Amendments to the Health Research Regulations
The Health Research Regulations provide the legal framework alongside European, Constitutional and common law principles that govern the collection, use, storing and sharing of an individual’s personal information for health research purposes.
Wednesday 21st April 2021
Trinity Roundtable: Amendments to the Health Research Regulations - What researchers need to know
Amendments to the Regulations, made by the Minister for Health in January, may affect what is permissible for health researchers considering new studies. The amendments relate to pre-screening of participants for the inclusion in research, retrospective chart review, deferred consent, informed consent obtained during the previous EU Data Protection Directive, clarifying ‘explicit’ consent as a safeguard, and other technical and appeal amendments. As such, all health researchers need to understand the implications of the amendments. Representatives from the Dept of Health, Data Protection Commission and the HRCDC Secretariat provide an insight into the amendments and their implications.
Wednesday 28th April 2021
Trinity Masterclass: Amendments to the Health Research Regulations - Exploring Consent
One major issue at the heart of the Regulations and the broader legal framework is that of consent. With recent amendments made to the Regulations, by the Minister for Health in January, there have been some changes made in relation to consent obtained prior to the Regulations, and deferred consent in cases of emergency care. This Trinity Masterclass brought together representatives from the Dept of Health, the HRCDC Secretariat and the Data Protection Commission to explore consent within the Regulations and the wider legal framework and certain challenges which remain around Assisted Decision Making.