Researchers will not be as adversely affected by new European Commission’s new Data Protection Regulations than was previously feared, after it transpired that the new regulations, as agreed in December 2015, will include provisions for data use in research with ‘broad’ rather than ‘specific’ consent required from individuals.
Amendments to the initial draft of the regulations, made in March 2014, significantly reduced the scope of exemptions for research purposes. This raised concerns in the science and research community that the scope to use data would be severely limited, thus threatening some studies.
The RSS, along with many other organisations, signed up to a joint statement drafted by the Wellcome Trust which urged the Commission to ‘maintain important exemptions for health and scientific research.’
These concerns have been acknowledged in the new regulations, which rejected the proposed amendments - an outcome which has been welcomed by many in the research community. Beth Thompson from the Wellcome Trust said the new regulations now allow ‘vital research to take place while protecting individuals’ privacy.’ The RSS also welcomes the news: ‘We are pleased that the final legislation takes a proportionate approach to research,’ said RSS executive director Hetan Shah.
Other additions to the new draft include clearer definitions of data concerning health and genetic data and a definition of ‘pseudonymisation’ in relation to personal data.
The new rules will apply from two years after the regulations enter into force in 2016 – this is expected to be the first half of 2018.