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NREC-MD expands remit to include review of in vitro medical devices

As the new EU In Vitro Medical Devices Regulation comes into effect on 26 May following a five-year transition period, the National Office for Research Ethics Committees is pleased to announce that the National Research Ethics Committee for Medical Devices (NREC-MD) will now expand its remit to review applications seeking ethical approval for performance studies …

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How NRECs support safe, successful clinical trials

As the health research community celebrates International Clinical Trials Day this week, it’s the perfect opportunity to look at the role of research ethics committees (RECs) in supporting safe and successful clinical trials – with a particular eye to Ireland’s own National Research Ethics Committees for Clinical Trials (NREC-CTs). What is the role of RECs …

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Status of assessment of clinical trial substantial amendments

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 …

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NREC members: working to protect research participants and facilitate ethical research

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 …

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Preparing for new EU clinical trials regulation in partnership with the HPRA

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 …

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Proposal for HPRA and NREC Clinical Trial Fees: Financial Year 2022

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 …

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REC reporting relationship for clinical investigations of medical devices approved prior to implementation of EU MDR

  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. …

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Pivoting in response to the pandemic: Dr Jennifer Ralph James reflects on one-year in office

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 …

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