COVID-19 Research: Navigating the European General Data Protection Regulation

in Journal of Medical Internet Research (2020)

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 ... [more ▼]

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. [less ▲]

Leveraging European infrastructures to access 1 million human genomes by 2022

in Nature Reviews. Genetics (2019)

Human genomics is undergoing a step change from being a predominantly research-driven activity to one driven through health care as many countries in Europe now have nascent precision medicine programmes ... [more ▼]

Human genomics is undergoing a step change from being a predominantly research-driven activity to one driven through health care as many countries in Europe now have nascent precision medicine programmes. To maximize the value of the genomic data generated, these data will need to be shared between institutions and across countries. In recognition of this challenge, 21 European countries recently signed a declaration to transnationally share data on at least 1 million human genomes by 2022. In this Roadmap, we identify the challenges of data sharing across borders and demonstrate that European research infrastructures are well-positioned to support the rapid implementation of widespread genomic data access. [less ▲]

EATRIS Infrastructure Accelerates Translation

in BIOforum Europe (2010), (1-2), 14-16

Efficient translation of research discoveries into clinical application is essential to improve human health and maintain Europe’s competitiveness in biomedical research and in health industry. A major ... [more ▼]

Efficient translation of research discoveries into clinical application is essential to improve human health and maintain Europe’s competitiveness in biomedical research and in health industry. A major bottleneck is the lack and the frag- mented nature of research infrastructure and know-how, leading to unacceptable delays or preventing of the development of new innovative medicines. The aim of EATRIS, European Advanced Translational Research InfraStructure in Medicine, is to fill this gap by developing a pan-European research infrastructure. [less ▲]