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22 new NREC members appointed

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 …

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EMA advice on transition of clinical trials from CTD to CTR

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 …

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Clinical trial applications must now be submitted through CTIS

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 …

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National Office establishes new research ethics committee for the National Irish COVID-19 Biobank

National Office establishes new research ethics committee for the National Irish COVID-19 Biobank

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 …

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Public consultation on proposal for NREC Fees – Financial year 2023

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 …

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National Office webinar: learnings, insights and next steps

We are delighted to invite all stakeholders, and those with an interest in the broader health and social care research ethics landscape to join us online for a morning of reflection and discussion. We will be discussing the work of the National Office and the National Research Ethics Committees (NRECs), including emerging trends in research …

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Video: NRECs and the National Office at a glance

What is a National Research Ethics Committee (NREC)? What is their role in the Irish research system? And how does the National Office support their work? Our new animated video provides a short introduction to the work of the NRECs and the National Office – take a look!

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