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
Authors | Rodger, D., Mack, J., Bobier, C., Padilla, L. and Hurst, D. |
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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. |
Keywords | Clinical trials; Xenotransplantation; Informed consent; Capacity; Public health; Transplantation |
Year | 2024 |
Journal | Xenotransplantation |
Journal citation | 31 (2), p. e12857 |
Publisher | Wiley |
ISSN | 1399-3089 |
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 | |
Online | 11 Apr 2024 |
Publication process dates | |
Accepted | 28 Mar 2024 |
Deposited | 05 Jun 2024 |
Publisher's version | License File Access Level Open |
Accepted author manuscript | License File Access Level Controlled |
https://openresearch.lsbu.ac.uk/item/96x94
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Publisher's version
Xenotransplantation - 2024 - Rodger - Xenotransplantation clinical trials Should patients with diminished capacity be.pdf | ||
License: CC BY 4.0 | ||
File access level: Open |
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