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伦理审查对保护人类受试者的贡献:评《衡量机构审查委员会的质量与绩效》

The Contribution of Ethics Review to Protection of Human Participants: Comment on "Measuring the Quality and Performance of Institutional Review Boards".

作者信息

Grady Christine

机构信息

1 NIH Clinical Center, Bethesda, MD, USA.

出版信息

J Empir Res Hum Res Ethics. 2019 Jul;14(3):197-199. doi: 10.1177/1556264619837774. Epub 2019 Mar 21.

DOI:10.1177/1556264619837774
PMID:30896324
Abstract

Measuring the quality and performance of IRBs requires clarity about what IRBs are supposed to do. Although many agree that IRBs are supposed to protect the rights and welfare of human subjects, exactly how review by an IRB contributes to protection is not always clear. Originally, ethics review was instituted as a way to check the interests, possible conflicts, and enthusiasm of investigators whose relationship to participants is different from physicians' relationship to patients. IRB performance might include evaluating how well IRBs do this.

摘要

衡量机构审查委员会(IRB)的质量和绩效需要明确其应履行的职责。尽管许多人都认同IRB的职责是保护人类受试者的权利和福祉,但IRB的审查究竟如何促进这种保护并不总是清晰明了。最初,伦理审查的设立是为了审视研究人员的利益、潜在冲突以及积极性,这些研究人员与参与者的关系不同于医生与患者的关系。IRB的绩效可能包括评估其在这方面的表现如何。

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