NIH数据共享政策历史比较分析及对我国的启示

Comparative historical study of NIH data sharing policies and its enlightenments for China

目的梳理美国国立卫生研究院(NIH)2020年发布《NIH数据管理与共享政策》提出的新要求,总结未来科学数据管理和共享的趋势和方向,为我国完善科学数据管理政策体系建设、推进生物医学科学数据共享实践提供启示与参考。方法采用历史比较分析法,从政策结构和政策内容两个角度对比研究NIH在2003年和2020年发布的两版数据管理与共享政策。结果新版NIH数据政策呈以下管理趋势:强制性的数据共享、高质量的数据汇交、前瞻性的数据管理和精细化的隐私保护。结论结合我国国情,提出以下数据管理建议:一是推动科研资助机构主导的强制化数据共享,二是完善我国科学数据汇交质量评价体系,三是形成前置化的数据管理与共享模式,四是制定人类参与者数据安全共享指南。

ObjectiveBy reviewing the new requirements of NIH Policy for Data Management and Sharing(DMS Policy)issued by the National Institutes of Health in 2020 and summarizing the trends of scientific data management and sharing in the future,this study provided enlightenment and reference for China to improve the construction of scientific data management policy system and promote the practice of biomedical scientific data sharing.MethodsUsing a comparative historical approach,this study compared the two editions of DMS policy published in 2003 and 2020 from the aspects of policy structure and policy contents.ResultsThe new DMS policy presented the following trends:mandatory data sharing,high-quality data submission,prospective data management,and intensified privacy protection.ConclusionsAccording to the national conditions of China,this paper put forward the following suggestions:promoting mandatory data sharing led by research funders,improving the quality evaluation system for scientific data submission;forming a prepositioned data management and sharing mode;and developing guidelines for secure sharing and use of data derived from human participants.