Health Research Regulations 2018 FAQ


All content related to GDPR and health research was created in close collaboration with the Department of Health. The responsiblity for compliance with the GDPR, the Data Protection Acts and the Health Research Regulations 2018 lies solely with the data controller or joint-data controllers.

The HRB’s “Guidance for health researchers” aims to assist research organisations and researchers who are processing personal data for the purposes of health research understand and implement their data protection obligations under GDPR, the Data Protection Act 2018 and the new Health Research Regulations 2018.

While the HRB’s guidance has been prepared with the utmost care and aims to be as accurate as possible, it should be noted that this is not legal advice.  The information provided here is strictly for guidance purposes only and the HRB is not liable for any erroneous, obsolete or incomplete information. 

It should also be noted that these are new legal instruments, and therefore, in many instances, it is not possible to provide definitive guidance at this point in time. 

The HRB is not in a position to provide project specific guidance or advice. 

Individual researchers who are processing personal data for the purposes of health research should seek project specific advice from their organisations’ Data Protection Officer before relying upon any information provided.

NEW 29/08/2018 Case Study 4

Would the processing of patient data in the search for a clinical trial treatment for the patient come under Article 6.1(d) (GDPR): processing is necessary in order to protect the vital interests of the data subject or of another natural person.  Since the clinical trial treatment may be vital to the successful recovery of the patient.

The following general points may be noted:

Data processing related to a specific patient in the context of choosing the best course of treatment for that patient is not for the purpose of health research but is for the purpose of identifying a potential course of treatment for a particular patient.  

The general points made in relation to Case Study 3 are also relevant.