The National Office for Research Ethics Committees is pleased to announce the appointment of 22 new National Research Ethics Committee (NREC) members. The new members were appointed by the Minister for Health Mr Stephen Donnelly following an expression of interest campaign which ran during August and September 2023. The NRECs for Clinical Trials (NREC-CT) have […]
On 31 January 2022, the new EU Clinical Trial Regulation (CTR) entered into force, replacing the previous Clinical Trial Directive (CTD). The new regulation requires that all clinical trial applications and assessments be managed through a new, unified online portal known as the Clinical Trial Information System (CTIS). Since January 2023, all new applications for clinical
EMA advice on transition of clinical trials from CTD to CTR Read More »
The National Office for Research Ethics Committees has published its Annual Report for 2022, providing an overview of a productive year for the office team and the NRECs it supports. The report demonstrates the breadth of work achieved by the National Office and NRECs, reflecting the vibrant health research landscape in Ireland. In addition to
2022 in review: National Office publishes Annual Report Read More »
As of Tuesday 31 January 2023, all applications for clinical trials in Ireland must be submitted through the one-stop online portal known as the Clinical Trials Information System (CTIS). In line with implementation of the EU Clinical Trial Regulation (CTR), this is now the mandatory system for the regulatory submission, authorisation and supervision of all
Clinical trial applications must now be submitted through CTIS Read More »
The National Irish COVID-19 Biobank (NICB) is a health research infrastructure that collects and stores biological samples and associated health data, with the aim of supporting Ireland’s research response to COVID-19. To ensure its operation is underpinned by robust ethical standards, the Department of Health has tasked the National Office for Research Ethics Committees with
On 27 October the National Office for Research Ethics Committees held a webinar for stakeholders and all those with an interest in health and social care research ethics. Over 400 people registered to join us as we took a look back at the journey of the National Office and National Research Ethics Committees (NRECs) to
Looking back, looking forward: National Office webinar roundup Read More »
Start date of consultation: 10 October 2022 Closing date of consultation: 28 October 2022 The public consultation on the proposal for NREC Fees is now closed. The response documents is now published and provides a general overview of the comments received and the changes made to the proposal as a result. Read the NREC
Public consultation on proposal for NREC Fees – Financial year 2023 Read More »
The National Office team is delighted to present our Annual Report for 2021. This marks our first full calendar year of operation, and one that proved to be a time of important milestones for Ireland’s new system of national research ethics review. The report captures a year of launch, growth and focus for both the
The National Office for Research Ethics Committees is pleased to announce the appointment of 17 new National Research Ethics Committee (NREC) members. The new members were appointed by the Minister for Health Mr Stephen Donnelly following an expression of interest campaign which ran from 24 February to 25 March 2022. The NRECs for Clinical Trials
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
NREC-MD expands remit to include review of in vitro medical devices Read More »