315.1 Risk to Research Non-Participants: Ethical Dimensions of Protecting Bystanders in Xenotransplantation Clinical Trials
Saturday October 28, 2023 from 11:35 to 12:35
Indigo A
Presenter

Daniel J Hurst, United States

Director of Medical Professionalism, Ethics, and Humanities

Family Medicine

Rowan-Virtua School of Osteopathic Medicine

Abstract

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. 


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