Refusal of transplant organs for non-medical reasons including COVID-19 status

Abstract

Transplant centers and physicians in the United States have limited guidance on the information which they can and cannot provide to transplant candidates regarding donors of potential organs. Patients may refuse organs for a variety of reasons ranging from pernicious requests including racism to misinformation about emerging medicine as with the COVID-19 vaccine and infection. Patient autonomy, organ stewardship, and equity are often at odds in these cases, but precedent indeed exists to help address these challenges. This work uses such cases to highlight the urgent need for uniform, national policy prohibiting informational requests unrelated to well-established risks.

Introduction

Among the many challenges raised by the COVID-19 pandemic is the variability in policies of individual transplant centers regarding vaccination. Vaccine hesitancy among transplant candidates is an issue that predates the COVID-19 pandemic. A year-long US and Canada multicenter study conducted from 2017 to 2018 demonstrated that, among pediatric transplant recipients, only 55% were up to date on immunizations according to the National Immunization Survey benchmark. ¹ While the cause of pediatric under-vaccination is multifactorial, including larger issues such as access to care and incomplete vaccine tracking, parental vaccine hesitancy is one such contributor. This is evidenced by one study, conducted prior to the COVID-19 pandemic, finding a one in three rate of parental vaccine concern voiced to pediatricians, and further a one in 10 rate of requesting delayed schedules. ² Transplant center response to this issue has been both variable and unclear. For instance, only 4% of surveyed individuals at pediatric transplant programs reported that their facility had written policies regarding parental vaccine refusal. ³ Adult patients as well demonstrate hesitancy in their own vaccinations, such as for the Flu vaccine where hesitancy is significantly associated with a lower likelihood of vaccination. ⁴ Here too, center-level policy is diverse and limited. ⁵ In order to allocate scarce resources in a just and ethical manner, standardization of such policies appears merited.

The COVID-19 vaccines are among those vaccines most likely to generate vaccine hesitancy among adults in the United States. COVID-19 vaccine acceptance in the United States was reported to be at only 64.6% as of July 2021 ⁶ and at the time of this writing in May 2022, only 66.3% of US residents are vaccinated. ⁷ Some ethicists and transplant centers have begun to advocate for policy-making related to the eligibility of unvaccinated patients to be listed on donor registries and to receive transplants. ⁸ For transplant centers, these recommendations rely on existing guidelines from organizations that publish vaccine guidance such as the Advisory Committee on Immunization Practices (ACIPs); however, the COVID-19 vaccine, which does not yet have an established track record, is not yet included in ACIP guidance. ⁹ While a national COVID-19 vaccine mandate for transplant centers remains a hypothetical possibility, many transplant centers have unilaterally instituted their own requirements. A survey of transplant centers through 2021 revealed that 35.7% have instituted a vaccine mandate for transplant candidates and that 42% of those centers which have a mandate also required the vaccination of living donors. ⁵ The same study found that centers most often cited efficacy and stewardship as reasons for their requirement. These centers are concerned with preventing COVID-related complications and view such preventions as a duty to organ stewardship and to the sacrifices made by donors.

One ethical issue that remains largely absent from discourse in the field of transplant policy relates to potential transplant recipients who refuse organs based on the vaccination status of prospective deceased donors. Medical ethics in the United States has long placed emphasis on the protection of patient autonomy within the context of shared decision-making by physicians, patients, and caregivers. ¹⁰ Existing literature lacks clear guidance for handling such requests or, for that matter, other requests based on non-medical factors related to the characteristics of the cadaveric donor. What follows are several hypothetical cases of such refusal of cadaveric organs and an analysis of how transplant centers ought to address them. This article first explores cases involving race-based and cause-of-death-based requests and then examines how they may prove valuable analogies to guide patients who wish to reject organs based on the vaccination status of donors. The hope is to highlight through this work the need for national policy to direct transplant centers on non-medical organ refusal.

Case 1

Mr P is a 55-year-old patient who has been undergoing seven years of dialysis for end-stage renal disease (ESRD) with no comorbidities. Mr P's transplant has no anticipated complications, and he receives a call from his transplant center that a healthy, well-matched organ is available. He asks to know the race of the donor and states that he will only accept an organ from a white donor because he believes that only a white person's organ will function well for him. In this case, the available kidney comes from a donor who was Black.

Analysis

Race-based organ requests are already the subject of clear precedent and policies, so starting with this case may inform discussions of vaccine-related demands. The case presents a conflict between the autonomy of Mr P and stewardship and justice goals of the transplant system. It is clear that Mr P's request is of such a nature that if he learns the organ comes from a Black donor, he likely will refuse the organ and wait for the next matching organ. The decision which then remains in the hands of the physician or transplant center is whether or not to provide the true information that the donor was Black. In other words, is informing a patient of the race of the donor either a required or an acceptable aspect of the informed-consent process? There is no available literature which explicitly handles such a case in large part because it is a policy set forth by UNOS not to disclose the race or ethnicity of a potential donor. ¹¹ So Mr P will have to proceed without the knowledge which may influence his decision.

While this policy resolves the case, it is worth discussing what a physician's ethical challenges might entail in the absence of such a policy. Assuming Mr P cannot be educated to change his prejudiced views, there would be three available options to the physician: to lie to the patient and say the organ comes from a white donor, to divulge accurately that the organ comes from a Black donor, or to refuse to share any information regarding the race of the donor despite the lack of uniform policy. Each of these approaches raises distinctive concerns.

Deception in medicine has been discussed at length elsewhere and is beyond the scope of this article. ¹² What is worth noting is that lying in this case would have the effect of the patient accepting the available organ and saving the patient's life. Additionally, in this case, the patient's beliefs about race and organ efficacy are incontrovertibly false and defy widely accepted medical knowledge. Patient preferences and views on medical decision making vary widely both among and within cultures, with beliefs ranging from truly shared decision making to leaving decisions entirely to medical professionals. ¹³ While such views may be varied, medical paternalism has certainly fallen out of favor.^12,14 A paternalistic lie, even in the interest of a beneficent patient's outcome, is an act which violates a patient's autonomy. It would undermine Mr P's autonomy to lie and subsequently allow him to make his decision under false assumptions. While Mr P's racist views may be disturbing to physicians and violate societal norms, it is generally held that in the absence of a hostile workplace, physicians have a duty to treat such patients, though some have called for limits to accommodation of racist requests. ¹⁵ Additionally, although Mr P's medical reasons for rejecting a Black donor may be unscientific and ill-informed, deception may cause him psychological damage if he does learn the truth after transplantation. Lying to a competent patient—except in the extraordinary circumstances of therapeutic privilege—is generally an ethically unacceptable option.

The second option available to the physician would be to share that the organ comes from a Black donor. The anticipated outcome is that Mr P will refuse such an organ. When he refuses the organ, he will remain at the top of the transplant list as his medical needs have not changed and there are no penalties for refusing any organ offer in accordance with the Kidney Allocation System (KAS). ¹⁶ However, it is possible within this system that refusing such a well-matched organ may cause the next offer of that organ to be made to a lesser-matched candidate or one in less need of an immediate transplant. It may then be argued that providing such information and allowing interruption to the KAS by non-medical refusals, though respectful of Mr P's autonomy, is in poor stewardship of the organ and therefore unjust in a systemic approach.

Finally, the physician might elect to refuse to provide information regarding the donor's race, as the current rule dictates. There are important practical implications to this choice. In the absence of such a rule, the possibility exists that the patient may simply pursue transplantation from physicians or centers which would give him the information he desires. While this case remains hypothetical due to the current uniform policy, parallels to other medical requests are abundant, such as a patient who is denied certain medicine from one physician and seeks out another. Preventing such tactics requires all providers and institutions to act similarly. Refusing to provide the information is only a satisfactory solution when doing so is embraced uniformly so that it cannot be easily circumvented.

Case 2

Ms Q is a 55-year-old patient, again just becoming eligible for kidney donation after seven years of dialysis without comorbidity. Ms Q historically follows her doctors’ advice on all medical matters. However, when she received the call about an available organ, she asks her doctor how the donor died and stated in the past that she would never accept an organ from a donor who had died by suicide. In this case, the donor had died by suicide but there is no evidence of injury to the organ in question.

Analysis

Ms Q's case resembles that of Mr P's in that she is mistaken regarding the medical quality of the organ she may receive. However, Ms Q's case does not run as clearly contrary to public policy and it would likely not strike most physicians or reasonable people as morally disturbing as Mr P's views. Suicide remains a highly stigmatized course of action in the United States, and this stigma has notable predictors. For example, gender, race, and education were found to be significant predictors of stigmatizing attitudes towards suicide. ¹⁷ It is reasonable to then conclude that significant differences would exist among groups regarding who would make such a request.

Ms Q is presumably motivated by misinformation that there is some biological component to the suicide which would be passed on to her through the transplanted organ. The exact cause of death and chronic conditions unrelated to the transplant are, like race, standard practice to not report to recipient candidates. ¹¹ It is unclear whether this UNOS policy recommendation exists to prevent discriminatory or otherwise pernicious requests for information. This policy may in fact only exist as a means of protecting donor and donor-family confidentiality. Regardless of the intention, the policy resolves the case similar to that of refusing to disclose race. In the absence of uniform guidance, the physician would be left with the same three options discussed in the prior case and would arrive at the same ethical conclusions, longing for a uniform embracement of withholding such non-medical information.

It is therefore not the repugnance of racist requests alone that demands a uniform policy. The suicide variant offers the same options and analysis and already has similar policies in place. Such non-medical information requests, particularly the medical misinformation requests highlighted by both Mr P and Ms Q, exist on a continuum of which there is clear precedent for standardization of withholding donor information.

Case 3

Ms R is a 55-year-old female who has been undergoing dialysis in New York City for seven years following a diagnosis of ESRD. She has no comorbidities and is up to date on all of her vaccinations except the COVID-19 vaccine, which she states that she is skeptical of and refuses for personal, non-religious reasons. She is evaluated by a transplant center which does not have a vaccine mandate in place for recipients and has received a call that a well-matched kidney with no high risks or foreseeable complications is available to her from a deceased donor. She asks whether the donor has received the COVID-19 vaccine and states that she will not accept a kidney from a donor who had received the vaccine antemortem because she fears that the kidney may have been damaged by the vaccine. She expresses a fear that she might suffer health consequences as a result of exposure to a vaccinated kidney. In this case, the potential donor was vaccinated.

Analysis

The cases of Mr P and Ms Q help shed light on that of Ms R. here. Notably, no uniform policy exists for Ms R's case; yet, the physician's potential options remain similar. He may lie, tell the truth, or withhold information. As stated earlier, the presumption is that lying is ethically unacceptable. The merits of the remaining two choices also remain largely the same. If the doctor is truthful, the patient will most likely refuse transplant, thereby leading the patient to forgo transplant and jeopardizing stewardship of the organ. However, withholding information unilaterally may cause the patient to seek care elsewhere. In this case, we face a situation in which, as previously noted, centers have taken diverging paths in their policies and physicians lack clarity. This needs to be addressed under two different frameworks: one in which the possibility that a vaccinated donor's organ might cause harm is acknowledged and another in which physicians are certain that it does not. To be clear, it is known that a variety of vaccines are efficacious and safe for COVID-19 despite the spread of misinformation. ¹⁸ However, there is ethical value to considering the case from the vantage point of hypothetical, as-yet-unknown risks.

If one accepts that there is no chance the vaccinated donor's organ may cause any harm to Ms R, then in some ways this resembles the first case, in which there is no chance race is a determinant of organ quality or that the donor's race can cause harm. Of course, discrimination based upon vaccine status does not have the deeply pernicious history that does discrimination based upon race, nor is vaccination-based discrimination tied to the same level of social damage. At the same time, weighed solely on the clinical merits, the best solution appears to be treating the cases similarly and adopting a uniform policy which prevents the sharing of all non-pertinent information.

More challenging is the case which allows for unknown future risks from vaccinated donors. In such a scenario, if the patient is permitted to learn that the organ comes from a vaccinated individual, and therefore refuses, that organ will be passed onward to the next candidate. This second candidate may not prove as fit a match. However, even if there are identical candidates in line per the KAS, that kidney will ultimately end up being accepted by either someone who is unconcerned about the donor vaccination status, or more alarmingly, someone who is as concerned as Ms R, but does not feel he has the power to refuse. It is critical to acknowledge that healthcare remains inequitable beyond COVID-19, and as such, not all patients access the same quality of care. Race and socioeconomic status correlate to poor health care. ¹⁹ In one study of early-stage breast cancer patients, Black women, when compared to white women, are less likely to report having their informational needs met and emphasized the importance of having advocates with them. ²⁰ Even closer to our subject, women and those without a college education are found to be significantly more likely to accept an increased-risk organ donation offer. ²¹

Even if Ms R's concern for risk is acknowledged within scientific possibility, her case raises another concern: equity. Those patients who have systematically been given less control in their healthcare, such as in the aforementioned instances, will disproportionately bear the risk if any is to exist. Ms R's autonomy and her right to information on the transplanted organ comes at the expense of equity because not all patients, for systemic reasons, have the same degree of comfort in seeking out the information that she does, nor does every patient have the means to switch centers to a doctor which will address their preferences.

Of course, physicians do inform patients of donor information which is medically known to produce risk, such as an HCV infection. This is fundamentally different from allowing patients to act on unknown risks because in the case of truly increased risk donations, the patient need not seek out information as it is incumbent upon the physician to inform patients of known risks, and physicians should not be in a position of subjecting patients to known risks without their approval. For Ms R, however, there is no known medical risk, and the possibility of one emerging is unwittingly borne by those least well-served by medicine.

Case 4

Mr S is a 55-year-old male who has also been undergoing seven years of dialysis for ESRD with no comorbidities. Mr S is up to date with all of his vaccinations including the COVID-19 vaccine for which he has obtained every recommended dose. When he receives the call from a transplant center that a healthy, well-matched organ is available, he demands to know whether the donor has received the COVID-19 vaccine and states that he would refuse any organ from a deceased donor who failed to acquire the COVID-19 vaccine antemortem or who had a known COVID-19 infection because he fears that the kidney may have been damaged by a COVID-19 infection. In this case, the donor was not vaccinated and has had a mild case of infection in the past.

Analysis

As Mr S is a vaccinated patient seeking a vaccinated organ, his cause might be thought of as the inverse of Ms R's. If the same approach were to be applied, the result would ensure that policymakers are not motivated by bias against, or a desire to penalize, those who refuse vaccination. The organ available to Mr S has no known medical risk and is as healthy as a vaccinated one. One might conclude then that Mr S should be treated no differently. The same equity issues which plague the prior case are also present here.

One notable difference, however, for Mr S is that there is a second piece of information he may desire in addition to vaccination status: whether or not the donor experienced a known COVID-19 infection. While the UNOS recommendations state that physicians should not share chronic illnesses unrelated to the transplant, this leaves room for interpretation in Mr S's case. It is known now that severe COVID-19 infection may cause acute kidney injury; in fact, this occurs in over a quarter of hospitalized COVID-19 patients. ²² So, physicians and centers are left to discern whether relevance to the transplant exists. In the absence of evidence of damage to the organ, this would be an as-yet-unknown risk.

Regardless of the validity of the concern, the issue of equity remains similar to the last case. In the absence of evidence-based risk characterized by damage to the organ or an active infection, the possible risks of the unknown will continue to be borne by those least empowered within medical systems.

Discussion

Whether preventing racially motivated organ transplant requests or unrelated medical requests such as suicide, there is clear ethical precedent to limiting information sharing to potential organ recipients rooted in donor confidentiality protection as well as organ stewardship. These policies and standard practices, though essential, are insufficient to cover emerging concerns such as that of COVID-19. While a physician cannot in good conscience transplant a known high-risk organ, such as one with a known HCV infection, unwittingly to the patient, other cases of concern for as-yet-unknown risk remain unresolved. Another issue of concern, but one largely beyond the scope of this paper, is that of the decisional capacity of patients making COVID-related transplant requests. Indeed, many cases may arise in which patients rejecting organs based upon transplant status lack such capacity. Our analysis applies to those cases, if and when they arise, when patients do otherwise meet capacity standards. In such cases, waiting for organizations to comfortably create requirements for new vaccines or diseases is too slow to be acceptable for emerging concerns. The only acceptable solution which balances organ stewardship, equity, and patient autonomy is one in which informational requests unrelated to the known quality and risks of an organ are prohibited uniformly by national policy.