Centre for Research Ethics & Bioethics (CRB)

Swedish research data inquiry on exceptions

2016-12-13

The Swedish Government has decided to commission a Research Data Inquiry to review regulations regarding the processing of personal data for research. The reference group includes three researchers from CRB: Mats G. Hansson, Anna-Sara Lind and Jane Reichel.

The General Data Protection Regulation (GDPR) was enacted by the European Union in April 2016. It has the legislative form of a regulation instead of a directive and frequently refers to the national legislators in the Member States and the enactment of national law. This is why the regulation has an implementation period of two years, and will not enter into force until May 2018.

Mats G. Hansson
Mats G. Hansson, Professor of Biomedical Ethics

The Swedish Government has decided to appoint several enquiries in order to meet the requirements posed by the regulation (some were discussed in the previous issue of Biobank Perspectives). For example, the Research Data Inquiry (U 2016:04) will focus on issues relating to processing of personal data in research to meet the requirement in article 89 of the GDPR where Member States, or the EU, may enact legislation in order to lay down appropriate safeguards for the processing of personal data in research, enabling the use of exceptions from general data protection requirements.

The Research Data Inquiry will suggest a general framework for research, which, among other things, will entail an investigation of the possibility of extending the requirement for ethical vetting to all personal data. The inquiry is further tasked with analysing the need for adapted rules for the National Biobank Registry, the National Board of Forensic Medicine’s Registry as well as other registries relevant for the research relating to health, genetics and environment.

Jane Reichel
Jane Reichel, Professor of Administrative Law

The reference group connected to the Research Data Inquiry consists of around 30 experts from academia, public authorities and NGOs, who will support the work of the inquiry. Jane Reichel is presently working in the Horizon 2020-project B3Africa on biobank collaboration between the EU and several African states. For her, the question of transfer of personal data outside the EU is especially relevant.

“I look forward to the opportunity to discuss the consequences the strict requirements for transfer of health data for research outside the EU, which may prove to be an obstacle in international collaborations”, says Jane Reichel.

Anna-Sara Lind
Anna-Sara Lind, Associate Professor of Public Law

Mats G. Hansson is interested in how the GDPR’s emphasis on data minimization should be balanced against the need of data mining of big data sets for linking omic- and phenotypic data.

Anna-Sara Lind is interested in making the GDPR functional in a complex setting where personal integrity is involved and regulated in many different ways such as EU law, constitutional acts and statutory legislation.

“I believe protecting integrity should be balanced with the societal interests of good public health, well-functioning health care and research that has the means to make the most out of modern technological achievements”, says Anna-Sara Lind

The Inquiry will present some of its findings on 1 June 2017 and a full report by 8 December 2017.

By Anna-Sara Lind

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