WG2. Bibliography & other reference materials

The regulatory function of the HTA with regard to living donation is set out in legislation. However, the manner in which it undertakes this function poses a number of challenges which require medium to long-term thinking. This document sets out the aims of the HTA with regard to its regulation of living donation for the period 2014 to 2017. This Plan has been informed by the findings of the IA and AA surveys undertaken during 2013/14.

The practice recommendations discussed here are based on the findings of the national survey as well as the opinions of the authors. The recommendations that are proposed here are not exhaustive and are aspirational in intent and are likely to evolve with time. Practice guidelines are recommended for legal and regulatory issues (e.g., state or federal laws), consumer or public benefit (e.g., improving service delivery, avoiding harm to the patient, decreasing disparities in underserved or vulnerable populations), and for professional guidance (e.g., new role, professional risk management issues, advances in practice). Without such practice guidelines, donors, and indirectly the candidates, may be at increased risk for possible bias or undue harm.

The commentary by Drs. Ambaqtsheer and Weimer provide an interesting criminological reflection regarding the Declaration of Istanbul in which they question whether efforts to prohibit organ trade have been either realistic or effective since its widespread adoption (1). They challenge the link of organ trafficking to transplant commercialism and drawing comparison from other demand crimes, speculate that the regulation of commercialism would be feasible and justified in the prevention of trafficking. However, the proposal to curtail trafficking by the regulation of monetary payments for organs is not convincing. Organ trafficking is indisputably linked to commercial profits and distinguishable from other demand crimes. The prohibition of both transplant commercialism and trafficking is required as essential to provide the criminological mechanism for detection and enforcement efforts. The ultimate value of the Declaration of Istanbul as effective policy exists not only in its prohibitionist stance but also in its promotion of effective donation and transplantation systems to reduce the demand for transplant tourism that gives rise to organ commercialism and trafficking.

Incentives for organ donation, currently prohibited in most countries, may increase donation and save lives. Discussion of incentives has focused on two areas: (1) whether or not there are ethical principles that justify the current prohibition and (2) whether incentives would do more good than harm. We herein address the second concern and propose for discussion standards and guidelines for an acceptable system of incentives for donation. We believe that if systems based on these guidelines were developed, harms would be no greater than those to today’s conventional donors. Ultimately, until there are trials of incentives, the question of benefits and harms cannot be satisfactorily answered.

Due to organ shortage and difficulties for availability of cadaveric donors, living donor transplantation is an important choice for having allograft. Live donor surgery is elective and easier to organize prior to starting dialysis thereby permitting preemptive transplantation as compared to cadaveric transplantation. Because of superior results with living kidney transplantation, efforts including the usage of “Medically complex living donors” are made to increase the availability of organs for donation. The term “Complex living donor” is probably preferred for all suboptimal donors where decision-making is a problem due to lack of sound medical data or consensus guidelines. Donors with advanced age, obesity, asymptomatic microhematuria, proteinuria, hypertension, renal stone disease, history of malignancy and with chronic viral infections consist of this complex living donors. This medical complex living donors requires careful evaluation for future renal risk. In this review we would like to present the major issues in the evaluation process of medically complex living kidney donor.

The Declaration of Istanbul is the first document that has been established by the international transplant community that defines and prohibits transplant commercialism and organ trafficking. Its Custodian Group has successfully led various countries to implement legislation against trafficking and commercialism. The question arises, however, whether efforts to prohibit organ trade are realistic and effective. The Declaration differentiates trafficking from commercialism, yet it does not mention howboth acts should be approached by policy. Policies that address transplant commercialism work differently from policies that tackle organ trafficking. There is considerable room for improvement in the current prohibitive approach to commercialism and organ trafficking. The Custodian Group and World Health Organization (WHO) should address commercialism by encouraging the expansion of living donation in the same manner as they encourage deceased donation. Furthermore, the Custodian Group and the WHO can improve their strategy to combat organ trafficking by raising awareness for enforcement. To achieve a consistent and effective prohibition of trafficking, legislation and law enforcement must go hand in hand. Ideally, this can best be achieved by close collaboration between the medical field and (international) criminal justice agencies.

In June of 1964, the World Medical Association developed the ‘Declaration of Helsinki’ available at www.wma.net) as a statement of ethical principles to provide guidance to investigators and physicians involved in human research. Over 40 years later the declaration remains ‘…a respected institution and one of the most influential documents in clinical research’ [1]. Though it is not binding to any local or international law, it draws its authority from the degree to which it has been codified, or influenced, as well as from national or regional legislation and regulations. De-spite criticisms, the declaration is widely accredited with improving both the ethical and scientific quality of clinical research.[...]

An international conference of transplant physicians, surgeons, and allied health professionals was held in Vancouver, Canada, on September 15 and 16, 2005 to address the care of the live lung, liver, pancreas, and intestine organ donor. The Vancouver Forum was convened under the auspices of the Ethics Committee of The Transplantation Society. Forum participants included over 100 leaders in organ transplantation, representing many countries from around the world, including participants from the following continents: Africa, Asia, Australia, Europe, North and South America.

The objective of the Vancouver Forum was to develop an international standard of care for the live lung, liver, pancreas and intestinal organ donor. This Vancouver Forum followed a conference convened in Amsterdam on the care of the live kidney donor (1, 2). [...]