Legislation
Ireland plays its part in the implementation of this legislative framework to deliver a coordinated ‘single national ethics opinion’ for regulated health research, within a defined legislative timeframe.
To achieve this, the National Research Ethics Committees (NRECs) have been established to provide ethical oversight of clinical trials on medicinal products (NREC-CTs), clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices (both under the remit of NREC-MD).
Legislation enactment
The Irish Statutory Instruments (S.I.s) give effect to the work of the National Office and NRECs.
As of 31 January 2022, clinical trials on investigational medicinal products are regulated by the Clinical Trials Regulations (CTR, EU No. 536/2014) which is nationally implemented by S.I. No 41/2022 and S.I. 99/2022.
As of 30 January 2025, no applications can be made under the Clinical Trials Directive (2001/20/EC) which is nationally implemented by S.I. No 190/2004.
As of 26 May 2021, clinical investigations of medical devices are regulated by the Medical Device Regulations (MDR, EU No. 2017/745), which is nationally implemented by S.I. No 261/2021 and S.I. No 671/2023.
As of 26 May 2022, performance studies of in vitro diagnostic medical devices are regulated by the In Vitro Diagnostic Medical Devices Regulation (IVDR, EU No. 2017/476), which is nationally implemented by S.I. No 256/2022 and S.I. No 257/2022.
Other legislative frameworks
The research ethics framework in Ireland is also complemented by Health Research Regulations (2018), which provide for a statutory consent declaration process when the public interest in conducting research significantly outweighs the need for explicit consent.
The Department of Health is also engaged with the National Office regarding additional legislation to strengthen the research ethics infrastructure in Ireland, through the development of the National Research Ethics Committee Bill (2019).
Useful links:
- EU Clinical Trials Regulation No 536/2014
- EU Medical Devices Regulation No 2017/745
- EU In Vitro Diagnostic Medical Devices Regulation No 2017/746
- General Scheme of the National Research Ethics Committees Bill
- S.I. No. 190/2004 - European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004
- S.I. No. 41/2022 - European Union (Clinical Trials on Medicinal Products for Human Use) (National Research Ethics Committees) Regulations 2022
- S.I. No. 257/2022 - European Union (National Research Ethics Committees for Performance Studies of In Vitro Diagnostic Medical Devices) Regulations 2022
- S.I. No. 671/2023 - European Union (National Research Ethics Committees for Clinical Investigations of Medical Devices) Regulations 2023
- S.I. No. 314/2018 – The Data Protection Act 2018 (Section 36(2)) (Health Research) Regulations 2018