Centre for Research Ethics & Bioethics (CRB)

New law for Biobank researchers

2014-04-25

The decision taken by the Swedish Data Inspection Board to stop the Life Gene research project was the point of departure for a lively nationwide debate on the legal criteria for biobank research projects in Sweden. The Data Inspection Board based its decision on the fact that Life Gene’s research purpose was not specific enough: This made it incompatible with the requirements of both the EU Data protection directive and the Swedish Personal Data Act.

To make research like the life gene project possible the Swedish Parliament (Riksdag) has enacted a new legislative Act on registers for research on the health implications of heritage and environment (Lag  [2013:794] om vissa register för forskning om vad arv och miljö betyder för människors hälsa) that entered into force on November 1st, 2013.  This Act provides a legal ground for universities and colleges to process personal data.

This legislation creates the basis for research projects dealing with the implications of heritage and environment for developing different deceases and the health of human beings in general.  A precondition for processing data is that the person (data subject) has given his or her expressed consent. The Act is in force until December 31st 2015, and will until then be evaluated in light of the legal changes in Sweden and in a European context such as the suggested EU Data Protection Regulation. The Riksdag has delegated to the Government to decide which universities will be entitled to carry out this data processing. This means that Life Gene is now up and running again!

By Anna-Sara Lind

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