LegalizeS.I. No. 377/2026 - European Union (Recognised Research Ethics Committees) Regulations 2026
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Notice of the making of this Statutory Instrument was published in
“Iris Oifigiúil” of 31st July, 2026.
I, JENNIFER CARROLL MACNEILL, Minister for Health, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972), for the purpose of giving further effect to Council Directive 2013/59/EURATOM of 5 December 20131 , as affected by Corrigendum of 17 March 20122 and Corrigendum of 11 June 20193 , insofar as it relates to medical exposures, hereby make the following regulations:
1.
These Regulations may be cited as the European Union (Recognised Research Ethics Committees) Regulations 2026.
2.
The European Union (Basic Safety Standards for Protection Against Dangers Arising from Medical Exposure to Ionising Radiation) Regulations 2018 ( S.I. No. 256 of 2018 ) are amended —
- (a) in Regulation 37(4), by substituting “Supervisory Body” for “Supervisory Authority”,
- (b) in Regulation 38, by inserting “or recognised under Regulation 40” after “Regulation 37”,
- (c) by substituting for Regulation 40 (Inserted by Regulation 5(b) of S.I. No. 29 of 2023 ) the following:
“40. Notwithstanding Regulation 37, the research ethics committees specified in Schedule 2 are recognised as research ethics committees for the purposes of these Regulations.”,
and
- (d) by inserting after Schedule 1 the following:
“Regulation 40
Schedule 2 Recognised Research Ethics Committees
Tallaght University Hospital / St. James’s University Hospital REC
Clinical Research Ethics Committee of the Cork Teaching Hospitals
Galway University Hospitals
Mater Misericordiae University Hospital / Mater Private Hospital
St. Vincent’s Healthcare Group
University of Limerick Hospitals
Beaumont Hospital REC
HSE South-Eastern Area
HSE North-East
National Maternity Hospital (Holles Street)
Irish College of General Practitioners
St. Luke’s Radiation Oncology REC
National Research Ethics Committee for Clinical Trials of Medicinal Products for clinical trials regulated by Regulation (EU) No. 536/2014
National Research Ethics Committee for Performance Studies of In Vitro Diagnostic Medical Devices for performance studies regulated by Regulation (EU) 2017/746
National Research Ethics Committees for Clinical Investigations of Medical Devices for clinical investigations regulated by Regulation (EU) 2017/745
GIVEN under my Official Seal,
22 July, 2026.
JENNIFER CARROLL MACNEILL,
Minister for Health.
EXPLANATORY NOTE
(This note is not part of the Instrument and does not purport to be a legal interpretation.)
These Regulations list the Recognised Research Ethics Committees for the purposes of S.I. 256/2018.
Footnotes
OJ No. L 13, 17.1.2014, p. 1
OJ No. L 72, 17.3.2016, p. 69
OJ No. L 152, 11.6.2019, p. 128
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