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New law protects the registry research

This year there will be a decision concerning new legislation/regulations protecting personal data in the EU.

The new data protection regulation is expected to be decided on in 2016 and will come into force in 2018. It covers everything involving integrity protection (except the needs of the police to track criminals).

When the European Parliament first presented its list of changes in the new data protection regulation in 2014 the European medicine research society reacted strongly. In particular they were concerned about requirements on consent from the individual each time registry data was to be used in a new study. Besides the practical difficulties researchers also meant that this could lead to skewed results. Since then researchers and research institutions have been committed to convincing the European legislators about the difficulties with this regulation, for example by a noticeable uprising in The Times. The European Council of Ministers hence came with a new suggestion last summer, more in line with the researchers’ wishes, and it is now clear that their points of view will be considered in the new regulations. Participants in registry studies will now be able to give a broader consent when collecting data for purposes that cannot be specified in advance, which characteristically applies for registry research.

When the new law comes into force it will replace the national legislation in the EU member states, for example the Swedish PUL, Personuppgiftslagen, will end and be replaced during spring 2018. However, certain paragraphs in the new legislation must be adjusted to the legislation in each country, for example the Etikprövningslagen in Sweden.

In Sweden work is being carried out to establish new rules about registry research. In 2011 Datainspektionen prohibited the population study LifeGene due to lack of legislation in the field. The study was put on hold until a new law came into force in 2013. This temporary law was originally valid until the end of 2015, but while waiting for the new law the government decided to prolong it until the end of 2017.

“This is a success for registry based research and for medical research overall. We are able to continue to perform research on big data as previously,” commented Magnus Stenbeck, Docent at the Institution for Clinical Neuroscience at Karolinska Institute to Läkartidningen. “It could be a little problematic, logistically and economically, when you need to inform all participants in a register about a new study, but they write that if it is impossible or unreasonable to inform everybody the rules may be adjusted to the situation, and that is now one reason today why a study is ethically evaluated.”