AMA Journal of Ethics^®

Organ procurement and transplantation involve ethically complex considerations across a variety of scenarios. Ethically sound practice in transplantation medicine requires, first and foremost, that both donors and recipients be carefully evaluated for suitability. Also central to all transplantation scenarios is ensuring that the rights and well-being of both donors and recipients are protected, that decisions to donate organs and tissues are well informed and voluntary, and that possible conflicts of interest are minimized. On the transplantation side, organs and tissues must be equitably distributed among patients on the basis of medical need.

Several opinions in the AMA Code of Medical Ethics address these fundamental requirements.

• E-2.03 Allocation of Limited Medical Resources
• E-2.15 Transplantation of Organs from Living Donors
• E-2.152 Solicitation of the Public for Directed Donation of Organs for Transplantation
• E-2.155 Presumed Consent and Mandated Choice for Organs from Deceased Donors
• E-2.157 Organ Donation After Cardiac Death
• E-2.16 Organ Transplantation Guidelines

Appropriately Selecting Donors and Recipients

Opinions E-2.15 [1], E-2.152 [2], and E-2.157 [3] all specify that prospective donors and transplant recipients must undergo appropriate clinical and psychosocial evaluation.

Informed, Voluntary Decisions

Opinions E-2.16 [4], E-2.15, and E-2.157 seek to facilitate deliberation by distinguishing among the different contexts in which decisions involving organ or tissue donations need to be made.

Living donation. Opinion E-2.15 states that living donors must provide separate consent to donate and to undergo surgery to retrieve the donated organ or tissue. A robust consent process is essential for living donation, in which donors undergo the harms of surgery with no prospect of physical benefit. In these situations, it is important to ensure that donors have not been unduly influenced, a consideration that may carry special weight under the (very limited) circumstances in which a minor may donate an organ or tissues. The opinion further identifies special considerations that should be addressed in consent for living donation because the donor’s right to withdraw from donation carries distinct implications for others, particularly in situations involving multiple donation-transplantation cycles. Scenarios that involve multiple donors and recipients can also raise unique privacy challenges.

Cadaveric donation. In cadaveric donation, opinion E-2.16 requires that death be determined by a physician other than the prospective transplant recipient’s physician. Providing guidance for organ donation specifically in the context of cardiac death, opinion E-2.157 requires that decisions to forgo or withdraw life-sustaining treatment be made independently of any decision to donate an organ or tissue. In addition, separate consent must be obtained to use interventions before cardiac death specifically to preserve organs and tissues with the goal of improving the opportunity for successful transplant.

Alternatives to the opt-in model of advance consent. Models of “presumed consent” and “mandated choice” about whether to donate organs after death are intended to increase the supply of cadaveric organs available for transplant. As opinion E-2.155 [5] notes, each model raises special issues about the voluntariness of informed consent. Ethically appropriate presumed consent by deceased donors requires three things: that individuals be made aware that it is presumed they wish to donate organs, that it be easy to document and honor refusals to donate, and that physicians verify that a donor’s family is unaware of any objection (on the part of the deceased patient) to donating. Mandated choice models of recruiting donors require an individual to declare her or his preferences regarding organ donation when performing a state-regulated task, such as obtaining or renewing a driver’s license. Mandated choice models are ethically appropriate only when an individual has sufficient information to make a meaningful and informed decision. Mandated choice models also require that physicians be able to verify one’s documented consent to donate, for example, on the back of one’s driver’s license.

Conflict of Interest

Concerns about voluntariness of consent to donate organs or tissues accompany concerns about possible conflicts of interest, especially among health care professionals. Opinion E-2.157 requires that end-of-life care for cardiac donors and organ retrieval are executed by independent medical teams. Similarly, opinion E-2.15 states that, in cases of living donation, both donors and recipients have independent advocate teams exclusively dedicated to their medical best interests and overall well-being.

Equitable Distribution of Donated Organs and Tissues

The Code of Medical Ethics also provides guidance about ethically appropriate distribution of organs and tissues in opinion E-2.03 [6], which holds that organs and tissues should be allocated among potential recipients solely on the basis of medical need. Ethically acceptable criteria include “likelihood of benefit, urgency of need, change in quality of life,” and “duration of benefit.” Supplementary criteria to distinguish among candidates who meet the foregoing criteria are, first, avoiding death or extremely poor outcomes and, second, anticipated “change in quality of life.” Under no circumstances should organs or tissues be allocated on the basis of nonmedical criteria, such as age, social worth, ability to pay, or the role of patients’ lifestyle and behavior in contributing to their illnesses.

Public solicitation of organs for directed donations—those made to a particular recipient—raises concerns about fairness in the distribution of organs for transplantation. Opinion E-2.152 holds that directed donation is ethically acceptable if it results in a net gain of organs in the pool without unreasonably disadvantaging other patients on a waiting list for a particular organ. This opinion prohibits payment to donors beyond reimbursement for travel, lodging, lost wages, and the medical care associated with donation.