National Office for Research Ethics Committees

 

National Office for
Research Ethics Committees

The National Office is an important new addition to the research environment in Ireland. Our mission is to embed a robust, transparent and cohesive research ethics review system that strengthens the national research infrastructure. We will 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 will work in a mixed-model system to support research ethics across the spectrum of health research in Ireland.

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
  • Facilitating an appeals mechanism for NREC decisions
  • Education and outreach

While NRECs will be established in a variety of health research areas over time, the initial priorities of national strategic importance are clinical trials of medicinal products for human use and clinical investigations of medical devices. This will ensure 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.  Additionally, with a view to meeting Ireland’s Member State obligations in line with pending EU Regulations on clinical trials (Regulation EU No 536/2014) and medical devices (Regulation EU 2017/745), we are working towards establishing dedicated NRECs in each of these areas in 2021.

Established in March 2020, the National Office team operationalised Ireland’s first NREC as a component of the national coordinated response to COVID-19. The Minister for Health established the NREC for COVID-19-related health research (NREC COVID-19) as a temporary measure to accelerate urgent studies clearly positioned to provide significant evidence for national and global efforts to deal with the virus outbreak. In addition to providing robust ethics review in an expedited manner, the NREC COVID-19 process enabled researchers to receive the necessary decisions from other bodies involved in the regulation of health research, namely the Health Products Regulatory Authority (HPRA) and the Health Research Declaration Committee (HRCDC), in coordination with their ethics outcome.

Supporting the NREC COVID-19 was an essential first order of business for the National Office to support the national research response to the public health emergency. Importantly, the NREC COVID-19 provided the proof of principle of the value of a ‘single national ethics opinion’ in Ireland.

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