The National Office for Research Ethics Committees will launch Ireland’s first National Research Ethics Committees (NRECs) in the areas of clinical trials of investigational medical products (NREC-CT) and clinical investigations of medical devices (NREC-MD) in May this year.
In the 12 months since the National Office was established, our team has been working closely with the key stakeholders in the regulation of health research, including the Department of Health, on a roadmap of transition to research ethics review at a national level for particular health research remits. At a webinar on 11 March, we shared plans for launch of the initial priority NRECs with over 500 attendees from the research community and beyond. The main points are summarised here.
Collaboration key to a successful transition
In line with the intention of the Minister for Health to appoint NRECs in these priority areas of health research, we are working in partnership with the Department to lead the transition to a mixed-model system of research ethics review at both national and local levels. Importantly, we are also working closely with the Health Products Regulatory Authority (HPRA) to ensure coordination where necessary for decisions at a national level for CTIMPs and clinical investigations of medical devices. EU Regulations will shortly require Member States to return a ‘single national decision’ in these areas, and the National Office is committed to ongoing collaboration with all bodies involved in the regulation of health research to ensure national readiness in this regard.
New NRECs set to start work in May
Two NRECs for CTIMPs (NREC-CT, A & B) and one for clinical investigations of medical devices (NREC-MD) will convene from May. Each committee will meet on a monthly basis to consider valid applications made to them via the National Office according to submission deadlines. The National Office team will support the NRECs to return timely decisions following a robust and predictable review process.
Working in partnership with local RECs
The National Office continues to engage with local research ethics committees as a key stakeholder for the transition. Existing ‘recognised RECs’ will continue to operate concurrently with the NREC-CT to provide ethics review for CTIMPs after the NREC launch in May for a defined transition period until December 2021. This will support and inform national preparedness for the EU Clinical Trial Regulation (No 536/2014), which is anticipated to be implemented in January 2022.
Given the imminent implementation date of the Medical Device Regulation (No 2017/745), a ‘hard-stop’ will be necessary for local RECs for review of clinical investigations of medical devices. Consequently, clinical investigations with an indicated start date after 26 May 2021 should be considered by the NREC-MD.
Details of the application process will be shared on the National Office website and, where appropriate, the HPRA website in the coming weeks. Dates for NREC meetings and associated submission cut-off dates will be shared on the National Office website shortly.