Following the Biobanking Seminar and Debate on 11 January, and subsequent roundtable discussion on 27 March, Dr Suzanne Bracken, Translational Research Manager at CRDI, agreed to draft a submission in consultation with the Irish biobanking community to voice concerns and pose questions about the General Data Protection Regulation (GDPR) (EU) 2016/679 in relation to biobanking.
The submission and a list of stakeholders endorsing it were sent by CRDI to the Office of the Data Protection Commissioner and the Department of Health (DoH) on 4 May. The submission can be viewed here.
A reply was received from the Office of the Data Protection Commissioner on the 14 May to say while they were open to meeting with CRDI and other stakeholders, they believed it would be of little benefit ahead of the finalised legislation for the processing of personal data for health research purposes by the Department of Health. They also pointed to the recently revised Article 29 Working Party guidelines in relation to consent and transparency which can be viewed here.
A reply was also received on 11 May from Jim Breslin, Secretary General of the DoH, to advise that Muiris O’Connor, Head of R&D and Health Analytics, would follow up directly with CRDI on these issues.
CRDI understands that the new Health Information Legislation will be ready shortly, and in the meantime, the DoH are open to receiving queries which may help formulate their guidance documents.
For further information, the Biobanking and BioMolecular resources Research Infrastructure – European Research Infrastructure Consortium (BBMRI-ERIC) held a webinar on GDPR and scientific research on 25 April. The webinar discussed the UK position which is shifting away from the use of consent as a lawful basis for scientific research, and distinguishes between consent as a lawful basis for processing data and consent as a common law duty of confidence required for ethical reasons. Click here to watch the webinar or here to view the slides.