Legislation

 

Legislation

Research ethics review framework in Ireland will be modernised through a twin-track legislative approach. The initial priority National Research Ethics Committees (NRECs) have been in the areas of clinical trials of medicinal products (NREC-CT), clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices (both reviewed by NREC-MD). These committees operate on a statutory basis by amendments (secondary legislation) to be made by the Minister for Health to existing Statutory Instruments. This first ‘track’ will enable Ireland to meet its obligations as a Member State to imminent EU Regulations for clinical trials of medicinal products (Regulation EU No 536/2014), clinical investigations of medical devices (Regulation EU No 2017/745) and performance studies of in vitro diagnostic medical devices (Regulation EU No. 2017/746). This includes the requirement to return a ‘single national decision’ following parallel regulatory and ethics review of research studies in these regulated areas within a defined timeframe. These EU Regulations harmonise how such research studies are conducted across the EU, and it is essential that Ireland is poised to implement their requirements to maximise the benefits for health and the economy.

The second ‘track’ to the twin-track approach to research ethics reform is the National Research Ethics Committee Bill. Drafted in July 2019, primary legislation based on this Bill will allow for NRECs to be established in other areas of health research over time. Work on the NREC Bill is a priority and will continue throughout 2021.

As of 31 January 2022, clinical trials of investigational medicinal products are now regulated by the Clinical Trials Regulation (CTR, EU no 536/2014) which is nationally regulated by S.I. 41/99 of 2022. Until the end of the transition period on 31 January 2023, all new applications can be made either under the CTR or the Clinical Trials Directive (2001/20/EC) which is nationally regulated by S.I. No 190/2004.

As of 26 May 2021, all clinical investigations of medical devices are regulated by the Medical Device Regulations (MDR, EU No. 2017/745), which is nationally implemented by S.I. 260/261 of 2021.

As of 26 May 2022, all new performance studies of in vitro diagnostic medical devices are regulated by the In Vitro Diagnostic Medical Devices Regulation No. 2017/476.

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