Organ donation and transplantation ethics
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.
David Allingham (Organ Recipient Partner) Mandated anonymity
John Basmaji (Western University) NRP Ethics, RCT guidelines
Laurie Blackstock (Donor Family Partner) NRP Ethics, RCT guidelines
Mayur Brahmania (University of Calgary) NRP Ethics
Erika Chamberlain (Western University) NeuPaRT
Jennifer Chandler (University of Ottawa) NeuPaRT
Frederic D’Aragon (Université Laval) RCT guidelines
Derek Debicki (Western University) NeuPaRT
Sonny Dhanani (University of Ottawa) NeuPaRT
Teneille Gofton (Western University) NeuPaRT
Andrew Healey (McMaster University) NRP Ethics, RCT guidelines
Geoff Laforge (Western University) NeuPaRT
Kim LeBlanc (Donor Family Partner) Mandated anonymity
Lindsay Wilson (Canadian Blood Services) NRP Ethics
Lorelei Lingard (Western University) NRP Ethics
Maureen Meade (McMaster University) NeuPaRT, RCT guidelines
Nicholas Murphy (Western University) NeuPaRT, NRP Ethics, RCT guidelines; Mandated anonymity
Loretta Norton (King’s University College) NeuPaRT
Mary Ott (Western University) NRP Ethics
Sam Shemie (McGill University) NeuPaRT, NRP Ethics
Anton Skaro (Western University) NRP Ethics
Marat Slessarev (Western University) NeuPaRT, NRP Ethics, RCT guidelines, Mandated anonymity
Maxwell Smith (Western University) NeuPaRT
Michael Ward (Trillium Gift of Life Network) Mandated anonymity
Matt Weiss (Université Laval) RCT guidelines
Anonymity for Organ Donors and Recipients Called into Question. Afternoon Drive with Chris dela Torre, CBC. April 21, 2022.
Mandated anonymity in deceased organ donation. The Morning Show with Devon Peacock, CFPL AM. April 21, 2022.
Mandated anonymity in deceased organ donation. The Alan Carter Radio Program, Global News April 22, 2022.
Mandated anonymity in deceased organ donation. World Report, CBC. April 22, 2022. 2022/08/22
New transplant procedure challenges ethics rules. Radio Alberta, Global News. October 20, 2022.
New organ donation technology raises ethics issues, 900 CHML, Global News Radio. October 24, 2022.
Western researchers urge legislation to end organ donation anonymity. Western News. April 21, 2022.
Western University researchers call for end to mandated anonymity in organ donation. Global News. April 22, 2022.
Time to rethink transplant-donor privacy rules: Western researchers. London Free Press. April 22, 2022.
New service aims to match living kidney donors with Canadians in need of life-saving transplants. CTV News. July 21, 2022.
Revival after death: New transplant procedure challenges ethics rules. National Post. October 19, 2022
Murphy N, Weijer C. Grey matter: The problems of incidental findings in neuroimaging research. The Journal of Law, Medicine & Ethics 2021; 49: 282-284.
Murphy N, Weijer C, Smith M, Chandler J, Chamberlain E, Gofton T, Slessarev M. Controlled donation after circulatory determination of death: A scoping review of ethical issues, key concepts, and arguments. Journal of Law, Medicine & Ethics 2021; 49(3): 418-440
van Beinum A, Murphy N, Weijer C, Gruben V, Sarti A, Hornby L, Dhanani S, Chandler J. Family experiences with non-therapeutic research on dying patients in the intensive care unit. Journal of Medical Ethics 2022; 48(11): 845-851.
Murphy N, Weijer C. Research bystanders, justice, and the state: Reframing the debate on third-party protections in health research. Bioethics 2022; 36(8): 865-873.
Murphy N, Weijer C, Debicki D, Laforge G, Norton L, Gofton T, Slessarev M. Ethics of non-therapeutic research on imminently dying patients in the intensive care unit. Journal of Medical Ethics 2022: doi: 10.1136/medethics-2021-107953
Gofton T, Dhanani S, Meade M, Boyd JG, Chamberlain E, Chandler J, Chassé M, Scales NB, Choi YH, D'Aragon F, Debicki D, English S, Fantaneanu TA, Kramer AH, Kromm J, Murphy N, Norton L, Singh J, Smith MJ, Weijer C, Shemie S, Bentall TC, Campbell E, Slessarev M. Neurologic Physiology after Removal of Therapy (NeuPaRT) study: study protocol of a multicentre, prospective, observational, pilot feasibility study of neurophysiology after withdrawal of life-sustaining measures. BMJ Open. 2023 Apr 27;13(4):e073643.
Murphy N, Weijer C, Ganesan L, Gofton T, Slessarev M. Nontherapeutic research with imminently dying and recently deceased study populations: addressing practical and ethical challenges. Canadian Journal of Anesthesia 2023: in press.
Basmaji J, Weijer C, Skaro A, Healey A, Shemie SD, Slessarev M. Paving the road for the adoption of normothermic regional perfusion in Canada. Critical Care Explorations 2021; 3(11): e0553.
Slessarev M, Gofton T, Shemie SD. Ensuring the permanent cessation of brain function during normothermic regional perfusion. Transplantation 2022; 106(9): 1726-1727.
Murphy N, Lingard L, Blackstock L, Ott M, Slessarev M, Basmaji J, Brahmania M, Healey A, Shemie S, Skaro A, Wilson L, Weijer C. Protocol for a qualitative pilot study to explore ethical issues and stakeholder trust in the use of normothermic regional perfusion in organ donation in Canada. BMJ Open 2022; 12(9): e067515.
Murphy N, Weijer C, Slessarev M, Chandler J, Gofton T. Implications of Canadian death determination guidelines for organ donation interventions that restore circulation after determination of death by circulatory criteria. Canadian Journal of Anesthesia 2023. Epub ahead of print.
Guidelines for donor intervention RCTs
Murphy N, Weijer C, Chandler J, D'Aragon F, Healey A, Weiss MJ, Slessarev M. Best foot forward: now is the time for Canadian ethical guidance on prospective interventional trials of antemortem interventions in organ donation. Canadian Journal of Anesthesia 2022; 69(10): 1196-1202.
Murphy N, Allingham D, LeBlanc K, Slessarev M, Ward M, Weijer C. A pressing need for effective, clear, and consistent regulations to facilitate direct contact between donor families and organ-transplant recipients. Canadian Journal of Cardiology 2022; 38(6): 703-704.
Murphy N, Weijer C. Healing Encounters. New Scientist. June 18, 2022.
Murphy N, Weijer C , Slessarev M, Gofton T. The secret house: the ethics of research with imminently dying patients. Journal of Medical Ethics Blog. June 30, 2022.
Van Beinum A, Murphy N, Weijer C, Chandler J. Finding meaning in loss: family experience of research on imminently dying patients in the intensive care unit. Journal of Medical Ethics Blog. November 11, 2022.
Murphy N. Controlled organ donation after circulatory determination of death: A scoping review of key concepts, arguments, and ethical issues. Critical Care Canada Forum. Toronto. October 6, 2020.
Murphy N. Nontherapeutic research on imminently dying patients: A case study. London Health Research Day, London. May 5, 2020.
Murphy N. What is owed to bystanders directly impacted by the conduct of health research? American Society for Bioethics and the Humanities. October 14, 2021.
Murphy N. Re-thinking mandated anonymity in deceased donation. London Health Sciences Donation Steering Committee. London. November 10, 2021.
Weijer, C. Ethical challenges in RCTs of antemortem interventions. Canadian Donation and Transplantation Research Program Annual Scientific Meeting. December 9, 2021.
Weijer C. Pilot study to explore ethical issues and stakeholder trust in the use of normothermic regional perfusion in organ donation in Canada. Canadian Donation and Transplantation Research Program (CDTRP) Theme 1 Webinar. March 23, 2022.
Murphy N. Research bystanders, justice, and the state: a defense of bystander protections in health research. World Congress of Bioethics. Basel, Switzerland. July 21, 2022.
Weijer C. Ethics of nontherapeutic research in imminently dying patients in the intensive care unit. Medicine Grand Rounds. Western University. October 21, 2022.
Murphy N. Revising organ donation organization policies in light of social media. Canadian Society of Clinical Perfusionists. October 28, 2022.
Murphy N. Death determination guidelines and reasonable accommodation. American Society for Bioethics and the Humanities. Portland, USA. October 29, 2022.
Murphy N. Rethinking policies of mandated anonymity in deceased organ donation. Canadian Donation and Transplantation Research Program Annual Scientific Meeting. Kelowna. December 7, 2022.
Weijer C. Mapping ethical, consent, and regulatory landscape for international ODT trials. Pragmatic and Adaptive Trials Workshop, Canadian Donation and Transplantation Annual Scientific Meeting. December 8, 2022.
Murphy N. Organ donation after circulatory death: scoping the ethical terrain. Alberta Transplant Institute Seminar Series. University of Alberta. December 15, 2022.
Murphy N. Ethics of abdominal normothermic regional perfusion. Canadian Liver Meeting. Halifax. March 5, 2023.
Weijer C, Murphy N. Responsible adoption of new technologies in organ donation: the case of abdominal normothermic regional perfusion. London Regional Bioethics Network. March 8, 2023.