Amendments to Health Research Regulations

The Minister for Health, Stephen Donnelly TD, has made amendments to the Health Research Regulations 2018 (S.I. No. 314 of 2018).

Those amendments deal with the following five substantive areas:

• processing of personal data to establish suitability or eligibility for inclusion in health research
• carrying out low risk retrospective chart reviews
• deferred consent for the processing of personal data for health research in exceptional situations
• informed consent for health research obtained during the time of the EU Data Protection Directive
• explicit consent for processing personal data in a health research context.

The amendments also deal with appeals and technical matters.