Informed consent is the primary mechanism to ensure that a person remains in control of what happens to his or her body. The basic idea is that a person’s body is his/her own and he/she should be in control of what happens to it. A person who gives his/her informed consent to a medical treatment is in control because he/she understands the treatment being offered and freely accepts it. A person who gives informed consent to participate in a research trial is in control because he/she understands the purpose of the research and the risks and benefits of participating in it.

Courts and regulatory bodies have developed procedures for obtaining informed consent . Generally, these procedures aim to ensure that choices are made free of coercion, after rational deliberation, and with a good understanding of the consequences of the choice. As the chapter proceeds, I will elaborate on how the concepts of coercion, rational deliberation, and understanding relate to living donation. Now, however, I want to focus on a deeper aspect of choice. This is the idea that our choices are the most authentic when they are consistent with our core values. If someone holds career advancement to be of the highest value in his/her life, yet consistently makes choices that inhibit career advancement, then there is a cause to worry that this incompatibility will lead to unhappiness and regret sometime down the road. Good decision-making means reflecting on one’s core values and day-to-day choices so that they serve each other. Of course, each of us has multiple core values, and negotiating among them is not an easy task. Indeed, refining core values in response to new information and changing desires is a lifelong process. Nonetheless, it is important to be clear about the values that are the center of our lives and to reflect on how our current choices relate to the realization of these values. The process that supports a person providing informed consent—for living donation or anything else—should aim to help the person reflect on the relationship among their current choices, the consequences of these choices, and their core values.

Consent is an important concept in many aspects of our lives. One provides consent to medical treatment or to being a research subject in a clinical trial. One consents to an employment contract or a mortgage contract to purchase a house. Even in our personal lives, there are laws about consent to physical contact. In each of these cases, the processes that define valid consent vary. This is because what is at stake in each decision differs, as do the potential barriers to autonomous decision-making. Therefore, it makes sense to ask what is distinctive about the decision to become a living donor because the informed consent process for living donation should be responsive to the special features of the decision.

Informed consent for living organ donation has many features in common with informed consent for medical treatment, but it is also different. The primary purpose of accepting a medical treatment for oneself is to benefit oneself through the curing of a disease, healing of an injury, or the prevention of future health problems. In contrast, the primary purpose of donating an organ is to benefit another person. Donor nephrectomy carries surgical and long-term medical risks, yet there is no countervailing medical benefit for the donor (even though there are potential nonmedical benefits such as a sense of achievement from helping another, enhanced self-esteem, closer emotional ties with family, etc.). For this reason, informed consent for living donation also has some important features in common with consenting to being a subject in a clinical research trial. Generally, one consents to being in a clinical trial in order to advance scientific knowledge, so that in the future others with the disease may benefit from improved treatments. The living donor also seeks to benefit another, but the beneficiary in living donation is generally an identifiable contemporary of the donor; indeed, in most cases it is someone to whom the donor shares a close emotional tie.

In living donation, the donor undergoes some harms and risks in order to benefit another person. This leads some commentators to suggest that proceeding with living donation requires strong ethical reasons that are independent of donor consent. Mark Aulisio et al. put it this way: “Harming an otherwise healthy person in order to benefit another person is prima facie wrong, and cannot be justified solely by the consent of the person harmed.” [1]

This prohibition on harming a healthy person derives from the “first do no harm” principle in medical ethics . Overriding the prima facie wrong to proceed with living donation presumably requires that there be the potential for a great benefit and strong protections against harms to the donor. However, Aulisio is skeptical that the argument has been made: “Ethically [living donation] requires a high standard to proceed, which has yet to be developed.” [1]

From the perspective of the donor, this approach may appear paternalistic. The idea is that living donation may be inappropriate even when it may benefit the recipient and the donor makes a fully informed, autonomous decision to donate—in essence, donation is wrong even if the donor wants to do it. Aulisio’s argument goes too far. It is true that consent of the person harmed is not always sufficient to ethically allow harming the person. Nonetheless, there are many circumstances in which we allow the people to accept risks in order to benefit others, and in many of these cases a third party assists people in the activities that put them at risk. Aulisio’s argument implies not that living donation is impermissible, but rather that the informed consent process should be exceptionally rigorous because the donor will not directly benefit but will assume some risks [2]. Others have pointed out that living donors do experience a strong psychological benefit from helping others, and thus it is a question of trading off risks and benefits, rather than merely accepting risks [3, 4].

In what ways should it be rigorous? This will depend on what the biggest barriers are to the living donor candidate making a knowledgeable, thoughtful, and voluntary choice. The especially close connection between donor and recipient provides the key, given that it gives rise to the greatest risks to informed and voluntary decisions. There are two ways in which the typically close family relationship between donor and recipient may inhibit free and informed consent . First, there is opportunity for family members (perhaps other than the recipient) to threaten material and emotional hardships on the donor. As an example, consider donation between two siblings, and the potential pressure that the parents could exert on the donor candidate, even as an adult. The implicit or explicit threats may be difficult for the potential donor to resist and difficult for the transplant program to discover. A second concern involves the close emotional connection the donor may feel with the recipient and other family members [5]. Family relationships can be complex and emotionally complicated, and it can take a good deal of introspection to detect one’s “true” feelings toward one’s family members. This raises the danger of the donor not being completely clear about his or her motivations for donation.

The concern that family relationships form the primary barrier to free and informed consent for living donation stands in contrast to the context in which the rules for informed consent were developed. The primary threat to patient self-determination was not thought to be family members, but the medical profession itself. From its very early history, there has been a tension in the medical profession between telling patients the truth and withholding information in an effort to protect the patient and ensure his cooperation. For example, the advice of the Hippocratic Oath is to “speak to the patient carefully and adroitly, concealing most things.” Thomas Percival, an English physician whose book Medical Ethics inspired the American Medical Association’s (AMA) first code of ethics, wrote in 1803, “To a patient who makes inquiries which, if faithfully answered, might prove fatal to him, it would be a gross and unfeeling wrong to reveal the truth. His right to it is suspended, and even annihilated.”

Communicating with patients has been closely tied to getting the patient to follow medical advice. So the early American physician (and signer of the Declaration of Independence) Benjamin Rush said, “Yield to patients in matters of little consequence, but maintain an inflexible authority in matters essential to life.” Not everyone agreed with these paternalistic statements. Percival’s critic, the Reverend Thomas Gisborne held that “the physician is invariably bound never to represent the uncertainty or danger as less than he actually believes it to be.”

Given this history, it is not surprising that the medical profession has been skeptical about patient consent until relatively recently. However, the US’s legal standards have long recognized the patient’s right to consent to treatment. In 1914, the New York Court of Appeals ruled in favor of Mary Schloendorff, who consented to examination of a tumor under anesthesia, but not to its removal. Justice Benjamin Cardozo, ruling against the surgeon who removed the tumor, famously wrote, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages (Schloendorff vs. Society of New York Hospitals 1914).”

This decision has provided the basis for informed consent in the legal cases since that time (though legal scholars debate whether consent should be grounded in rules against assault or in negligence). The term “informed consent” was used for the first time in Salgo v. Board of Trustees, Stanford University in 1957. This case turned on the question of which surgical risks should be disclosed to the patient. A central case that clarifies the level of detail a physician must provide about the risks of proposed interventions is Canterbury v. Spence 464 F.2d 772 (D.C. Cir. 1972). The decision criticized the view that “usual and customary practice” in the medical community should be used to set the standard for disclosure, instead of opting for a “reasonable person” standard. The reasonable person standard says that the risks of a treatment must be disclosed to a patient if a reasonable person would likely find these risks to be relevant to the decision about whether to undergo the treatment. Here is a central quote from the decision:

From these considerations we derive the breadth of the disclosure of risks legally to be required. The scope of the standard is not subjective as to either the physician or the patient; it remains objective with due regard for the patient’s informational needs and with suitable leeway for the physician’s situation. In broad outline, we agree that ‘[a] risk is thus material when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk or cluster of risks in deciding whether or not to forego the proposed therapy.’ [6]

Canterbury carves out two exceptions to the risk disclosure requirement: (1) in emergencies and (2) when risk disclosure would harm the patient. Judge Robinson cautions about the overuse of the second exception—one should not withhold information about the risks of a procedure just because it might cause the patient some anxiety.

The current prominence of informed consent has more to do with its use in research, rather than medical treatment. This history can be traced to the trial of Nazi physicians at Nuremberg. A criticism of the physician-researchers—seemingly mild compared to the atrocities they committed—was that they did not give the subjects of their research the opportunity to choose voluntarily whether to be involved. The prosecutors at the trial claimed that voluntarily consent to participation in a research study was an international standard of medical research. Leo Alexander, MD, of Harvard University, authored an initial code for the conduct of research, which was adopted and expanded by the Nuremberg Court. The first principle of the Nuremberg Code laid out the basic of informed consent :

The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him/her to make an understanding and enlightened decision.

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