研究对象真的得到充分告知了吗？
Are research subjects really informed?
作者信息
Schultz A L, Pardee G P, Ensinck J W
出版信息
West J Med. 1975 Jul;123(1):76-80.
Abstract
To determine how adequately patients who participate as subjects for clinical investigation understand their commitment, 50 patients admitted to the Clinical Research Center of the University of Washington were interviewed. Their responses were compared with the detailed statements in the consent forms for the 23 specific protocols under which they were being studied. In spite of careful controls in accord with guidelines of a review committee, only half the patients were able to describe accurately their expectations of the studies to which they had given signed consent.
摘要
为了确定参与临床研究的患者对自身所做承诺的理解程度，我们对华盛顿大学临床研究中心收治的50名患者进行了访谈。将他们的回答与针对他们所参与研究的23项具体方案的知情同意书中的详细说明进行了比较。尽管严格按照审查委员会的指导方针进行了仔细控制，但只有一半的患者能够准确描述他们对已签署同意书的研究的期望。
相似文献
1
Are research subjects really informed?研究对象真的得到充分告知了吗？
West J Med. 1975 Jul;123(1):76-80.
2
Ethical issues in genetic research: disclosure and informed consent.基因研究中的伦理问题：信息披露与知情同意
Nat Genet. 1997 Jan;15(1):16-20. doi: 10.1038/ng0197-16.
3
Informed consent.知情同意。
SCI Nurs. 1992 Aug;9(3):86-91.
4
Ethics of clinical research.临床研究伦理
BMJ. 1989 Aug 19;299(6697):513-4.
5
The Cartwright report and consent.卡特赖特报告与同意书。
N Z Med J. 1988 Oct 26;101(856 Pt 1):671.
6
"Ethics and clinical research" revisited. A tribute to Henry K. Beecher.《再谈“伦理与临床研究”》。向亨利·K·比彻致敬。
Hastings Cent Rep. 1993 Sep-Oct;23(5):31-9.
7
8
Legal liability for injury to research subjects.对研究对象造成伤害的法律责任。
Clin Invest Med. 1991 Apr;14(2):176-80.
9
Informed consent in clinical research: policies and practices in Singapore.临床研究中的知情同意：新加坡的政策与实践
J Biolaw Bus. 2003;6(1):65-75.
10
[Comparing ethics committees from France and Quebec with respect to incapacity to consent to research].[比较法国和魁北克关于无能力同意参与研究的伦理委员会]
Rev Epidemiol Sante Publique. 2009 Aug;57(4):231-9. doi: 10.1016/j.respe.2009.03.005. Epub 2009 Jun 21.
引用本文的文献
1
An open access pilot freely sharing cancer genomic data from participants in Texas.公开获取的试点项目，免费分享来自德克萨斯州参与者的癌症基因组数据。
Sci Data. 2016 Feb 16;3:160010. doi: 10.1038/sdata.2016.10.
2
Informed consent in paediatric critical care research--a South African perspective.儿科重症监护研究中的知情同意——南非视角
BMC Med Ethics. 2015 Sep 9;16:62. doi: 10.1186/s12910-015-0052-6.
3
Investigating the informed consent process, therapeutic misconception and motivations of Egyptian research participants: a qualitative pilot study.调查埃及研究参与者的知情同意过程、治疗误解及动机：一项定性试点研究。
East Mediterr Health J. 2015 May 19;21(3):155-63. doi: 10.26719/2015.21.3.155.
4
Protecting vulnerable research subjects in critical care trials: enhancing the informed consent process and recommendations for safeguards.保护重症监护试验中的脆弱研究对象：加强知情同意过程和保障措施建议。
Ann Intensive Care. 2011 Apr 13;1(1):8. doi: 10.1186/2110-5820-1-8.
5
Children's understanding of the risks and benefits associated with research.儿童对与研究相关的风险和益处的理解。
J Med Ethics. 2005 Dec;31(12):715-20. doi: 10.1136/jme.2003.003228.
6
Patient attitudes following participation in a health outcome survey.参与健康结果调查后的患者态度。
Am J Public Health. 1981 Dec;71(12):1396-8. doi: 10.2105/ajph.71.12.1396.
7
Clinical trials in cancer: the role of surrogate patients in defining what constitutes an ethically acceptable clinical experiment.癌症临床试验：替代患者在界定何为符合伦理道德的可接受临床试验方面的作用。
Br J Cancer. 1989 Mar;59(3):388-95. doi: 10.1038/bjc.1989.78.
本文引用的文献
1
Consent in clinical experimentation: myth and reality.临床实验中的同意：神话与现实。
JAMA. 1966 Jan 3;195(1):34-5.
2
Obtaining informed consent. Form or substance.
Arch Intern Med. 1969 Jun;123(6):682-8.
3
Emerging assets and liabilities of a committee on human welfare and experimentation.人类福利与实验委员会新出现的资产与负债。
N Engl J Med. 1970 Feb 19;282(8):427-31. doi: 10.1056/NEJM197002192820806.
4
Ethics and clinical research.伦理与临床研究
N Engl J Med. 1966 Jun 16;274(24):1354-60. doi: 10.1056/NEJM196606162742405.
5
Informed consent. A study of patient reaction.知情同意。一项关于患者反应的研究。
JAMA. 1971 May 24;216(8):1325-9. doi: 10.1001/jama.216.8.1325.
6
Children's concepts of research hospitalization.儿童对住院治疗研究的概念。
N Engl J Med. 1972 Sep 21;287(12):589-92. doi: 10.1056/NEJM197209212871205.
7
Informed (but uneducated) consent.知情（但未经专业教育）同意。
N Engl J Med. 1972 Aug 31;287(9):465-6. doi: 10.1056/NEJM197208312870912.
8
New dimensions in legal and ethical concepts for human research. 3. Special problems of related professions. Serving investigator, patient, and community in research studies.人类研究中法律与伦理概念的新维度。3. 相关专业的特殊问题。在研究中为研究者、患者和社区服务。
Ann N Y Acad Sci. 1970 Jan 21;169(2):429-34. doi: 10.1111/j.1749-6632.1970.tb54751.x.
9
Ethics of experiments on children.儿童实验的伦理问题。
N Engl J Med. 1973 Apr 12;288(15):791-2. doi: 10.1056/NEJM197304122881514.
Zotero 插件