Xenotransplantation Clinical Trials and Equitable Patient Selection

• Published in: Cambridge quarterly of healthcare ethics Vol. 33; no. 3; pp. 425 - 434
• Main Authors: Bobier, Christopher, Rodger, Daniel
• Format: Journal Article
• Language: English
• Published: United States Cambridge University Press 01.07.2024
• Subjects: Alternative medicine; Beneficence; Bioethics; Clinical research; Clinical significance; Clinical trials; Clinical Trials as Topic - ethics; Criticism; FDA approval; Heart; Human subjects; Humans; Informed consent; Informed Consent - ethics; Medical research; Participation; Patient Selection - ethics; Patients; Physiology; Quality of life; Social Justice; Transplantation, Heterologous - ethics; Transplants & implants; Xenografts; United States > US; clinical trial; fairness; research subjects; justice; xenotransplantation; consent; ethics; allotransplantation; equity
• ISSN: 0963-1801; 1469-2147; 1469-2147
• DOI: 10.1017/S096318012300052X

Xenotransplant patient selection recommendations restrict clinical trial participation to seriously ill patients for whom alternative therapies are unavailable or who will likely die while waiting for an allotransplant. Despite a scholarly consensus that this is advisable, we propose to examine this restriction. We offer three lines of criticism: (1) The risk–benefit calculation may well be unfavorable for seriously ill patients and society; (2) the guidelines conflict with criteria for equitable patient selection; and (3) the selection of seriously ill patients may compromise informed consent. We conclude by highlighting how the current guidance reveals a tension between the societal values of justice and beneficence.