Are changes to the common rule necessary to address evolving areas of research? A case study focusing on the human microbiome project.
Are changes to the common rule necessary to address evolving areas of research? A case study focusing on the human microbiome project.
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为了应对不断发展的研究领域，是否有必要改变共同规则？
DOI：
10.1111/jlme.12055
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发表时间：
2013
期刊：
影响因子：
--
通讯作者：
Ravel,Jacques
中科院分区：
文献类型：
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作者：
Hoffmann,DianeE;Fortenberry,JDennis;Ravel,Jacques
在最近的《拟议规则制定预先通知》（ANPRM）中描述的对《共同规则》的拟议修改，是在美国卫生与公众服务部于1991年通过该规则20多年之后提出的。从那时起，人类受试者研究发生了重大变化。不仅临床研究的数量急剧增长，而且这项研究现在经常在美国以外的多个合作地点进行。研究不仅发生在学术医疗中心，而且在门诊诊所，社区医院和其他非传统场所。此外，技术进步，如复杂的计算机软件程序、互联网、社交媒体、新的研究方法和移动的应用程序，已经成倍增加了可用数据的数量以及访问、分析和共享这些数据的可能性。
The proposed changes to the Common Rule, described in the recent Advanced Notice of Proposed Rulemaking (ANPRM), come more than 20 years after the U.S. Department of Health and Human Services adopted the Rule in 1991. Since that time, human subjects research has changed in significant ways. Not only has the volume of clinical research grown dramatically, this research is now regularly conducted at multiple collaborative sites that are often outside of the United States. Research takes place not only in academic medical centers, but also at outpatient clinics, community hospitals, and other nontraditional venues. In addition, technological advances, such as sophisticated computer software programs, the Internet, social media, new research methods, and mobile applications have exponentially increased the volume of data available and the possibilities for accessing, analyzing, and sharing that data.