This document discusses the ethical and legal issues involved in renal replacement therapy (RRT). It addresses several key points: 1) RRT involves chronic dialysis therapies like peritoneal dialysis and hemodialysis as well as kidney transplantation, and raises issues around treatment decisions, costs, organ donation and allocation of scarce resources. 2) Principles of autonomy, nonmaleficence, beneficence, and justice influence medical decision-making for patients undergoing RRT. Cultural and religious factors also impact decisions. 3) In developing nations where dialysis resources are scarce, principles of justice and beneficence guide selection of patients most likely to benefit from treatment. Medical indications must be considered to avoid

1. ETHICAL AND LEGAL ISSUES INVOLVED IN
RENAL REPLACEMENT THERAPY
DR BASAWANTRAO
ASSISSTANT PROFESSOR
DEPT OF GENERAL MEDICINE

2. • Chronic kidney disease (CKD) has become a major public health problem
worldwide with significant mortality, morbidity and economic burden.
• The prevalence of CKD is estimated to be 8–16% around all continents
• Renal replacement therapy (RRT) is essential for the management of advanced
CKD
• and encompasses chronic ambulatory peritoneal dialysis (CAPD), haemodialysis
and renal transplantation
• Chronic peritoneal dialysis and haemodialysis are dialytic therapies which
remove toxins, solute and fluid from blood through three principal mechanisms –
osmosis, diffusion and filtration
• Kidney transplantantation is acknowledged as a major advance of RRT which
provides high quality years to patients with irreversible kidney failure worldwide

3. • RRT in CKD management has raised many ethical issues and dilemmas
as the renal team deals with multiple issues surrounding treatment,
the high cost of long-term dialysis therapy, kidney donation and
transplantation, and allocation of scarce resources (mainly in
developing nations).
• This is further exacerbated by forces outside the medical field, namely
politicians, human rights lawyers and lay persons.
• The ethical principles of autonomy (self-determination),
nonmaleficence (to not cause harm), beneficence (to maximize good)
and justice (what is due or owed) influence all aspects of medical
decision making, including those undergoing RRT

4. • Haemodialysis and peritoneal dialysis are complementary therapies
and patient’s preference plays a part in the selection of dialysis
modality.
• However, this is often overridden by other factors that include
availability of haemodialysis and kidney transplant stations, difficulty
in vascular access, technique failure of peritoneal dialysis (PD the
proportion of patients presenting late as uremic emergencies
• Additionally, strict selection criteria in some countries affects
selection of dialysis modality.

5. • Autonomy is implicit in informed consent, beneficence and non-
maleficence in decisions to offer RRT.
• The principle of justice underlies RRT decisions in which scarcities of
dialysis resources, donor organs for kidney transplant and financial
issues are concerns
• Although there are virtually unlimited resources in developed
countries, the principle of justice may impact dialysis decisions when
one considers more expensive but potentially advantageous therapies
like daily dialysis
• However, in the less developed world, justice plays a more prominent
role in ethical decision making regarding RRT.

6. • Legal and cultural matters in RRT are of paramount importance in the
management of CKD patients.
• Medical ethics, law and professional policy require that medical
professionals not only refrain from carrying out unwanted interventions
but also promote a patient’s ability to make informed decisions
• They should discuss clinical circumstances and prognosis with patients and
families to understand patient’s values and goals within this clinical
context.
• Healthcare providers must recognise that many patients, particularly from
different cultures, may prefer that the family or community receive and
disclose information before initiation or withdrawal of RRT, make decisions
and coordinate patient care even when they are competent
• In this regard, cultural beliefs surrounding the cause and meaning of illness
may complicate further ethical decision making in RRT among the CKD
population.

7. • Greater knowledge and technical advances in the field of transplantation
have increased the demand for organ donation beyond the current
capacity to supply them resulting in a great demand for transplanted
kidneys.
• While these patients are waiting for kidney donation, they are sustained on
dialysis which is also costly.
• The imbalance between large numbers of patients waiting for transplant
and the limited availability of donors has led to numerous ethical and
moral issues as well as controversies around the ethically acceptable
sources of donation and the system of organ allocation
• On the other hand, kidney transplant is hampered by religious beliefs,
cultural traditions, social norms and ethical principles.

8. • One’s ability to understand starting or stopping dialysis is inherent in the informed
consent process and involves the principle of autonomy.
• Patients with the capacity to understand relevant information, consider its implications
and come to a communicable decision are deemed to have decision making capacity and
this should be respected
• For all medically indicated treatment, the preferences of the patient based on his or her
own values and personal assessment of benefits and risks, are ethically relevant.
• Any injury or illness threatens persons with actual or potential reduced quality of life
manifested in the signs and symptoms of their disease and the goal of medical
intervention is to restore, maintain or improve quality of life
• In this view, the patient is the best judge for his or her quality of life and his or her view
should be respected.
• Dialysis should be provided only if it is reasonably likely to achieve the individual
patient’s goals

9. • Haemodialysis and peritoneal dialysis are complementary therapies and
patient’s preference plays a part in the selection of dialysis modality.
• However, this is often overridden by other factors that include availability
of haemodialysis stations, difficulty in vascular access, technical failure of
peritoneal dialysis, and the proportion of patients presenting late as uremic
emergencies
• In situations where a patient is incapacitated, a patient’s wishes should
have been discussed with an appointed surrogate as part of the process of
advance care planning; permitting the surrogate to make decisions that the
patient would have made for him or herself
• Moreover, surveys and responses to hypothetical scenarios have
repeatedly shown that a patient’s ability to relate and respond to the world
is the most important factor in decisions to initiate and withdraw dialysis.

10. • However, it is ethically appropriate to withhold initiation of or withdraw
ongoing dialysis therapy for patients with CKD in the following situations
• Patients with decision making capacity who, being fully informed and
making voluntary choices, refuse dialysis or request that dialysis therapy be
discontinued.
• patients who no longer possess decision making capacity who previously
have indicated refusal of dialysis therapy in an oral or written advance
directive
• Patients who no longer possess decision making capacity and whose
properly appointed legal agents refuse dialysis therapy or request that it is
discontinued patients with irreversible profound neurologic impairment
such that they lack signs of thought, sensation, purposeful behaviour and
awareness of self and environment

11. • The concept of autonomy best highlights the contrast between western
and non-western cultures.
• The western principle of autonomy implies that every person has the right
to self-determination and non-western cultures are characterized by strong
communal values and social harmony.
• In nonwestern cultures, a person is viewed as a relational self, a self for
whom social relationships, rather than individualism provide the basis for
the moral judgement).
• Although western ethics promote the patient as the best person to make
decisions, there are tremendous cross cultural differences in decision
making models
• The family functions as both the collective decision maker and the conduit
for moral, religious and social norms

12. Principle of justice in dialysis
• The ethical principle of justice dictates that there is a societal obligation to
allocate scarce resources equitably and appropriately.
• Although dialysis is an expensive therapy, it is generally paid for in
developed countries and is therefore not a scarce resource.
• A western bioethical framework places importance on justice that dictates
that there is societal obligation to allocate resources equitably and
appropriately.
• However, registry data report racial differences in dialysis care, with ethnic
minorities at a disadvantage

13. • On the contrary, developing nations cannot afford the substantial cost
of treating all patients with renal failure by dialysis and the problem is
fuelled by a higher incidence of renal failure.
• Consequently, the mode of selection becomes inevitable.
• The aim of the selection should be to use scarce resources to provide
maximum benefit and that involves selecting patients for treatment
who are likely to enjoy a good quality of life.
• Selection should not be influenced by race, colour, creed, caste or
political affiliation.

14. • Medical ethics, law and professional policy require that medical
professionals not only refrain from carrying out unwanted
interventions, but also promote a patient’s ability to make informed
decisions
• The professionals should discuss clinical circumstances and prognosis
with patients and families to understand patient’s values and goals
within this clinical context.
• In addition, selection should be the responsibility of the nephrologists
and their team who are best qualified to judge prognosis.
• Professional integrity requires physicians to refrain from providing
dialysis when it is not medically indicated.

15. • Medical indications require a consideration of the patient’s diagnosis,
overall medical condition, prognosis and treatment options.
• All these considerations reflect the ethical principles of beneficence
and non-maleficence.
• In circumstances in which RRT is not medically indicated, a patient or
family preference to receive dialysis does not justify its provision
• The ethical principle of beneficence and non-maleficence mandate
that health professionals provide only treatments that offer a
reasonable expectation of benefit without unacceptable harm

16. • While it is not up to health professional to decide how expenditure
should be apportioned among renal failure patients, they are
certainly responsible for determining whether or not to place all
patients with CKD on RRT.
• Exclusion on the basis of economic standing, personality and social
utility is unacceptable.
• The motives for exclusion from dialysis have included non-uremic
dementia, incurable neoplastic disease, terminal stages of epileptic
disease, multiorgan failure making survival extremely unlikely and the
need to restrain or sedate the patient during dialysis in order to
maintain access functioning

17. • In developing nations where kidney transplant is available, the admission
of CKD patients to the dialysis programme is eligibility for a kidney
transplant.
• The patient must also be free of significant diseases like ischaemic heart
disease, cerebral-vascular disease, peripheral vascular disease, chronic liver
disease and chronic lung disease
• These issues present conflicting ethical principles of justice and autonomy.
• However, private hospitals and clinics play an important role in these
situations where patients do not meet the selection criteria in public
hospitals as their criteria for acceptance onto dialysis programmes are not
as strict, but naturally the patient must have the funds in order to sustain
treatment.

18. RRT in the elderly CKD population
• Dialysis withholding in the elderly is certainly one of the most hotly debated topics in the
literature but the age threshold has been increasing over time with the ageing population.
• Age per se is not listed as a criterion for withholding dialysis but clearly impacts patient survival.
• Therefore it is a factor to be considered in discussions about dialysis
• It is reasonable to discuss estimated prognosis and time limited trials of dialysis in order to
provide informed consent to initiate dialysis in the elderly
• Patient age, therefore, is a factor in decision making about dialysis initiation but should not be the
sole criterion on which to base decisions to start dialysis.

19. • Considering the principle of beneficence, dialysis is beneficial in the elderly
with CKD. The available studies show mthat elderly kidney failure patients
who begin dialysis live longer than those who do not
• This is supported by a retrospective analysis of CKD patients of over 75
years where the researchers found a significantly better survival among
patients who started dialysis than those who were treated conservatively
• Other considerations bear on the economic side of the problem where the
elderly have contributed more to the National Health Service than the
young ones and it will be odd if dialysis were to be held from the former

20. • Moreover, the elderly person is better suited to home dialysis, which
is less expensive, and if active, the person may also be socially more
useful in view of his or her greater heritage of knowledge and
experience
• With regard to transplant, deceased donor’s kidneys are a scarce
resource and thus, the issue of transplanting the elderly deserves
some considerations within this context.
• Again, transplant programmes have criteria for excluding potential
recipients but age alone is generally not considered a contraindication
to transplantation in the elderly.

21. Kidney donation and transplantation
• Transplantation is the best treatment for many patients with end stage organ
failure
• As the shortage of organ donation escalates, the methods and criteria used for
kidney allocation are debatable whilst the ethical principle of justice refers to fair
and equitable treatment.
• The number of organs available each year is much lower than the patients in
need of organs and this alone creates ethical dilemmas based on justice and
utility.
• Any system designed to distribute organs efficiently is likely to be seen as unjust
or unfair.

22. • Proponents of maximising utility focus on doing as much good as possible with a limited
resource.
• On the contrary, advocates of justice have their eyes on a pattern of distribution that
they consider fair and in their view, justice means giving benefit to the worst off Another
ethical issue is allocation of meagre financial resources to different segments of
healthcare.
• One kidney transplant costs about R1,450,000 and these costs may rise to about R5
million for the follow-up care and immunosuppressive drugs needed .
• The strategic question facing societies is whether these huge funds should be spent on
transplants that benefit a small minority of patients or should they be allocated to
common health problems.

23. Racial differences in kidney donation and
transplantation
• Organ donor referrals among Africans in 1995 and 2000 were 28% and
17%, respectively while it was 60% and 72% among whites in South Africa.
• African Americans are reportedly accounting for 13% of organ donors and
18% of organ recipients and they have a high incidence of kidney problems,
hence the need for transplantation.
• This racial and cultural discrepancy in organ donation was found to be
caused by lack of knowledge, religious fears, fear of surgical complications
and lack of communication between lay families and healthcare personnel
among black Americans

24. • For reasons that are not well understood, ethnic minorities such as blacks,
aboriginal people, east Asian and Asian patients have significantly lower rates of
kidney transplantation compared with white patients after adjusting for potential
confounders including blood type and remote location of Residence
• This disparity is the greatest for transplants from living donors, which is important
because this inequity is potentially amenable to intervention
• Blacks are less likely to discuss organ donation within the family, have less
knowledge about organ donation, are less likely to sign a donor card and have a
higher level of mistrust of the healthcare system
• This is reflective inmost African countries like South Africa and Zimbabwe.
• Factors affecting organ donation in blacks include ignorance,misconceptions and
cultural beliefs .

25. Cadaveric kidney transplantation
• Cadaveric transplantation is hampered by religious beliefs, cultural
traditions, social norms and ethical principles.
• In Japan, death is not considered to occur at an exact instant but is a
continuum that requires several days and the body must remain
whole.
• A dead person with an incomplete body before burial or cremation is
associated with misfortune and this also applies to African cultures.

26. • In South Africa, Zulu speaking people believe in the creator and that they
have no authority to donate their bodies or organs
• Moreover, cadaveric transplantation is problematic because the availability
of the organs means that someone has died.
• The donor should be a young healthy person who has been injured or killed
violently.
• This alone creates several ethical and religious issues, including the
acquisition of the appropriate consent and the various interpretations of
brain death in different cultures.

27. • Due to the limited number of cadaveric organs, the ethical principle of equity
looms large in the allocation of this scarce resource.
• Currently, Spain, USA, France, Germany and Italy have relatively high donation
rates for cadaver transplants due to legal and ethical frameworks that have been
put in place to address the inequalities.
• These frameworks include the Spanish Model for Organ Donation, World Health
Organization Guiding Principles on Human Cell, Tissue and Organ Donation (2010)
and the Madrid Resolution on Organ Donation and Transplantation (2011).
• However, cadaveric donors are failing to meet demands for kidney
transplantation in all countries, despite the frameworks that have been put in
place.
• This alone is causing a significant number of candidates with end-stage renal
disease to die while waiting or become too sick for transplantation

28. Living kidney donation
• There is ever increasing use of living donors as sources of kidneys since cadaveric donors are
failing to meet the demands of kidney transplantion in all countries.
• This is causing the development of unregulated markets for donation and consequently increased
organ trafficking and transplant tourism
• As a result, there are controversies and ethical issues of living donation It is estimated that organ
trafficking accounts for 5% to 10% of the kidney transplants performed annually throughout the
world
• Kidney markets have been documented in Pakistan, Philippines, South Africa, Egypt, India, South
America and Eastern Europe
• According to Verger (2012), Israel has struggled to curb kidney markets for many years but since
the introduction of its law in 2008, there has been redued organ trafficking and transplant.

29. • Commercialising human organs is criticised because it puts those who
can afford transplant at an advantage and leads to financial
exploitation of the vulnerable .
• Despite the declaration of Instabul on Organ Trafficking, Transplant
Tourism and Commercialism (2008), the Amsterdam Forum on the
care of the Live Kidney Donor (Delmonico, 2005) and World Health
Assembly Resolution adopted in 2004 (WHA57.18), transplant
tourism continues to expose vulnerables like minors, illiterate
individuals, impoverished, undocumented immigrants, prisoners,
economic and political refugees.

30. • The use of children as kidney donors is still questionable and it is
really an ethical problem when they are the only possible donors for
their parents or siblings.
• The children may not be old enough to understand the informed
consent process and the complications of donating an organ as they
may feel pressurised by their parents.
• Nonetheless, a young girl might feel that she should be given the
opportunity to save her mother through donation
• In this view, the use of children in kidney donation should regarded as
a special circumstance and needs guidance, counselling and ethics.

31. • Again, use of kidneys from executed prisoners remains an ethical
issue as this is considered repulsive and morally repugnant (Tilney,
2003).
• This is violation of autonomy, informed consent and justice.
• Since November 2013, China is in the process of stepping towards an
ethical organ donor system as it is one of the countries who have
been using organs from executed prisoners (Alcorn, 2013).

32. • There are ethical principles to consider when dealing with living kidney
donor transplantation and these principles are respect for autonomy, no
maleficence, beneficence and justice
• Respect for autonomy means that an unrelated kidney donor is acting
freely, rationally and able to understand and decide on the information
presented.
• Nonmaleficence emphasises that nobody should be injured intentionally
• In kidney living donation, physical harmis unavoidable and there is
violation of this ethical principle as living kidney donation is associated
with a mortality rate of 0.03% in donors and some surgical complications.
Nevertheless, it provides enormous benefit to the recipient

33. • The ethical principle, beneficence, instructs to do good for others.
• It is clear that living kidney donation provides huge benefit to patients with CKD.
• However, the enormous benefit to the recipient does not provide enough
justification for accepting all kidney donors.
• The donor may receive benefits from the restored health of the recipients as in
spousal transplantation.
• In addition, many donors benefit psychologically by making a major sacrifice and
saving a life.
• Some donors benefit physically when their treatable health problems are
detected during the donor evaluation

34. Use of kidneys from brain dead patients
• With regards to brain death, a kidney is harvested from a donor whose brain is dead but
with a heartbeat.
• The concept of brain death has been accepted by the majority of people and strict
medical criteria must be fulfilled before undergoing a transplant from a brain dead donor
• However, the acceptance of the concept of brain death is essential for retrieving healthy
viable organs and this view is not universally accepted.
• For example, Orthodox Jewish Beliefs identify death as the termination of heart function,
not the brain.
• Brain death is not recognised in some parts of Asia

35. CONCLUSION
• The economic differences and competing public health problems in
different countries have made it far more difficult to formulate a
series of rights that could be applicable to all individuals with CKD.
• The conflict between justice and autonomy is important to analyse
when looking at the existence of RRT for CKD around the world.
• Health professionals want to provide their patients with the greatest
autonomy but this can be limited by one’s ability to access RRT in
different countries.

36. • The principle of justice would support a mechanism that could meet the
needs of all people suffering from chronic kidney failure regardless of their
ability to pay or access such care.
• However, there are insufficient amounts of dialysis units and kidney
transplantation in nations with emerging economies.
• This contributes to a lack of distributive justice as well as facilitating a
healthcare patient relationship that is non-maleficence.
• Inadequate dialysis and kidney transplant, high risk of infection and
inconsistenties in treatment could be considered to cause more harm to
patients than benefits (maleficence versus beneficence).
• Consequently, there is limited patient engagement in RRT resulting in non-
adherence thus ineffective management among CKD patients.

37. THANK YOU