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本文引用的文献

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Fees and research ethics committees.费用与研究伦理委员会。
Bull Med Ethics. 1999 Oct;No. 151:18-20.
2
Deciding when to withhold or withdraw life-sustaining treatment for children.决定何时对儿童停止或撤除维持生命的治疗。
Bull Med Ethics. 1997 Apr;No. 127:13-20.
3
The need for a national body for research misconduct. Nothing less will reassure the public.需要一个处理科研不当行为的国家机构。只有这样才能让公众放心。
BMJ. 1998 Jun 6;316(7146):1686-7. doi: 10.1136/bmj.316.7146.1686.
4
Monitoring approved research protocols--a question of balance. National Health and Medical Research Council.
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5
Short course of zidovudine cuts transmission of HIV.齐多夫定短疗程可降低艾滋病毒传播率。
BMJ. 1998 Feb 28;316(7132):645. doi: 10.1136/bmj.316.7132.645.
6
Local Research Ethics Committees can audit ethical standards in research.当地研究伦理委员会可以对研究中的伦理标准进行审核。
J Med Ethics. 1997 Dec;23(6):379-81. doi: 10.1136/jme.23.6.379.
7
Misconduct in research: editors respond.研究中的不当行为:编辑回应。
BMJ. 1997 Jul 26;315(7102):201-2. doi: 10.1136/bmj.315.7102.201.
8
Review by a local medical research ethics committee of the conduct of approved research projects, by examination of patients' case notes, consent forms, and research records and by interview.当地医学研究伦理委员会通过检查患者病历、知情同意书和研究记录以及进行访谈,对已批准的研究项目的实施情况进行审查。
BMJ. 1997 May 31;314(7094):1588-90. doi: 10.1136/bmj.314.7094.1588.

当地的研究伦理委员会是否应该监督他们已经批准的研究?

Should local research ethics committees monitor research they have approved?

作者信息

Pickworth E

机构信息

University of Manchester.

出版信息

J Med Ethics. 2000 Oct;26(5):330-3. doi: 10.1136/jme.26.5.330.

DOI:10.1136/jme.26.5.330
PMID:11055034
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1733278/
Abstract

The function of local research ethics committees is to consider the ethics of research proposals using human participants. After approval has been given, there is no comprehensive system in place to monitor research and ensure that recommendations are carried out. Some suggest that research ethics committees are ideally placed to fulfil this function by carrying out random monitoring of research they have reviewed. The health service guideline creating local research ethics committees is under review. This paper suggests that increasing the monitoring role of ethics committees in the present climate would be inappropriate. This is due to the large workload of the committees, their voluntary nature and the change a monitoring role might cause to the relationship between researcher and ethics committee, which might herald an increasing recourse to judicial review. A radical overhaul of the system would be necessary in order for ethics committees adequately to fulfil a monitoring function.

摘要

地方研究伦理委员会的职能是审议涉及人类受试者的研究提案的伦理问题。提案获批后,却没有一个全面的系统来监督研究并确保各项建议得以落实。一些人认为,研究伦理委员会完全有能力通过对其已审查的研究进行随机监督来履行这一职能。目前正在对设立地方研究伦理委员会的医疗卫生服务指南进行审查。本文认为,在当前情况下增加伦理委员会的监督作用是不合适的。这是因为委员会工作量巨大、具有自愿性质,而且监督角色可能会改变研究者与伦理委员会之间的关系,这可能预示着司法审查的增多。为使伦理委员会充分履行监督职能,有必要对该系统进行彻底改革。