当地研究伦理委员会可以对研究中的伦理标准进行审核。
Local Research Ethics Committees can audit ethical standards in research.
作者信息
Berry J
机构信息
Princess Royal Hospital, Haywards Heath, West Sussex.
出版信息
J Med Ethics. 1997 Dec;23(6):379-81. doi: 10.1136/jme.23.6.379.
OBJECTIVES
To show that a Local Research Ethics Committee (LREC) can carry out an audit of ethical standards in research. To find out if a researcher met certain ethical standards in recruiting subjects for clinical trials and in obtaining their consent.
DESIGN
Postal questionnaire.
SETTING
Clinical research by one doctor during one year.
SUBJECTS
Eleven patients entered in clinical trials.
MAIN OUTCOME MEASURES
Success in ethics committee obtaining data. Achievement of ethical standards in recruitment of subjects and in obtaining consent.
RESULTS
The audit was successfully carried out and standards were partly met.
CONCLUSIONS
Local Research Ethics Committees can carry out audits of the conduct of research projects which they have approved. Provision for possible audits can be made at the time of application to the committee. Our committee thought the ethical standards in the research which we audited were acceptable.
目的
证明地方研究伦理委员会（LREC）能够对研究中的伦理标准进行审核。查明研究人员在招募临床试验受试者以及获取他们的同意方面是否符合某些伦理标准。
设计
邮寄问卷调查。
背景
一名医生在一年内进行的临床研究。
研究对象
参与临床试验的11名患者。
主要观察指标
伦理委员会成功获取数据情况。在招募受试者和获取同意方面达到伦理标准的情况。
结果
审核成功进行，部分标准得到满足。
结论
地方研究伦理委员会可以对其已批准的研究项目的实施情况进行审核。在向委员会申请时可以考虑可能的审核。我们的委员会认为我们所审核的研究中的伦理标准是可以接受的。
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