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本文引用的文献

1
The "Vulnerability" of Psychiatric Research Participants: Why This Research Ethics Concept Needs to Be Revisited.精神科研究参与者的“脆弱性”：为何这一研究伦理概念需要重新审视。
Can J Psychiatry. 2016 Jun;61(6):335-9. doi: 10.1177/0706743716633422. Epub 2016 Apr 5.
2
Confronting Ethical and Regulatory Challenges of Emergency Care Research With Conscious Patients.应对针对清醒患者的急诊护理研究中的伦理和监管挑战。
Ann Emerg Med. 2016 Apr;67(4):538-45. doi: 10.1016/j.annemergmed.2015.10.026. Epub 2015 Dec 18.
3
Use of altered informed consent in pragmatic clinical research.在实用临床研究中使用变更后的知情同意书。
Clin Trials. 2015 Oct;12(5):494-502. doi: 10.1177/1740774515597688. Epub 2015 Sep 15.
4
Assessment of Capacity to Consent to Research Among Psychiatric Outpatients: Prevalence and Associated Factors.精神科门诊患者对研究的同意能力评估：患病率及相关因素
Psychiatr Q. 2016 Mar;87(1):89-105. doi: 10.1007/s11126-015-9365-3.
5
Balancing ethical goals in challenging individual participant scenarios occurring in a trial conducted with exception from informed consent.在一项免除知情同意进行的试验中出现的具有挑战性的个体参与者情形下平衡伦理目标。
Acad Emerg Med. 2015 Mar;22(3):340-6. doi: 10.1111/acem.12602. Epub 2015 Feb 25.
6
Enduring and emerging challenges of informed consent.知情同意的持久和新兴挑战。
N Engl J Med. 2015 Feb 26;372(9):855-62. doi: 10.1056/NEJMra1411250.
7
Have we asked too much of consent?我们对同意的要求是否过高了？
Hastings Cent Rep. 2014 Jul-Aug;44(4):33-4. doi: 10.1002/hast.329.
8
Cognitive impairment and PD patients' capacity to consent to research.认知障碍与 PD 患者同意参与研究的能力。
Neurology. 2013 Aug 27;81(9):801-7. doi: 10.1212/WNL.0b013e3182a05ba5. Epub 2013 Jul 26.
9
How closely do institutional review boards follow the common rule?机构审查委员会在多大程度上遵循普通规定？
Acad Med. 2012 Jul;87(7):969-74. doi: 10.1097/ACM.0b013e3182575e2e.
10
Is informed consent broken?知情同意是否被打破了？
Am J Med Sci. 2011 Oct;342(4):267-72. doi: 10.1097/MAJ.0b013e31822a6c47.

Capacity, Vulnerability, and Informed Consent for Research.

作者信息

Biros Michelle

机构信息

Ernest and Bernice Endowed Professor of Emergency Medicine and Interim Chief of the Department of Emergency Medicine at the University of Minnesota School of Medicine. She is an elected member of the National Academy of Medicine (formerly the Institute of Medicine). In 1994, she worked with the FDA to help develop the Exception from Informed Consent (EFIC) Requirements for Emergency Research. She currently serves as the Advisor for Vulnerable Populations for the Human Subjects Protection Program at the University of Minnesota.

出版信息

J Law Med Ethics. 2018 Mar;46(1):72-78. doi: 10.1177/1073110518766021. Epub 2018 Mar 27.

DOI:10.1177/1073110518766021
PMID:29991882
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6035898/
Abstract
摘要