Xenotransplantation Clinical Trials: Should Patients with Diminished Capacity be Permitted to Enroll?

Journal article


Rodger, D., Mack, J., Bobier, C., Padilla, L. and Hurst, D. (2024). Xenotransplantation Clinical Trials: Should Patients with Diminished Capacity be Permitted to Enroll? Xenotransplantation. 31 (2), p. e12857. https://doi.org/10.1111/xen.12857
AuthorsRodger, D., Mack, J., Bobier, C., Padilla, L. and Hurst, D.
Abstract

Before xenotransplantation clinical trials begin, it is essential to establish clear and equitable participant selection criteria. Selection criteria have been suggested in the literature, as well as in a proposed kidney xenotransplantation phase 1 clinical trial.1-4 In each, inclusion criteria is predicated on patients possessing clinical decision-making capacity. Ensuring informed consent for xenotransplantation clinical trials with patients who have decision-making capacity is recognized as complex for the following reasons: the possibility of therapeutic misconception, potential for xenozoonosis, and the potentially burdensome requirement for lifelong biosurveillance.5, 6 Informed consent for enrollment in a xenotransplantation trial with adult persons who have diminished capacity would involve additional complexities. By diminished capacity, we mean to describe someone who—for various medical reasons—does not have the ability to provide informed consent. To our knowledge, no xenotransplantation investigator, nor the proposed kidney xenotransplantation phase I clinical trial in the United States, currently proposes including persons with diminished capacity. Nonetheless, the topic has been broached, and we believe it requires additional independent scrutiny.

KeywordsClinical trials; Xenotransplantation; Informed consent; Capacity; Public health; Transplantation
Year2024
JournalXenotransplantation
Journal citation31 (2), p. e12857
PublisherWiley
ISSN1399-3089
Digital Object Identifier (DOI)https://doi.org/10.1111/xen.12857
Web address (URL)https://onlinelibrary.wiley.com/doi/full/10.1111/xen.12857
Publication dates
Online11 Apr 2024
Publication process dates
Accepted28 Mar 2024
Deposited05 Jun 2024
Publisher's version
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File Access Level
Open
Accepted author manuscript
License
File Access Level
Controlled
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