Dáil Éireann Debate, Tuesday - 25 July 2023
1180. Deputy John Paul Phelan asked the Minister for Health to provide an update the status of the National Research Ethics Committees Bill 2019; whether he will provide a statement on the Government's position on the legislation; and if he will make a statement on the matter. [35963/23]
View answerNational Research Ethics Committees (NRECs) are important because they ensure a robust ethical review process for health research is in place, one that relies on national expert opinions and public/patient engagement. NRECs also allow for the formation of one national ethical decision on health research. This decision eliminates the requirement for multiple ethical approvals on studies being conducted across multiple national sites. It also reduces wait times for ethical approval and strengthens the Irish health research landscape, making Ireland a more attractive location for clinical trials.
The National Research Ethics Committee (NREC) Bill is currently under review. The draft Heads of Bill were originally developed in 2019 but the Government decision was to prioritise moving ahead with secondary legislation in order to meet tight timelines emerging from EU regulation.
Since then the National Office for Research Ethics Committees was established as a constituent unit within the Health Research Board and two NREC have become operational through Statutory Instruments:
• The NREC for clinical trials on medicinal products for human use operates under S.I. 99/2022, which is linked to EU Regulation 536/2014
• The NREC for clinical investigations of medical devices operates under S.I. 260/2021, which is linked to EU Regulation 2017/745
• S.I. 256/2022 established a national research ethics committee for the purposes of conducting ethical reviews of in vitro diagnostic devices (linked to EU Regulation 2017/746) (IVDR). In Ireland this NREC is operated under the same NREC as medical devices, with members appointed based on corresponding legislation.
It is important that the original draft heads of Bill are considered in light of the lessons learned from these developments.
