Becker Regina, Thorogood Adrian, Ordish Johan, Beauvais Michael J S
ELIXIR-Luxembourg, Luxembourg Centre for Systems Biomedicine (LCSB), University of Luxembourg, Esch-sur-Alzette, Luxembourg.
Centre of Genomics and Policy, McGill University, Montreal, QC, Canada.
J Med Internet Res. 2020 Aug 27;22(8):e19799. doi: 10.2196/19799.
Researchers must collaborate globally to rapidly respond to the COVID-19 pandemic. In Europe, the General Data Protection Regulation (GDPR) regulates the processing of personal data, including health data of value to researchers. Even during a pandemic, research still requires a legal basis for the processing of sensitive data, additional justification for its processing, and a basis for any transfer of data outside Europe. The GDPR does provide legal grounds and derogations that can support research addressing a pandemic, if the data processing activities are proportionate to the aim pursued and accompanied by suitable safeguards. During a pandemic, a public interest basis may be more promising for research than a consent basis, given the high standards set out in the GDPR. However, the GDPR leaves many aspects of the public interest basis to be determined by individual Member States, which have not fully or uniformly made use of all options. The consequence is an inconsistent legal patchwork that displays insufficient clarity and impedes joint approaches. The COVID-19 experience provides lessons for national legislatures. Responsiveness to pandemics requires clear and harmonized laws that consider the related practical challenges and support collaborative global research in the public interest.
研究人员必须在全球范围内开展合作，以便对新冠疫情迅速做出应对。在欧洲，《通用数据保护条例》（GDPR）对个人数据（包括对研究人员有价值的健康数据）的处理进行规范。即便在疫情期间，研究工作仍需要有处理敏感数据的法律依据、处理这些数据的额外理由以及将数据传输至欧洲境外的依据。如果数据处理活动与所追求的目标相称并伴有适当的保障措施，那么GDPR确实提供了能够支持应对疫情研究的法律依据和豁免规定。在疫情期间，鉴于GDPR所规定的高标准，基于公共利益的依据对于研究而言可能比基于同意的依据更具前景。然而，GDPR将基于公共利益依据的许多方面留给了各成员国自行决定，而各成员国并未充分或统一地利用所有选项。其结果是形成了一个不一致的法律拼凑局面，缺乏足够的清晰度，阻碍了联合行动。新冠疫情的经历为各国立法机构提供了经验教训。应对疫情需要制定明确且协调一致的法律，这些法律要考虑到相关实际挑战，并支持符合公共利益的全球合作研究。
