In The Name of God

Ethical Aspects of Iranian Modelof LURDSM Gatmiri, MD, NephrologistAssistant Professor of TUMS, NRC, Imam Khomeini hospitalNovember 2012

In The Name of GodLiving unrelated renal donation (LURD) is a hot topic in organ shortage. ESRD & Demand for RRT(HD, PD, LRD,LURD & BDD) is increasing SoLURD is in the core of medical caregivers attention. But controversial aspects of this entity, requiring ethical consideration.

AndTransplantation societies and WHO try to prevent unethical practices in LURD. The declaration of Istanbul (2008) is a global efforts to stop commercial exploitation in this field. 1-Socioeconomic & cultural differences, -Religious beliefs, -Legislative barriers, and -Lack of infrastructure between countries, prevent setting standard international guidelines. HISTORY OF RRT INIRANIranIn 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, 6At 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, 81995 (1374)Rejection of BDD in the parliament1997 (1376) Board of Ministers approvedGift of Altruism. 7, 9And ThenDramatic 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, 8Shortly after the adoption of LURD program, MOHME adopted Same Natinality Donation. 2000 (1379) Legalizing brain-dead organ donation (BDD).9Different modalities of RRT[HD, PD, Tx (LRD, LURD, BDD)] are free of charge.Figure 1 | RRT trend in iran between 2001 and 2010.

THE PROCESS OF LURD Figure 2 THE PROCESS OF LURD Only 18- to 35-year-old person

First StepPatients 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 stepPotential donor and recipient are introduced to each other. 4th stepRefer 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 kidney Tx.45th 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 brokersAnd-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 . 7MEDICAL CONCERNS IN LURDShort-term RiskSurgeryOverall mortality risk in universe is 0.020.03%. Major(1.5%) and Minor(8.5%) perioperative complications. 14Kasiske found (0.05%) mortality at surgery. 0.03% risk of mortality found in surveys from UNOS-approved 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 risksRisk of ESRD: 030.05% 17, 18 Survival of the donors:similar, if not superior, compared with general population. 15, 16, 17, 18In the Ibrahim17 study, 12.29.2 years after donation the prevalence of HTN was 32.1% and Microalbuminuria was 12.7%. In Iranian donors in the only short-term follow up (17.25.0 months) HTN was 37.5% and Microalbuminuria was 10.4%. 19ETHICAL ISSUEINLURDIn 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, 9ETHICAL CONCERNS INLURDFinancial connection between donor and recipientMain question of international expertsIs not direct payment by the government and recipient to the donor defined as Vending?

Monetary compensationOnce poor people are in the market to sell a kidney, such sales will be coercive even in the context of informed consent.20, 21Nobody denies that the most important motivation for donation in the Iranian model is not emotional/altruisticNor does anyone deny that most of the donors belong to the low socioeconomic class.22 ButThere 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. EvenPreventing this act may mean paternalism. 23, 24ExamplesHigher ratio of lower socioeconomic groups in the -US military service-Mining . 25Or-Firefighters and-Policemen who take high-risk jobs to protect others. 24No CoercionIn 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 donors motivation only altruistic? 24

Socioeconomic situation of donors compared with recipients:

Financial motivation is the main driving force for donation. 2671Iranian 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 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