As the end of the year approaches, the National Office team would like to inform our stakeholders of some important dates to bear in mind. If you are applying for approval from a National Research Ethics Committee (NREC) and you wish to have your application reviewed in January 2024, please take note of the following …
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 »
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 …
National Office webinar: learnings, insights and next steps Read More »
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!