The assessment of living kidney donors presents unique ethical challenges and complex psychosocial implications. This study aimed to ascertain the perspectives of transplant nephrologists and surgeons on living kidney donor assessment. Semi-structured, face-to-face interviews were conducted with 110 transplant nephrologists and surgeons from 43 transplant units in 12 countries from Europe, Australasia and North America. The challenge of defining acceptable risk to the donor was central to five themes identified: burden of responsibility (personal accountability, policing morality, democratic decision making, meeting legal obligations, optimizing outcomes and innovation, relinquished control); medical protectiveness (prognostic uncertainty, skepticism of donor risk perception, avoidance of undue coercion, concerns for dubious motivations and coercion, safeguard donor well-being, ethical information disclosure); respecting donor autonomy (facilitate informed-decision making, concede to donor risk acceptance, benefit of the doubt, donor mandate to maintain health, acceptable altruism); driving ideologies (preserving equity, championing living donation, cognizance of anti-paternalism) and contextual pressures (evolving donor demographic, resource limitations). Living kidney donor assessment involves complex interactions between safeguarding the donors' welfare and respecting their autonomy. In our opinion, authoritative and well-described transplant unit, hospital and public policy positions that make explicit the considerations that are often implicit may reduce the uncertainty within which living donors are assessed today.
human leukocyte antigen
United Network for Organ Sharing
Living kidney donation has been accepted in most transplant units worldwide and represents approximately half of all kidney transplants in many high-income countries including the United States, United Kingdom and Australia [1-3]. However, donor evaluation practices, policies and thresholds vary considerably [4-9], and importantly, long waitinglists have stimulated nondirected altruistic donation and paired exchange programs [10-12], which present their own unique legal and ethical challenges, controversies and complex psychosocial implications [10, 13-15].
While living kidney donation offers the recipient better outcomes than deceased kidney donation, live donors face the risks of surgical complications, death and long-term health and psychological harms [16-18]. The donor mortality rates attributed to surgical complications is 0.03% . A small proportion of donors have reported relationships problems, depression, anxiety, stress, reduced quality of life and psychiatric symptoms . A recent study found that recipient death and graft loss were associated with an increased risk of depression among living kidney donors .
The risk to donors means that physicians and surgeons are confronted with unique clinical and ethical dilemmas [15, 21]. These critical clinical and psychosocial decisions are influenced by their own beliefs, values and attitudes toward living kidney donor assessment. We aimed to understand the perspectives of transplant nephrologists and surgeons on the challenges and complexities they face in this task, to promote more transparent and consistent decision making and public policy development in this area, and so better protect the health and well-being of living kidney donors.
Materials and Methods
Participant selection and practice setting
Transplant nephrologists or surgeons involved in living kidney donor transplantation in Europe, United States, Canada, Australia and New Zealand were purposively selected to capture a range of years of clinical experience, age, gender, practice locations and transplant unit size. Invitations were made by e-mail, in the first instance, to an initial group of participants known to J.R.C./A.T. A snowballing technique was then used whereby participants could nominate other transplant nephrologists and surgeons who they believed could offer a different, relevant or important perspective about living kidney donor assessment. Interviews were conducted in clinic offices, meeting rooms or at conference venues globally. The University of Sydney provided ethics approval.
The interview guide was based on a literature review of clinical guidelines and consensus statements on living kidney donation [5, 10, 22], and discussion among the research team (Table S1). A.T. conducted a face-to-face semi-structured interview with each participant from May to October 2012. Participant recruitment ceased when theoretical saturation was reached. All interviews were digitally audio-recorded and transcribed.
The transcripts were entered into HyperRESEARCH software (Version 3.0, ResearchWare, Inc., Randolph, MA) for coding qualitative data. Using the principles of grounded theory  and thematic analysis, A.T. read the transcripts line-by-line, conceptualized and coded all meaningful sections of text into concepts identified inductively in the data. New codes were created when necessary. After coding was completed, the software was used to generate a report of all codes with the corresponding text. This was reviewed to ensure that all concepts related to living kidney donor assessment were captured. Similar concepts were grouped into themes and subthemes. Patterns, relationships and conceptual links between themes were identified, discussed among the research team and mapped into a thematic schema using Microsoft PowerPoint. To enhance the validity of the study, we used member checking in which the preliminary themes were e-mailed to all participants. Participants were given 2 weeks to suggest additional opinions that had not been included. These were coded and integrated into subsequent revisions of the themes.
Of the 122 invited transplant nephrologists and surgeons, 110 (89%) from 43 transplant units in 12 countries participated. Sixty-four (58%) were transplant nephrologists and 46 (42%) surgeons. Nonparticipation was due to travel and clinical commitments. The mean duration of interviews was 45 min. Two interviews were completed in less than 30 min due to the participant's clinical priorities. The participant characteristics are provided in Table 1, and their transplant unit characteristics in Table 2.
|Participant characteristics (n = 110)||No. of participants||%|
|Years of experience in living kidney donation|
|Location of practice (country)|
|Hospital office or meeting room||85||77.3|
|No. of centers (n = 43) (%)||Total|
|North America||Europe||Australia/New Zealand|
|Number of living kidney donor nephrectomies in the last 12 months|
|1–10||0 (0.0)||1 (2.3)||5 (11.6)||6 (14.0)|
|11–20||1 (2.3)||0 (0.0)||2 (4.7)||3 (7.0)|
|21–30||2 (4.7)||5 (11.6)||3 (7.0)||10 (23.3)|
|31–50||4 (9.3)||2 (4.7)||4 (9.3)||10 (23.3)|
|>50||8 (18.6)||6 (14.0)||0 (0.0)||14 (32.6)|
|Number of deceased donor kidney transplants in the last 12 months|
|1–10||0 (0.0)||0 (0.0)||1 (2.3)||1 (2.3)|
|11–20||0 (0.0)||0 (0.0)||4 (9.3)||4 (9.3)|
|21–30||0 (0.0)||0 (0.0)||1 (2.3)||1 (2.3)|
|31–50||5 (11.6)||1 (2.3)||4 (9.3)||10 (23.3)|
|>50||10 (23.3)||13 (30.2)||4 (9.3)||27 (62.8)|
|Number of nondirected donors accepted in the last 12 months|
|0||0 (0.0)||5 (11.6)||5 (11.6)||10 (23.3)|
|1–10||13 (30.2)||7 (16.3)||9 (20.9)||29 (67.4)|
|11–20||2 (4.7)||2 (4.7)||0 (0.0)||4 (9.3)|
|Number of paired-exchange donors accepted in the last 12 months|
|0||0 (0.0)||4 (9.3)||4 (9.3)||8 (18.6)|
|1–10||12 (27.9)||7 (16.3)||9 (20.9)||28 (65.1)|
|11–20||1 (2.3)||1 (2.3)||1 (2.3)||3 (7.0)|
|21–30||0 (0.0)||2 (4.7)||0 (0.0)||2 (4.7)|
|31–50||1 (2.3)||0 (0.0)||0 (0.0)||1 (2.3)|
|>50||1 (2.3)||0 (0.0)||0 (0.0)||1 (2.3)|
The central concept was the task of “defining acceptable (donor) risk” unifying five major themes: burden of responsibility, medical protectiveness, respecting donor autonomy, driving ideologies and contextual pressures (Figure 1). The physicians' multiple responsibilities straddled medical protectiveness while respecting donor autonomy, despite ideological and contextual pressures (Figure 1). Selected quotations illustrate how these themes were expressed (Table 3) with additional representative quotations in Table S2. The subthemes and potential differences between countries are detailed in the following section.
|Burden of responsibility|
|Personal accountability||The surgeons are the ones who are going to inflict the injury, the assault on this body. We're the ones who are likely to cause the potential damage and in a few cases possibly deaths. (Male surgeon, 60s, UK)|
|I feel a very strong responsibility for doing an operation that patient doesn't need for somebody else's benefit, I feel very uncomfortable if we push the boundaries. Some are keen to get more donor procedures and say well what's the evidence that a BMI of 30 plus is a bad thing? Live donation is completely different. (Male surgeon, 50s, UK)|
|Let's say this patient is an elderly patient who has a life expectancy of only seven or eight years and a brother or son wants to donate. Should you tell that person that his life expectancy is very limited? My feeling about it is that if they're willing, they understand that gift could be lost within 2 minutes. (Male nephrologist, 50s, Canada)|
|Policing morality||It's the only specialty in medicine where you have to figure out if your patient is lying to you for money. We're not equipped to do this. The whole basis of medicine is that you trust your patient, because it's in their best interest. This is one circumstance where it's not in their best interest to tell you the truth. (Female nephrologist, 40s, US)|
|Democratic decision making||So it's not one person's unilateral decision. Because it's a lot to live up to. (Male nephrologist, 30s, US)|
|Meeting legal obligations||The regulations don't understand what the limitations are on our side. Saying that everybody needs to have a living donor advocate. That's a great idea, but what exactly is a living donor advocate? In some centres, it's a social worker. In some centres, it's somebody not even related to living donation so that there's no bias. It's kind of weird. It's nebulous. It doesn't really explain what we're doing at each centre and how that should really look. (Female surgeon, 40s, US)|
|Optimizing outcomes and innovation||Because there's always this inherent conflict that we are in the business of doing transplants. (Male nephrologist, 60s, US, 31–50 LKDT in the past 12 months)|
|That's the danger—to increase your numbers, to increase revenues. Be then more liberal. And we stretch the limits. On the other hand it's our job to stretch the limits and the frontiers because we are doing research, we are doing transplantation. It's also our job to go and to push the limits a little it. (Male nephrologist, 50s, Europe, 21–30 LKDT in the past 12 months)|
|Relinquish control||We can take responsibility for the outcome of the procedure as a team but if my donor is getting done elsewhere in the US and I'm doing the recipient, I have to receive that kidney and put it in. If it wasn't procured the way I wanted to, then somehow I'm taking responsibility for the outcome of the procedure We trust how they did the donor evaluation so the transplant business is used to that, trusting remote centres and remote people. (Male nephrologist, 40s, US)|
|Prognostic uncertainty||It's a double-edged sword. On the one hand you don't want to scare people off, but on the other hand you want to encourage people to believe that this is something that they can do when it's appropriate. I think the hardest challenge is striking that balance. (Male nephrologist, 50s, Australia)|
|On the living donor side, the data's not as strong, so it's more extrapolation than estimation. (Male surgeon, 50s, US)|
|Skepticism of donor risk perception||I don't think they really care and understand what you're telling them, because they're going to donate—they do not want their kid on dialysis. Those situations are very difficult, because it doesn't matter what you're saying. They're not listening. (Male nephrologist, 40s, Canada)|
|Like medical literacy, sometimes people are not necessarily the most educated in that sense. Maybe they haven't been going to physicians all this time, what does diabetes mean, what does hypertension mean, what is dialysis? (Female nephrologist, 30s, US)|
|Concerns for dubious motivations and coercion||Sometimes these children are under a high pressure from their parents. Their parents say, if one day I die, you don't get anything because you didn't give me the kidney. (Male surgeon, 60s, Europe)|
|That puts a burden upon us to weed out health motivation from unhealthy motivation and under those circumstances, I think motivation experts should talk to these [nondirected donors] and not the care providers, not a surgeon. You don't want a surgeon making that decision. That's not my field. (Male surgeon, 60s, US)|
|Safeguard donor well-being||If someone's giving to their spouse and they've got a joined up quality of life issue together, we may be more relaxed about well-treated hypertension in a spouse situation. If it was a just a friend and they weren't going to get dual benefit from the transplant, I would be less inclined to relax our criteria. (Male surgeon, 60s, UK)|
|We've had to expand our definition of what benefit means for a donor. That puts a new onus of discernment on the healthcare team so we don't abuse people. (Male surgeon, 60s, US)|
|Ethical information disclosure||If someone had a partner who was Hep B positive but was Hep B negative that would be considered exceptional distribution. We would have to let the recipient know that. They would meet exceptional distribution criteria. The recipient has to be informed that this is not a standard kidney. (Male nephrologist, 40s, Canada)|
|We have a significant number of HIV positive recipients, many from Africa. They have very commonly said to us, here's my brother he wants to donate to me. He's come over from Africa to donate. Please don't tell him I'm HIV positive, he won't care but he'll tell my mum. If he tells my mum it will destroy her completely. It's considered a big taboo, she'll disown me. In the past we used to do say, we're not going to transplant you because the donor needs to know, because they might change their mind'. I think that was a stupid thing to say. Now we say, fine, we won't tell them. But many centres still have that requirement. I think there's increasing evidence that there may be a little bit of extra risk but it's not that risky. There's very little justification to tell them anything other than the risks are increased. (Male surgeon, 50s, UK)|
|Respecting donor autonomy|
|Facilitate informed decision making||I'm here to give service, not to make decisions for the patient. (Male surgeon, 60s, Europe)|
|Once they understand all of the potential complications and they still want to do this, then I feel I've kind of done my job. (Female nephrologist, 40s, US)|
|Concede to donor risk perception||Sometimes I think the guidelines that we have are unacceptably strict in certain circumstances and in other circumstances they're unacceptably narrow. I think a parent donating to a child; they should be allowed to accept a little bit more risk as you would certainly not prevent them diving in front of a car to stop their child from getting hit, yet a theoretical risk of renal failure 30 years from now because they develop type 2 diabetes is considered forbidden. (Male surgeon, 50s, US)|
|Giving benefit of the doubt||My attitude has been challenged recently. I operated on a donor I didn't think had a particularly valid reason to donate. He was a slightly crazy guy. We approved him. My attitude was challenged, why should he not have the opportunity to donate, just because he didn't have what I perceived to be a special reason. (Male surgeon, 40s, UK)|
|Donor mandate to maintain health||But I share all the facts and emphasise that she's going to keep herself in really good health and have her testing done on an annual basis to be picked up if there are any problems. (Male nephrologist, 40s, Canada)|
|Acceptable altruism||Can young 18 to 25 year old donors make those kinds of decisions? In this country they let those people go fight wars. If somebody is allowed to choose to fight for the army how can you say that you can't donate a kidney to your parent? (Male surgeon, 60s, US)|
|We understand that people now make contacts with other people in nontraditional ways. So people can make friends over the internet. It's not for me to necessarily critique that. Over the years we have occasionally accepted such donors. (Male nephrologist, 60s, US)|
|Preserving equity||It's people with social influence that have the ability to get [a transplant]. People who can get your story out there, who know how to work the system. You become the person that's at the front of the queue and the one that people want to give to, because you can create something around your story—it works. So it's not going to be a level playing field. It will have inherent inequities. (Male surgeon, 50s, UK)|
|Championing living donation||There are clinicians, even if they had an abundant supply of deceased donor transplants, would still do living donor transplants because the outcomes are better for the recipient. (Male surgeon, 60s, UK)|
|We regard dialysis as a bridge to transplantation. (Male nephrologist, 60s, Norway)|
|A lot of people forget because they're not involved in dialysis what a bad thing dialysis is. (Male nephrologist, 40s, Australia)|
|Cognizance of societal values||That's part of just a general American spirit, we're very autonomous, we like to make our own decisions, we don't want other people telling us. If there's a certain risk, we want to be able to take that and we want to be the one to decide whether to take that risk, not have someone else tell us. (Male nephrologist, 40s, US)|
|Evolving donor demographic||Well the really challenging thing now, which we didn't have 20 years ago, is the rates of obesity and diabetes in the general population. (Female surgeon, 50s, Australia)|
|I think our data is reasonable but as we look at a change in the demographic of donors, as we look at fat or older people coming forward as wanting to be a donor, I don't think we've accepted what our thresholds are for outcomes. I don't think we have our thresholds. It can't be a zero adverse event. Each time we make an incremental thing towards fatter and older people, we will get more complications and we will have more untoward events than we wanted to in the past. (Male surgeon, 60s, US)|
|Resource limitations||If your resources aren't following that properly then there is a concern that the safety margin gets eaten into. We must be careful that we never push it so far that safety begins to be threatened and our unit is just a microcosm of what we need to make sure in the UK. (Male nephrologist, 40s, UK)|
Burden of responsibility
Protecting donor safety was a priority. Caution was especially driven by knowledge of past adverse events. Surgeons felt directly responsible for “inflicting an unnecessary injury” and controlling the immediate risks to the donor. They had an expectation of perfection and were mindful not to view the operation as a “mundane routine.” Nephrologists emphasized their role in understanding prognostic indicators to limit any significant increase in long-term risks. Nephrologists directly involved in the care of dialysis patients and who empathized with their plight tended to support a liberal approach in donor assessment. In considering the donor's risk against the estimated incremental gains for the recipient, participants felt confronted with the ethical dilemma of resolving fairness and utility in their decision making. They questioned whether young people should donate to older recipients with limited life expectancy, and if it was reasonable for a living donor to donate to high-risk recipients such as highly sensitized patients, those with recurrent disease or those known to be nonadherent.
Participants did not want to contravene law against paid donation but were uncertain about exercising diligent inquiry versus justifiable investigation. When financial coercion was suspected, many felt unduly challenged about interrogating potential donors about their motivations. They felt unable to deny donation unless their suspicion could be substantiated. Some were apprehensive about directed donation to strangers as this would introduce additional ethical, regulatory and legal quandaries, diverting their focus from medical matters.
Democratic decision making
Collective input of the transplant team into a decision was valued. Participants believed that the shared responsibility defrayed their burden, enabled more thorough assessment, detected potential coercion and counteracted emotional involvement and vested interests by an individual clinician.
Meeting legal obligations
The participants were required to consider particular legal requirements such as determining the donor–recipient relationship (e.g. unrelated donation is permitted in Germany only if there is an existing emotional relationship). While regulation was regarded as a necessary protective measure, several felt that excessive regulation stifled innovation, restricted autonomy or did not account for resource limitations. A few argued for clearer national policies concerning controversial issues such as public solicitation of living donors.
Optimizing outcomes and driving innovation
Participants contended with external pressures to increase living donation rates and acknowledged their inherent conflict of being “in the business of doing transplants.” Some believed that they should not be swayed by any competitive, financial or political pressure on units to increase the number of transplants, and instead remain focused on donor safety and outcomes. Some participants practicing in larger pioneering units felt committed to being progressive, innovative and to “stretch the limits” of transplantation.
In paired kidney exchange most participants trusted their colleagues to perform comprehensive donor assessment and competent procurement procedures. However, within larger exchange programs, a few had reservations about inadequate information exchange, variable levels of experience and standards and differential acceptance criteria.
The major concern for most participants was the limitations and complexities in projecting individual donor risk because of the lack of long-term data on ethnic minorities and clinically “borderline” donors. The ambiguities of “objectively considering subjective issues” and balancing minor theoretical risks against substantial risks for donors meant that participants often felt uncertain about providing explicit justification for decisions. Many were particularly conservative about the potential cumulative health risk in young donors and the risk of subsequent pregnancy complications in women donors, using persuasive counseling to discourage donation and protect vulnerable individuals.
Skepticism of risk perception by the donor
Many were skeptical about the donor's capacity to understand medical information, undertake complex decision making and actually appreciate the consequences of donation. There was concern that particular donors had romanticized notions of donation or were highly motivated and emotionally invested in the donation and did not want to “hear any risks” or consider “information in an objective and detached way.” Participants felt anxious about individuals who had mental health problems, language barriers, poor medical literacy or wanted to donate anonymously. Some believed that younger individuals felt invincible and would not consider their risks seriously. At times, participants had to reiterate education and counsel donors who received contradictory advice from other clinicians or misinformation from the media or recipients.
Concerns for dubious motivations and coercion
Participants felt that donors should have legitimate motivations but this was sometimes difficult to define and validate. Most believed that donors should not be motivated by financial gain or a “projected benefit that may not exist.” Also, donation should not be an act of restitution. Suspicion was heightened if donors had responded to a public solicitation or were nondirected donors. Participants felt partly “complicit” if they discovered after the procedure that a donor had received financial benefits.
All participants believed that donation should be voluntary and devoid of “emotional blackmail” from recipients or family members, but it was sometimes difficult to delineate between coercion, obligation and duty in related donors. Efforts were made to provide independent assessment with a donor advocate, psychological screening, extended workup, anonymity, selection of the most motivated donor among all potential donors and refusing donors in a disempowered relationship with their recipient or who had responded to public solicitation.
Participants felt it would be unethical to compel an individual to donate and that potential conflict of interest should be minimized or made transparent. In paired exchange, some expressed unease about potential pressure on donors who could be asked to donate “unnecessarily” to achieve broader benefit, which might remove a donor's “reprieve” from donation for those who only wanted to donate to their intended recipient.
Safeguarding donor well-being
Since long-term donor consequence could not be absolutely excluded, participants had anxieties about donors without health insurance (particularly in the United States), social support, or those unlikely to attend follow-up. However, they were somewhat reassured if donors had a “safety net” such as waitlisting priority in the United States. Some doubted their own capacity to be responsible for long-term donor follow-up, particularly for geographically distant donors who they were therefore reluctant to accept.
The majority wanted to be confident of psychosocial gains that would justify the donor's risk. Participants expressing a greater need to be convinced about this reflective benefit believed in stricter criteria for nonfamily donors. There was concern about the burden of tests on donors and the consequences of discovering previously unknown medical problems or nonpaternity, potential conflicts between the donor and recipient, and devastating disappointment if the individual was deemed unacceptable for donation, or if the transplant failed or recipient died.
Ethical information disclosure
Applying the principle of patient privacy was in practice highly contentious. While there was concern about breaching privacy, some believed in unequivocal transparency, in which the donor had a right to know all about the recipient's health status to gain a realistic expectation of the transplant outcome. This was controversial if social stigma was attached, for example if the recipient was HIV positive or an alcoholic.
In cases of “exceptional distribution,” where the kidney could be a risk to the recipient, participants felt it was within their duty of care to seek consent from the donor to inform the recipient. Another opinion was that recipients should be aware of the specific risks to the donor to inform their decision about accepting the transplant, but this was debatable if it was a sensitive medical issue or perceived as discriminatory.
Noting that HLA testing may expose misattributed paternity, some believed it would be inappropriate to disclose this, especially if it would be emotionally detrimental to the donor or recipient. Others felt obligated to disclose it on the basis that it could impact on the decision to donate and that patients expected to be told the truth.
Respecting donor autonomy
Facilitate informed decision making
Empowering patients to make informed decisions, by advising on possible complications and harms, was a way of allaying some of the conflicts participants held. If there was no foreseeable substantive risk, participants believed that well-informed donors should decide whether it was “right” to donate.
Conceding to donor acceptance of risk
Some believed donors had an intrinsic right to donate, and felt it would be wrong for clinicians to play “God” and interfere with the donors personal choice. They thought donors should have the opportunity to weigh the risks. Participants recognized that the donors would be willing to donate for even a modest survival gain and sympathized with a desire to help a loved one, and therefore they were more willing to stretch the criteria for borderline family donors.
Giving benefit of the doubt
Some believed it was not always feasible to ascertain truth and there was no ethical ground to question or reject donors merely on intuition. They had “to take people at face value,” even if they held suspicion about the donor's intentions. For some, their assumptions and attitudes toward donor motivations were challenged, particularly in anonymous nondirected donation.
Donor duty to maintain health
For donors who did not meet eligibility criteria including body mass index (BMI) thresholds, the participants encouraged lifestyle modifications to improve their health status. While participants were worried about donors failing to maintain their long-term health, this was only speculative and did not warrant preclusion.
Some felt that individuals were entitled to take risks for altruistic reasons, arguing moral inconsistencies where individuals were paid to risk life war yet prohibited from donating a kidney. Being a “good citizen” and “wanting to give something back” were perceived as plausible and admirable motivations for nondirected donors. Social connections formed via the Internet were inevitable and accepted by some as just as valid as those formed in other ways, and thus a justifiable relationship for donation.
Many participants would be averse to accepting donors who had responded to a public appeal made by a recipient, or donors identified through a donor–recipient matching organization. They argued this was a “beauty contest” and believed it would introduce inequities by advantaging media-savvy, influential and wealthy patients. They were concerned about possible commercial transaction, taking advantage of the poor and uninformed; and some anticipated that it would be a “get out clause for the middle class” who preferred that others should take the risk for them not family and friends.
In paired–kidney exchange, participants wanted to be confident of a fair exchange such that the donor kidney received would be of comparable quality. Some insisted that more uniform guidelines were needed to avert potential attempts by transplant units to unfairly “trade up,” from an older to younger organ.
Championing living donation
Participants acknowledged that they were influenced by the philosophical convictions of their colleagues and opinion leaders. A commitment to improving recipient outcomes promoted more intense advocacy for living donation, including preemptive transplantation. Some believed that the higher risk acceptance in living donor liver and lung transplantations challenged the conservatism in kidney transplantation. At times, some felt their personal boundaries were being pushed by others and were apprehensive about subjecting donors to risks, or perceived that deceased donor transplantation offered comparable outcomes.
Cognizance of societal values
Some participants were wary of being too conservative believing Western communities would not tolerate “patriarchal” decision making; recognizing that many patients sought active involvement in health management decisions, and “wanted to do things that they wanted to do and they don't want anybody telling them not to.”
Evolving donor demographic
Higher rates of obesity, diabetes and hypertension in the potential donor population increased pressures to extend transplant boundaries, although in countries with shorter transplant Waitinglists, “the pressure was not there to expand the living donor program.”
Participants believed that adequate resources must be available to support increasing living donations to avoid compromising donor safety. Infrastructural and resource shortages limit living donation capacity and, in smaller units, prevent independent donor assessment. There was reluctance to accept publicly solicited or nondirected donors, since it implied “additional workload in a new area that was quite complicated.”
Living organ donation provides unique ethical challenges through risking the life of a healthy individual to prolong or improve the life of another with end-stage kidney disease . Defining acceptable risks in living kidney donor assessment involves the interplay of donor autonomy and protecting donor safety. Transplant nephrologists and surgeons are challenged with multiple and sometimes conflicting responsibilities to safeguard the well-being of individual donors, manage controversial moral and legal obligations, maximize transplant outcomes and drive innovation. Increasing organ demand, changing donor demographic, societal anti-paternalism and championing of living kidney donation test the thresholds for donor acceptance. Efforts to maintain equity and avoid discrimination and exploitation in living kidney donation are strongly advocated across all countries.
Variation in attitudes toward living kidney donor assessment was more apparent among individuals and units, rather than countries where differences are driven by national policies, legislation, funding models and waitlist times . The drive to be innovative and pioneering was more evident in the larger, high-volume transplant units and explained some of the differences seen. A proactive culture supporting living kidney donation appears more evident in larger transplant units with a longer history of successful living donor transplants, greater surgical confidence and closer proximity to the higher-risk, living liver and lung transplantation programs.
Guidelines and position statements include recommendations for living kidney donor assessment [22, 24-27]. However, our findings highlight additional key areas such as donor advocacy, assessment of donor motivations, disclosing prognostic uncertainty for donors, evaluating donor comprehension of risk and both donor and recipient information disclosure.
There was near unanimous support for independent, multidisciplinary donor assessment . In some units, a donor advocate is mandated to represent the donor's interests, usually an independent health professional without a vested interest in living kidney donation . In the United States, the requirement for an Independent Donor Advocate is mandated by the Centres for Medicare and Medicaid Services as well as in the United Network for Organ Sharing (UNOS) ByLaws . However, the specific roles and accountabilities of a donor advocate remain ill-defined. A new UNOS policy proposal is available for public comment to specify the training and requirements of the independent donor advocate . There are concerns about donor motivations when they include desire for recognition, improving relationships and expectation of secondary gain such as financial support from the recipient, all of which have been identified as risk factors for poor psychosocial outcomes in living kidney donors . Uncertainty remains about how to approach these challenges, particularly since it is difficult to justify excessive and intrusive investigation of donors and donor/recipient relationships and very hard to define psychosocial thresholds for donor acceptance.
As found in other studies, there were notable differences in opinion among nephrologists and surgeons regarding the acceptability of medically complex donors including those with high BMI, hypertension or impaired glucose tolerance . There are data to suggest that long-term survival and the risk of end-stage kidney disease in kidney donors are comparable to the general population; however, the donor population are generally screened to be healthier and most studies have small sample sizes, are retrospective and subject to selection bias [19, 32-34]. Of note, recent data suggest that while the absolute risk of end-stage kidney disease (ESKD) within 15 years of donation is low, the incidence of end-stage kidney disease at 15 years may be eight times higher for living kidney donors than for healthy matched controls . Given the lack of definitive data, long-term follow-up of donors and comparison to appropriate control populations are needed [6, 36, 37] including the use of living donor registries [4, 22, 38]. In younger donors, there is anxiety about cumulative risk and comprehension of those potential risks. Guidelines and most national legislation state that minors (aged less than 18 years) may not donate nonregenerative tissue , and current UNOS Policy states that both age less than 18 years and mentally incapable of making an informed decision constitute exclusion at a national level. When center-specific policies can vary, UNOS policy does not require exclusion based on young age alone. However, there are no specific recommendations about young adult donors.
Prognostic uncertainties drive different views about how risk should be communicated to donors, and to what extent potential donors should demonstrate accurate comprehension of this information. It has been argued that ethically defensible practice demands that donors prove they have an accurate understanding of the benefits and risks, and be able to reiterate their quantitative risk estimates of end-stage kidney disease [38-40].
Information disclosure regarding stigmatized conditions and misattributed parentage is an important area of contention, yet few units have clearly enunciated strategies to manage incidentally discovered information . To resolve the conflict between protecting the recipient's right to privacy and the donor's right to be informed, some recommended that donors must be advised beforehand that the recipient's health information is protected and their decision to donate should be based on the recipient medical suitability for kidney transplantation . Similarly, it is argued that transplant physicians do not have a justifiable imperative to disclose misattributed paternity. The potential discovery of nonparentage qualifies as a foreseeable risk and informed consent processes should include an explanation that HLA and ABO testing is done to screen for compatibility only, and that other implications such as possible misattributed parentage will not be disclosed [41, 43, 44]. A recent survey was conducted with potential donors, recipients and health professionals on sharing personal health information in living kidney donation. The findings supported greater sharing of personal health information but requires careful consideration of which information is relevant, and how to appropriately communicate and obtain consent from all involved in the decision making . Our study raises key areas for policy makers to consider and important unanswered questions for future research (Table 4).
|Key issues||Suggested research and policy priorities|
|Donor advocacy||● Define the roles, responsibilities and accountabilities of a donor advocate|
|Dubious motivations||● Identify practical ways to evaluate and manage potential or suspected financial coercion|
|● Identify practical ways to evaluate and manage desire for recognition or social gain|
|Prognostic uncertainty||● Clarify the considerations for younger donors (≤30 years) (e.g. cumulative risk)|
|● Clarify the considerations for donors from ethnic minorities (e.g. targeted education)|
|● Clarify the considerations for “high risk” or medically complex donors|
|● Develop a framework to help potential donors work through the risks in a better way|
|● Identify the range of possible harms of excluding a potential donor based on a “minor theoretical risk”|
|Donor comprehension of risk||● Identify ways to counsel highly motivated and emotionally invested donors|
|● Identify ways to counsel younger donors|
|● Identify ways to counsel donors with low health literacy|
|● Clarify how risks should be defined (e.g. risk quantification)|
|● Identify the risks of testing burdens and consequences of incidental discovery of medical problems|
|● Provide strategies for donors to demonstrate accurate knowledge, comprehension and acceptance of risks|
|Conflict of interest||● Identify psychosocial and ethical implications in paired kidney exchange programs (e.g. potential coercion or pressure)|
|Information disclosure||● Identify strategies to manage misattributed paternity (e.g. prior consent to nondisclosure of paternity results)|
|● Develop policies regarding nondisclosure of private medical information for both the donor and recipient? (e.g. HIV, life-limiting disease, adherence, lifestyle choices—alcoholism)|
|Equity||● Develop policies regarding publicly solicited donors (e.g. Internet/media appeals)|
|● Develop policies regarding donors identified in independent donor–recipient matching organizations|
|● Provide mechanisms to facilitate a “fair” exchanged in paired–kidney exchange programs|
There are potential limitations to this study. It was conducted in 12 high-income countries with the majority of participants recruited from high-volume transplant units. Participant feedback on the preliminary analysis and conceptual saturation (i.e. when no new ideas or concepts were emerging from subsequent interviews) was broadly achieved; however, we cannot exclude differences in attitudes toward living kidney donor evaluation among other healthcare providers in different healthcare settings, socio-economic, cultural or religious contexts, and in low-and middle-income countries. It would be important to conduct further research to ascertain the views of transplant coordinators, social workers, nurses and other health professionals, on the challenges and uncertainties in living kidney donor assessment. Finally, our study does not assess frequency of opinion and therefore suggest that our findings can inform the development of a survey to ascertain the prevalence of opinions on these issues.
Living kidney donation assessment demands skill and experience to undertake careful assessment of medical risks, identify psychosocial implications for the donor and recipients, but also demands moral and ethical judgments, knowledge of regulatory requirements and societal values. Our findings indicate that implicit decisions regarding living kidney are made and some participants believe there is a need for guidance to support decision making about specific uncertainties in living kidney donor assessment. In the context of uncertainty and the lack of evidence, expert consensus statements are the next best alternative. For example, the Consensus Statement of the Amsterdam Forum on the Care of the Live Kidney Donor  and the Ethics Statement of the Vancouver Forum on the living donors [46, 47] have been adopted in many transplant centers worldwide. We think policy statements can make explicit the uncertainties faced in living kidney donor assessment to guide more transparent clinical decision making, and clarify the clinical considerations and ethical principles underpinning some of these challenges. Authoritative, comprehensive and well-described national policies and professionals' position statements would support decision making and make explicit that which is often implicit.
We sincerely thank all the participants for contributing their time and efforts, and sharing their insightful perspectives and opinions. With permission, we acknowledge by name (by region and interview order): United States—Gabriel Danovitch, Anjay Rastogi, Naim Issa, Richard Spong, Ty Dunn, Hassan Ibrahim, Raja Kandaswamy, Arthur Matas, Tim Pruett, Bertram Kasiske, Ajay Israni, Arthur Ney, Mark Odland, Meena Sahadevan, Nabil Dagher, Karl Womer, Robert Montgomery, Bernd Schroppel, Barbara Murphy, Rajani Dinavahi, Vinay Nair, Michelle Josephson, Robert Steiner, Nahel Elias, Heidi Yeh, Francis Delmonico, Paul Tso, Kenneth Newell, Stephen Pastan, Nicole Turgeon, Thomas Pearson, Sudha Tata, Allan Kirk, Sundus Lodhi, Jonathan Bromberg; Canada—Ed Cole, Bryce Kiberd, John Gill, Amit Garg, Greg Knoll; United Kingdom—Alan Jardine, Hany Riad, Gabriel Oniscu, Lorna Marson, David Kluth, John Forsythe, Anil Vaidya, Paul Harden, Phil Mason, Ed Sharples, Neville Jamieson, Nicholas Torpey, Andrew Bradley, Chris Watson; Europe—Hallvard Holdaas, Khe Tran, Jan Ijzermans, Willem Weimar, Joke Roodnat, Michiel Betjes, Frank Dor, Jacqueline van de Wetering, Madelon van Agteren, Ferdinand Muhlbacher, Dirk Kuypers, Yves Vanrentergheh, Gabriela Berlakovich, Klemens Budde, Guenter Kirste, Nizam Mamode, the late Henrik Ekberg, Martin Drage, Fritz Diekman, Josep Campistol, Fabian Halleck; Australia/New Zealand—Richard Phoon, Brian Nankivell, Wai Lim, Bulang He, Paolo Ferrari, John Kanellis, Henry Pleass, Deborah Verran, Richard Allen, Steve Chadban, Carol Pollock, Bruce Cooper, Grant Luxton, Bruce Pussell, James Mackie, Jonathan Erlich, Josette Eris, Stephen Munn, Nicholas Cross, Ian Dittmer, Paul Trevillian, Munish Heer, Scott Campbell, Nikky Isbel, Simon Wood, Christine Russell, Toby Coates, Robert Carroll, Solomon Menahem, William Mulley, Amanda Robertson, Nancy Suh, Peter Hughes.
A.T., J.R.C., G.W., J.C.C. contributed to the study concept and design. A.T. collected the data. All authors drafted the manuscript and reviewed the article critically for important intellectual content.
Access to data
A.T. had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of data analysis.
Sources of funding and support
This project is supported by the Australian Research Council (ARC) (no. DE120101710).
The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation.