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 ensure a robust, transparent and cohesive national research ethics review system that strengthens and complements the research infrastructure in Ireland.
We establish, operationalise and support National Research Ethics Committees (NRECs) whose remit is to deliver a single national ethics opinions for regulated health research studies, including areas of national strategic importance:
- clinical trials on medicinal products
- clinical investigations of medical devices
- performance studies of in vitro diagnostic medical devices
- national Irish COVID19 biobank
Working alongside local research ethics committees and supported by the National Office team, the NRECs operate within a mixed-model system to support research ethics across the spectrum of health research in Ireland.
We work closely with our national competent authority, the Health Products Regulatory Authority (HPRA), to ensure that the delivery of all national ethics opinions for regulated research areas is achieved in a parallel and coordinated manner, in accordance with national and European Union (EU) legislation.
Background
The National Office was established in 2020 as a business unit within the Health Research Board (HRB), Ireland’s leading agency responsible for supporting and funding health research, generating health information and promoting the use of evidence in policy and practice. The HRB supports and enables the operational and strategic work of the National Office team.
The establishment of the National Office was a pivotal in reforming the research ethics committee framework in Ireland, led by the Department of Health.
In March 2020, the National Office launched the first NREC as part of the national coordinated response to COVID-19.
In 2021 the National Office established NRECs for clinical trials of medicinal products for human use and clinical investigations of medical devices, to ensure Ireland meets its obligations as an EU Member State in line with EU Regulations.
In 2022, the remit of NRECs expanded further to include the ethics review of performance studies of in vitro diagnostic medical devices in line with EU regulations.
The establishment of the NRECs enables Ireland to deliver robust and trusted single national ethics opinions be an attractive country 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.
Role of the National Office
As an office with a statutory function, the core business of the National Office for Research Ethics Committees involves:
- Establishing NRECs in specific areas of health research
- Constituting the membership of the NRECs
- Providing operational support NRECs
- Advising the NRECS on the implementation of the EU Regulations
- Supporting national and European initiatives of strategic importance
- Issuing guidelines for the work of NRECs, researchers and Sponsor applicants, and
- Delivering education and outreach on research ethics more broadly