In a statement issued by the Wellcome Trust and co-signed by more than 40 organisations, the group now urges the European Commission and Parliament to ‘find a solution' that safeguards personal data without stifling important social science and medical research as it begins to finalise the regulations.
The process to revise the EU rules around data protection began in 2012, to replace outdated regulation from 1995 which was inadequate to deal with technological advances in areas such as social networking and cloud computing.
A key challenge for those involved throughout this process has been balancing individuals’ right to object to the processing of their personal data, while maintaining key exemptions to allow for historical, statistical or scientific research purposes (with appropriate safeguards in place).
An initial draft by the European Commission in 2012 acknowledged that gaining specific consent from individuals, regarding the safe use of their personal data, is not always possible for research. The European Parliament’s amendments to this draft in March 2014 significantly reduced the scope of research exemptions, raising concerns in the science and research community. However, the new 'general approach' from the European Council, detailed in this June 2015 statement, presents a more positive position for research as key exemptions are maintained.
A position paper drawn up by the Wellcome Trust explains that, in practice, a lot of important research would become ‘impossible’ if the use of personal data was not allowed in research without specific consent.‘The requirement for specific consent fails to take account of the fact that this research is subject to ethical approval and strict confidentiality safeguards, and the identity of individuals is often masked,’ it says. 'This would put at risk significant European investments in genetics, cohort studies, biobanks, disease registries and the use of routinely collected data, and associated progress towards understanding society, health, and disease that delivers real patient benefit.'
The EU Council will begin negotiations with the European Parliament and European Commission on 24 June 2015, with the intention of finalising the legislation by 2016.