BACKGROUND To foster responsible data sharing in health research, ethical governance complementary to the EU General Data Protection Regulation is necessary. A governance framework for Big Data-driven research platforms will at least need to consider the conditions as specified a priori for individual datasets. We aim to identify and analyze these conditions for the Innovative Medicines Initiative's (IMI) BigData@Heart platform. METHODS We performed a unique descriptive case study into the conditions for data sharing as specified for datasets participating in BigData@Heart. Principle investigators of 56 participating databases were contacted via e-mail with the request to send any kind of documentation that possibly specified the conditions for data sharing. Documents were qualitatively reviewed for conditions pertaining to data sharing and data access. RESULTS Qualitative content analysis of 55 relevant documents revealed overlap on the conditions: (1) only to share health data for scientific research, (2) in anonymized/coded form, (3) after approval from a designated review committee, and while (4) observing all appropriate measures for data security and in compliance with the applicable laws and regulations. CONCLUSIONS Despite considerable overlap, prespecified conditions give rise to challenges for data sharing. At the same time, these challenges inform our thinking about the design of an ethical governance framework for data sharing platforms. We urge current data sharing initiatives to concentrate on: (1) the scope of the research questions that may be addressed, (2) how to deal with varying levels of de-identification, (3) determining when and how review committees should come into play, (4) align what policies and regulations mean by "data sharing" and (5) how to deal with datasets that have no system in place for data sharing.

中文翻译：

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大数据驱动的转化研究平台中负责任的数据共享：经验教训。

背景 为了促进健康研究中负责任的数据共享，有必要对欧盟通用数据保护条例进行补充的道德治理。大数据驱动的研究平台的治理框架至少需要考虑为单个数据集先验指定的条件。我们的目标是为创新药物倡议 (IMI) 的 BigData@Heart 平台识别和分析这些条件。方法 我们对参与 BigData@Heart 的数据集指定的数据共享条件进行了独特的描述性案例研究。我们通过电子邮件联系了 56 个参与数据库的主要研究人员，要求他们发送任何可能指定数据共享条件的文件。对文件的数据共享和数据访问相关条件进行了定性审查。结果 对 55 份相关文件的定性内容分析显示，其条件存在重叠：(1) 仅共享用于科学研究的健康数据，(2) 以匿名/编码形式，(3) 经指定审查委员会批准后，同时 (4) ) 遵守所有适当的数据安全措施并遵守适用的法律和法规。结论 尽管存在相当大的重叠，但预先指定的条件给数据共享带来了挑战。同时，这些挑战也启发了我们对数据共享平台道德治理框架设计的思考。我们敦促当前的数据共享举措集中于：（1）可能解决的研究问题的范围，（2）如何处理不同程度的去识别化，（3）确定审查委员会应何时以及如何参与发挥，（4）调整“数据共享”的政策和法规的含义，以及（5）如何处理没有数据共享系统的数据集。