Since the establishment of the NREC-CTs, the number of substantial amendments submitted for ethics review has far surpassed the forecasted volume and what could feasibly be assessed by two voluntary committees under their current structure working at capacity. This has created a backlog in the system and significant delays in the review of complex substantial […]
In this video, Minister Stephen Donnelly reflects on why the introduction of new EU clinical trial regulation marks an important milestone in the advancement of Irish health research, and pays tribute to the pivotal role of the National Office for Research Ethics Committees (NRECs) volunteer committee members in championing better health and care for all. Having entered into
New Clinical Trial Regulation: Minister Donnelly pays tribute to NREC committee members Read More »
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. Our parent department, the Department of Health is fully
Status of assessment of clinical trial substantial amendments Read More »
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
NREC members: working to protect research participants and facilitate ethical research Read More »
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.
Status of assessment of clinical trial substantial amendments Read More »
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
Preparing for new EU clinical trials regulation in partnership with the HPRA Read More »
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
Proposal for HPRA and NREC Clinical Trial Fees: Financial Year 2022 Read More »
The following is important information for Sponsors / Principal Investigators of clinical investigations of medical devices that were approved under the Council Directives 93/42/EEC and 90/385/EEC (and their transposing legislation SI 252/1994 and SI 253/1994 as amended) and were still ongoing on the date of effect (26th May 2021) of the EU Medical Device Regulation (MDR; EU No.
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