Multiple ethical challenges converge in deceased organ donation and transplantation, including questions relating to the allocation of scarce resources, appropriate consent models, and the permissible limits of surgical organ recovery practices. Moreover, clinical trials in organ donation and transplantation challenge traditional research ethics frameworks due to their unique design. We are involved in several interrelated projects that collectively aim to improve donation and transplantation practices for the benefit of all stakeholders.

Neurologic Physiology After Removal of Therapy (NeuPaRT) is an interdisciplinary research study funded by the Canadian Institutes of Health Research that seeks to document the temporal relationship between the cessation of neurologic and circulatory function during the dying process after the withdrawal of life-sustaining measures in the intensive care unit. Led by Marat Slessarev and Teneille Gofton, NeuPaRT will inform practices in organ donation after circulatory determination of death, the fastest-growing source of transplantable organs internationally. Because participants in this study are imminently dying and incapable of first-person consent, the research poses substantial ethical challenges. For example, under what circumstances is it ethical to enroll the vulnerable, imminently dying patient in nontherapeutic research? How can the impacts on end-of-life care be minimized consistent with sound scientific design? And, while not themselves research participants, what protections might be owed to the families of research participants?

Normothermic regional perfusion (NRP) is a new organ recovery technology that could reduce the shortfall in organs for transplantation by improving the quantity and quality of donated organs. NRP works by perfusing organs in the donor’s body after death determination in donation after circulatory death. Despite its promise, NRP faces ethical challenges, not least of which is the perception that the technology leads to violations of the “dead donor rule,” the ethical injunction that organ procurement can only occur after a donor’s death. These ethical challenges must be addressed to the satisfaction of stakeholders before NRP’s implementation to preserve hard-won trust in deceased donation systems. Our ethics of NRP study, funded by the Canadian Donation and Transplantation Research Program and Trillium Gift of Life Network, explores perspectives of NRP among donors’ family members, organ recipients, healthcare providers, and representatives from organ donation organizations. Our consultations will determine whether NRP is acceptable to stakeholders, and if so, how NRP can be implemented in a responsible, trust-preserving way.

Developing guidelines for the ethical design and conduct of randomized controlled trials (RCTs) of donor interventions. Donor interventions are performed on patients who are consenting candidates for organ donation. Encompassing the administration of nontherapeutic medications and donor care protocols, donor interventions seek to improve organ supply, organ viability, and subsequent transplant outcomes for recipients. However, robust evidence of the safety and effectiveness of donor interventions is lacking. Evidence gaps can only be resolved through RCTs. Unfortunately, RCTs in deceased donation face myriad ethical challenges not yet addressed in research ethics guidelines. To address these obstacles to research, in 2022 we began work on a multi-year Canada-United Kingdom collaboration to develop authoritative guidelines on the ethical design and conduct of donor intervention randomized controlled trials.

Revising the policy of mandated anonymity in deceased organ donation. Historically, all Canadian provinces barred donation organizations from disclosing information identifying deceased donors’ families and organ recipients, even with their mutual consent. The rationale was to protect stakeholders from such risks as financial exploitation and unreasonable or unwelcome emotional demands. We believe that these policies needlessly frustrate the autonomy of competent adults. Moreover, the rise of social media has made this restrictive policy obsolete: stakeholders now can and do find each other, meaning the concerns that once spoke to the need for restrictive policies now speak to the need for responsible oversight. Together with other stakeholders, we are advocating for a balanced approach to donor family and recipient contact, one that will help to protect anonymity for those who want it and responsibly facilitate contact for those who do not.