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长期护理机构中研究的知情同意。

Informed consent to research in long-term care settings.

作者信息

Lingler Jennifer Hagerty, Jablonski Rita A, Bourbonniere Meg, Kolanowski Ann

机构信息

Department of Health and Community Systems, University of Pittsburgh School of Nursing, Pennsylvania 15261, USA.

出版信息

Res Gerontol Nurs. 2009 Jul;2(3):153-61. doi: 10.3928/19404921-20090428-03. Epub 2009 May 29.

DOI:10.3928/19404921-20090428-03
PMID:20078005
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2889624/
Abstract

Informed consent to nursing home research is a two-tiered process that begins with obtaining the consent of a long-term care community at the institutional level and progresses to the engagement of individuals in the consent process. Drawing on a review of the literature and the authors' research experiences and institutional review board service, this article describes the practical implications of nurse investigators' obligation to ensure informed consent among participants in long-term care research. Recommendations focus on applying a community consent model to long-term care research, promoting an evidence-based approach to the protection of residents with decisional impairment, and increasing investigators' attention to ethical issues involving long-term care staff.

摘要

养老院研究的知情同意是一个分两个层次的过程,首先是在机构层面获得长期护理社区的同意,然后推进到让个人参与同意过程。基于对文献的回顾以及作者的研究经验和机构审查委员会服务,本文描述了护士研究人员有义务确保长期护理研究参与者获得知情同意的实际意义。建议集中在将社区同意模式应用于长期护理研究、推广基于证据的方法来保护有决策障碍的居民,以及提高研究人员对涉及长期护理工作人员的伦理问题的关注。

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Conducting Clinical Research in Post-acute and Long-term Nursing Home Care Settings: Regulatory Challenges.在长期护理养老院环境中开展临床研究:监管挑战。
J Am Med Dir Assoc. 2019 Jul;20(7):798-803. doi: 10.1016/j.jamda.2019.04.022.
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Setting up a clinical trial in care homes: challenges encountered and recommendations for future research practice.在养老院开展临床试验:遇到的挑战及对未来研究实践的建议。
BMC Res Notes. 2015 Jul 16;8:306. doi: 10.1186/s13104-015-1276-8.

本文引用的文献

1
Measuring the oral health of nursing home elders.测量养老院老年人的口腔健康状况。
Clin Nurs Res. 2009 Aug;18(3):200-17. doi: 10.1177/1054773809335306. Epub 2009 Apr 22.
2
Mouth care in nursing homes: knowledge, beliefs, and practices of nursing assistants.养老院中的口腔护理:护理助理的知识、观念与实践
Geriatr Nurs. 2009 Mar-Apr;30(2):99-107. doi: 10.1016/j.gerinurse.2008.06.010. Epub 2008 Nov 17.
3
Decisional capacity for research participation in individuals with mild cognitive impairment.轻度认知障碍个体参与研究的决策能力。
J Am Geriatr Soc. 2008 Jul;56(7):1236-43. doi: 10.1111/j.1532-5415.2008.01752.x. Epub 2008 May 12.
4
Informed consent for dementia research: the study enrollment encounter.痴呆症研究的知情同意:研究入组环节
IRB. 2007 Jul-Aug;29(4):7-14.
5
Decisions about transfer from nursing home to emergency department.关于从养老院转至急诊科的决策。
J Nurs Scholarsh. 2007;39(3):266-72. doi: 10.1111/j.1547-5069.2007.00179.x.
6
Proxies and consent discussions for dementia research.痴呆症研究的代理人及同意书讨论
J Am Geriatr Soc. 2007 Apr;55(4):556-61. doi: 10.1111/j.1532-5415.2007.01101.x.
7
Consent and assent to participate in research from people with dementia.痴呆症患者参与研究的同意与赞成。
Nurs Ethics. 2007 Jan;14(1):27-40. doi: 10.1177/0969733007071355.
8
Reliability and validity of the evaluation to sign consent measure.签署同意措施评估的可靠性和有效性。
Gerontologist. 2007 Feb;47(1):69-77. doi: 10.1093/geront/47.1.69.
9
Assessment of decision-making capacity in older adults: an emerging area of practice and research.老年人决策能力评估:一个新兴的实践与研究领域。
J Gerontol B Psychol Sci Soc Sci. 2007 Jan;62(1):P3-P11. doi: 10.1093/geronb/62.1.p3.
10
Comparison of two enhanced consent procedures for patients with mild Alzheimer disease or mild cognitive impairment.两种针对轻度阿尔茨海默病或轻度认知障碍患者的强化同意程序的比较。
Am J Geriatr Psychiatry. 2007 Feb;15(2):163-7. doi: 10.1097/JGP.0b013e31802dd379.