An Ethical Framework

Dr. Joseph Murray who performed the first successful living donor kidney transplant in 1954, was of two minds about his success, noting that “we make a basic qualitative shift in our aims when we risk the health of a well person, no matter how pure our motives.”^{Reference Murray, Wolstenholme and O'Connor10} Today, we continue to permit — even encourage — living donation because of the inadequate organ supply, knowing that donors are exposed to short-term risks (e.g., pain, bleeding, infection, and even death) as well as a small but calculable increased risk of long-term health problems including hypertension, chronic renal failure, and pre-eclampsia.^{Reference Ibrahim, Akkina and Leister11} As such, the question is not whether but how much risk is the transplant community and society at large willing to expose an individual? Additionally, it asks which candidates should be allowed to assume these risks?

Elsewhere we proposed a moral framework involving five principles for exploring the ethics of living donation.^{Reference Ross and Thistlethwaite12} The first three are principles modified from the principles of human subjects protections in research as articulated in the Belmont Report: 1) respect for persons; 2) beneficence; and 3) justice.¹³ The fourth principle is adapted from Kenneth Kipnis' work in which he argues that the focus on vulnerable groups in the Belmont Report is inadequate and offers instead a typology of the various types of vulnerabilities that individuals may face in research.^{Reference Kipnis14} We have modified this typology to apply to living donors (see Table 1).^{Reference Ross and Thistlethwaite15} The fifth principle focuses on the concepts of special relationships and special responsibilities. In his book, Protecting the Vulnerable, Robert Goodin starts from the premise that vulnerability is relational and assigns special responsibilities for protecting the vulnerable on those with whom the vulnerable are in special relationships: “we bear special responsibilities for protecting those who are particularly vulnerable to us.” In living donor transplantation, then, the donor's health care team are moral agents who are responsible for empowering prospective donors to address their vulnerabilities, and/or for protecting those who cannot by disqualifying them from donation.^{Reference Elliott16}

Table 1Eight Vulnerabilities of Potential Living Donors *

Abbreviation: C-S = Candidate-Subject

* This table was first published in L. F Ross and J. R. Thistlethwaite, “The Prisoner as Living Organ Donor,” Cambridge Quarterly of Healthcare Ethics 27, no. 1 (2018): 93-108, at 97. Reprinted with permission from Cambridge University Press.

How do these five principles play out in the case reports from Rotterdam (Case A) and Wisconsin (Case B)?

Consider, first, the principle of respect for persons which is operationalized in the concept of informed consent. The individuals from Rotterdam and Wisconsin had decision making capacity at the time they sought to be a living donor. All actively sought to donate, and their decision was consistent with other life decisions (e.g., signing a donor card). The principle of respect for persons would support the voluntary and informed decisions of these patients.

However, this principle must be balanced against the other principles. The principle of beneficence would support donations provided that the benefits outweigh the harms. Whether living organ donation from a person with a LLC fulfills this principle is controversial. Some would argue that the benefits of successfully being an organ donor outweigh the harms of undergoing surgery and the risks of postoperative complications even if one has only a short life-expectancy. They may also argue that the physicians may be harming someone like W.B. psychologically in thwarting his goals even as they protect him physically. Others, however, would argue that most of the benefit can be achieved by post-mortem donation and one cannot justify taking a patient with a LLC to the operating room if the individual has a serious risk of an adverse outcome from the elective surgery, as might be expected in an individual with stage III Gold chronic obstructive pulmonary disease (Case A) or ALS (Case B).

The third principle to consider is justice understood as fairness in participant selection. Traditional living donors were adult biologically related family members, but today programs encourage patients to find living donors from a wider pool: from spouses and friends to acquaintances located on social media and even strangers. Participants were traditionally very healthy to minimize both short-term peri-operative risks and long-term health risks although today programs accept less healthy individuals.¹⁷ While long-term risks are of less concern in individuals with a LLC, some individuals with a LLC are at increased short-term risks (e.g., W.B. was at risk of becoming ventilator dependent). If transplant programs were to target persons with a LLC,^{Reference Denu, Mendonca and Fost18} this might raise suspicions of discrimination and devaluation. But one must recall that WB approached the transplant center on his own volition as did all of the individuals described in Rotterdam, and all were seeking to donate nondirectedly. This is an important distinction. The proposed donations are not the brainchild of transplant programs (and/or families) who may suggest donation because they de-value the life of those with LLCs and are willing to expose such individuals to risk because they have “less to lose.” Rather, these cases involve individuals with LLC who autonomously propose living donation to give meaning to their numbered days. Non-directed donation by individuals with LLC is consistent with the principle of justice (although a campaign to encourage such donations would not be). It is fair because it treats all adults with decisional capacity equally in respecting their right to decide whether to serve as a living donor.

While the principles of respect for persons, beneficence, and justice are all consistent with respecting the donation request, such a conclusion raises discomfort in part because of the potential vulnerabilities of those with a LLC. Below we consider each of the vulnerabilities enumerated in Table 1.

In both the descriptions from Rotterdam (Case A) and Wisconsin (Case B), the work-ups did not find the potential donors to be cognitively vulnerable. Rather all were able to give an informed consent. Nor were there any juridic (overriding authority who had an independent interest in the donation), deferential (patterns of behavior that may mask unwillingness), medical (serious health-related condition in the intended recipient) or situational (time pressure that would interfere with donor education or deliberation) vulnerabilities as the idea to donate was their own and they had chronic illnesses but were not imminently dying.

We believe that the donors from Rotterdam and the potential Wisconsin donor possibly had allocational vulnerability — lacking in subjectively important social goods that would be gained by donation. First, many were described as unfit for work, and several were quoted as saying that the donation would make them “useful” suggesting that they lacked social respect which they hoped could be gained by donating.¹⁹ This does not seem heavily persuasive as donation would be a one-time event, unlikely to maintain an ongoing sense of productivity or self-worth. A second important social good is the sustaining of relationships. A major fear of critically ill individuals is abandonment by their families and health care providers.^{Reference Back, Young and McCown20} Again, this does not seem persuasive as kidney donation by such individuals would create short-term relationships with new health care providers that would be unlikely to help maintain family relationships and, if anything, would temporarily supplant and risk interfering with relationships with ongoing health care providers. In additional, family members' responses may be mixed — while some may view the donor as a self-sacrificing hero; others may think the donor is “crazy” or “reckless.”^{Reference Challenor and Watts21}

The potential donors from Rotterdam and Wisconsin were also potentially socially vulnerable because of their illness and/or disabilities. The medical profession has a long history of abandoning dying patients, as do some friends and families,^{Reference Pohl, Given and Collins22} and this is one way that patients may seek to be engulfed into relationships out of a position of strength and not of vulnerability.

The threats of social and allocational vulnerability must be examined against the backdrop that these donors had approached the transplant programs on their own initiative. In both Cases A and B, the donors decided by themselves that they (and society) would get more benefit from their donating a kidney as living donors rather than wait until their death when their declining health or the dying process might make the organs unusable for transplantation. Permitting living donation in individuals with LLC empowered the individuals in Rotterdam to achieve their goal of helping a third party through organ donation at a time when they themselves felt that they had few other opportunities to contribute to society.

The concerns that the individuals' vulnerabilities adversely interfere with their ability to consent voluntarily to living organ donation requires careful evaluation by a skilled independent living donor advocate or living donor advocate team (LDA[T]).^{Reference LaPointe Rudow23} Since 2007, the LDA(T) is a mandated component of all living donor evaluations in the US.²⁴ For any potential living donor, the LDA(T) must assess the various vulnerabilities delineated in Table 1. While all potential donors have potential vulnerabilities, when the potential donor has a LLC, some vulnerabilities may be exacerbated and different vulnerabilities may be at issue. The LDA(T) should ensure that the potential donor is informed, is acting consistent with his or her own values, understands his or her right to renege, and that the vulnerabilities have been evaluated and addressed. Using Goodin's concepts of special relationships and special responsibilities, this means that the LDA(T) is responsible for evaluating all the different types of vulnerability threats that the potential donor may experience and for ensuring that they are adequately addressed in order to empower the potential donor to give a voluntary and informed consent.

Even if the LDA(T) determines that the donor is acting freely and without undue pressure, the surgeons are moral agents and in the Wisconsin case, they stated that they have a responsibility to minimize harm and leaving a donor ventilator-dependent post-operatively is not consistent with their interpretation of their obligations in the elective living donor setting.²⁵ The Wisconsin surgeons were also worried about institutional reputation.²⁶ While their decision may conflict with their patient's interest, it is important for the community of patients for whom they provide care. Thus, the Wisconsin surgeons, as moral agents, can and did refuse to accommodate W.B.'s desire to be a living donor. As Carl Elliott so eloquently explained: a physician as a moral agent decides “not simply whether a subject's choice is reasonable or morally justifiable, but whether he [the physician] is morally justified in helping the subject accomplish it.”²⁷

In sum, Cases A and B describe cases in which competent adults request to serve as living donors. The donations only differ from the standard non-directed donor in that the non-directed donor is usually very healthy with a long life expectancy. While the potential donor with a LLC may be more socially and allocationally vulnerable, the donation can be consistent with their own life goals. A thorough living donor work-up including evaluations by mental health providers and LDA(T) are essential. While morally permissible for the Rotterdam physicians to respect the donation decisions by individuals with decisional capacity who have a LLC, the physicians in Wisconsin, as moral agents, were also within their right to refuse to take W.B. to the operating room if they thought they would leave him seriously worse off.

Interestingly, all the donors from Rotterdam and Wisconsin were seeking to donate non-directedly. Although not described in detail in this published manuscript, Rakké and colleagues in Rotterdam noted that they had also procured kidneys from two individuals with Huntington's Disease who donated to a specified recipient.²⁸ Directed living donation from individuals with LLC potentially may generate defer-ential vulnerability concerns (for example, if the idea is proposed by another family member to whom the individual with the LLC is deferential). The need for an organ by a family member also raises concerns about medical and situational vulnerabilities. On the one hand, the individual with a LLC may be selected by the family as more expendable than others, and the individual may feel pressured to donate quickly before his or her symptoms worsen and make him or her ineligible to be a living donor. On the other hand, the donor may also experience significant benefit in knowing that he or she has helped a family member, and it may increase his or her social standing within the family.^{Reference Jacobs, Johnson and Anderson29} As such, potential directed donors with LLC raise both similar and different vulnerabilities than potential donors with LLC who seek to donate non-directedly. Both require careful evaluation by an LDA(T) to assess donor understanding, voluntariness, and that the vulnerabilities are appropriately addressed.

Did Rotterdam go too far? We don't think so. Agreeing to accept donations from donors with LLC is consistent with the ethical framework that we enumerated. While safeguards are necessary for all living donors, the potential donor with a LLC may have some additional vulnerability risks that require careful assessment by an LDA(T). It will be an uncommon request, but its fulfillment may help individuals give meaning to their lives as they struggle to live with progressive and ultimately fatal debilitation. However, such donations should be limited to persons with decisional capacity who voluntarily and independently raise this option. Public endorsements or campaigns by transplant professionals to attract such candidates for either directed or non-directed donation should be avoided.

Ethics Framework for Imminent Death Donation (IDD)

Case C is ethically straight-forward because the family gives permission for the patient to become a DCD donor (which, in this case, we know is consistent with the patient's signed donor card). Case D is more ethically controversial because the patient's tragic condition was acute and the patient had no time to consider how he would want to be treated if he became severely brain injured and was not expected to recover. A proxy decision-maker, usually a family member, must decide what he would have wanted. The proxy can also authorize DCD donation if this is what the patient would have wanted. It is not clear that the proxy can consent for the patient to serve as a living solid organ donor without going to court.^{Reference Nygren47}

The five principle framework can be used to evaluate IDD by an individual who lacks decisional capacity (Case D).

Consider, first, the 3 principles from the Belmont Report. Case D differs from all the earlier cases because consent for living donation is being given by a surrogate and not by the patient. Respect for persons requires that we respect the wishes of a patient with decisional capacity and protect those who lack capacity.⁴⁸ Whether the patient in Case D would have wanted to be a living donor and undergo surgery prior to treatment withdrawal is not known. Given his incapacity and lack of stated wishes, the principle of respect for persons requires protection even from well-meaning family members and transplant professionals and would not support donation. Pre-mortem donation is also not consistent with the principle of beneficence. The procurement would clearly not be for his medical benefit and may even cause physical harm (pain), without any potential psychological benefit. This contrasts with Cases A and B in which psychological benefit of being a donor was an important motivation for the individuals to serve as living donors. Given the lack of prior stated wishes in Case D about living donation, it is hard to justify exposing him to any risks of pain or discomfort to benefit an unknown third-party. Justice arguments also support limiting living organ donation to individuals who can provide their own voluntary and informed consent.

The vulnerabilities analysis also must be re-evaluated in light of the potential donor's cognitive vulnerability which means he cannot consent for himself and differentiates him from the donors in Cases A and B above. The patient is also socially vulnerable because his neurological prognosis is poor, even if he were maximally treated. The data show that the severely disabled are frequently disvalued.^{Reference Gill49} The patient in Case D also clearly has situational vulnerability: the severe brain injury prevents the education and opportunity to deliberate about whether to participate as a living donor. If there were a known potential transplant candidate in the family, the patient may also have medically vulnerability: the family may seek to procure the organ for their loved one pre-mortem to avoid the possibility of an aborted DCD donation due to the patient's prolonged survival after withdrawal of life support.

While cases of IDD type 1 do not violate the letter of the DDR, we believe they do violate its spirit. The main reason for the individual to donate pre-mortem is because DCD may not come to fruition. In contrast, we believe that the harms of surgical intervention in the last hours of life — not for the benefit of the patient, but for the benefit of a third-party, cannot be justified. As moral agents, transplant providers should invoke the DDR to protect dying patients. IDD is being done to circumvent the DDR which protects dying patients because it requires pre-mortem care to be focused on the patient as a person (an end-in-oneself) and not solely as a potential source of organs (as merely a means to another's ends).^{Reference Kant and Ellington50} IDD also threatens public trust in the transplant and palliative care enterprises. We do not support IDD type 1.

Cases of IDD type 2 (Case E) differ from Cases of IDD type 1 (Case D) because the hypothetical individual in Case E has decisional capacity and makes the request for and by himself. While this makes him less vulnerable, he is still quite socially vulnerable given his severe disability.⁵¹ Again, IDD is only being considered because DCD may not be actualized due to many factors beyond the control of the patient and transplant team. Thus, cases of IDD type 2, like cases of IDD type 1, are ethically problematic because they also attempt to circumvent the DDR and the protections it affords to those who are dying.

Case F is slightly different than IDD as described by the UNOS Ethics Committee because in this case, the individual whose death is imminent does not die shortly after donation but actually the donation is the proximate cause of death. Case F challenges the premise of the DDR. It promotes organ procurement from individuals who are not dead but only “nearly dead” or “as good as dead.”⁵² That is, Case F forces one to ask what protections does the DDR provide in a case where life-sustaining treatment will be removed in the near future with imminent death expected.

The utilitarian asks whether the benefits of obtaining organs from dying patients before they die and violating the DDR outweighs the harms. While the donors (or their families) in these cases might say that the benefits outweigh the harms, we must ask what society at large would think and whether such actions would reduce public trust, not just in transplantation, but also in medical care of the dying. Some may be concerned that permitting donation by those with LLCs suggests that their lives are expendable, or at least they are perceived as expendable by health care providers. Thus, although procuring organs from the dying may increase organ procurement in the short-run, if public trust is lost, it may cause fewer organs to be procured in the long-run. Thus, utilitarians may or may not support living donation by the imminently dying — depending on their assessment of the anticipated consequences, both intended and unintended. Other utilitarians may argue for at least a trial to determine what impact donation of the dying would have on the overall number of organ donations.

From a deontological or principle-based perspective, it is not enough to ask whether the benefits outweigh the harms, but to consider certain fundamental principles of bioethics that must be satisfactorily addressed. One such principle is whether death by organ procurement is consistent with respect for persons or whether it is treating the moribund donor as a means (a source of organs) and not focused on the patient as a person or an end-in-him- or herself.⁵³

There is also a logistical problem: Transplant surgeons may not be willing to be the proximate cause of the patient's death. In the spirit of the DDR, patients are declared dead by health care providers not involved in the organ procurement, and the transplant team only gets involved after the patient is declared dead.

But what if transplant surgeons were willing to take patients to the operating room and procure their organs as a form of physician-assisted suicide rather than waiting until after a patient's death by natural causes after life support is withdrawn, should it be permitted? Currently it is not legal, and we believe that death by organ procurement should remain illegal because it circumvents important safeguards: the separation of patient care and patient care decisions from organ procurement as well as the separation of the determination of death from organ procurement.^{Reference Kotloff, Blosser and Fulda54} These separations are important to ensure respect for the dying patient and to maintain patient and community trust in the transplant enterprise, and the medical system more broadly.

In sum, the DDR helps to ensure respectful and appropriate care for the dying. There is value in maintaining a clear division of responsibilities between end of life care and organ procurement with two separate medical teams involved even though it means that the organs suffer a warm ischemic insult because the patient must die before his or her organs are removed.