Will the Eu Data Protection Regulation 2016/679 Inhibit Critical Care Research?

There is an inherent tension between critical care research and data protection. Because
of their condition it is not possible to ask for the patients’ informed consent to be enrolled in observational research at the point of admission to the hospital. Often this is
not possible at a later moment either. Yet informed consent is the baseline to be
enrolled in research with personal data and exceptions must be allowed for by national
legislation. This was the case under Directive 95/96/EC and will be the case under the
General Data Protection Regulation (GDPR, Regulation 2016/679 EU) which will
replace the Directive from 25 May 2018 onwards. Though being a Regulation and
therefore directly applicable in the Member States, the long debate about the research
exceptions in the GDPR left many aspects of observational research including the exception to the informed consent principle, mainly to the Member States. It may be assumed
that most Member States will leave their present state of the law intact in this respect as
that was part of the political compromise. We compared existing national privacy legislation from the perspective of critical care research and found great variation. Although
this may not impede the collection of emergency and critical care research with data
without prior informed consent in countries which are more responsive to such
research, it might be a challenge to exchange such data from the national nodes in
European wide research collaboration. We make a case that countries which are not responsive to such research should adapt their legislation in the interests of future critical
care patients.