The Consensus Statement of the Amsterdam Forum on the Care of the Live Kidney Donor

Abstract

Kidney transplant physicians and surgeons met in Amsterdam, the Netherlands, from April 1–4, 2004 for the International Forum on the Care of the Live Kidney Donor. Forum participants included over 100 experts and leaders in transplantation, representing over 40 countries from around the world — including Sweden, Israel, Turkey, Saudi Arabia, Pakistan, India, and China — and all of the continents, including Africa, Asia, Australia, Europe, North and South America. The objective of the Forum was to develop an international standard of care with a position statement of the Transplantation Society regarding the responsibility of the community for the live kidney donor. The position statement as reported herein has subsequently been adopted by the Council of the Transplantation Society. The international transplant community recognizes that the use of kidneys from the living donor needs to be performed in a manner that will minimize the physical, psychological, and social risk to the individual donor and does not jeopardize the public trust of the healthcare community. The donation decision should be performed in an environment that enables the potential donor to decide in an autonomous manner. Because of the need for more transplantable kidneys, persons with conditions that may increase the health risks for the potential donor and/or recipient (for example, hypertension) are currently being considered and used as donors. The international transplant community recommends that the acceptance of such individuals as kidney donors be conducted in an ethical manner, accounting for the autonomy and safety of the donor and with rigorous attention to clinical outcomes. In view of these evolving trends in living donor kidney transplantation, the following recommendations were adopted: Prior to a live kidney donation to a potential recipient (known by the potential donor or not known in the circumstance of anonymous donation), the donor must receive a complete medical and psychosocial evaluation to include: Quantification (as available) and assessment of the risk of donor nephrectomy on the individual’s overall health, subsequent renal function, and any potential psychological and social consequences (including employability); Assessment of the suitability of the donor’s kidney for transplantation to the recipient (anatomy, function, and risk for transmissible disease). Prior to donor nephrectomy, the potential donor must be informed of: The nature of the evaluation process; The results and consequences/morbidity of testing, including the possibility that conditions may be discovered that can impact future healthcare, insurability and social status of the potential donor; The risks of operative donor nephrectomy, as assessed after the complete evaluation. These should include, but not be limited to: the risk of death, surgical morbidities, changes in health and renal function, impact upon insurability/ employability and unintended effects upon family and social life; The responsibility of the individual and health and social system in the management of discovered conditions (for example, if the donor is discovered to have tuberculosis, the donor should undergo treatment, the community has a responsibility to help the donor secure proper care with referral to an appropriate physician); The expected transplant outcomes (favorable and unfavorable) for the recipient and any specific recipient conditions which may impact upon the decision to donate the kidney; Disclosure of recipient specific information which must have the assent of the recipient. The potential donor should be informed of alternative renal replacement therapies available to the potential recipient. The potential donor should be capable of understanding the information presented in the consent process. The decision to donate should be voluntary, accompanied by: The freedom to withdraw from the donation process at any time; Assurance that medical and individual reasons for not proceeding with donation will remain confidential. After kidney donation, the transplant center is responsible for: Overseeing and monitoring the postoperative recovery process of the donor until that individual is stable, including provision of care for morbidity that is a direct consequence of donor nephrectomy; Facilitating the long-term follow-up and treatment of the kidney donor with preexisting or acquired conditions (related to uninephrectomy) that are thought to represent a health risk such as — but not exclusive to — hypertension, obesity, diabetes, and proteinuria. In the absence of an established follow-up process for individuals with preexisting conditions that may possibly place the donor at health risk, organ donation should be avoided; Identifying and tracking complications that may be important in defining risks for informed consent disclosure; Working with the general healthcare community to provide optimal care/surveillance of the living kidney donor. A Donor Advocate In order to minimize the appearance of a “conflict of interest,” transplant centers should make efforts to assure that the medical and psychosocial assessments and the decision to donate incorporates health care professional(s) not involved in the care of the recipient. The concept of this recommendation is to provide a health care professional advocating the welfare of the potential donor. Procedural safeguards should be utilized and explored to minimize coercion and enhance autonomous decision-making, for example, by a “cooling off period” and assessment of donor retention of information. Medical Judgment versus Donor Autonomy Donor consent and autonomy is necessary, but not sufficient, to proceed to kidney donation. Medical evaluation and concurrence is essential. Donor autonomy does not overrule medical judgment and decision-making. Minors as Donors Minors less than 18 years of age should not be used as living kidney donors. Donor Registry An international registry for “sentinel events” after living kidney donation should be established and maintained (including the recording of donor deaths or the need for dialysis or kidney transplantation by the donor). Appropriate prospective research should address the long-term outcomes of donors considered to be at potential increased risk for adverse events. Acknowledgments The Forum was convened by the Ethics Committee of The Transplantation Society, administered by the National Kidney Foundation U.S., and sponsored by the following: Novartis Transplantation and Immunology; Fujisawa Healthcare, Inc.; Roche Pharmaceuticals; Genzyme Corporation; Wyeth Pharmaceuticals; the International Society of Nephrology; the National Kidney Foundation of Singapore; and the Transplantation Society. We are also appreciative of the participation of representatives from the World Health Organization.