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审视评审者:对澳大利亚机构伦理委员会的一项调查

Reviewing the reviewers: a survey of institutional ethics committees in Australia.

作者信息

McNeill P M, Berglund C A, Webster I W

机构信息

School of Community Medicine, University of New South Wales, Kensington.

出版信息

Med J Aust. 1990 Mar 19;152(6):289-96. doi: 10.5694/j.1326-5377.1990.tb120948.x.

Abstract

Completed questionnaires were received from 89 (88%) of the 101 Australian institutions identified as having an ethics committee which reviewed research on human subjects. The majority (75%) of committees complied with national requirements to include a layman, a laywoman, a minister of religion, a lawyer and a medical graduate with research experience in their membership. On average, the committees considered 41 research protocols in the year from mid 1987 to mid 1988. The proposed projects were from the medical sciences, including health services and epidemiology research (80% of projects), and the behavioural and social sciences (20% of projects). Less than half the committees monitored research projects in progress as a general practice. Most of the monitoring that was conducted was based on a report from the researcher on the progress of the study. Although monitoring, frequency of meetings, selection of committee members, member involvement in the review of their own protocols and provisions for expedited review gave cause for concern, most committees were found to follow the national guide-lines.

摘要

在被确定设有审查人体研究伦理委员会的101家澳大利亚机构中,有89家(88%)提交了完整的调查问卷。大多数(75%)委员会符合国家要求,其成员包括一名男性外行、一名女性外行、一名宗教部长、一名律师以及一名有研究经验的医学毕业生。从1987年年中到1988年年中,这些委员会平均每年审议41项研究方案。拟议项目来自医学科学领域,包括卫生服务和流行病学研究(占项目的80%)以及行为和社会科学领域(占项目的20%)。不到一半的委员会将监测正在进行的研究项目作为常规做法。所进行的大多数监测是基于研究人员关于研究进展的报告。尽管监测、会议频率、委员会成员的选择、成员参与对其自身方案的审查以及快速审查的规定令人担忧,但大多数委员会被发现遵循国家指导方针。

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