Maintaining public trust in organ donation while expanding the organ pool

Abstract

New strategies for preserving organs and new kinds of transplant research could lead to more high-quality organs for the millions of people with organ failure across the United States. But if these strategies proceed without ensuring public understanding and approval, they could exacerbate existing distrust and reduce the number of willing donors on which all of transplantation relies. This article describes features that undergird trust in organ donation and explores how trust could be challenged by techniques like restarting circulation in the donor and by maintaining the deceased on a ventilator to test genetically edited pig organs. Maintaining trust will likely require educating people earlier and more thoroughly about donation options. This education would better enable patient autonomy and might best come from clinicians caring for patients at the end of life.

Public trust in the organ donation system is supported by our right to decide what happens to our organs after we die and historically by separating those who facilitate donation and transplantation from those who take care of us while we are alive. Without these safeguards, some are concerned that the goal of getting organs will supersede the goal of giving the best clinical care.¹ In the United States, each individual gets to choose whether or not to opt in to donating their organs after death and also for which purposes—transplant, education, and/or research. The opt-in system requires informed authorization, which means that after we die, our organs and bodies will only be used in ways that we permit. A second component of organ donation trust is the donation conversation firewall—separating those who are responsible for clinical care from those who are responsible for speaking to family members of a dying/deceased patient about organ donation. This firewall exists to prevent organ recovery intentions from improperly influencing clinical care decisions for patients. In practice, this means that clinicians will guide end-of-life conversations, and Organ Procurement Organization (OPO) representatives will speak with family members about organ donation.

Efforts to preserve trust in organ donation might need to be reinforced and updated because of new strategies to increase the organ pool. These strategies include a new method of keeping organs preserved for donation after the donor's heart stops and research involving the newly deceased to advance xenotransplantation. Informing patients and their family members specifically about these strategies might be necessary to enable patient autonomy and preserve trust in organ donation, which might require breaching parts of the donation conversation firewall.

The organ pool could increase significantly if more organs are recovered after circulatory death in hospitals.² Circulatory death in hospitals occurs when life-sustaining treatment is withdrawn, and then oxygenated blood permanently stops circulating in the deceased patient's body. But this scenario creates challenges for the donation conversation firewall. Donation after death by neurologic criteria is the primary mode of donation in the United States. After death by neurologic criteria, the deceased can remain on mechanical support perfusing organs while an OPO representative discusses donation with family members. In contrast, donation after death by circulatory criteria must occur rapidly because the organs start degrading without blood flow. To respect the firewall in such cases, when should an OPO representative discuss organ donation with the patient's family? OPOs talking to family members before the decision to withdraw life-sustaining treatment might be viewed as pressure to end the patient's life in favor of organ donation. If OPOs talk to family members after the decision to withdraw treatment has been made, the conversation must happen before the action of withdrawing treatment for the organs to remain viable. If an OPO representative is not immediately available—and sometimes they are not—this can put the patient's clinical care team in the awkward position of timing the life-sustaining treatment withdrawal conversation around the organ donation conversation. In this situation, it can be argued that organ donation intentions are influencing clinical care decisions. This erodes the firewall and might cause patients and family members to think their healthcare providers care too much about getting their organs, which could reduce trust in organ donation and medicine. Instead, clinicians could be trained to sensitively broach the organ donation conversation; in some cases, they could ascertain the patient's decision before losing capacity, and in other cases they could obtain the family's decision while learning what the patient would have wanted for their end-of-life care.

To complicate the matter, there is a new form of ethically challenging organ preservation after circulatory death called thoraco-abdominal normothermic regional perfusion (hereafter TA-NRP). TA-NRP preserves organs inside the donor's body (in situ) after the heart stops pumping blood to the other organs. This can make it possible to recover healthier organs after circulatory death.² In TA-NRP, after the donor is declared dead based on circulatory criteria, surgeons occlude blood flow to the brain and then the donor's blood is recirculated to transplantable organs in situ, which also re-establishes heartbeat. This reduces organ damage that occurred during time without blood flow, which improves transplant outcomes. Some scholars say TA-NRP undermines the determination of the donor's death because the heart is restarted inside the body, and some suggest that clinicians cause death when they cut off blood flow to the brain during TA-NRP.^{3, 4}

Currently, there is no clear policy for how OPO representatives should obtain authorization from family members when TA-NRP will be performed—some say nothing about recirculating blood and preventing blood flow to the brain after death. Do these features of TA-NRP make it different or concerning enough that it should require specific authorization? Those who feel the details of TA-NRP are important to the decision-making process might think lack of disclosure makes OPOs less trustworthy. Some donor family members have expressed that they would prefer not to know details about TA-NRP. Providing too much information or too little information about TA-NRP could cause people to choose not to donate at all and to lose trust in organ donation. Studies are underway to understand how to frame conversations around TA-NRP that would best enable patient autonomy and donor families to honor their loved one's wishes. The results of these studies should then inform whether clinicians or OPOs should host the TA-NRP conversation and how to disclose morally relevant information.

The lack of available human organs for donation has turned attention to using genetically edited pig organs for transplantation (xenotransplantation), which is relying on a research model that requires human body donation. Transplanting edited pig organs into deceased humans declared dead according to neurologic criteria (newly deceased) can provide useful translational data while reducing harm to nonhuman research animals and to living human research subjects.⁵ Since most people do not think about bodies being used in this way when registering to be organ donors, donor family members are asked to authorize this whole body research, even when the deceased are registered donors. Family members should be given essential information including the fact that pig organs are being used; the fact that this research will not immediately result in lives saved; whether there is a risk of viral transmission from the deceased to close contacts; how long the research will last; whether the family can change their minds halfway through; and whether the body can be returned for laying to rest. This information needs to be conveyed accurately and sensitively, and the family must understand and feel respected throughout the process. But there is currently no standard protocol for who should seek authorization for transplant research involving the newly deceased and what should be disclosed. Failure to provide adequate disclosure and ensure understanding could undermine trust in transplant research, organ donation, and institutions where this research takes place.

To be eligible for this research, the deceased must have died according to neurologic criteria, which would almost always preclude the possibility of clinicians discussing this research with patients during end-of-life conversations. In collaboration with OPOs, clinicians should be able to broach this research opportunity with family members after the patient's death, and further research should inform what details are necessary to adequately inform family members. As this research gains mainstream media attention,^{6, 7} patients are calling research hospitals to indicate their wishes to participate after death. Just as there are whole-body donation programs for medical education, whole body research programs can create their own donation registries and can partner with clinicians at their institutions to discuss the program with patients who express interest in organ or body donation.

The innovations described above suggest that perhaps we need more education and understanding of strategies to advance organ donation to give informed authorization. When most of us register as organ donors, we are not given information about the specific processes or circumstances that will result in the use of our bodies for transplant or research. Information that is relevant to our decision-making process cannot be easily conveyed on a form at the Department of Motor Vehicles or in an online registry, where most people register to be donors. This education could be provided in venues that circumvent the traditional donation conversation firewall. Our physicians, including those in palliative, hospice, and intensive care environments, might be best suited to discuss not just our goals of clinical care but also our goals for “after care.” Organ donation, specific innovative methods for donation like NRP, and whole body donation for xenotransplant research, could also potentially be included in advance directive conversations or added to upper-level high school biology curricula. Because organ and body donation can provide solace and meaning for patients as the end of life approaches, these decisions might rightly be considered a component of shared decision making in holistic clinical care.

There will be challenges with expecting clinicians to host these conversations. Some might be concerned about time constraints, and how to fit this discussion into an already overwhelmed schedule. But organ donation should integrate naturally into existing goals of care conversations without taking too long. Organ donation can be a powerful manifestation of one's values. It is likely that many patients would find consolation designating their organs and bodies for different kinds of donation and research knowing that death is approaching, just as they participate in shared decision making for their medical treatment.

Clinicians will need training in the language and structure of after-care conversations. OPO representatives are carefully trained in how to use sensitive language and how to pick up on cues during conversation to determine what an individual wants to hear or not about organ donation. There are some examples of OPO representatives training hospital clinicians to be donation authorization requesters,⁸ which can ease the burden on resource-strained OPOs and make the donation conversation smoother. Hospitals could contract with current and former OPO representatives to develop education materials and host training sessions with clinicians in ICUs, palliative care settings, and hospice to sensitively incorporate discussions about organ donation into their goals of care conversations. In regions employing unique strategies like TA-NRP or doing whole body research, the clinical and research teams using these strategies could partner with OPOs to develop training specific to these topics for clinicians. Strategically breaching the OPO/clinician firewall would not compromise trust, but would better preserve public trust in donation and medicine when clinicians help empower potential donors and their family members to make more informed donation decisions.

The author declares no conflict of interest.