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自然正义与人体研究伦理委员会:一项全澳大利亚范围的调查。

Natural justice and human research ethics committees: an Australia-wide survey.

作者信息

Van Essen Gabrielle L, Story David A, Poustie Stephanie J, Griffiths Max M J, Marwood Cynthia L

机构信息

Department of Anaesthesia, Austin Health, Austin Hospital, Heidelberg, VIC, Australia.

出版信息

Med J Aust. 2004 Jan 19;180(2):63-6. doi: 10.5694/j.1326-5377.2004.tb05800.x.

Abstract

OBJECTIVE

To determine how familiar human research ethics committees (HRECs) are with the principles of natural justice and whether they apply these principles.

DESIGN AND SETTING

A postal survey conducted between April and September 2002 of the Chairs of all HRECs registered with the Australian Health Ethics Committee of the National Health and Medical Research Council (NHMRC) in 2001.

MAIN OUTCOME MEASURES

HRECs' reported familiarity with, and application of, three principles of natural justice: (1). the hearing rule, requiring a decision maker to allow a person affected by a decision to present his or her case; (2). the rule against bias, requiring a decision maker to be unbiased in the matter to be decided; and (3). the evidence rule, requiring that a decision be based on the evidence provided, and not irrelevant issues.

RESULTS

From 201 Chairs of HRECs Australia-wide, we received 110 completed questionnaires (55% response rate). About 33% of respondents were very familiar with the principles of natural justice, and 25% completely unfamiliar. Most respondents felt that natural justice should be, and usually is, applied by HRECs. In cases of possible positive bias of an HREC member towards a research proposal, 70% of respondents said they would exclude the member from decision making. In cases of possible negative bias, 43% said they would exclude the HREC member.

CONCLUSION

The degree of familiarity with principles of natural justice varies widely among Chairs of HRECs. While many respondents felt that HRECs usually apply natural justice, responses to questions about bias suggest that HRECs do not always exclude members with possible bias, contrary to NHMRC guidelines.

摘要

目的

确定人类研究伦理委员会(HRECs)对自然正义原则的熟悉程度,以及它们是否应用这些原则。

设计与背景

2002年4月至9月对2001年在澳大利亚国家卫生与医学研究委员会(NHMRC)的澳大利亚卫生伦理委员会注册的所有HRECs主席进行了邮政调查。

主要观察指标

HRECs报告的对自然正义三项原则的熟悉程度及应用情况:(1)听证规则,要求决策者允许受决策影响的人陈述其情况;(2)禁止偏见规则,要求决策者在待裁决事项上保持无偏见;(3)证据规则,要求决策基于所提供的证据,而非无关问题。

结果

在澳大利亚各地的201位HRECs主席中,我们收到了110份完整问卷(回复率为55%)。约33%的受访者对自然正义原则非常熟悉,25%完全不熟悉。大多数受访者认为自然正义应由HRECs应用,而且通常也是如此。在HRECs成员对研究提案可能存在积极偏见的情况下,70%的受访者表示他们会将该成员排除在决策之外。在可能存在消极偏见的情况下,43%的受访者表示他们会排除该HRECs成员。

结论

HRECs主席对自然正义原则的熟悉程度差异很大。虽然许多受访者认为HRECs通常应用自然正义,但关于偏见问题的回答表明,与NHMRC指南相反,HRECs并不总是排除可能存在偏见的成员。

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