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时间、地点与意识:美国机构审查委员会意义的三个维度。

Time, place, and consciousness: three dimensions of meaning for US institutional review boards.

作者信息

Putney Sarah B, Gruskin Sofia

机构信息

Human Subjects Committee, François-Xavier Bagnoud Center for Health and Human Rights, Harvard School of Public Health, Boston, MA 02120, USA.

出版信息

Am J Public Health. 2002 Jul;92(7):1067-70. doi: 10.2105/ajph.92.7.1067.

Abstract

In the past few years, US federal agencies governing research with human subjects and institutional review boards have taken a higher-profile path than ever before, both at home and internationally. This trend carries profound significance for US-based institutions and has implications also for the rest of the world. What does this critical moment of heightened federal scrutiny mean for the workings of US institutional review boards? We examined board activity across 3 dimensions: time, place, and consciousness. We conclude that although institutions in all areas of biomedical and social science research are adapting their practices, the field of public health is especially well positioned to adapt to, and succeed in, new efforts to ensure protection of human research subjects.

摘要

在过去几年里,负责监管涉及人类受试者研究的美国联邦机构和机构审查委员会在国内外都采取了比以往更高调的路线。这一趋势对美国的机构具有深远意义,对世界其他地区也有影响。联邦审查力度加大的这一关键时刻对美国机构审查委员会的运作意味着什么?我们从时间、地点和意识三个维度审视了委员会的活动。我们得出的结论是,尽管生物医学和社会科学研究所有领域的机构都在调整其做法,但公共卫生领域尤其有能力适应并成功开展确保保护人类研究受试者的新举措。

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