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中国老年临床研究的伦理指南。

Ethical guidance for geriatric clinical research in China.

作者信息

Yu Lingling, Li Xiaoling, Zhang Pengjun, Zhang Guojun

机构信息

Scientific Research Administration Department Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences Beijing China.

Ethics Committee Xuanwu Hospital Capital Medical University National Center for Clinical Research on Geriatric Diseases Beijing China.

出版信息

Aging Med (Milton). 2020 Dec 21;3(4):218-223. doi: 10.1002/agm2.12138. eCollection 2020 Dec.

DOI:10.1002/agm2.12138
PMID:33392425
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7771564/
Abstract

In China, the population is aging rapidly, and the elderly have enormous medical needs. However, the elderly are underrepresented in clinical research, potentially forcing them to use medical devices and treatments that may be not suitable for them. Elderly patients are characterized by multiple comorbidities, concomitant treatments, and high incidence of cognitive impairment, and consequently are at increased risk of participating in clinical research. To reduce the risks involved with the elderly participating in clinical research, guidance on the ethical review of geriatric research is necessary. Based on a literature review and panel discussion, we have developed the , aiming to provide guidance on the ethical review of geriatric clinical research.

摘要

在中国,人口老龄化迅速,老年人有着巨大的医疗需求。然而,老年人在临床研究中的代表性不足,这可能迫使他们使用可能并不适合自己的医疗设备和治疗方法。老年患者具有多种合并症、伴随治疗以及认知障碍发生率高的特点,因此参与临床研究的风险增加。为降低老年人参与临床研究的风险,老年研究伦理审查指南很有必要。基于文献综述和专家小组讨论,我们制定了[具体名称未给出],旨在为老年临床研究的伦理审查提供指导。

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1
Ethical guidance for geriatric clinical research in China.中国老年临床研究的伦理指南。
Aging Med (Milton). 2020 Dec 21;3(4):218-223. doi: 10.1002/agm2.12138. eCollection 2020 Dec.
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Toward the realization of a better aged society: messages from gerontology and geriatrics.迈向更美好的老年社会:老年学和老年医学的信息。
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本文引用的文献

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Assessing capacity to consent for research in cognitively impaired older patients.评估认知受损老年患者的研究同意能力。
Clin Interv Aging. 2017 Sep 26;12:1553-1563. doi: 10.2147/CIA.S141905. eCollection 2017.
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ETHICS IN GERIATRIC MEDICINE RESEARCH.老年医学研究中的伦理问题。
Turk Geriatri Derg. 2014;17(2):188-195.
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[Chinese guidelines for diagnosis and management of cognitive impairment and dementia (VII): care and ethical consultation].《中国认知障碍和痴呆诊断与治疗指南(七):照护与伦理咨询》
Zhonghua Yi Xue Za Zhi. 2011 Apr 26;91(16):1081-3.
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Ethics, health research, and Canada's aging population.伦理、健康研究与加拿大的老龄化人口
Can J Aging. 2010 Dec;29(4):577-85. doi: 10.1017/s0714980810000565.
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An overview of the design, implementation, and analyses of longitudinal studies on aging.衰老纵向研究的设计、实施和分析概述。
J Am Geriatr Soc. 2010 Oct;58 Suppl 2(Suppl 2):S287-91. doi: 10.1111/j.1532-5415.2010.02916.x.
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Fighting against age discrimination in clinical trials.反对临床试验中的年龄歧视。
J Am Geriatr Soc. 2010 Sep;58(9):1791-6. doi: 10.1111/j.1532-5415.2010.03032.x.
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Ethical and legal issues in conducting research involving elderly subjects.涉及老年受试者的研究中的伦理和法律问题。
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