Brazil. CEP: 90850-250.
Alexandra K. Glazier
Vice President & General Counsel
New England Organ Bank
One Gateway Center
Newton, MA 02458
E-mail: alexandra_glazier@neob.org
Mariangela Gritta Grainer
postal address: via pedescala 22
36078 Valdagno (Vicenza)
E-mail: mgrainer@interplanet.it
Anna Guermani
Piedmont Regional Organ Procurement Organization
E-mail: aguermani@molinette.piemonte.it
Transplantation • Volume 88, Number 7S, October 15, 2009
Blanca Martinez
Department of Anesthesiology and Intensive Care Medicine.
Santa Maria della Misericordia University Hospital
Piazzale Santa Maria della Misericordia 15, 33100 Udine, Italy
E-mail: blancamartinez@libero.it
Rafael Matesanz
Organización Nacional De Trasplantes (ONT)
Sinesio Delgado 6
28029, Madrid, Spain
E-mail: rmatesanz@msc.es, rafmatesanz@yahoo.es
Jose O. Medina-Pestana
Hospital do Rim e Hipertensão, Universidade Federal de São
Paulo, São Paulo, SP, Brazil. Rua Borges Lagoa 960, 11° andar,
Vila Clementino, São Paulo - SP, Brazil. CEP: 04038-002.
E-mail: medina@hrim.com.br
Ferdinand Muehlbacher
Medical University of Vienna
Dept. of Surgery, Unit of transplantation General Hospital Vienna
Währinger Guertel 18-20
1090 Vienna
E-mail: ferdinand.muehlbacher@meduniwien.ac.at
Donadio Pier Paolo
Piedmont Regional Organ Procurement Organization
Responsible, Azienda Ospedaliero
Universitaria Molinette San Giovanni Battista Di Torino
Corso Bramante 88/90-10126 Torino
E-mail: pdonadio@molinette.piemonte.it
Walter Schaupp
Professor of Moral Theology
Faculty of Catholic Theology
Karl-Franzens University Graz
A-8010 Graz, Heinrichstrasse 78B
E-mail: walter.Schaupp@uni-graz.at
J.M. Simón i Castellvı́
President of the FIAMC (World Federation of the Catholic
Medical Associations)
Palazzo San Calisto
00120-Città del Vaticano
E-mail: metges@federaciocristians.org www.fiamc.org
Antonio G. Spagnolo
Dpt. Educational Sciences, University of Macerata and Center
for Bioethics, Catholic University of Sacred Heart, Rome
E-mail: agSpagnolo@unimc.it
www.transplantjournal.com |
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