促进器官移植病人的研究。

IRB Pub Date : 2018-09-01
Sarah R Lieber, Thomas D Schiano, Rosamond Rhodes
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引用次数: 0

摘要

考虑到与患者选择、手术技术和移植后护理相关的众多问题需要基于证据的答案,移植项目应该与等待接受器官移植的患者和已经接受器官移植的患者进行研究。然而,在移植医学领域,人类受试者的研究仍然缺乏。在这里,我们讨论了可能阻碍移植项目从事移植相关研究的挑战。以肝移植为例,我们解释了终末期器官衰竭患者的脆弱性,以及决策能力、强制和研究入组时间等复杂的伦理问题。最后,我们认为应该邀请并鼓励所有的移植候选人参与研究。我们认为临床护理应该在积极研究的背景下提供,这样临床医生可以进一步了解移植医学,同时也可以提供高质量的患者护理。我们建议尽早与患者讨论参与研究和研究预先指示可能有助于克服对人类受试者移植研究的不情愿和伦理挑战。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Promoting Research with Organ Transplant Patients.

Given the numerous questions related to patient selection, surgical technique, and posttransplant care requiring evidence-based answers, transplantation programs should be conducting research with patients waiting to receive an organ and those who have undergone organ transplantation. Yet, there continues to be a dearth of human subjects research in the field of transplantation medicine. Here, we discuss challenges that may deter transplantation programs from engaging in transplant-related research. Taking liver transplantation as our illustrative example, we explain the vulnerabilities of patients with end-stage organ failure and the complex ethical issues of decisional capacity, coercion, and the timing of study enrollment. Ultimately, we argue that all transplant candidates should be invited and encouraged to participate in research. We maintain that clinical care should be provided in the context of active research so that clinicians can further their understanding of transplantation medicine while also providing high-quality patient care. We suggest that early discussion with patients about participating in research and about a research advance directive may help to overcome reluctance about and the ethical challenges of transplantation research with human subjects.

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