Legislation
Background
An agreement was reached under Section 11 of the Statistics Act, 1993 to enable the Central Statistics Office (CSO) to collate COVID-19 data in areas including testing, tracing, infectious disease notification and hospitalisation for processing under the Statistics Act. To date, this data has been used solely by a subgroup of the National Public Health Emergency Team (NPHET).
A mechanism has now been established to facilitate secure and controlled access to Irish COVID-19 datasets for research purposes, via the CSO Researcher Microdata Files (RMFs) process under Section 20(c) of The Statistics Act 1993 and utilising the existing governance safeguards in the research system. The Research Data Governance Board (RDGB) provides a central governance focus integrating all the necessary protocols and safeguards to ensure compliance and best practice under the Statistics Act, 1993 and the Data Protection Act 2018/Health Research Regulations 2018 within a single, collaborative, transparent process.
Ensuring compliance
Access by the CSO to the sensitive confidential health data is underpinned by the written permission of the Minister for Health and provided for under Section 30 of the Statistics Act 1993 - ‘Use of Records of Public Authorities for Statistical Purposes’. The collaboration between the CSO, Health Service Executive (HSE) and Department of Health (DoH) is enabled by Section 11 of the Statistics Act, 1993 which provides for the 'Cooperation and Liaison with other Public Authorities and Persons'.
The processing of all personal data as contained in the COVID-19 Data Flows by RMF researchers must be compliant with the Health Research Regulations (Data Protection Act 2018 (Section 36 (2) Health Research Regulations 2018 018). Such processing is permitted under Article 6.1.e, Article 9.2.i and j of the General Data Protection Regulation (GDPR). Processing of personal health data as contained in the COVID-19 Data Flows is also permitted under Sections 38.1.a, 42.1.c, 53 and 54.c of the Data Protection Act 2018. Data access is restricted to approved researchers who are appointed as Officers of Statistics under Section 20(c) of the Statistics Act, 1993.
Application to the Health Research Consent Declaration Committ
As explicit consent is not the legal basis for processing RMFs for health research but is a mandatory safeguard under the Health Research Regulations, all RMF researchers must apply to the Health Research Consent Declaration Committee (HRCDC) for a consent declaration.
A consent declaration shall only be made by the HRCDC when it is satisfied all data protection safeguards and technical and organisational measures have been met, and the public interest in carrying out the health research significantly outweighs the public interest in requiring the explicit consent of the individual who owns the personal data.
All health research involving patients and the public must also be governed according to prevailing international best practice and ethical principles.
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