In The Name of God
Ethical Aspects of
Iranian Model
of LURD
SM Gatmiri, MD, Nephrologist
Assistant Professor of TUMS, NRC, Imam Khomeini hospital
November 2012
Living unrelated renal
donation (LURD) is a
hot topic in organ
shortage.
ESRD & Demand for
RRT(HD, PD, LRD,LURD & BDD)
is increasing
So
LURD is in the core of medical
caregivers’ attention.
But controversial aspects of this
entity, requiring ethical
consideration.
And
Transplantation
societies and WHO try
to prevent unethical
practices in LURD.
The declaration of
Istanbul (2008) is a global
efforts to stop
commercial exploitation
1
in this field.
-Socioeconomic & cultural
differences,
-Religious beliefs,
-Legislative barriers, and
-Lack of infrastructure between
countries, prevent setting
standard international guidelines.
HISTORY OF RRT
IN
IRAN
Iran
In 1974 (1353)
First HD center
>35 years ago.
Gradually, the number of
patients on RRT
increased from 587 in
Tehran in 1991 to >25,000
(360 pmp) in 2006.
First kidney Tx
1967(1346)
But 112 renal Tx
were performed
until 1985.
In 1985 (1364)
MOHME funded
Renal Tx abroad
(living related donor). 5, 6
At that time in 1985 (1364), two
renal Tx centers were
established and 274 renal
Txs were performed
within 2 years.
In 1988 (1367)
Council of Guardians
regulated LURD
program.
1988 (1367)
LURD program was an
outstanding achievement
for patients with no access
to dialysis and health
authorities with limited
budgets. 5, 7, 8
1995 (1374)
Rejection of
BDD in the
parliament
1997 (1376)
Board of Ministers
approved
7,
9
Gift of Altruism.
And Then
Dramatic increase in Tx centers
from
- 2 in 1985 (1364) to
-13 in 199210 (1371) and
-23 in 2001 (4) (1380)
1999 (1378)
Disappearance of
waiting list. 6, 7, 8
Shortly after the adoption of LURD
program,
MOHME adopted
Same Natinality
Donation.
2000 (1379)
Legalizing braindead organ
donation
9
(BDD).
Different
modalities of RRT
[HD, PD, Tx (
)] are
free of charge.
LRD, LURD, BDD
Figure 1 | RRT trend in iran between 2001
and 2010.
THE PROCESS
OF
LURD
Figure 2
THE PROCESS
OF
LURD
Only 18- to 35year-old
person
First Step
Patients chooses LURD
& potential donor will
be referred to
Patients’ Kidney
Foundation(PKF).
Second Step
Obtaining an informed
consent from both
donors and their next
of kin.
3th step
Potential donor and
recipient are
introduced to each
other.
th
4
step
Refer to a
nephrologist for
final evaluation in
detail.
Organ donation will be
barred if borderline
laboratory data has
been seen.
Family pressure &
coercion is considered
when the potential
donor is female.
At any time that
potential donor like
donation procss can
stopped.
Male to female donor
ratio=1.6:1 in >21,000
related and unrelated
4
kidney Tx.
th
5
step
Negotiation between the
donor and the recipient
concerning an extra
compensation for the
donor.
PKF does not keep
records of the agreed
money for exchange.
PKF maintains some control
on the issue by introducing
another potential donor to
the recipient if a donor asks
for an unusual amount of
money.
-There is no brokers
And
-Recipients and donors
meet face to face.
6th step
After Donation, donor refer
to Charity Foundation for
Special Diseases (CFSD) to
get ‘gift of altruism’ and 1
year of medical insurance. 7, 13
Tx expense is paid
by health
insurance agencies
and MOHME . 7
MEDICAL
CONCERNS
IN
LURD
Short-term Risk
Surgery
Overall mortality risk in
universe is 0.02–0.03%.
Major(1.5%) and
Minor(8.5%)
perioperative
complications. 14
Kasiske found
(0.05%) mortality
at surgery.
0.03% risk of
mortality found in
surveys from UNOSapproved centers.
Segev 16 found
surgical mortality
of 3.1 per 10,000 in
US.
Short-term complications
in Iran are comparable to
other international
studies.
By laparoscopic
nephrectomy,
procedure became
more safe with lower
morbidities.
Long-term risks
Risk of ESRD:
03–0.05%
17, 18
Survival of the donors:
similar, if not superior,
compared with general
population.
15, 16, 17, 18
In the Ibrahim study,
12.2±9.2 years after donation
the prevalence of
HTN was 32.1% and
Microalbuminuria was
12.7%.
17
In Iranian donors in the
only short-term follow up
(17.2±5.0 months)
HTN was 37.5% and
Microalbuminuria was 10.4%. 19
ETHICAL ISSUE
IN
LURD
In the Iranian LURD
several serious ethical
problems have been
successfully managed:
-No brokers,
-No transplant tourism &
commercialism
-Same citizenship law
-No financial benefit for Tx teams
-Informed consent not only from
recipients but also their next of kin. 5, 7, 9
ETHICAL
CONCERNS
IN
LURD
Financial
connection
between donor and
recipient
Main question of international experts
Is not direct payment
by the government and
recipient to the donor
defined as
Vending?
Monetary compensation
Once poor people are in the
market to sell a kidney, such
sales will be coercive
even
in the context of informed
20,
21
consent.
Nobody denies that the most
important motivation for donation
in the Iranian model is not
emotional/altruistic
Nor does anyone deny that most of
the donors belong to the low
socioeconomic class.22
But
There are two points:
-Autonomy, and
-Socioeconomic situation of
donors in comparison with
recipients.
Autonomy
-Poverty
-Everybody has the right
to overcome his/her
problems by socially
acceptable approaches.
In the Iranian LURD nobody
interferes in the decision
making of the poor donor to
take a higher risk that the
rich do not normally take.
Even
Preventing this
act may mean
paternalism.
23, 24
Examples
Higher ratio of lower
socioeconomic groups
in the
-US military service
-Mining .
25
Or
-Firefighters and
-Policemen
who take high-risk
jobs to protect others.
24
No Coercion
In the Iranian LURD, donor
is referred to the PKF by
his/her own will.
Obviously the economic
situation influences such
decision.
Bioethical principles
-Autonomy
-Beneficence
-Justice, and
-Nonmaleficence
Why should be all
of the donor’s
motivation only
altruistic? 24
Socioeconomic
situation of donors
compared with
recipients:
Financial
motivation is the
main driving force
for donation.
26
Iranian donor situation is
different with
socioeconomic status of
the vendors in Pakistan as
an example of
commercialism. 5, 22, 26, 28
90% of the vendors in
Pakistan were illiterate
(Iranian donors illiteracy
rate is <6% in most studies)
& live on <US$1 a day
(>94%). 5, 22, 26, 28
In iranian LURD,
economic situations of
the donor and
recipient are not very
different.
From 500 Iranian
recipients
50.4% was poor (those who
could not afford average housing,
food, or college training for their
children). 5
From 500 Iranian recipients
36.2% defined as the
middle class.
And Surprisingly
just 13.4% were
classified as wealthy. 5
Charity
organizations and
generous people
support recipients.
5, 6, 7
Promotion of BDD by LURD
In a study on 2630 HD
patients, only 7% of
medically eligible ones were
registered on a BDD
waiting list in Tehran
province in 2005 (1384).
26, 31
Commercialism!!!
Major financial source of
organ trafficking in most
developing countries is
from recipients from
developed countries.
23, 24
law of same citizenship in iran
Blocked
commercial
organ Tx.
Direct method of payment
Governmental or
donor
5,
8
direct payment?!
LURD as a realistic approache
Many of countries evaluate expensive
ways to increase organ resources,
including:
-Desensitization protocols for ABO
incompatible & positive cross-match
pairs,
-Marginal donors, and
-Organs from cardiac-dead donors.
Owing to the inadequate
budget participation of
recipients in direct
compensation could not
be prohibited.
BDD Bariers
-Cultural barier
-Medical barier (longer
ischemic time &…).
Redirection of
budget from
LURD program to
BDD program.
Multi-exchange-rate system
1750 rials/US dollar to
4000 rials/US dollar
7900 rials/US dollar In March 2002
10000 rials/US dollar
>30000 and rials/US dollar
Now 25000 rials/US dollar .
It means that value of the governmental financial
incentive for LURD decreased from
>US$3500 in late 1990s to
US$1265 in 2002 and to
US$900 2011
<US$400 2012.
Recommendation???
Rise in official
governmental incentive
and non-directed
(altruistic anonymous)
LURD without recipients
compensation.
BDD program needs
infrastructure and
don’t exist in many
developing countries.
Many surgery, urology
residents, and nephrology
fellows were trained in
transplantation wards
with LURD.
Transplantation as a
routine instead of a
complicated
exceptional procedure.
Increase of BDD:
-2.2%, (0.4 pmp) in 2000
-26%, (7.9 pmp) in 2010. 32
BDD problems
-Infrastructural
deficiencies
-Cultural barriers
(73% refusal rate of BDD families).33
Cultural obstacles
are not easy to
overcome.
Some believe that poor
donors are generally
underinformed and
informed consent should be
set aside
Donation process
Decisions making
Under pressure or
Freely.
But
Informed consent satisfy
medical team that the
donor (probably) is able to
make a rational decision
on the basis of his/her
free will.
Even familial
relationship does
not guarantee the
altruistic donation.
The informed consent from
the next of kin of donor in
the Iranian model is an
attempt to make LURD the
choice a consensus decision
of the family.
Participation of a not-forprofit charity–based
system in the process of
getting the informed
consent.
Is it appropriate
to ban
LURD?
So
Current approach of many
countries in response to
shortage of organs is to
encourage live donation.
So
Ban of LURD
would be
unrealistic and
unreasonable.
BDD cannot keep pace
with the increasing
number of ESRD
patients.
LURD program had a
great impact in
development of
infrastructure for
BDD.
Ten years of experience with
scientific, social, and public
educational efforts made
most people of the country
familiar with the issue and
decreased refusal rate of
BDD.
Future Plan
Move to presumed consents
(assumed to have given their
consent to organ donation unless
they officially record their
unwillingness during life) of all
residents of the country.
By this law,
coordinators can
approach mourning
families easier.
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