Ireland’s new Health Research Regulations (August 2018) are part of the Data Protection Act (May 2018), enacted in response to the GDPR (General Data Protection Regulations) of the European Union.

The new Regulations will safeguard data privacy for patients who, having been fully informed, give consent to have their blood, cancer tissue and associated coded data used for research. Informed consent has been best practice and is now being complemented by more stringent requirements to safeguard patient data. Biobanks and researchers have adopted the Regulations for new research projects.

However, the research community has serious concerns about (1) the vulnerability of ongoing research projects and (2) the research use of archival diagnostic pathology samples and data, under the new legislation. There is active discussion among relevant stakeholders and with the Department of Health, amid genuine fears that research will be impeded rather than encouraged.