Since January 2020 I have been Director of Medical Professionalism, Ethics, and Humanities at Rowan-Virtua School of Osteopathic Medicine (RowanSOM), holding the rank of Assistant Professor in the Department of Family Medicine. Previously (2017-2019), I held a dual role as Clinical Assistant Professor at the University of Alabama at Birmingham (UAB) and Curriculum and Research Director at the Cahaba-UAB Family Medicine Residency. I was a bioethics consultant to a major European-based biopharmaceutical company prior to that.
I have a forthcoming edited volume on ethical, social, and regulatory aspects of xenotransplantation with Springer (expected 2023). In early 2019, I began working on bioethics issues and research studies with the UAB xenotransplantation program, which is where my interest in this line of research stems. My previous research experience has included both qualitative and quantitative methods.
Dr. Hurst earned his PhD in bioethics from Duquesne University and his MSc in Global Health and Infectious Diseases from the University of Edinburgh in Scotland. In addition, he holds graduate degrees in theology (Master of Divinity) and theological / philosophical ethics (Master of Theology). In 2011 he was commissioned an officer in the US Air Force and currently serves in the Reserve, holding the rank of Major.
Risk to Research Non-Participants: Ethical Dimensions of Protecting Bystanders in Xenotransplantation Clinical Trials
Daniel Hurst1, Luz Padilla2, Daniel Rodger3, Tamar Schiff4, David KC Cooper5.
1Family Medicine, Rowan-Virtua School of Osteopathic Medicine, Stratford, NJ, United States; 2Epidemiology and Surgery, The University of Alabama at Birmingham, Birmingham , AL, United States; 3Psychological Sciences, Birkbeck, University of London, London, United Kingdom; 4Population Health , New York University Grossman School of Medicine, New York City, NY, United States; 5Center for Transplantation Sciences, Massachusetts General Hospital, Charlestown, MA, United States
Introduction: Ethical issues regarding clinical xenotransplantation have been described for decades with most of the issues centering on animal welfare, the risks posed to the recipient, and the potential public health risks. Much less attention has been given to thinking through ethical issues for those who may care for xenograft recipients (e.g., caregivers, family members), especially when the recipient returns home. These caregivers or bystanders, due to their close interaction with the xenotransplantation recipient, face potential exposure to a xenozoonotic disease, with implications regarding informed consent for that risk, and whether or not such bystanders should be regularly monitored for infection, as is proposed for recipients.
Methods: This presentation raises concerns for the risks to bystanders in xenotransplantation which we believe have not been adequately addressed in the literature to date. We will propose several options for how bystanders should be informed of, and consented for, the risks of close contact with a xenotransplant recipient. The benefits and pitfalls of each potential option are explored.
Results: We conclude that only the xenograft recipient needs to provide their informed consent to the xenotransplantation and agree to lifelong (or long-term) monitoring. As no legal enforcement mechanism currently exists for requiring recipients to be monitored without evidence of infectious disease, such monitoring could only be strongly encouraged and agreed to at the point of xenotransplantation, but not required. In addition, we argue that the xenograft recipient, prior to xenotransplantation, should provide a list of members of the same household/close contacts for record keeping and future possible contact tracing. We propose at a minimum that all members listed should be provided with an information sheet or assent form that contains the basic elements of the informed consent form but does not require a signature or other declaration of agreement. This approach seeks to balance ethical concerns, namely the potential risks posed to bystanders and how strong a duty this creates to protect them and support their right to choose how or if they continue to interact with the potential xenograft recipient, with the recipient's reasonable right to patient privacy.
Conclusion: This presentation discusses a significant concern related to xenotransplantation, made increasingly pressing by the possibility of forthcoming clinical trials. By the end of the presentation, the audience will better understand the bystander risk, differing modes of mitigating that risk, and why it is important to foster dialogue and develop policy on this issue.
