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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 […]

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

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

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

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

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