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EU Data Protection Regulation

The new European Data Protection Regulation was agreed in April 2016 and will take effect from May 2018.

It updates the EU’s data privacy law. Once the Regulation takes effect the processing of personal data will have to comply with the rules it sets out.

The Regulation applies to any research that uses personal data, including scientific research and studies in the arts and humanities. This may include public health research, studies on health outcomes, epidemiology, clinical trials, social sciences, politics and modern history. It does not apply to anonymous data, which does not identify specific individuals.

In general, the new Regulation provides a supportive framework for scientific research, including safeguards to ensure personal information is used appropriately and remains secure. However some of the rules for research are delegated to Member States and need to be implemented at a national level before they can apply.

During preparation, the HRB was a member of the EU Lobby Group led by the Wellcome Trust that worked to ensure that the voice of research was heard.  Further details on the timeline, the position taken during negotiations, and an analysis of the key clauses of the Regulation related to research are available online on the Welcome Trust website.

Implementing the Regulation to support research

The HRB will continue to work with other research and patient organisations in Europe to ensure that implementation supports research.

Member States now have a crucial role to play in implementation. It is essential that Member States take action as soon as possible to review and amend their current laws to enable research to take place and provide legal clarity and certainty for researchers, including:

  • Introducing safeguards that allow the special rules for scientific research, such as those in Articles 5, 6 and 9, to apply.
  • Introducing further scientific research exemptions under Article 89.
  • Introducing exemptions for freedom of expression for academic purposes under Article 85.

See joint statement from EU Member States on implementation, published on the Science Europe and Wellcome Trust websites.



HRB Webinar on EU Data Protection Regulation and research - June 2014

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