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异种移植的临床试验:应要求放弃退出临床试验的权利。

Clinical trials of xenotransplantation: waiver of the right to withdraw from a clinical trial should be required.

作者信息

Spillman Monique A, Sade Robert M

机构信息

Department of Obstetrics and Gynecology at the University of Colorado at Denver and Health Sciences Center, Denver,Colorado, USA.

出版信息

J Law Med Ethics. 2007 Summer;35(2):265-72. doi: 10.1111/j.1748-720X.2007.00135.x.

DOI:10.1111/j.1748-720X.2007.00135.x
PMID:17518852
Abstract

Xenotransplantation pits clinical research ethics against public health needs because recipients must undergo long-term, perhaps life-long, surveillance for infectious diseases. This surveillance requirement is effectively an abrogation of the right to withdraw from a clinical trial. Ulysses contracts, which are advance directives for future care, may be an ethical mechanism by which to balance public health needs against limitation of individual rights.

摘要

异种移植使临床研究伦理与公共卫生需求产生了冲突,因为接受者必须接受针对传染病的长期(甚至可能是终身)监测。这种监测要求实际上是对退出临床试验权利的一种废除。尤利西斯契约作为未来医疗的预先指示,可能是一种在公共卫生需求与个人权利限制之间取得平衡的伦理机制。

相似文献

1
Clinical trials of xenotransplantation: waiver of the right to withdraw from a clinical trial should be required.异种移植的临床试验:应要求放弃退出临床试验的权利。
J Law Med Ethics. 2007 Summer;35(2):265-72. doi: 10.1111/j.1748-720X.2007.00135.x.
2
In "Clinical trials of xenotransplantation: waiver of the right to withdraw from a clinical trial should be required".在《异种移植临床试验:应要求放弃退出临床试验的权利》中。
J Law Med Ethics. 2007 Winter;35(4):516-7; author reply 517-8.
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Ethical and regulatory issues for clinical trials in xenotransplantation.异种移植临床试验的伦理和监管问题。
Methods Mol Biol. 2012;885:281-305. doi: 10.1007/978-1-61779-845-0_18.
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Some ethical, social, and legal considerations of xenotransplantation.异种移植的一些伦理、社会和法律考量。
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The International Xenotransplantation Association consensus statement on conditions for undertaking clinical trials of porcine islet products in type 1 diabetes--chapter 7: Informed consent and xenotransplantation clinical trials.国际异种移植协会关于开展1型糖尿病猪胰岛产品临床试验条件的共识声明——第7章:知情同意与异种移植临床试验
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引用本文的文献

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Ethical Analysis of Voluntariness in Pig Kidney Xenotransplant First-in-Human Clinical Trials.猪肾异种移植首次人体临床试验中自愿性的伦理分析
Xenotransplantation. 2025 May-Jun;32(3):e70052. doi: 10.1111/xen.70052.
2
Clinical Islet Xenotransplantation: Development of Isolation Protocol, Anti-Rejection Strategies, and Clinical Outcomes.临床胰岛异种移植:分离方案的开发、抗排斥策略和临床结果。
Cells. 2024 May 13;13(10):828. doi: 10.3390/cells13100828.
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Corneal xenotransplantation: Where are we standing?角膜异种移植:我们处于什么位置?
Prog Retin Eye Res. 2021 Jan;80:100876. doi: 10.1016/j.preteyeres.2020.100876. Epub 2020 Aug 2.
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Withdrawing from research: a rethink in the context of research biobanks.退出研究:研究生物库背景下的再思考。
Health Care Anal. 2011 Sep;19(3):269-81. doi: 10.1007/s10728-011-0194-8.
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Human subjects protections in biomedical enhancement research: assessing risk and benefit and obtaining informed consent.生物医学增强研究中的人体受试者保护:评估风险与益处并获得知情同意。
J Law Med Ethics. 2008 Fall;36(3):546-9. doi: 10.1111/j.1748-720X.2008.303.x.