Sharing individual level data from observational studies and clinical trials: a perspective from NHLBI

被引：36

作者：

Coady, Sean A. ^{[1
]}

Wagner, Elizabeth ^{[2
]}

机构：

[1] NHLBI, Div Cardiovasc Sci, Bethesda, MD 20892 USA

[2] Div Blood Dis & Resources, Bethesda, MD USA

来源：

TRIALS | 2013年 / 14卷

关键词：

Data sharing; Clinical trials; Cohort studies; HIPAA; OPEN SCIENCE; RAW DATA; PRIVACY; ACCESS;

D O I：

10.1186/1745-6215-14-201

中图分类号：

R-3 [医学研究方法]; R3 [基础医学];

学科分类号：

1001 ;

摘要：

There are numerous benefits to the research community from data sharing, and yet the open sharing of participant level data is not without potential pitfalls. In addition to the scientific community, the interests of study participants who volunteered their data must be considered, along with the interests of study investigators who expend a substantial amount of effort into the design, conduct, and analytical plans for the study. The National Heart, Lung, and Blood Institute (NHLBI) has developed a data-sharing protocol focused on balancing the interests of study participants, study investigators, and the research community with independent oversight by the NHLBI IRB. The data repository presently includes individual level data on more than 560,000 participants from 100 Institute-supported clinical trials and observational studies.

引用

页数：3

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