Health minister Stephen Donnelly has signed the Health Research Regulation 2018 Amendments on 22nd January. The Department of Health has issued a press release on the amendment.
Full details and documentation on the amended regulations are available on the gov.ie website.
The Amendments relate to five substantive areas: Pre-screening to establish suitability or eligibility for inclusion in health research; carrying out low risk retrospective chart reviews; deferred consent in exceptional medical situations and new rules on consent generally.
The Health Research Consent Declaration Committee have placed guidance on the amendment on the HRCDC website.