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) will be in the areas of clinical trials of medicinal products (NREC-CT) and clinical investigations of medical devices (NREC-MD). These committees will 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) and for clinical investigations of medical devices (Regulation EU No 2017/745). 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 will 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.

Until the legislative processes described above are complete, clinical trials in Ireland will continue to be regulated by S.I. No. 190/2004. As of 26th 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.

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