From Research Exemption to Research Norm: Recognising an Alternative to Consent for Large Scale Biobank Research

Abstract

The Data Protection Directive (95/46/EC) allows Member States the option of implementing (with adequate safeguards) what might be described as ‘Research Exemptions’. This allows for specific, limited derogations from the ordinary operation of the rights and duties of the Directive in the specific circumstances of scientific, historical and statistical purposes. This article argues that this option should be considered not as an ‘exemption’ (implying an ‘abnormal’ route), but as an equally acceptable route to achieve protection when secondary-processing data in large biobanks and data sets, operating without attending to any kind of consent. This can be done without reducing data subjects' privacy and related interests, through appropriate safeguards. We have suggested that such appropriate safeguards require research organisations to implement stringent security for the processing of data, robust assessment of proportionality, the possibility of opt-out for individuals, and introducing various forms of public participation.