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The Data Protection Act 2018 (Section 36(2)) (Health Research)
Regulations 2018 (S.I. No. 314/2018) (the
Health
Research
Regulations ), which
contain stringent rules in relation to the collection, use and
sharing of personal data for health research purposes, have been
amended by the Minister for Health by way of the Data Protection
Act 2018 (Section 36(2)) (Health Research) (Amendment) Regulations
2021 (the
2021 Regulations ).
As discussed in a 2019 briefing on the Health Research
Regulations (available here) The
Department of Health had identified retrospective chart reviews,
pre-screening for the purpose of assessing eligibility/suitability
Dr Mairéad O’Driscoll, HRB chief executive
Health Research Board welcomes update to personal data guidelines
The Health Research Board (HRB) has welcomed an update to regulations governing the collection of personal information for health research purposes.
The Health Research Regulations (HRR) were introduced in 2018 in response to the European-wide General Data Protection Regulations (GDPR) to protect the rights and freedoms of research participants.
The recent amendments covered pre-screening to establish suitability or eligibility for inclusion in health research; carrying out low risk retrospective chart reviews; deferred consent in exceptional medical situations; and new rules on consent generally.
Dr Mairead O’Driscoll, Chief Executive at the Health Research Board, said that the amendments were “important and pragmatic changes to the Health Research Regulations in response to matters raised by the research community”.