National Office for
Research Ethics Committees
The National Office for Research Ethics Committees is an important component of the research environment in Ireland. Our mission is to continue to embed a robust, transparent and cohesive research ethics review system that strengthens the national research infrastructure. We establish National Research Ethics Committees (NRECs) in prescribed areas of health research at the request of the Minister for Health. An essential aspect of the NREC system is the mandate to return ethics decisions that are respected nationally (‘single national ethics opinion’). Working alongside local research ethics committees and supported by the National Office team, the NRECs work in a mixed-model system to support research ethics across the spectrum of health research in Ireland.
The National Office was established in early 2020 as an important component of the reform of the research ethics committee framework in Ireland led by the Department of Health. In partnership with the other regulators of health research, we are implementing a roadmap of transition to a national system of research ethics review for regulated remits, including clinical trials of medicinal products, clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices. We are working closely with local research ethics committees to ensure this transition is as seamless as possible for researchers and research-performing organisations. As a major change to the research environment, this transition requires shared coordination, cooperation and momentum.
Role of the National Office
As an independent office with a statutory function, our role at the National Office for Research Ethics Committees includes the following:
- Establishing NRECs in specific areas of health research
- Managing Expressions of Interest for NREC membership
- Providing operational support to NRECs
- Monitoring and oversight of NRECs
- Issuing guidelines for NREC work
- Education and outreach
Initial priority areas
The National Office launched the first NREC in March 2020 as part of the national coordinated response to COVID-19. While NRECs will be established in a variety of health research areas over time, the initial priorities of national strategic importance were clinical trials of medicinal products for human use, clinical investigations of medical devices and performance studies of in vitro diagnostic medical devices, to ensure Ireland is meeting the obligations as an EU Member State in line with EU Regulations on clinical trials (Regulation EU 536/2014),medical devices (Regulation EU 2017/745) and in vitro diagnostic medical devices (Regulation EU 2017/746). In addition, this ensured Ireland is an attractive place to conduct research in these important areas and maximise the opportunity for Irish patients to participate in forefront research, gaining access to innovative medicines and services. In 2022 the remit of NREC expanded further and now also includes the ethical review of performance studies of in vitro diagnostic medical devices in line with EU regulation on in vitro diagnostic medical devices (Regulation EU 2017/746).