On 24 June 2015, the EU Council of Ministers, European Parliament and European Commission will begin trilogue discussions on the EU Data Protection Regulation.
While the positions of the Commission and the Council include significant exemptions for scientific research, the Parliament’s position significantly limits the scope of the exemptions.
In February 2015, the Nuffield Council on Bioethics published its report The collection, linking and use of data in health care and biomedical research: ethical issues.
Dr Peter Mills, Assistant Director of the Nuffield Council on Bioethics, said:
“In the era of ‘Big Data’ where data are increasingly linked and re-used, the risk of individuals being re-identified cannot be completely eliminated. Much discussion around the Data Protection Regulation has focussed on the form of consent required and the terms of research exemptions, especially for biomedical and genetic research.
“As our recent report argues, ethically responsible data use involves finding a correspondence between three important considerations: the nature of the privacy interests actually at stake, the nature of the choice available to participants, and the governance measures that apply in each case.
“In well-governed research, with low risks to individual privacy, ‘broad’ consent, which envisages data being used for a defined range of possible research purposes, can be perfectly adequate and, in such cases, should not be regarded as an inferior form of consent compared to more narrowly specified forms. However, as the report finds, no particular type of consent is either necessary or sufficient to protect the privacy interests of those involved. Consent can only ever be part of the equation.”