News

Ireland has three National Research Ethics Committees (NRECs) in the areas of clinical trials and medical devices. Each NREC comprises volunteer members who give their time to help pave the way for new treatment options and medical innovations for Irish patients who need them most in the areas. Committee members come from all walks of […]

Applicants should note that the NREC-CT is experiencing a very high number of substantial amendment submissions. Your patience is appreciated while the National Office team and the committees work at capacity to process these. Please note the team cannot correspond on the status of individual submissions.

Upcoming EU clinical trials regulation will bring change to the way in which clinical trial documentation is submitted and introduce a new one-stop submission process for applications that require approval by both the Health Products Regulatory Authority (HPRA) and the National Research Ethics Committees (NRECs).   The new Clinical Trials Regulation was first adopted by the European Medicines Agency

Open for submissions from 13 September 2021 Submissions close on 8 October 2021   The National Office for Research Ethics Committees (NREC) in partnership with the Health Products Regulatory Authority (HPRA) invite submissions, observations and comments on proposed clinical trial fees to be implemented in 2022.   The objective of this public consultation process is to

Dr Jennifer Ralph James, Head of the National Office for Research Ethics Committees, reflects on one-year in office during a global health emergency, and shares the vision for the National Office going forward.   The National Office was established in March 2020 as a fundamental component of the transition to a national system of research

  Welcome to our inaugural Annual Report. It reflects a year in which the National Office for Research Ethics Committees was first established, and played a pivotal role in the national research response effort during one of the most significant and unpredictable health challenges in decades. Our response to the pandemic is testament to our

A €6-million investment by our colleagues at the Health Research Board (HRB) in Clinical Trial Networks will create new opportunities for people on the island of Ireland to contribute to cutting-edge clinical research and help advance patient care.   People with dementia, diabetes, and infectious diseases, as well as patients of paediatrics, primary care and

Minister for Health, Stephen Donnelly has appointed the membership of Ireland’s first National Research Ethics Committees (NRECs) in the areas of Clinical Trials of Investigational Medicinal Products (NREC-CT) and Clinical Investigations of Medical Devices (NREC-MD).   In total, 18 members have been appointed to each of the three NRECs – two in clinical trials and

In May 2021, the National Office and the Health Products Regulatory Authority (HPRA) will launch the CTR-National Collaboration Project. This jointly run project will test and appraise the national preparedness for a new piece of legislation due to be implemented at an EU-level in early 2022.   This new legislation, known as the EU Clinical